Please note that the copy function is not enabled for this field.
If you wish to
modify
existing outcomes, please copy and paste the current outcome text into the Update field.
LOGIN
CREATE ACCOUNT
LOGIN
CREATE ACCOUNT
MY TRIALS
REGISTER TRIAL
FAQs
HINTS AND TIPS
DEFINITIONS
Trial Review
The ANZCTR website will be unavailable from 1pm until 3pm (AEDT) on Wednesday the 30th of October for website maintenance. Please be sure to log out of the system in order to avoid any loss of data.
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this
information for consumers
Download to PDF
Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/study/NCT00658359
Registration number
NCT00658359
Ethics application status
Date submitted
9/04/2008
Date registered
15/04/2008
Date last updated
23/02/2018
Titles & IDs
Public title
Extension Study Of Subjects From Study A3921030 For The Prevention Of Acute Rejection In Kidney Transplant Patients
Query!
Scientific title
A Phase 2, Multicenter, Open-label, Active Comparator-controlled, Extension Trial To Evaluate The Long-term Safety And Efficacy Of Cp-690,550 In Renal Allograft Recipients
Query!
Secondary ID [1]
0
0
2008-002345-23
Query!
Secondary ID [2]
0
0
A3921050
Query!
Universal Trial Number (UTN)
Query!
Trial acronym
Query!
Linked study record
Query!
Health condition
Health condition(s) or problem(s) studied:
Kidney Transplantation
0
0
Query!
Condition category
Condition code
Intervention/exposure
Study type
Interventional
Query!
Description of intervention(s) / exposure
Treatment: Drugs - Cyclosporine
Treatment: Drugs - CP-690,550
Treatment: Drugs - CP-690,550
Active comparator: Treatment Arm 1 - Treatment Arm 1 will also receive standard of care medications
Experimental: Treatment Arm 2 - Treatment Arm 2 will also receive standard of care medications
Experimental: Treatment Arm 3 - Treatment Arm 3 will also receive standard of care medications
Treatment: Drugs: Cyclosporine
Standard of care
Treatment: Drugs: CP-690,550
CP-690,550 tablets dosed BID Months 12-72
Treatment: Drugs: CP-690,550
CP-690,550 tablets dosed BID Months 12-72
Query!
Intervention code [1]
0
0
Treatment: Drugs
Query!
Comparator / control treatment
Query!
Control group
Query!
Outcomes
Primary outcome [1]
0
0
Kaplan-Meier Analysis of Percentage of Participants With Clinically Significant Infection by Visit
Query!
Assessment method [1]
0
0
Clinically significant infection was defined as the presence of documented infection confirmed by culture, biopsy, genomic, or serologic findings post-randomization and requiring hospitalization or parenteral anti-infective treatment, or otherwise deemed significant by the investigator. The 'Number' and 'Other Confidence Interval Level' columns represent cumulative proportions and 60% confidence intervals (CIs) as estimated from the fitted Kaplan-Meier curves for each treatment at scheduled visits.
Query!
Timepoint [1]
0
0
Months 12, 15, 18, 24, 30, 36, 42, 48, 54, 60, 66, 72
Query!
Primary outcome [2]
0
0
Percentage of Participants With Malignancies
Query!
Assessment method [2]
0
0
All treatment-emergent malignancies in Study A3921050 were included as collected on the Malignancy Case Report Form page.
Query!
Timepoint [2]
0
0
Months 12 through 72.
Query!
Primary outcome [3]
0
0
Least Squares Means of Measured Glomerular Filtration Rate (GFR) (Iohexol Serum Clearance in Milliliters Per Minute [mL/Min])
Query!
Assessment method [3]
0
0
Glomerular filtration rate (GFR): an index of kidney function. GFR described the flow rate of filtered fluid through the kidney. GFR was calculated using iohexol serum clearance. For determination of iohexol serum clearance, iohexol was administered as an intravenous (IV) bolus over 5 minutes immediately after morning dosing of Tofacitinib or CsA on day of GFR evaluation. Blood samples for iohexol (3 millilitres \[mL\] each to provide a minimum of 1 mL serum) were collected into appropriately labeled tubes containing no additives at 120, 180, 240, and 300 minutes after the end of the iohexol IV bolus. A normal GFR is greater than (\>) 90 mL/min, although children and older people usually have a lower GFR. Lower values indicated poor kidney function. A GFR less than (\<) 15 mL/min indicated kidney failure.
Query!
Timepoint [3]
0
0
Month 36
Query!
Primary outcome [4]
0
0
Percentage of Participants With Progression of Chronic Allograft Lesions at Month 36
Query!
Assessment method [4]
0
0
Progression of chronic allograft lesions was defined as an increase in the Banff chronicity score (Banff-CS) in biopsy from the implantation (baseline) biopsy in a given participant. Banff-CS was the sum of the Banff scores for the 4 chronic basic lesions (allograft glomerulopathy \[cg\] + interstitial fibrosis \[ci\] + tubular atrophy \[ct\] + vascular intimal thickening \[cv\]). The Banff-CS ranged from 0-12, higher score indicated greater lesions and Month 36 Banff-CS greater than the implantation biopsy score indicated progression of lesions.
Query!
Timepoint [4]
0
0
Month 36
Query!
Primary outcome [5]
0
0
Kaplan-Meier Analysis of Percentage of Participants With First Biopsy Proven Acute Rejection (BPAR) by Visit
Query!
Assessment method [5]
0
0
BPAR was category acute rejection as interpreted by the central blinded pathologist according to the Banff 97 working classification. The 'Number' and 'Other Confidence Interval Level' columns represent cumulative proportions and 60% confidence intervals (CIs) as estimated from the fitted Kaplan-Meier curves for each treatment at scheduled visits.
Query!
Timepoint [5]
0
0
Months 12, 15, 18, 24, 30, 36, 42, 48, 54, 60, 66, 72
Query!
Primary outcome [6]
0
0
Kaplan-Meier Analysis of Percentage of Participants With Treated Clinical Acute Rejection by Visit
Query!
Assessment method [6]
0
0
Treated clinical acute rejection was defined as an acute rejection episode that was diagnosed based on local biopsy readout and received anti-rejection treatment. The 'Number' and 'Other Confidence Interval Level' columns represent cumulative proportions and 60% confidence intervals (CIs) as estimated from the fitted Kaplan-Meier curves for each treatment at scheduled visits.
Query!
Timepoint [6]
0
0
Months 12, 15, 18, 24, 30, 36, 42, 48, 54, 60, 66, 72
Query!
Secondary outcome [1]
0
0
Kaplan-Meier Analysis of Percentage of Participants With Efficacy Failure by Visit
Query!
Assessment method [1]
0
0
Efficacy failure was the first occurrence of BPAR diagnosed by the central pathologist or graft loss including participant death. BPAR (category acute rejection) was interpreted by the central blinded pathologist according to the Banff 97 working classification. The 'Number' and 'Other Confidence Interval Level' columns represent cumulative proportions and 60% confidence intervals (CIs) as estimated from the fitted Kaplan-Meier curves for each treatment at scheduled visits.
Query!
Timepoint [1]
0
0
Months 12, 15, 18, 24, 30, 36, 42, 48, 54, 60, 66, 72
Query!
Secondary outcome [2]
0
0
Kaplan-Meier Analysis of Percentage of Participants With Combined Banff Rejection by Visit
Query!
Assessment method [2]
0
0
Banff 97: standard classification for scoring and classifying rejection of kidney transplant biopsies in 6 diagnostic categories: normal, antibody-mediated rejection, borderline changes: 'suspicious' for acute cellular rejection, acute/active cellular rejection, chronic/sclerosing allograft nephropathy, and other. Combined Banff rejection was calculated from categories of antibody-mediated rejection (Category 2) plus borderline changes (Category 3) plus acute rejection (Category 4), as interpreted by the central pathologist. The 'Number' and 'Other Confidence Interval Level' columns represent cumulative proportions and 60% confidence intervals (CIs) as estimated from the fitted Kaplan-Meier curves for each treatment at scheduled visits.
Query!
Timepoint [2]
0
0
Months 12, 15, 18, 24, 30, 36, 42, 48, 54, 60, 66, 72
Query!
Secondary outcome [3]
0
0
Kaplan-Meier Analysis of Percent of Participants With Graft Survival With Death Censored by Visit
Query!
Assessment method [3]
0
0
Graft loss was defined as graft nephrectomy, subject death, retransplantation, or return to dialysis for at least 6 consecutive weeks. The 'Number' and 'Other Confidence Interval Level' columns represent cumulative proportions and 60% confidence intervals (CIs) as estimated from the fitted Kaplan-Meier curves for each treatment at scheduled visits. Included data up to 2 months postdose in the clinical Follow-up visit.
Query!
Timepoint [3]
0
0
Months 12, 15, 18, 24, 30, 36, 42, 48, 54, 60, 66, 72
Query!
Secondary outcome [4]
0
0
Kaplan-Meier Analysis of Percentage of Participants Surviving by Visit
Query!
Assessment method [4]
0
0
The 'Number' and 'Other Confidence Interval Level' columns represent cumulative proportions and 60% confidence intervals (CIs) as estimated from the fitted Kaplan-Meier curves for each treatment at scheduled visits. Included data up to 2 months postdose in the clinical Follow-up visit.
Query!
Timepoint [4]
0
0
Months 12, 15, 18, 24, 30, 36, 42, 48, 54, 60, 66, 72
Query!
Secondary outcome [5]
0
0
Percentage of Participants Discontinuing From the Study
Query!
Assessment method [5]
0
0
Discontinuations were due to any reason including those occurring as a result of protocol Amendments 3 and 4.
Query!
Timepoint [5]
0
0
Months 12 through 72.
Query!
Secondary outcome [6]
0
0
Least Squares Means of Total Serum Cholesterol Levels (Milligrams Per Deciliter [mg/dL]) by Visit
Query!
Assessment method [6]
0
0
Model contained treatment, visit and treatment by visit interaction as fixed effects and Baseline (predose in Study A3921030) as a covariate. A first-order autoregressive variance-covariance structure was used.
Query!
Timepoint [6]
0
0
Months 15, 18, 24, 30, 36, 42, 48, 54, 60, 66, 72
Query!
Secondary outcome [7]
0
0
Least Squares Means of Total Serum Low Density Lipoprotein (LDL) Cholesterol Levels (mg/dL) by Visit
Query!
Assessment method [7]
0
0
Model contained treatment, visit and treatment by visit interaction as fixed effects and Baseline (predose in Study A3921030) as a covariate. A first-order autoregressive variance-covariance structure was used.
Query!
Timepoint [7]
0
0
Months 15, 18, 24, 30, 36, 42, 48, 54, 60, 66, 72
Query!
Secondary outcome [8]
0
0
Least Squares Means of Total Serum High Density Lipoprotein (HDL) Cholesterol Levels (mg/dL) by Visit
Query!
Assessment method [8]
0
0
Model contained treatment, visit and treatment by visit interaction as fixed effects and Baseline (predose in Study A3921030) as a covariate. A first-order autoregressive variance-covariance structure was used.
Query!
Timepoint [8]
0
0
Months 15, 18, 24, 30, 36, 42, 48, 54, 60, 66, 72
Query!
Secondary outcome [9]
0
0
Least Squares Means of Total Serum Triglycerides (mg/dL) by Visit
Query!
Assessment method [9]
0
0
Model contained treatment, visit and treatment by visit interaction as fixed effects and Baseline (predose in Study A3921030) as a covariate. A first-order autoregressive variance-covariance structure was used.
Query!
Timepoint [9]
0
0
Month 15, 18, 24, 30, 36, 42, 48, 54, 60, 66, 72
Query!
Secondary outcome [10]
0
0
Mean Absolute Neutrophil Counts (ANC) (Kelvin Per Millimeter Cubed [K/mm^3]) by Visit
Query!
Assessment method [10]
0
0
Follow-up visit included Month 74 visit for completers and 2-month postdose visit for early withdrawals.
Query!
Timepoint [10]
0
0
Months 15, 18, 24, 30, 36, 42, 48, 54, 60, 66, 72 and Follow-up
Query!
Secondary outcome [11]
0
0
Mean Hemoglobin (Hgb) (Grams Per Deciliter [g/dL]) by Visit
Query!
Assessment method [11]
0
0
Follow-up visit included Month 74 visit for completers and 2-month postdose visit for early withdrawals.
Query!
Timepoint [11]
0
0
Months 15, 18, 24, 30, 36, 42, 48, 54, 60, 66, 72 and Follow-up
Query!
Secondary outcome [12]
0
0
Mean Glycosylated Hemoglobin (HBA1c) (Percent [%]) by Visit
Query!
Assessment method [12]
0
0
HbA1c is a form of hemoglobin which is measured primarily to identify the average plasma glucose concentration over prolonged periods of time. The normal range for the HbA1c test is between 4% and 5.6%. HbA1c levels between 5.7% and 6.4% indicate increased risk of diabetes and levels of 6.5% or higher indicate diabetes.
Query!
Timepoint [12]
0
0
Months 24, 36, 48, 60, 72
Query!
Secondary outcome [13]
0
0
Least Squares Means of Fasting Serum Glucose Levels (mg/dL) by Visit
Query!
Assessment method [13]
0
0
Model contained treatment, visit and treatment by visit interaction as fixed effects and Baseline (predose in Study A3921030) as a covariate. A compund symmetry variance-covariance structure was used.
Query!
Timepoint [13]
0
0
Months 15, 18, 24, 30, 36, 42, 48, 54, 60, 66, 72
Query!
Secondary outcome [14]
0
0
Percentage of Participants by Proteinuria Category by Visit
Query!
Assessment method [14]
0
0
Proteinuria was defined as the presence of an excess of serum proteins in the urine. Normal value of proteinuria is below 0.15 grams per 24 hours (g/24 hr). Follow-up visit included Month 74 visit for completers and 2-month postdose visit for early withdrawals.
Query!
Timepoint [14]
0
0
Months 24, 36, 48, 60, 72 and Follow-up
Query!
Secondary outcome [15]
0
0
Least Square Means of Estimated GFR Calculated Using the Nankivell Equation by Visit
Query!
Assessment method [15]
0
0
GFR: an index of kidney function. GFR described the flow rate of filtered fluid through the kidney. GFR was measured directly or estimated using established formulas. GFR was calculated using Nankivell formula, where:
Creatinine clearance (mL/min) = 6.7/serum creatinine (millimols per litre \[mmol/L\]) - serum urea (mmol/dL)/2 + actual body weight (kilograms \[kg\])/4 - 100/Height (metres \[m\])\^2 + (35 for male or 25 for female).
A normal GFR for adults is \> 90 mL/min. Lower values indicate poor kidney function. A GFR \<15 is consistent with kidney failure.
Model contained treatment, visit and treatment by visit interaction as fixed effects. An unstructured variance-covariance structure was used.
Query!
Timepoint [15]
0
0
Month 15, 18, 24, 30, 36, 42, 48, 54, 60, 66, 72
Query!
Secondary outcome [16]
0
0
Least Squares Means of Estimated GFR Calculated Using the Cockcroft-Gault Equation by Visit
Query!
Assessment method [16]
0
0
GFR: an index of kidney function. GFR described the flow rate of filtered fluid through the kidney. GFR was measured directly or estimated using established formulas. GFR (mL/min) was calculated using Cockcroft-Gault equation. GFR by Cockcroft-Gault equation= body weight (kg)\*(140 minus age in years) divided by (72\*serum creatinine \[mg/dL\]). For females value obtained was multiplied by 0.85. A normal GFR is \>90 mL/min, although children and older people usually have a lower GFR. Lower values indicated poor kidney function. A GFR \<15 mL/min indicated kidney failure.
Model contained treatment, visit and treatment by visit interaction as fixed effects. An unstructured variance-covariance structure was used.
Query!
Timepoint [16]
0
0
Months 15, 18, 24, 30, 36, 42, 48, 54, 60, 66, 72
Query!
Secondary outcome [17]
0
0
Least Squares Means of Estimated GFR (eGFR) (mL/Min/1.73 Square Meter [m^2]) Calculated by the Modification of Diet in Renal Disease (MDRD) Equation With Last Observation Carried Forward (LOCF) Plus Imputation (eGFR=0 for Graft Loss/Death) by Visit
Query!
Assessment method [17]
0
0
GFR: an index of kidney function. GFR described the flow rate of filtered fluid through the kidney. GFR was calculated using MDRD equation. GFR (mL/min/1.73 m\^2) by MDRD equation = 170 \* (serum creatinine \[mg/dL\])\^(-0.999) \* (age in years)\^(-0.176) \* (0.762 if female) \* (1.18 if black) \* (blood urea nitrogen concentration \[mg/dL\])\^(-0.170) \* (serum albumin concentration \[g/dL\])\^(0.318). A normal GFR is \>90 mL/min/1.73 m\^2, although children and older people usually have a lower GFR. Lower values indicated poor kidney function. A GFR \<15 mL/min/1.73 m\^2 indicated kidney failure.
Model contained treatment, visit and treatment by visit interaction as fixed effects. An unstructured variance-covariance structure was used.
Query!
Timepoint [17]
0
0
Months 15, 18, 24, 30, 36, 42, 48, 54, 60, 66, 72
Query!
Secondary outcome [18]
0
0
Least Squares Means of Short Form 36 Version 2 (SF-36 V2) Component and Domain Scores at Months 24 and 36
Query!
Assessment method [18]
0
0
SF-36 v2 is a self-administered 36-item generic health status measure with 8 general health concepts which are the weighted sums of the questions in their section: Physical Functioning, Role Physical, Bodily Pain, General Health, Vitality, Social Functioning, Role Emotional, and Mental Health. Each scale is transformed into a 0 (minimum) to 100 (maximum) scale on the assumption each question carries equal weight. These concepts were also summarized into 2 summary scores; Physical Component Summary and Mental Component Summary (both a 0-100 scale). The 8 subscales, 2 summary scores and transition Question 2 (TR Scale, measured on a scale of 1 \[minimum\] to 5 \[maximum\]) were subjected to analysis. Higher domain, summary scores, and TR scale scores indicate better health status. Model contained treatment, visit and treatment by visit interaction as fixed effects and Baseline (predose in Study A3921030) as a covariate. First-order autoregressive variance-covariance structure was used.
Query!
Timepoint [18]
0
0
Months 24, 36
Query!
Secondary outcome [19]
0
0
Least Squares Means of End-Stage Renal Disease (ESRD) Symptom Checklist (SCL) -Transplantation Modules at Months 24 and 36
Query!
Assessment method [19]
0
0
ESRD-SCL: a 43-item disease specific self-administered questionnaire. Participants' rated the question "At the moment,how much do you suffer?" for each item on a 5 point scale, range (Ra) from 0 (not at all) to 4 (extremely). Consisted of 6 subscales: Cardiac and Renal (CR) dysfunction; Ra 0 to 28, Increased(In) Growth of Gum and Hair (IGGH); Ra 0 to 20, Limited Cognitive Capacity (LCC); Ra 0 to 32, Limited Physical Capacity (LPC); Ra 0 to 40, Side Effects (SEs) of Corticosteroids; Ra 0 to 20, Transplantation Associated Psychological Distress (TAPD); Ra 0 to 32. Total Score: 0 to 172, higher scores indicate greater dysfunction.
Model contained treatment, visit and treatment by visit interaction as fixed effects and Baseline (predose in Study A3921030) as a covariate. A first-order autoregressive variance-covariance structure was used.
Query!
Timepoint [19]
0
0
Months 24, 36
Query!
Secondary outcome [20]
0
0
Least Squares Means of Severity of Dyspepsia Assessment (SODA) Subscales at Months 24 & 36
Query!
Assessment method [20]
0
0
SODA:17-item health scale, assessed participant-reported perceptions of dyspepsia; consists of 3 subscales: Pain Intensity (PI, 6-items to assess pain and intensity of abdominal discomfort; Range: 2 to 47, higher score indicates greater pain and abdominal discomfort), Non-Pain Symptoms (NPS, 7-items to assess severity and impact of non-pain symptoms: burping/belching, heartburn, bloating, flatulence, sour taste, nausea, and bad breath; Range: 7 to 35, higher scores indicate increased symptom severity and influence), and Satisfaction (4-items to assess degree of satisfaction with abdominal discomfort; Range: 2 to 23, higher scores indicate more satisfaction).
Model contained treatment, visit and treatment by visit interaction as fixed effects and Baseline (predose in Study A3921030) as a covariate. A first-order autoregressive variance-covariance structure was used.
Query!
Timepoint [20]
0
0
Months 24, 36
Query!
Secondary outcome [21]
0
0
Mean Trough Levels of Tofacitinib by Visit
Query!
Assessment method [21]
0
0
The dates and times were recorded for the 6 doses of tofacitinib administered before each scheduled pharmacokinetic (PK) sampling. The participant was instructed to follow a 12 hourly schedule for these 6 doses of tofacitinib, with each dose administered within 1 hour of the scheduled time. Trough samples were collected 0 to 10 minutes prior to the morning dose. 1 hour postdose samples were required within 10 minutes of the nominal time point. Samples taken at -2 hours predose and at time points \>1 hour post dose were required within 30 minutes of the nominal time point.
Query!
Timepoint [21]
0
0
Months 18 and 24 (-2 hours, predose, 1 hour, 2 hours), Month 30 (predose, 1 hour and 2 hours), Month 36 (predose, 1, 2, and 4 hours), Months 42, 48, 54, 60, 66, 72 (predose and 2 hours)
Query!
Secondary outcome [22]
0
0
Mean Trough Levels of Cyclosporine by Visit
Query!
Assessment method [22]
0
0
All CsA samples were taken predose (collected 0 to 10 minutes prior to the morning dose).
Query!
Timepoint [22]
0
0
Predose: Months 18, 24, 36, 48, 60, 72
Query!
Eligibility
Key inclusion criteria
* Subjects who successfully completed Study A3921030
Query!
Minimum age
18
Years
Query!
Query!
Maximum age
70
Years
Query!
Query!
Sex
Both males and females
Query!
Can healthy volunteers participate?
No
Query!
Key exclusion criteria
* Subjects who are on the waiting list for a second kidney transplant or any non-renal organ transplants
Query!
Study design
Purpose of the study
Prevention
Query!
Allocation to intervention
Randomised controlled trial
Query!
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Query!
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Query!
Masking / blinding
Open (masking not used)
Query!
Who is / are masked / blinded?
Query!
Query!
Query!
Query!
Intervention assignment
Parallel
Query!
Other design features
Query!
Phase
Phase 2
Query!
Type of endpoint/s
Query!
Statistical methods / analysis
Query!
Recruitment
Recruitment status
Completed
Query!
Data analysis
Query!
Reason for early stopping/withdrawal
Query!
Other reasons
Query!
Date of first participant enrolment
Anticipated
Query!
Actual
1/08/2008
Query!
Date of last participant enrolment
Anticipated
Query!
Actual
Query!
Date of last data collection
Anticipated
Query!
Actual
1/06/2015
Query!
Sample size
Target
Query!
Accrual to date
Query!
Final
178
Query!
Recruitment in Australia
Recruitment state(s)
NSW,SA,VIC
Query!
Recruitment hospital [1]
0
0
Royal Prince Alfred Hospital - Camperdown
Query!
Recruitment hospital [2]
0
0
Westmead Hospital, Department of Renal Medicine - Westmead
Query!
Recruitment hospital [3]
0
0
Central Northern Adelaide Renal and Transplantation Service - Adelaide
Query!
Recruitment hospital [4]
0
0
The Queen Elizabeth Hospital - Woodville
Query!
Recruitment hospital [5]
0
0
Royal Melbourne Hospital - Parkville
Query!
Recruitment postcode(s) [1]
0
0
2050 - Camperdown
Query!
Recruitment postcode(s) [2]
0
0
2145 - Westmead
Query!
Recruitment postcode(s) [3]
0
0
5000 - Adelaide
Query!
Recruitment postcode(s) [4]
0
0
5011 - Woodville
Query!
Recruitment postcode(s) [5]
0
0
3050 - Parkville
Query!
Recruitment outside Australia
Country [1]
0
0
United States of America
Query!
State/province [1]
0
0
California
Query!
Country [2]
0
0
United States of America
Query!
State/province [2]
0
0
Colorado
Query!
Country [3]
0
0
United States of America
Query!
State/province [3]
0
0
Connecticut
Query!
Country [4]
0
0
United States of America
Query!
State/province [4]
0
0
Florida
Query!
Country [5]
0
0
United States of America
Query!
State/province [5]
0
0
Illinois
Query!
Country [6]
0
0
United States of America
Query!
State/province [6]
0
0
Michigan
Query!
Country [7]
0
0
United States of America
Query!
State/province [7]
0
0
Missouri
Query!
Country [8]
0
0
United States of America
Query!
State/province [8]
0
0
North Carolina
Query!
Country [9]
0
0
United States of America
Query!
State/province [9]
0
0
Pennsylvania
Query!
Country [10]
0
0
United States of America
Query!
State/province [10]
0
0
South Carolina
Query!
Country [11]
0
0
United States of America
Query!
State/province [11]
0
0
Texas
Query!
Country [12]
0
0
Belgium
Query!
State/province [12]
0
0
Brussels
Query!
Country [13]
0
0
Belgium
Query!
State/province [13]
0
0
Leuven
Query!
Country [14]
0
0
Brazil
Query!
State/province [14]
0
0
RS
Query!
Country [15]
0
0
Brazil
Query!
State/province [15]
0
0
SP
Query!
Country [16]
0
0
Brazil
Query!
State/province [16]
0
0
Sao Paulo
Query!
Country [17]
0
0
Canada
Query!
State/province [17]
0
0
Alberta
Query!
Country [18]
0
0
Czechia
Query!
State/province [18]
0
0
Praha 4 Krc
Query!
Country [19]
0
0
France
Query!
State/province [19]
0
0
Paris Cedex 15
Query!
Country [20]
0
0
France
Query!
State/province [20]
0
0
Vandoeuvre Les Nancy
Query!
Country [21]
0
0
Germany
Query!
State/province [21]
0
0
Berlin
Query!
Country [22]
0
0
Italy
Query!
State/province [22]
0
0
RM
Query!
Country [23]
0
0
Italy
Query!
State/province [23]
0
0
Bologna
Query!
Country [24]
0
0
Korea, Republic of
Query!
State/province [24]
0
0
Seoul
Query!
Country [25]
0
0
Netherlands
Query!
State/province [25]
0
0
Rotterdam
Query!
Country [26]
0
0
Norway
Query!
State/province [26]
0
0
Oslo
Query!
Country [27]
0
0
Poland
Query!
State/province [27]
0
0
Wroclaw
Query!
Country [28]
0
0
Portugal
Query!
State/province [28]
0
0
Coimbra
Query!
Country [29]
0
0
Portugal
Query!
State/province [29]
0
0
Lisboa
Query!
Country [30]
0
0
Spain
Query!
State/province [30]
0
0
Barcelona
Query!
Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Query!
Name
Pfizer
Query!
Address
Query!
Country
Query!
Ethics approval
Ethics application status
Query!
Summary
Brief summary
This is a study that will follow transplant patients from Study A3921030 to monitor for long term safety, tolerability and efficacy for 5 additional years, except in Portugal where the study will follow transplant patients through Month 36 posttransplant. Patients will continue their study medications that were previously assigned.
Query!
Trial website
https://clinicaltrials.gov/study/NCT00658359
Query!
Trial related presentations / publications
Query!
Public notes
Query!
Contacts
Principal investigator
Name
0
0
Pfizer CT.gov Call Center
Query!
Address
0
0
Pfizer
Query!
Country
0
0
Query!
Phone
0
0
Query!
Fax
0
0
Query!
Email
0
0
Query!
Contact person for public queries
Name
0
0
Query!
Address
0
0
Query!
Country
0
0
Query!
Phone
0
0
Query!
Fax
0
0
Query!
Email
0
0
Query!
Contact person for scientific queries
No information has been provided regarding IPD availability
What supporting documents are/will be available?
No Supporting Document Provided
Results publications and other study-related documents
No documents have been uploaded by study researchers.
Results are available at
https://clinicaltrials.gov/study/NCT00658359
Download to PDF