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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
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
Secondary ID [1] 0 0
2008-002345-23
Secondary ID [2] 0 0
A3921050
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Kidney Transplantation 0 0
Condition category
Condition code

Intervention/exposure
Study type
Interventional
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
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Kaplan-Meier Analysis of Percentage of Participants With Clinically Significant Infection by Visit
Timepoint [1] 0 0
Months 12, 15, 18, 24, 30, 36, 42, 48, 54, 60, 66, 72
Primary outcome [2] 0 0
Percentage of Participants With Malignancies
Timepoint [2] 0 0
Months 12 through 72.
Primary outcome [3] 0 0
Least Squares Means of Measured Glomerular Filtration Rate (GFR) (Iohexol Serum Clearance in Milliliters Per Minute [mL/Min])
Timepoint [3] 0 0
Month 36
Primary outcome [4] 0 0
Percentage of Participants With Progression of Chronic Allograft Lesions at Month 36
Timepoint [4] 0 0
Month 36
Primary outcome [5] 0 0
Kaplan-Meier Analysis of Percentage of Participants With First Biopsy Proven Acute Rejection (BPAR) by Visit
Timepoint [5] 0 0
Months 12, 15, 18, 24, 30, 36, 42, 48, 54, 60, 66, 72
Primary outcome [6] 0 0
Kaplan-Meier Analysis of Percentage of Participants With Treated Clinical Acute Rejection by Visit
Timepoint [6] 0 0
Months 12, 15, 18, 24, 30, 36, 42, 48, 54, 60, 66, 72
Secondary outcome [1] 0 0
Kaplan-Meier Analysis of Percentage of Participants With Efficacy Failure by Visit
Timepoint [1] 0 0
Months 12, 15, 18, 24, 30, 36, 42, 48, 54, 60, 66, 72
Secondary outcome [2] 0 0
Kaplan-Meier Analysis of Percentage of Participants With Combined Banff Rejection by Visit
Timepoint [2] 0 0
Months 12, 15, 18, 24, 30, 36, 42, 48, 54, 60, 66, 72
Secondary outcome [3] 0 0
Kaplan-Meier Analysis of Percent of Participants With Graft Survival With Death Censored by Visit
Timepoint [3] 0 0
Months 12, 15, 18, 24, 30, 36, 42, 48, 54, 60, 66, 72
Secondary outcome [4] 0 0
Kaplan-Meier Analysis of Percentage of Participants Surviving by Visit
Timepoint [4] 0 0
Months 12, 15, 18, 24, 30, 36, 42, 48, 54, 60, 66, 72
Secondary outcome [5] 0 0
Percentage of Participants Discontinuing From the Study
Timepoint [5] 0 0
Months 12 through 72.
Secondary outcome [6] 0 0
Least Squares Means of Total Serum Cholesterol Levels (Milligrams Per Deciliter [mg/dL]) by Visit
Timepoint [6] 0 0
Months 15, 18, 24, 30, 36, 42, 48, 54, 60, 66, 72
Secondary outcome [7] 0 0
Least Squares Means of Total Serum Low Density Lipoprotein (LDL) Cholesterol Levels (mg/dL) by Visit
Timepoint [7] 0 0
Months 15, 18, 24, 30, 36, 42, 48, 54, 60, 66, 72
Secondary outcome [8] 0 0
Least Squares Means of Total Serum High Density Lipoprotein (HDL) Cholesterol Levels (mg/dL) by Visit
Timepoint [8] 0 0
Months 15, 18, 24, 30, 36, 42, 48, 54, 60, 66, 72
Secondary outcome [9] 0 0
Least Squares Means of Total Serum Triglycerides (mg/dL) by Visit
Timepoint [9] 0 0
Month 15, 18, 24, 30, 36, 42, 48, 54, 60, 66, 72
Secondary outcome [10] 0 0
Mean Absolute Neutrophil Counts (ANC) (Kelvin Per Millimeter Cubed [K/mm^3]) by Visit
Timepoint [10] 0 0
Months 15, 18, 24, 30, 36, 42, 48, 54, 60, 66, 72 and Follow-up
Secondary outcome [11] 0 0
Mean Hemoglobin (Hgb) (Grams Per Deciliter [g/dL]) by Visit
Timepoint [11] 0 0
Months 15, 18, 24, 30, 36, 42, 48, 54, 60, 66, 72 and Follow-up
Secondary outcome [12] 0 0
Mean Glycosylated Hemoglobin (HBA1c) (Percent [%]) by Visit
Timepoint [12] 0 0
Months 24, 36, 48, 60, 72
Secondary outcome [13] 0 0
Least Squares Means of Fasting Serum Glucose Levels (mg/dL) by Visit
Timepoint [13] 0 0
Months 15, 18, 24, 30, 36, 42, 48, 54, 60, 66, 72
Secondary outcome [14] 0 0
Percentage of Participants by Proteinuria Category by Visit
Timepoint [14] 0 0
Months 24, 36, 48, 60, 72 and Follow-up
Secondary outcome [15] 0 0
Least Square Means of Estimated GFR Calculated Using the Nankivell Equation by Visit
Timepoint [15] 0 0
Month 15, 18, 24, 30, 36, 42, 48, 54, 60, 66, 72
Secondary outcome [16] 0 0
Least Squares Means of Estimated GFR Calculated Using the Cockcroft-Gault Equation by Visit
Timepoint [16] 0 0
Months 15, 18, 24, 30, 36, 42, 48, 54, 60, 66, 72
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
Timepoint [17] 0 0
Months 15, 18, 24, 30, 36, 42, 48, 54, 60, 66, 72
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
Timepoint [18] 0 0
Months 24, 36
Secondary outcome [19] 0 0
Least Squares Means of End-Stage Renal Disease (ESRD) Symptom Checklist (SCL) -Transplantation Modules at Months 24 and 36
Timepoint [19] 0 0
Months 24, 36
Secondary outcome [20] 0 0
Least Squares Means of Severity of Dyspepsia Assessment (SODA) Subscales at Months 24 & 36
Timepoint [20] 0 0
Months 24, 36
Secondary outcome [21] 0 0
Mean Trough Levels of Tofacitinib by Visit
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)
Secondary outcome [22] 0 0
Mean Trough Levels of Cyclosporine by Visit
Timepoint [22] 0 0
Predose: Months 18, 24, 36, 48, 60, 72

Eligibility
Key inclusion criteria
* Subjects who successfully completed Study A3921030
Minimum age
18 Years
Maximum age
70 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
* Subjects who are on the waiting list for a second kidney transplant or any non-renal organ transplants

Study design
Purpose of the study
Prevention
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Phase 2
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/08/2008
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
1/06/2015
Sample size
Target
Accrual to date
Final
178
Recruitment in Australia
Recruitment state(s)
NSW,SA,VIC
Recruitment hospital [1] 0 0
Royal Prince Alfred Hospital - Camperdown
Recruitment hospital [2] 0 0
Westmead Hospital, Department of Renal Medicine - Westmead
Recruitment hospital [3] 0 0
Central Northern Adelaide Renal and Transplantation Service - Adelaide
Recruitment hospital [4] 0 0
The Queen Elizabeth Hospital - Woodville
Recruitment hospital [5] 0 0
Royal Melbourne Hospital - Parkville
Recruitment postcode(s) [1] 0 0
2050 - Camperdown
Recruitment postcode(s) [2] 0 0
2145 - Westmead
Recruitment postcode(s) [3] 0 0
5000 - Adelaide
Recruitment postcode(s) [4] 0 0
5011 - Woodville
Recruitment postcode(s) [5] 0 0
3050 - Parkville
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
California
Country [2] 0 0
United States of America
State/province [2] 0 0
Colorado
Country [3] 0 0
United States of America
State/province [3] 0 0
Connecticut
Country [4] 0 0
United States of America
State/province [4] 0 0
Florida
Country [5] 0 0
United States of America
State/province [5] 0 0
Illinois
Country [6] 0 0
United States of America
State/province [6] 0 0
Michigan
Country [7] 0 0
United States of America
State/province [7] 0 0
Missouri
Country [8] 0 0
United States of America
State/province [8] 0 0
North Carolina
Country [9] 0 0
United States of America
State/province [9] 0 0
Pennsylvania
Country [10] 0 0
United States of America
State/province [10] 0 0
South Carolina
Country [11] 0 0
United States of America
State/province [11] 0 0
Texas
Country [12] 0 0
Belgium
State/province [12] 0 0
Brussels
Country [13] 0 0
Belgium
State/province [13] 0 0
Leuven
Country [14] 0 0
Brazil
State/province [14] 0 0
RS
Country [15] 0 0
Brazil
State/province [15] 0 0
SP
Country [16] 0 0
Brazil
State/province [16] 0 0
Sao Paulo
Country [17] 0 0
Canada
State/province [17] 0 0
Alberta
Country [18] 0 0
Czechia
State/province [18] 0 0
Praha 4 Krc
Country [19] 0 0
France
State/province [19] 0 0
Paris Cedex 15
Country [20] 0 0
France
State/province [20] 0 0
Vandoeuvre Les Nancy
Country [21] 0 0
Germany
State/province [21] 0 0
Berlin
Country [22] 0 0
Italy
State/province [22] 0 0
RM
Country [23] 0 0
Italy
State/province [23] 0 0
Bologna
Country [24] 0 0
Korea, Republic of
State/province [24] 0 0
Seoul
Country [25] 0 0
Netherlands
State/province [25] 0 0
Rotterdam
Country [26] 0 0
Norway
State/province [26] 0 0
Oslo
Country [27] 0 0
Poland
State/province [27] 0 0
Wroclaw
Country [28] 0 0
Portugal
State/province [28] 0 0
Coimbra
Country [29] 0 0
Portugal
State/province [29] 0 0
Lisboa
Country [30] 0 0
Spain
State/province [30] 0 0
Barcelona

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Pfizer
Address
Country

Ethics approval
Ethics application status

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.
Trial website
https://clinicaltrials.gov/study/NCT00658359
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Pfizer CT.gov Call Center
Address 0 0
Pfizer
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/study/NCT00658359