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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT00483756




Registration number
NCT00483756
Ethics application status
Date submitted
6/06/2007
Date registered
7/06/2007
Date last updated
14/03/2013

Titles & IDs
Public title
Study of a JAK3 Inhibitor for the Prevention of Acute Rejection in Kidney Transplant Patients
Scientific title
A Phase 2 Randomized, Multicenter, Active Comparator-Controlled Trial to Evaluate the Safety and Efficacy of Co-administration of CP-690,550 and Mycophenolate Mofetil / Mycophenolate Sodium in De Novo Renal Allograft Recipients
Secondary ID [1] 0 0
A3921030
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: 1 - Treatment Arm 1 will also receive standard of care medications

Experimental: 2 - Treatment Arm 2 will also receive standard of care medications

Experimental: 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 15 mg BID for Months 1-6, then 10 mg BID for Months 7-12

Treatment: Drugs: CP-690,550
CP-690,550 15 mg BID for Months 1-3, then 10 mg BID for Months 4-12
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Number of Participants With First Clinical Biopsy Proven Acute Rejection (BPAR) Episode 6 Months Post-Transplant
Timepoint [1] 0 0
Baseline up to Month 6
Primary outcome [2] 0 0
Glomerular Filtration Rate (GFR) at Month 12
Timepoint [2] 0 0
2, 3, 4, and 5 hrs post iohexol intravenous bolus at Month 12
Secondary outcome [1] 0 0
Glomerular Filtration Rate (GFR) at Month 6
Timepoint [1] 0 0
2, 3, 4, and 5 hrs post iohexol intravenous bolus at Month 6
Secondary outcome [2] 0 0
Number of Participants With Progression of Chronic Allograft Lesions at Month 12
Timepoint [2] 0 0
Month 12
Secondary outcome [3] 0 0
Number of Participants With First Clinical Biopsy Proven Acute Rejection (BPAR) 12 Months Post Transplant
Timepoint [3] 0 0
Baseline up to Month 12
Secondary outcome [4] 0 0
Number of Participants With Treated Clinical Acute Rejection
Timepoint [4] 0 0
Month 6, 12
Secondary outcome [5] 0 0
Number of Participants With Combined Banff Rejection Categories (Categories 2, 3, and 4)
Timepoint [5] 0 0
Month 6, 12
Secondary outcome [6] 0 0
Number of Participants With Graft Loss
Timepoint [6] 0 0
Month 6, 12
Secondary outcome [7] 0 0
Number of Participants With Efficacy Failure
Timepoint [7] 0 0
Month 6, 12
Secondary outcome [8] 0 0
Number of Participants Who Died
Timepoint [8] 0 0
Month 6, 12
Secondary outcome [9] 0 0
Lymphocyte Subset
Timepoint [9] 0 0
Month 1, 3, 6, 12
Secondary outcome [10] 0 0
Population Pharmacokinetics (PK)
Timepoint [10] 0 0
Pre-dose-2(P-2), Pre-dose(P), 0.5,1,2 hr post-dose(PD) on Day14, Month(M) 3; P,1,2 hr PD on M1; P, 0.5, 2, 4 hr PD on M6; P-2, P, 0.5 hr PD on M9, M12 as per randomization in CP-690,550 treated; P on M3 and P, 2, 4 hr PD on M6 in CsA treated participants
Secondary outcome [11] 0 0
Glomerular Filtration Rate (GFR) by The Nankivell Equation
Timepoint [11] 0 0
Month 1, 3, 6, 9, 12
Secondary outcome [12] 0 0
Glomerular Filtration Rate (GFR) by The Cockcroft-Gault Equation
Timepoint [12] 0 0
Month 1, 3, 6, 9, 12
Secondary outcome [13] 0 0
Glomerular Filtration Rate (GFR) by The Modification of Diet in Renal Disease (MDRD) Equation
Timepoint [13] 0 0
Month 1, 3, 6, 9, 12
Secondary outcome [14] 0 0
Glomerular Filtration Rate (GFR) by The Abbreviated Modification of Diet in Renal Disease (MDRD) Equation
Timepoint [14] 0 0
Month 1, 3, 6, 9, 12
Secondary outcome [15] 0 0
Number of Participants With Clinically Significant Infections
Timepoint [15] 0 0
Baseline up to Month 12
Secondary outcome [16] 0 0
36-Item Short-Form Health Survey (SF-36)
Timepoint [16] 0 0
Baseline, Month 6, 12
Secondary outcome [17] 0 0
End-Stage Renal Disease Symptom Checklist Transplantation Module (ESRD-SCL)
Timepoint [17] 0 0
Baseline, Month 6, 12
Secondary outcome [18] 0 0
Severity of Dyspepsia Assessment (SODA)
Timepoint [18] 0 0
Baseline, Month 6, 12

Eligibility
Key inclusion criteria
* Recipient of a first-time kidney transplant
* Between the ages of 18 and 70 years, inclusive
Minimum age
18 Years
Maximum age
70 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
* Recipient of any non-kidney transplant

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
1/08/2007
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
1/04/2010
Sample size
Target
Accrual to date
Final
338
Recruitment in Australia
Recruitment state(s)
NSW,SA,VIC
Recruitment hospital [1] 0 0
Pfizer Investigational Site - Camperdown
Recruitment hospital [2] 0 0
Pfizer Investigational Site - Westmead
Recruitment hospital [3] 0 0
Pfizer Investigational Site - Adelaide
Recruitment hospital [4] 0 0
Pfizer Investigational Site - Woodville
Recruitment hospital [5] 0 0
Pfizer Investigational Site - Clayton
Recruitment hospital [6] 0 0
Pfizer Investigational Site - 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
3168 - Clayton
Recruitment postcode(s) [6] 0 0
3050 - Parkville
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
Arkansas
Country [2] 0 0
United States of America
State/province [2] 0 0
California
Country [3] 0 0
United States of America
State/province [3] 0 0
Colorado
Country [4] 0 0
United States of America
State/province [4] 0 0
Connecticut
Country [5] 0 0
United States of America
State/province [5] 0 0
Florida
Country [6] 0 0
United States of America
State/province [6] 0 0
Illinois
Country [7] 0 0
United States of America
State/province [7] 0 0
Maryland
Country [8] 0 0
United States of America
State/province [8] 0 0
Massachusetts
Country [9] 0 0
United States of America
State/province [9] 0 0
Michigan
Country [10] 0 0
United States of America
State/province [10] 0 0
Minnesota
Country [11] 0 0
United States of America
State/province [11] 0 0
Missouri
Country [12] 0 0
United States of America
State/province [12] 0 0
New Jersey
Country [13] 0 0
United States of America
State/province [13] 0 0
New York
Country [14] 0 0
United States of America
State/province [14] 0 0
North Carolina
Country [15] 0 0
United States of America
State/province [15] 0 0
Oregon
Country [16] 0 0
United States of America
State/province [16] 0 0
Pennsylvania
Country [17] 0 0
United States of America
State/province [17] 0 0
South Carolina
Country [18] 0 0
United States of America
State/province [18] 0 0
Texas
Country [19] 0 0
Belgium
State/province [19] 0 0
Anderlecht
Country [20] 0 0
Belgium
State/province [20] 0 0
Leuven
Country [21] 0 0
Brazil
State/province [21] 0 0
RS
Country [22] 0 0
Brazil
State/province [22] 0 0
SP
Country [23] 0 0
Canada
State/province [23] 0 0
Alberta
Country [24] 0 0
Czech Republic
State/province [24] 0 0
Praha 4
Country [25] 0 0
France
State/province [25] 0 0
Nantes
Country [26] 0 0
France
State/province [26] 0 0
Paris Cedex 15
Country [27] 0 0
France
State/province [27] 0 0
Toulouse Cedex 9
Country [28] 0 0
France
State/province [28] 0 0
Vandoeuvre Les Nancy
Country [29] 0 0
Germany
State/province [29] 0 0
Berlin
Country [30] 0 0
Germany
State/province [30] 0 0
Hamburg
Country [31] 0 0
Italy
State/province [31] 0 0
Bologna
Country [32] 0 0
Italy
State/province [32] 0 0
Roma
Country [33] 0 0
Korea, Republic of
State/province [33] 0 0
Seoul
Country [34] 0 0
Netherlands
State/province [34] 0 0
Rotterdam
Country [35] 0 0
Norway
State/province [35] 0 0
Oslo
Country [36] 0 0
Poland
State/province [36] 0 0
Warszawa
Country [37] 0 0
Poland
State/province [37] 0 0
Wroclaw
Country [38] 0 0
Portugal
State/province [38] 0 0
Coimbra
Country [39] 0 0
Portugal
State/province [39] 0 0
Lisboa
Country [40] 0 0
Spain
State/province [40] 0 0
Barcelona

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

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
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

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/NCT00483756