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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/NCT00402168
Registration number
NCT00402168
Ethics application status
Date submitted
20/11/2006
Date registered
22/11/2006
Date last updated
5/01/2017
Titles & IDs
Public title
A Study of BMS-224818 (Belatacept) in Patients Who Have Undergone a Kidney Transplant and Are Currently on Stable Cyclosporine or Tacrolimus Regimen With or Without Corticosteroids
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Scientific title
Belatacept Conversion Trial in Renal Transplantation
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Secondary ID [1]
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LEA29Y
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Secondary ID [2]
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IM103-010
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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 Transplant
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Condition category
Condition code
Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
Treatment: Drugs - Belatacept
Treatment: Drugs - Cyclosporine A
Treatment: Drugs - Tacrolimus
Experimental: A: Belatacept -
Active Comparator: B: calcineurin inhibitor (CNI)-based immunosuppressive regimen -
Treatment: Drugs: Belatacept
IV, IV Infusion, 5 mg/kg once every 28 days for one year
Treatment: Drugs: Cyclosporine A
Tablets, Oral, Trough of 100-250 ng/mL, 2* daily for one year
Treatment: Drugs: Tacrolimus
Tablets, Oral, Trough of 5-10 ng/mL, 2* daily for one year
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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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Mean Change From Baseline in Calculated Glomerular Filtration Rate (GFR) With Imputed Values to 12 Months Post Randomization - All Randomized Participants (Intent-to-Treat Population)
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Assessment method [1]
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Calculated GFR assessment used the modification of diet in renal disease (MDRD) formula. GFR was measured as mL/min/1.73 m^2. For death or graft loss participants, calculated GFR (cGFR) value 10 was used, for other participants who had a post baseline cGFR value missing, but had baseline value and at least 2 post baseline values available, which were at least 120 days apart, linear regression model was used to impute the cGFR value. Baseline = value at screening. Randomization/First Dose was on Day 1.
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Timepoint [1]
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Baseline to 12 months post randomization
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Secondary outcome [1]
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Mean Change From Baseline in Calculated Glomerular Filtration Rate (GFR) With Imputed Values to 6 Months Post Randomization - All Randomized Participants (Intent-to-Treat Population)
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Assessment method [1]
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Calculated GFR assessment used the modification of diet in renal disease (MDRD) formula. GFR was measured as mL/min/1.73 m^2. For death or graft loss participants, calculated GFR (cGFR) value 10 was used, for other participants who had a post baseline cGFR value missing, but had baseline value and at least 2 post baseline values available, which were at least 120 days apart, linear regression model was used to impute the cGFR value. Baseline = value at screening.
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Timepoint [1]
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Baseline to 6 months post randomization
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Secondary outcome [2]
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Number of Participants With Acute Rejection (AR) by Months 6 and 12 Post Randomization - All Randomized Participants
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Assessment method [2]
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AR defined: if either a or b was satisfied: a: the reason for clinical suspicion was reported to be an unexplained rise of serum creatinine = 25% from baseline creatinine; or an unexplained decreased urine output; or fever and graft tenderness and the episode was a case of biopsy proven AR (AR of Banff histopathologic classification Grade IA or higher as assessed by the blinded central pathologist); b: the reason for clinical suspicion was reported to be something other than: an unexplained rise of serum creatinine = 25% from baseline creatinine; or an unexplained decreased urine output; or fever and graft tenderness; the episode was a case of biopsy proven AR, and the participant was treated for this episode. Banff 97 diagnostic category for renal allograft biopsies is an international standardized histopathological classification. AR is defined by a renal biopsy demonstrating a Banff 97 classification of Grade IA or greater, with higher scores indicating more severe rejection.
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Timepoint [2]
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At 6 and 12 months post randomization
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Secondary outcome [3]
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Percentage of Participants Surviving With a Functioning Graft, Have Graft Loss or Death (Graft Loss, Death, Death With Functioning Graft) By Month 6 and Month 12 Post Randomization
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Assessment method [3]
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Graft loss was defined as either functional loss or physical loss. Functional loss was defined as a sustained level of serum creatinine (SCr) = 6.0 mg/dL (530 µmol/L) for = 4 weeks or administration of a maintenance dialysis regimen for at least 56 days or impairment of renal function to such a degree that the participant undergoes re-transplantation.
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Timepoint [3]
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At 6 and 12 months post randomization
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Secondary outcome [4]
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Number of Participants Who Had Any Study Drug Dose Alteration by Month 12 Due to Any Reason - Randomized and Treated Participants
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Assessment method [4]
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Reasons for study drug dose modification included categories of decline in renal function (as determined by the investigator), treatment of acute rejection, and other reasons. More than 1 reason could be given for dose alteration.
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Timepoint [4]
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Month 12
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Secondary outcome [5]
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Percentage of Participants With a Composite Endpoint of Death, Graft Loss and Acute Rejection at Month 12
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Assessment method [5]
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Percentage=number with composite divided by number randomized. Graft loss was functional loss or physical loss. Functional loss = sustained level of serum creatinine (SCr) = 6.0 mg/dL for = 4 weeks or administration of a maintenance dialysis regimen for at least 56 days or impairment of renal function to such a degree that participant undergoes re-transplantation. AR: if either a or b: (a) the reason for clinical suspicion was reported to be an unexplained rise of serum creatinine = 25% from baseline; or an unexplained decreased urine output; or fever and graft tenderness and the episode was a case of biopsy-proven AR (grade IA or higher as assessed by the blinded central pathologist); (b) the reason for clinical suspicion was reported to be something other than: an unexplained rise of serum creatinine = 25% from baseline; or an unexplained decreased urine output; or fever and graft tenderness; the episode was a case of biopsy-proven AR, and the participant was treated for it.
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Timepoint [5]
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12 Months post randomization
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Secondary outcome [6]
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Percentage of Participants With New Onset Diabetes Mellitus - All Randomized Participants
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Assessment method [6]
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A participant who did not have diabetes prior to randomization is determined to have new onset diabetes mellitus if they received an antidiabetic medication for a duration of at least 30 days or at least two fasting plasma glucose (FPG) tests indicated that FPG is >=126 mg/dL. Percentage was the number of participants with new onset of diabetes mellitus divided by the number of participants without pre-randomization diabetes.
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Timepoint [6]
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Month 12 post randomization
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Secondary outcome [7]
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Number of Participants With Anti-Donor Human Leukocyte Antigen (HLA) Positive Antibodies
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Assessment method [7]
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Samples were obtained at Day 1 (first dose), Week 24, and Week 52 (or end of therapy). This was a cumulative summary in that once a participant was positive, that participant remained positive for later time points. Evaluation of anti-donor HLA antibodies was performed by an external laboratory (Emory University, Atlanta, Georgia).
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Timepoint [7]
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Month 6 and Month 12 Post Randomization
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Secondary outcome [8]
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Mean Change From Baseline to Month 6 and to Month 12 in Serum Creatinine - All Randomized Participants
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Assessment method [8]
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Baseline was value at screening or prior to first dose of study drug. Serum creatinine was measured in milligrams per deciliter (mg/dL). Baseline = value at screening.
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Timepoint [8]
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Baseline to Month 6 and Month 12 Post Randomization
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Secondary outcome [9]
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Number of Participants With Serious Adverse Events (SAEs), Deaths, and Discontinuation Due to Adverse Events (AEs) From First Dose up to Month 12
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Assessment method [9]
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AE=any new unfavorable symptom, sign, or disease or worsening of a preexisting condition that may not have a causal relationship with treatment. SAE=a medical event that at any dose results in death, persistent or significant disability/incapacity, or drug dependency/abuse; is life-threatening, an important medical event, or a congenital anomaly/birth defect; or requires or prolongs hospitalization. Treatment-related=having certain, probable, possible, or missing relationship to study drug.
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Timepoint [9]
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First Dose (Day 1) to Month 12
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Secondary outcome [10]
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Mean Change From Baseline in SF-36 Questionnaire Physical Component Score and in Mental Component Score at Month 12 - All Randomized Participants
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Assessment method [10]
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SF-36 was a Participant-Reported Quality of Life (QoL) Short Form (SF) questionnaire. The subscale in the mental component (MCS) part of the instrument ranged from 1 to 6 with 1=all of the time and 6= none of the time. The subscale for physical component (PCS) ranged from 1 to 3 with 1=Yes, limited a lot and 3=No, not limited at all. The subscale for the extent that physical health or emotional problems interfered with normal activities ranged from 1 to 5 with 1=not at all and 5= extremely. Baseline was at randomization or prior to first dose. Baseline = value at screening. The subscale scores were transformed using norm-based methods that standardized the scores to a mean of 50 and a standard deviation of 10 in the general population. The scores range from a minimum of 0 to a maximum of 100, with a higher score indicating better quality of life.
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Timepoint [10]
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Baseline, Month 12
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Secondary outcome [11]
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Mean Change From Baseline to Month 12 for Eight Domain Scores of Quality of Life (QoL) Instrument SF-36 - All Randomized Participants
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Assessment method [11]
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SF-36 was a Participant-Reported Quality of Life (QoL) Short Form (SF) questionnaire measuring health-related quality of life (HRQL) covering 8 domains of physical and mental component summaries: physical function, role limitations due to physical problems, pain, general health perception, and vitality, social function, role limitations due to emotional problems, and mental health.
All domains were scored using norm-based methods that standardized the scores to a mean of 50 and a standard deviation of 10 in the general population. The scores range from a minimum of 0 to a maximum of 100, with a higher score indicating better quality of life.
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Timepoint [11]
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Baseline (screening) to Month 12
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Secondary outcome [12]
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Ridit Score at Month 12 - All Randomized Participants
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Assessment method [12]
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The Modified Transplant Symptom Occurrence and Symptom Distress Scale (MTSOSD-59R) was used to assess the occurrence (never, occasionally, regularly, almost always, always) and distress (0=no distress to 4=terrible distress) of symptoms associated with immunosuppressive therapies. Ridit (relative to an identified distribution) analysis (Fleiss JL. Statistical methods for rates and proportions. New York: John Wiley & Sons, Inc. 1991) was used. Ridit scores were calculated at 12 months for overall symptom occurrence score and overall symptom distress. The Ridit score reflects the probability that a score observed for an individual randomly selected from a group would be higher (worse symptom) than a score observed for a randomly selected individual from the reference group. The reference group was constituted by the frequency distribution of the responses of all participants on all items at baseline. The ridit of the reference group is by definition, 0.5.
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Timepoint [12]
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Month 12
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Secondary outcome [13]
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Number of Participants Meeting Marked Laboratory Abnormality Criteria From Baseline up to Month 12 - Randomized and Treated Participants
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Assessment method [13]
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Upper limits of normal (ULL). Leukocytes: < 2.0*10^3 cells per microliter (c/µL); Lymphocytes (absolute): < 0.5*10^3 c/µL; bilirubin: > 3.0*ULN milligrams per deciliter (mg/dL); Potassium: < 3.0 milliequivalents per liter (meq/L) or > 6.0 meq/L; Magnesium >2.6 meq/L; Sodium: < 130 meq/L; Phosphorus: < 2.0 mg/dL; Uric Acid: > 10 mg/dL. Baseline = value at screening.
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Timepoint [13]
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Baseline up to Month 12
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Secondary outcome [14]
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Long Term Period: Mean Change From Baseline to 54 Months Post Randomization in Calculated GFR on Imputed Values at Specified Timepoints - Intent to Treat (ITT) Participants Who Entered LT Period
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Assessment method [14]
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ITT=participants randomized to their original treatment arm and who entered the LT period are presented. Baseline=value at screening. Calculated GFR assessment used the MDRD formula. GFR was measured as mL/min/1.73 m^2. For death or graft loss participants, calculated GFR (cGFR) value of 0 was imputed and carried forward after death or graft loss up to the end of the analysis period. Sponsor discontinued the CNI treatment arm in Year 3, and participants treated with CNI could elect to switch to belatacept. If a participant did not switch to belatacept, they were required to discontinue from the study. Therefore, efficacy results from Month 36 through Month 54 are difficult to interpret. No formal comparisons were planned between the belatacept and CNI treatment groups post Month 36, and the data up to the final database lock should be interpreted with caution.
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Timepoint [14]
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Baseline, Month 3, 6, 12, 18, 24, 30, 36, 42, 48, 54
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Secondary outcome [15]
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Long Term Period: Number of Participants With Acute Rejection (AR) - All Randomized Participants in LT Period
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Assessment method [15]
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AR was defined: if either a or b was satisfied: (a) the reason for clinical suspicion was reported to be an unexplained rise of serum creatinine = 25% from baseline creatinine; or an unexplained decreased urine output; or fever and graft tenderness and the episode was a case of biopsy proven AR (AR of Banff histopathologic classification grade IA or higher as assessed by the blinded central pathologist); (b) the reason for clinical suspicion was reported to be something other than: an unexplained rise of serum creatinine = 25% from baseline creatinine; or an unexplained decreased urine output; or fever and graft tenderness; the episode was a case of biopsy proven AR, and the participant was treated for this episode. Banff 97 working classification of kidney transplant pathology was used to categorize the severity of the AR.
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Timepoint [15]
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Post Month 12 up to Year 6 of the Study
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Secondary outcome [16]
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Long Term Period: Number of Participants Who Survived With a Functioning Graft or Survived With Pure Graft Loss or Death With Functioning Graft - ITT Participants Who Entered the LT Period
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Assessment method [16]
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Graft loss = either pure graft loss (participant survived to the end of the study period after graft loss) or death with functioning graft. Pure graft loss = either functional loss or physical loss. Functional loss = a sustained level of serum creatinine (SCr) = 6.0 mg/dL (530 µmol/L) for = 4 weeks or administration of a maintenance dialysis regimen for at least 56 days or impairment of renal function to such a degree that the participant undergoes re-transplantation. The table was designed with built-in redundancy to capture all possible combinations of death and/or graft loss, but not all lines can be summed to reach the total number surviving and the total number who die and/or lose grafts. If a participant experiences pure graft loss and dies at a later date independent of the graft loss event, they are counted only once in the cumulative tabulation of death or graft loss. Only the first event experienced by the participant counted toward the cumulative total.
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Timepoint [16]
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Post Months 24, 36, 48, up to Year 6 of the Study
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Secondary outcome [17]
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Long Term Period: Percentage of Participants With New Onset Diabetes Mellitus Up to Month 36- All Randomized Participants Who Entered LT Period
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Assessment method [17]
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A participant who did not have diabetes prior to randomization is determined to have new onset diabetes mellitus if they received an antidiabetic medication for a duration of at least 30 days or at least two fasting plasma glucose (FPG) tests indicated that FPG is >=126 mg/dL. Percentage was the number of participants with new onset of diabetes mellitus divided by the number of participants without pre-randomization diabetes.
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Timepoint [17]
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Baseline (screening) up to Month 36 post randomization
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Secondary outcome [18]
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Long Term Period: Number of Participants With SAEs, Death, Discontinuation Due to AEs - All Randomized Participants Who Entered the Long Term Period
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Assessment method [18]
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AE=any new unfavorable symptom, sign, or disease or worsening of a preexisting condition that may not have a causal relationship with treatment. SAE=a medical event that at any dose results in death, persistent or significant disability/incapacity, or drug dependency/abuse; is life-threatening, an important medical event, or a congenital anomaly/birth defect; or requires or prolongs hospitalization. Treatment-related=having certain, probable, possible, or missing relationship to study drug.
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Timepoint [18]
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First dose after randomization (Day 1) to 56 days post last dose, up to Year 6 of the Study
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Secondary outcome [19]
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Long Term Period: Number of Participants With AEs of Special Interest - All Randomized Participants Who Entered the Long Term Period
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Assessment method [19]
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Prospectively identified events of special interest which were a subset of all AEs, and were either SAEs or non-serious AEs, included the following categories: Serious Infections, Thrombolic/embolic events, Autoimmune Disease, Malignancy, Peri-infusional reactions (only belatacept treatment group was IV) , Acute Peri-infusional events occurring within 24 hours of injection, Pulmonary Edema and Congestive Heart Failure. AE=any new unfavorable symptom, sign, or disease or worsening of a preexisting condition that may not have a causal relationship with treatment. SAE=a medical event that at any dose results in death, persistent or significant disability/incapacity, or drug dependency/abuse; is life-threatening, an important medical event, or a congenital anomaly/birth defect; or requires or prolongs hospitalization.
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Timepoint [19]
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First dose after randomization (Day 1) to last dose, plus 56 days, up to Year 6 of the Study
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Secondary outcome [20]
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Long Term Period: Mean Change From Baseline to Month 54 in Serum Creatinine- ITT Participants Who Entered LT Period
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Assessment method [20]
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Baseline was value at screening. Serum creatinine was measured in mg/dL. Only participants who entered into Long Term Period were included in the analysis.
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Timepoint [20]
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Baseline, Months 3, 6, 12, 18, 24, 30, 36, 42, 48, 54
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Secondary outcome [21]
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Long Term Period: Number of Participants Meeting Marked Laboratory Abnormality Criteria - All ITT Participants Who Entered the Long Term Period
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Assessment method [21]
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Upper limits of normal (ULN). Hemoglobin: < 8 g/dL; Platelet count: < 50*10^9 c/L; Leukocytes: < 2.0*10^3 c/µL; Lymphocytes (absolute): < 0.5*10^3 c/µL; Neutrophils: < 1.0*10^3 c/µL; Alanine Aminotransferase (ALT): > 5.0*ULN Units per liter (U/L); bilirubin: > 3.0*ULN mg/dL; Creatinine: > 3.0*ULN mg/dL; Calcium: < 7 mg/dL; Bicarbonate: > 12.5 mg/dL; Potassium: < 3.0 meq/L or > 6.0 meq/L; Magnesium >2.6 meq/L; Sodium: < 130 meq/L; Phosphorus: < 2.0 mg/dL; Uric Acid: > 10 mg/dL.
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Timepoint [21]
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Baseline (Screening), up to Year 6 of the Study
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Secondary outcome [22]
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Long Term Period: Mean Change From Baseline to Month 54 in Systolic Blood Pressure
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Assessment method [22]
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Blood pressure was measured while the participant was sitting quietly for 5 minutes and was measured in millimeters of mercury (mmHg). Baseline was value at screening. Only those participants who entered long term period were evaluated.
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Timepoint [22]
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Baseline, Months 6, 12, 18, 24, 30, 36, 42, 48, 54
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Secondary outcome [23]
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Long Term Period: Mean Change From Baseline to Month 54 in Diastolic Blood Pressure
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Assessment method [23]
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Blood pressure was measured while the participant was sitting quietly for 5 minutes and was measured in mmHg. Baseline was value at screening. Only those participants who entered long term period were evaluated.
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Timepoint [23]
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Baseline, Months 6, 12, 18, 24, 30, 36, 42, 48, 54
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Secondary outcome [24]
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Participants Who Switched From CNI to Belatacept in Long Term Period : Mean Change in Calculated GFR Based on Imputed Values From Day of Switch to Week 96 Post Switch
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Assessment method [24]
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Calculated GFR assessment used the MDRD formula. GFR was measured as mL/min/1.73 m^2. For death or graft loss participants, calculated GFR (cGFR) value 10 was used, for other participants who had a post baseline cGFR value missing, but had baseline value and at least 2 post baseline values available, which were at least 120 days apart, linear regression model was used to impute the cGFR value. Day of Switch = the first belatacept infusion day.
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Timepoint [24]
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Day of Switch (first belatacept dose) to Week 96 Post Switch
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Secondary outcome [25]
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Participants Who Switched to Belatacept in Long Term Period: Number of Participants With AEs and SAEs
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Assessment method [25]
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AE=any new unfavorable symptom, sign, or disease or worsening of a preexisting condition that may not have a causal relationship with treatment. SAE=a medical event that at any dose results in death, persistent or significant disability/incapacity, or drug dependency/abuse; is life-threatening, an important medical event, or a congenital anomaly/birth defect; or requires or prolongs hospitalization. Day of Switch = the first belatacept infusion day.
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Timepoint [25]
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Day of Switch (first dose of belatacept ) to last dose plus 56 days, up to Year 6 of the Study
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Eligibility
Key inclusion criteria
Key
- Men and women age 18 and older
- 6-36 months after kidney transplant receiving cyclosporine or tacrolimus
- calculated GFR =35 and =75mL/min/1.73 m²
- subjects must have completed 1 year in the IM103-010ST and remained on study treatment
(Long Term Extension)
Key
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Minimum age
18
Years
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Maximum age
No limit
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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
- Significant infection
- acute rejection within 3 months
- prior graft loss due to rejection
- pregnancy
- positive crossmatch
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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 2
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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
1/01/2007
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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
1/06/2013
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Sample size
Target
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Accrual to date
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Final
173
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Recruitment in Australia
Recruitment state(s)
VIC
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Recruitment hospital [1]
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Local Institution - Parkville
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Recruitment postcode(s) [1]
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3050 - Parkville
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Recruitment outside Australia
Country [1]
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0
United States of America
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State/province [1]
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0
Arizona
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Country [2]
0
0
United States of America
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State/province [2]
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0
California
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Country [3]
0
0
United States of America
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State/province [3]
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Illinois
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Country [4]
0
0
United States of America
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State/province [4]
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0
Louisiana
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Country [5]
0
0
United States of America
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State/province [5]
0
0
North Carolina
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Country [6]
0
0
United States of America
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State/province [6]
0
0
Wisconsin
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Country [7]
0
0
Argentina
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State/province [7]
0
0
Buenos Aires
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Country [8]
0
0
Argentina
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State/province [8]
0
0
Santa Fe
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Country [9]
0
0
Argentina
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State/province [9]
0
0
Cordoba
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Country [10]
0
0
Belgium
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State/province [10]
0
0
Bruxelles
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Country [11]
0
0
Belgium
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State/province [11]
0
0
Edegem
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Country [12]
0
0
Brazil
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State/province [12]
0
0
Parana
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Country [13]
0
0
Brazil
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State/province [13]
0
0
Rio De Janeiro
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Country [14]
0
0
Brazil
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State/province [14]
0
0
Rio Grande Do Sul
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Country [15]
0
0
Brazil
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State/province [15]
0
0
Rs
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Country [16]
0
0
Brazil
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State/province [16]
0
0
Sao Paulo
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Country [17]
0
0
Canada
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State/province [17]
0
0
Alberta
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Country [18]
0
0
Canada
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State/province [18]
0
0
Nova Scotia
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Country [19]
0
0
Canada
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State/province [19]
0
0
Ontario
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Country [20]
0
0
Canada
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State/province [20]
0
0
Saskatchewan
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Country [21]
0
0
France
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State/province [21]
0
0
Cedex 15
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Country [22]
0
0
France
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State/province [22]
0
0
Toulouse
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Country [23]
0
0
Germany
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State/province [23]
0
0
Berlin
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Country [24]
0
0
Germany
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State/province [24]
0
0
Homburg/saar
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Country [25]
0
0
India
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State/province [25]
0
0
Ahmedabad
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Country [26]
0
0
India
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State/province [26]
0
0
Gujarat
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Country [27]
0
0
India
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State/province [27]
0
0
Kerala
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Country [28]
0
0
Mexico
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State/province [28]
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Distrito Federal
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Mexico
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Morelos
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Mexico
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Snl
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Mexico
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Aguascalientes
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Country [32]
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Mexico
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State/province [32]
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Tlalpan, C P
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Country [33]
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Poland
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State/province [33]
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Bydgoszcz
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Poland
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State/province [34]
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Szczecin
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Poland
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Warszawa
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Spain
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Barcelona
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Spain
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Valencia
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Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
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Name
Bristol-Myers Squibb
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Ethics approval
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Summary
Brief summary
The purpose of this study is to learn if conversion to belatacept from cyclosporine or
tacrolimus will preserve kidney function in people who have had a kidney transplant. The
safety and tolerability of this treatment will also be studied
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Trial website
https://clinicaltrials.gov/ct2/show/NCT00402168
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Public notes
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Contacts
Principal investigator
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Bristol-Myers Squibb
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Address
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Bristol-Myers Squibb
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Contact person for scientific queries
Summary Results
For IPD and results data, please see
https://clinicaltrials.gov/ct2/show/NCT00402168
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