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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/ct2/show/NCT00371826
Registration number
NCT00371826
Ethics application status
Date submitted
1/09/2006
Date registered
4/09/2006
Date last updated
19/08/2013
Titles & IDs
Public title
SOCRATES: Steroid or Cyclosporine Removal After Transplantation Using Everolimus
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Scientific title
A Prospective, Open-label, Controlled Multicenter Trial to Assess the Efficacy and Safety of an Induction Regimen of Cyclosporine Micro Emulsion, Enteric-coated Mycophenolate Sodium (EC-MPS) and Corticosteroids, Followed by Administration of Everolimus and Enteric-coated Mycophenolate Sodium (EC-MPS), With Either the Withdrawal of Cyclosporine Micro Emulsion or Corticosteroids in de Novo Kidney Transplant Recipients
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Secondary ID [1]
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CRAD001A2421
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Universal Trial Number (UTN)
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Trial acronym
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Renal Transplanted Recipients
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Condition category
Condition code
Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
Treatment: Drugs - Everolimus (RAD001)
Treatment: Drugs - Cyclosporine (Calcineurin Inhibitor (CNI))
Treatment: Drugs - Methylprednisone/prednisone
Treatment: Drugs - Mycophenolate sodium (MPA)
Experimental: Calcineurin Inhibitor (CNI) Withdrawal - Every randomized patient in this group received
Day 1 - Day 14: cyclosporine as Calcineurin Inhibitor (CNI) 5 mg/kg twice daily (b.i.d.), dose adjusted to achieve C2 target of 1,500 ng/mL (range 1,400-1,600 ng/mL) + mycophenolate sodium (MPA)720 mg b.i.d. + methylprednisone/prednisone 500 mg intra-operatively, 250 mg on day 1, then 10-30 mg/day prednisone
Day 15 - Day 60: everolimus 1.5 mg b.i.d. to achieve target 6-10 ng/mL + cyclosporine decrease dose as per protocol guideline + MPA 720 mg b.i.d. until everolimus trough >6 ng/mL, then MPA was stopped + prednisone 10-30mg/day
Day 61 - Day 120: everolimus dose adjusted to achieve target 6-10 ng/mL + cyclosporine 25% dose reduction per fortnight, to be discontinued by day 120 as per protocol (or commence reduction by day 120 at discretion of investigator, to be completed within 2 months of commencement) + prednisone 10-30mg/day Day 121 - Month 36: everolimus dose adjusted to achieve target 8-12 ng/mL + prednisone 5-10 mg/day
Experimental: Steroid Withdrawal - Every randomized patient in this group received
Day 1 -14: cyclosporine 5 mg/kg b.i.d., dose adjusted to achieve C2 target as per protocol + mycophenolate sodium (MPA) 720 mg b.i.d. + methylprednisone/prednisone 500 mg intra-operatively, 250 mg on day 1, then 10-30 mg prednisone per day
Day 15 - 60: everolimus 1.5 mg b.i.d. to achieve target 6-10 ng/mL + cyclosporine decrease dose as per protocol guideline + MPA 720 mg b.i.d. until everolimus trough >6 ng/mL, then MPA was stopped + prednisone 10-30mg per day
Day 61 - 120: Everolimus dose adjusted + cyclosporine adjust dose according protocol guideline (or commence reduction by day 120 at discretion of Investigator, to be completed within 2 months of commencement) + gradual withdrawal of prednisone by 1 mg/week to be discontinued by Day 120.
Day 121 - Month 36: At Day 121, Month 7 and Month 13 Everolimus dose was adjusted to achieve target 6-10 ng/mL + Cyclosporine adjust dose to achieve C2 target as per protocol
Active Comparator: CNI+MPA+ Steroid - Patients randomized to this group received:
Day 1 - Month 36: cyclosporine 5 mg/kg b.i.d., dose adjusted to achieve the protocol defined C2 Targets + mycophenolate sodium 720mg b.i.d. + Methylprednisone/prednisone 500mg intra-operatively, 250mg on day 1, 10-30mg prednisone per day until month 12 (as per local practice), 5-10mg/day months 13-36.
Treatment: Drugs: Everolimus (RAD001)
Treatment: Drugs: Cyclosporine (Calcineurin Inhibitor (CNI))
Treatment: Drugs: Methylprednisone/prednisone
Treatment: Drugs: Mycophenolate sodium (MPA)
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Intervention code [1]
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Treatment: Drugs
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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Calculated Glomerular Filtration Rate (cGFR) After Kidney Transplant to Evaluate Kidney Function (12 Months Analysis)
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Assessment method [1]
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The glomerular filtration rate (GFR) was calculated by the Nankivell formula: GFR = 6.7 / Scr + BW / 4 - Surea / 2-100 / (height)^ 2 + C where Scr is the serum creatinine concentration expressed in mmol/L, BW the body weight in kg, Surea the serum urea in mmol/L, height in m, and the constant C is 35 for male and 25 for female patients.
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Timepoint [1]
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At Month 12
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Secondary outcome [1]
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Calculated Glomerular Filtration Rate (cGFR) After Kidney Transplant to Evaluate Kidney Function (36 Months Analysis)
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Assessment method [1]
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The glomerular filtration rate (GFR) was calculated by the Nankivell formula: GFR = 6.7 / Scr + BW / 4 - Surea / 2-100 / (height)^ 2 + C where Scr is the serum creatinine concentration expressed in mmol/L, BW the body weight in kg, Surea the serum urea in mmol/L, height in m, and the constant C is 35 for male and 25 for female patients.
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Timepoint [1]
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At Month 24 and 36
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Secondary outcome [2]
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Number of Participants With Biopsy Proven Acute Rejection (BPAR) Per Treatment Group (12 Months Analysis)
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Assessment method [2]
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A biopsy-proven acute rejection is defined as a biopsy graded IA, IB, IIA, IIB, or III as per Banff 97 classification.
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Timepoint [2]
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At Month 12
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Secondary outcome [3]
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Number of Participants With Biopsy Proven Acute Rejection (BPAR) Per Treatment Group (36 Months Analysis)
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Assessment method [3]
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A biopsy-proven acute rejection is defined as a biopsy graded IA, IB, IIA, IIB, or III as per Banff 97 classification.
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Timepoint [3]
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At Month 12, 24 and 36
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Secondary outcome [4]
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Number of Participants With Composite Endpoint of Treatment Failure (12 Months Analysis)
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Assessment method [4]
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Composite endpoint of treatment failure includes biopsy-proven acute rejection (BPAR), graft loss, death and loss-to-follow-up. A BPAR is defined as a biopsy graded IA, IB, IIA, IIB, or III as per Banff 97 classification.
The allograft was presumed to be lost on the day the patient started dialysis and was not able to subsequently be removed from dialysis. If the patient underwent a graft nephrectomy, then the day of nephrectomy was the day of graft loss.
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Timepoint [4]
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Month 12
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Secondary outcome [5]
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Number of Participants With Composite Endpoint of Treatment Failure (36 Months Analysis)
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Assessment method [5]
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Composite endpoint of treatment failure includes biopsy-proven acute rejection (BPAR), graft loss, death and loss-to-follow-up. A BPAR is defined as a biopsy graded IA, IB, IIA, IIB, or III as per Banff 97 classification.
The allograft was presumed to be lost on the day the patient started dialysis and was not able to subsequently be removed from dialysis. If the patient underwent a graft nephrectomy, then the day of nephrectomy was the day of graft loss.
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Timepoint [5]
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At Month 12, 24 and 36
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Secondary outcome [6]
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Number of Participants With Histological Evidence Chronic Allograft Nephropathy (CAN) (12 Months Analysis)
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Assessment method [6]
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A per-protocol biopsy was performed at Baseline and Month 12 and read by an independent blinded pathologist in order to assess chronic allograft nephropathy. Chronic rejection is characterized by a slow progressive decline in renal function and is typically preceded by the histological picture of chronic allograft nephropathy. The presence of biopsy confirmed Grade I, II or III chronic allograft nephropathy by Banff 97 criteria was assessed on all optional biopsies obtained for clinical suspicion of chronic rejection.
Data summarized by 3 categories. "Yes" - Patients with histological evidence of CAN ; "No" - Patients with histological evidence of CAN and "Not Done" - Central protocol defined kidney allograft biopsies were not done.
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Timepoint [6]
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At Month 12
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Secondary outcome [7]
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Number of Participants With Histological Evidence Chronic Allograft Nephropathy (CAN) (36 Months Analysis)
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Assessment method [7]
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Chronic rejection is characterized by a slow progressive decline in renal function and is typically preceded by the histological picture of chronic allograft nephropathy. The presence of biopsy confirmed Grade I, II or III chronic allograft nephropathy by Banff 97 criteria was assessed on all optional biopsies obtained for clinical suspicion of chronic rejection.
Data summarized by 3 categories. "Yes" - Patients with histological evidence of CAN ; "No" - Patients with histological evidence of CAN and "Not Done" - Central protocol defined kidney allograft biopsies were not done.
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Timepoint [7]
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At Month 36
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Secondary outcome [8]
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Number of Participants With Sub Clinical Acute Rejection (12 Months Analysis)
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Assessment method [8]
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Based on Banff 97 criteria, sub clinical acute rejection can be:
GRADE IA - Cases with significant interstitial infiltration (>25% of parenchyma affected) and foci of moderate tubulitis (>4 mononuclear cells/tubular cross section or group of 10 tubular cells).
GRADE IB - Cases with significant interstitial infiltration (>25% of parenchyma affected) and foci of moderate tubulitis (>10 mononuclear cells/tubular cross section or group of 10 tubular cells).
GRADE IIA - Cases with significant interstitial infiltration and mild to moderate intimal arteritis (v1).
GRADE IIB - Cases with moderate to severe intimal arteritis comprising >25% of the luminal area (v2).
GRADE III - Cases with "transmural" arteritis or fibrinoid change and necrosis of medial smooth muscle cells (v3).
"Borderline" category is used when no intimal arteritis is present, but there are foci of mild tubulitis (1 to 4 mononuclear cells/tubular cross section).
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Timepoint [8]
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At Month 12
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Secondary outcome [9]
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Number of Participants With Sub Clinical Acute Rejection (36 Months Analysis)
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Assessment method [9]
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Based on Banff 97 criteria, sub clinical acute rejection can be:
GRADE IA - Cases with significant interstitial infiltration (>25% of parenchyma affected) and foci of moderate tubulitis (>4 mononuclear cells/tubular cross section or group of 10 tubular cells).
GRADE IB - Cases with significant interstitial infiltration (>25% of parenchyma affected) and foci of moderate tubulitis (>10 mononuclear cells/tubular cross section or group of 10 tubular cells).
GRADE IIA - Cases with significant interstitial infiltration and mild to moderate intimal arteritis (v1).
GRADE IIB - Cases with moderate to severe intimal arteritis comprising >25% of the luminal area (v2).
GRADE III - Cases with "transmural" arteritis or fibrinoid change and necrosis of medial smooth muscle cells (v3).
"Borderline' category is used when no intimal arteritis is present, but there are foci of mild tubulitis (1 to 4 mononuclear cells/tubular cross section).
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Timepoint [9]
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At Month 36
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Secondary outcome [10]
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Mean Serum Creatinine (12 Months Analysis)
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Assessment method [10]
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Timepoint [10]
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At Month 12
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Secondary outcome [11]
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Mean Serum Creatinine (36 Months Analysis)
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Assessment method [11]
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Timepoint [11]
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At Month 12, 18, 24 and 36
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Secondary outcome [12]
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Creatinine Clearance (CrCl) Calculated by the Cockcroft-Gault Formula (12 Months Analysis)
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Assessment method [12]
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Creatinine clearance were calculated according to the Cockcroft-Gault formula:
CrCl (males) = (140-A) × BW/(72 × Cr) CrCl (females) = CrCl (males) × 0.85 where A is age [years], BW is body weight [kg], and Cr is the serum concentration of creatinine [mg/dL].
The Cockcroft-Gault formula estimates creatinine clearance based on serum creatinine level, body weight, and age.
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Timepoint [12]
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At Month 12
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Secondary outcome [13]
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Creatinine Clearance Calculated by the Cockcroft-Gault Formula (36 Months Analysis)
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Assessment method [13]
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Creatinine clearance were calculated according to the Cockcroft-Gault formula:
CrCl (males) = (140-A) × BW/(72 × Cr) CrCl (females) = CrCl (males) × 0.85 where A is age [years], BW is body weight [kg], and Cr is the serum concentration of creatinine [mg/dL].
The Cockcroft-Gault formula estimates creatinine clearance based on serum creatinine level, body weight, and age.
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Timepoint [13]
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At Month 12, 24 and 36
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Secondary outcome [14]
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Mean Urine Albumin/Creatinine Ratio (ACR) as Measurement of Proteinuria (12 Months Analysis)
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Assessment method [14]
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Proteinuria is measured by spot morning urine Albumin/Creatinine Ratio [ACR]. When the ACR is more than or equal to 30 mg/mmol then it is known as proteinuria.
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Timepoint [14]
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At Month 12
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Secondary outcome [15]
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Mean Urine Albumin/Creatinine Ratio [ACR] as Measurement of Proteinuria (36 Months Analysis)
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Assessment method [15]
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Proteinuria is measured by spot morning urine Albumin/Creatinine Ratio [ACR]. When the ACR is more than or equal to 30 mg/mmol then it is known as proteinuria.
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Timepoint [15]
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At Month 12, 18, 24 and 36
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Secondary outcome [16]
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Number of Participants With Post Transplant Diabetes Mellitus (PTDM) and Impaired Fasting Glucose (12 Months Analysis)
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Assessment method [16]
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The symptoms of post transplant diabetes mellitus (PTDM) and impaired fasting glucose are defined as any of the following conditions:
Patients receiving glucose lowering treatment
Fasting plasma glucose (FPG) >= 126 mg/dL on 2 separate occasions
Hemoglobin subtype A1c (HbA1c) > 6.5%
Diabetes reported as treatment emergent AE with end date > Day 15
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Timepoint [16]
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At Month 12
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Secondary outcome [17]
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Number of Participants With New Onset Diabetes Mellitus After Transplantation (NODAT) and Impaired Fasting Glucose (36 Months Analysis)
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Assessment method [17]
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The symptoms of new onset diabetes mellitus after transplantation (NODAT) and impaired fasting glucose are defined as any of the following conditions:
Patients receiving glucose lowering treatment
2 fasting plasma glucose (FPG) values >= 126 mg/dL or 2 random plasma glucose (RPG) values >= 200 mg/dL or FPG value >= 126 mg/dL and 1 RPG value >= 200 mg/dL
Diabetes reported as treatment emergent AE with end date > Day 15
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Timepoint [17]
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At Month 36
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Secondary outcome [18]
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Number of Participants With Notable Abnormal Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) as Measurement of Effect of Treatment on Cardiovascular Health (12 Months Analysis)
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Assessment method [18]
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Notable abnormal systolic blood pressure is defined as :
Either an increase of >=30 that results in >=180 or >200 (mm/Hg)
OR a decrease of >=30 that results in <=90 or <75 (mm/Hg)from baseline
Notable abnormal diastolic blood pressure is defined as :
Either an increase of >=20 that results in >=105 or >115 (mm/Hg)
OR a decrease of >=20 that results in <=50 or <40 (mm/Hg) from baseline
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Timepoint [18]
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Baseline, Overall post-baseline up to 12 month
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Secondary outcome [19]
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Number of Participants With Notable Abnormal Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) as Measurement of Effect of Treatment on Cardiovascular Health (36 Months Analysis)
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Assessment method [19]
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Notable abnormal systolic blood pressure is defined as :
Either an increase of >=30 that results in >=180 or >200 (mm/Hg)
OR a decrease of >=30 that results in <=90 or <75 (mm/Hg) from baseline
Notable abnormal diastolic blood pressure is defined as :
Either an increase of >=20 that results in >=105 or >115 (mm/Hg)
OR a decrease of >=20 that results in <=50 or <40 (mm/Hg) from baseline
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Timepoint [19]
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Baseline, Overall post baseline up to Month 36
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Secondary outcome [20]
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Number of Participants With Erythropoietin Usage (12 Months Analysis)
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Assessment method [20]
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0
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Timepoint [20]
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Month 12
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Secondary outcome [21]
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Number of Participants With Erythropoietin Usage (36 Months Analysis)
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Assessment method [21]
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0
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Timepoint [21]
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Month 36
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Secondary outcome [22]
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Mean Short-form 36 Health Survey (SF-36) Score as a Measure of Quality of Life Assessment (12 Months Analysis)
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Assessment method [22]
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SF-36 measures impact of disease on overall quality of life (QoL). 36-item survey has 8 subscales. The 8 subscales are: Physical functioning (PF), Role-physical (RP), Bodily pain (BP), General health (GH), Vitality (VT), Social functioning (SF), Role-emotional (RE) and Mental health (MH).
Score for eash sub-scale has been standardized with the use of norm-based methods based on assessment of the general U.S. population free of chronic conditions. Scores range from 1-100 with a mean=50 and a standard deviation=10. A higher score indicates less impact on QoL.
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Timepoint [22]
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At Month 12
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Secondary outcome [23]
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Mean Short-form 36 Health Survey (SF-36) Score as a Measure of Quality of Life Assessment (36 Months Analysis)
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Assessment method [23]
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SF-36 measures impact of disease on overall quality of life (QoL). 36-item survey has 8 subscales. The 8 subscales are : Physical functioning (PF), Role-physical (RP), Bodily pain (BP), General health (GH), Vitality (VT), Social functioning (SF), Role-emotional (RE) and Mental health (MH).
Score for each sub-scale has been standardized with the use of norm-based methods based on assessment of the general U.S. population free of chronic conditions. Scores range from 1-100 with a mean=50 and a standard deviation=10. A higher score indicates less impact on QoL.
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Timepoint [23]
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At Month 24
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Secondary outcome [24]
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Number of Participants Hospitalized for Reasons Other Than Primary Transplantation (12 Months Analysis)
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Assessment method [24]
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This analysis is reporting number of participants hospitalized for reasons (such as acute rejection, infection, gastrointestinal (GI) events, cardiovascular event, metabolic disorder and Other) other than primary transplantation.
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Timepoint [24]
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Month 12
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Secondary outcome [25]
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Number of Participants Hospitalized for Reasons Other Than Primary Transplantation (36 Months Analysis)
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Assessment method [25]
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This analysis is reporting number of participants hospitalized for reasons (such as acute rejection, infection, gastrointestinal (GI) events, cardiovascular event, metabolic disorder and Other) other than primary transplantation.
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Timepoint [25]
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Month 36
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Secondary outcome [26]
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Number of Participants With Employment Status (12 Months Analysis)
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Assessment method [26]
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The various employment status reported are:
Employed/self employed full time
Employed part time
Unemployed
Homemaker
Volunteer
Permanently disabled
Non-permanently disable
Retired
Other
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Timepoint [26]
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At screening (at day 0 +/- 7 days ), At Month 12
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Secondary outcome [27]
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Number of Participants With Employment Status (36 Months Analysis)
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Assessment method [27]
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The various employment status reported are:
Employed/self employed full time
Employed part time
Unemployed
Homemaker
Volunteer
Permanently disabled
Non-permanently disable
Retired
Other
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Timepoint [27]
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At screening (at day 0 +/- 7 days ), At Month 36
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Secondary outcome [28]
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Number of Participants With Wound Problems(12 Months Analysis)
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Assessment method [28]
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Patients with any wound healing problem such as infection related to kidney surgery, dehiscence, lymphocele, hernia, seroma, hematoma, ureteral anastomotic complication and other were reported in this analysis.
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Timepoint [28]
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At Month 12
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Secondary outcome [29]
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Number of Participants With Any Wound Problems (36 Months Analysis)
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Assessment method [29]
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Patients with any wound healing problem such as infection related to kidney surgery, dehiscence, lymphocele, hernia, seroma, hematoma, ureteral anastomotic complication and other were reported in this analysis.
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Timepoint [29]
0
0
At Month 12, 24 and 36
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Secondary outcome [30]
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Number of Participants With Notable Abnormalities in Total Cholesterol and Triglycerides as Measurement of Effect of Treatment on Cardiovascular Health (12 Months Analysis)
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Assessment method [30]
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Notable abnormal total cholesterol is defined as : High: >= 9.1 mmol/L , normal range is 0.00 - 5.17 mmol/L
Notable abnormal triglycerides is defined as : High: >= 8.5 mmol/L, normal range is 0.30 - 2.00 mmol/L
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Timepoint [30]
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Overall post baseline up to month 12
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Secondary outcome [31]
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Number of Participants With Notable Abnormalities in Total Cholesterol and Triglycerides as Measurement of Effect of Treatment on Cardiovascular Health (36 Months Analysis)
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Assessment method [31]
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Notable abnormal total cholesterol is defined as : High: >= 9.1 mmol/L , normal range is 0.00 - 5.17 mmol/L
Notable abnormal triglycerides is defined as : High: >= 8.5 mmol/L, normal range is 0.30 - 2.00 mmol/L
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Timepoint [31]
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0
Overall Post Baseline up to month 36
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Secondary outcome [32]
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0
Number of Participants With Antibody-mediated Rejection Per Treatment Group (12 Months Analysis)
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Assessment method [32]
0
0
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Timepoint [32]
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0
At Month 12
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Secondary outcome [33]
0
0
Number of Participants With Antibody-mediated Rejection Per Treatment Group (36 Months Analysis)
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Assessment method [33]
0
0
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Timepoint [33]
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0
At Month 12, 24 and 36
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Secondary outcome [34]
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0
Number of Participants With Biopsy Proven Acute Rejection (BPAR) Influenced by Demographic Characteristics and Morbidities (12 Months Analysis)
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Assessment method [34]
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0
The influence of demographic characteristics and comorbidities on incidence of BPAR were analyzed in the following way: Demographic characteristics were age (<55 years, =55 years), Expanded criteria Donor (ECD) organ (donor age >60 years or donor non heart-beating and donor age >50), gender, living vs. deceased donor, Body Mass Index (BMI) classes (underweight <18.5, normal 18.5 - <25.0, overweight 25.0 - <30.0, obesity 30.0 and above), years on dialysis before transplantation (<1, 1-5, >5 years). Comorbidities were diabetes, hypertension, cardiovascular diseases/events, nephrosclerosis, glomerulonephritis/glomerular disease, polycystic disease, and Cytomegalovirus status.
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Timepoint [34]
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0
At Month 12
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Secondary outcome [35]
0
0
Number of Participants With Biopsy Proven Acute Rejection (BPAR) Influenced by Demographic Characteristics and Morbidities (36 Months Analysis)
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Assessment method [35]
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0
The influence of demographic characteristics and comorbidities on incidence of BPAR were analyzed in the following way: Demographic characteristics were age (<55 years, =55 years), Expanded Criteria Donor [ECD] organ (donor age >60 years or donor non heart-beating and donor age >50), gender, living vs. deceased donor, Body Mass Index (BMI) classes (underweight <18.5, normal 18.5 - <25.0, overweight 25.0 - <30.0, obesity 30.0 and above), years on dialysis before transplantation (<1, 1-5, >5 years). Comorbidities were diabetes, hypertension, cardiovascular diseases/events, nephrosclerosis, glomerulonephritis/glomerular disease, polycystic disease, and Cytomegalovirus status.
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Timepoint [35]
0
0
At Month 36
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Secondary outcome [36]
0
0
Number of Patient Survival and Graft Survival (12 Months Analysis)
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Assessment method [36]
0
0
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Timepoint [36]
0
0
At Month 12
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Secondary outcome [37]
0
0
Number of Patient Survival and Graft Survival (36 Months Analysis)
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Assessment method [37]
0
0
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Timepoint [37]
0
0
At Month 12, 24 and 36
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Secondary outcome [38]
0
0
Change in Bone Mineral Density Between Week 2 and Month 24 (36 Months Analysis)
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Assessment method [38]
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0
Measurements of bone mineral density (BMD) by Dual Energy X-ray Absorptiometry (DEXA) were done at Week 2 and Month 24. Change in BMD between week 2 and Month 24 were done for neck of femur and lumbar spine.
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Timepoint [38]
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0
Week 2, Month 24
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Eligibility
Key inclusion criteria
Inclusion criteria
1. Males and females aged 18-65 years inclusive.
2. First time recipients of cadaveric, living unrelated or living related donor kidney
transplants.
3. Patients who are willing and able to participate in the study and from whom written
informed consent has been obtained.
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Minimum age
18
Years
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Maximum age
65
Years
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Sex
Both males and females
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Can healthy volunteers participate?
No
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Key exclusion criteria
Exclusion criteria
1. Patients who are recipients of multiple organ transplants, including more than one
kidney, kidney and pancreas, or previous transplant with any organ other than kidney.
2. Patients at high immunological risk of graft loss, indicated by peak PRA >50% or loss
of a previous renal allograft within the first 6 months of transplantation due to
acute rejection.
3. Patients who have received an investigational drug within 4 weeks prior to the
screening visit.
4. Presence of any severe allergy or hypersensitivity to drugs similar to everolimus
(e.g. antibiotics such as Clindamycin)
Other protocol-defined inclusion/exclusion criteria may applied
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Study design
Purpose of the study
Treatment
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Allocation to intervention
Randomised controlled trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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Masking / blinding
Open (masking not used)
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Who is / are masked / blinded?
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Intervention assignment
Parallel
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Other design features
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Phase
Phase 4
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Type of endpoint/s
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Statistical methods / analysis
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Recruitment
Recruitment status
Completed
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Data analysis
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Reason for early stopping/withdrawal
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Other reasons
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Date of first participant enrolment
Anticipated
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Actual
1/03/2006
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
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Actual
1/06/2012
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Sample size
Target
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Accrual to date
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Final
126
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Recruitment in Australia
Recruitment state(s)
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Recruitment hospital [1]
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Royal Prince Alfred Hospital - NSW
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Westmead Hospital - NSW
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Recruitment hospital [3]
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Princess Alexandra Hospital - QLD
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Recruitment hospital [4]
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Monash Medical Centre - Sale
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Recruitment hospital [5]
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Queen Elizabeth Hospital - Sale
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Recruitment hospital [6]
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Royal Melbourne Hospital - VIC
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Recruitment hospital [7]
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Sir Charles Gairdner Hospital - WA
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Recruitment postcode(s) [1]
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- NSW
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Recruitment postcode(s) [2]
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- QLD
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Recruitment postcode(s) [3]
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- Sale
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Recruitment postcode(s) [4]
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- VIC
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Recruitment postcode(s) [5]
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- WA
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Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
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Name
Novartis Pharmaceuticals
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Address
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Country
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Ethics approval
Ethics application status
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Summary
Brief summary
The aim of this study is to assess the safety and efficacy of corticosteroid discontinuation
versus cyclosporine micro emulsion discontinuation in recipients receiving reduced exposure
cyclosporine micro emulsion and corticosteroids plus enteric-coated mycophenolate sodium
(EC-MPS) initially, changed to everolimus at 2 weeks post-transplant. These two groups will
be compared to a third control group, who will receive treatment consisting of cyclosporine
micro emulsion, enteric-coated mycophenolate sodium (EC-MPS) and steroids.
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Trial website
https://clinicaltrials.gov/ct2/show/NCT00371826
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
Name
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Novartis
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Address
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Novartis
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Country
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Phone
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Fax
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Email
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Contact person for public queries
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Address
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Contact person for scientific queries
Summary Results
For IPD and results data, please see
https://clinicaltrials.gov/ct2/show/NCT00371826
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