Trial record 1 of 1 for:    NCT00483756
Previous Study | Return to List | Next Study

Study of a JAK3 Inhibitor for the Prevention of Acute Rejection in Kidney Transplant Patients

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Pfizer
ClinicalTrials.gov Identifier:
NCT00483756
First received: June 6, 2007
Last updated: February 8, 2013
Last verified: February 2013
Results First Received: December 3, 2012  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Open Label;   Primary Purpose: Prevention
Condition: Kidney Transplantation
Interventions: Drug: Cyclosporine
Drug: CP-690,550

  Participant Flow
  Hide Participant Flow

Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
No text entered.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
Initially 7 participants were enrolled and randomized under original protocol but enrollment was terminated because 2 participants developed Grade 2B rejection. Protocol amendment 1 was implemented to increase aggregate level of immunosuppression and 331 participants were enrolled. Results of participants enrolled under amendment 1 are reported.

Reporting Groups
  Description
Cyclosporine Cyclosporine (CsA) microemulsion at a starting dose of 8 to 10 milligram per kilogram per day (mg/kg/day) orally twice daily in 2 equal doses for 12 months. Dosages were adjusted according to trough whole blood level and standard institutional practice. Participants also received mycophenolate mofetil tablet 1 gram orally twice daily (up to 1.5 gram orally twice daily in Black participants) for 12 months.
CP-690,550 15 mg for Months 1 to 6 CP-690,550 15 milligram (mg) tablet orally twice daily for Month 1 to 6, then 10 mg tablet orally twice daily for Month 7 to 12. Participants also received mycophenolate mofetil 1 gram tablet orally twice daily for 12 months.
CP-690,550 15 mg for Months 1 to 3 CP-690,550 15 mg tablet orally twice daily for Month 1 to 3, then 10 mg tablet orally twice daily for Month 4 to 12. Participants also received mycophenolate mofetil 1 gram tablet orally twice daily for 12 months.

Participant Flow:   Overall Study
    Cyclosporine     CP-690,550 15 mg for Months 1 to 6     CP-690,550 15 mg for Months 1 to 3  
STARTED     110     110     111  
Treated     109     106     107  
COMPLETED     77     60     59  
NOT COMPLETED     33     50     52  
Death                 2                 0                 1  
Adverse Event                 19                 38                 40  
Lack of Efficacy                 1                 0                 0  
Lost to Follow-up                 3                 1                 0  
Withdrawal by Subject                 5                 3                 4  
Unspecified                 2                 4                 3  
Randomized, Not Treated                 1                 4                 4  



  Baseline Characteristics
  Hide Baseline Characteristics

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
Cyclosporine Cyclosporine (CsA) microemulsion at a starting dose of 8 to 10 milligram per kilogram per day (mg/kg/day) orally twice daily in 2 equal doses for 12 months. Dosages were adjusted according to trough whole blood level and standard institutional practice. Participants also received mycophenolate mofetil tablet 1 gram orally twice daily (up to 1.5 gram orally twice daily in Black participants) for 12 months.
CP-690,550 15 mg for Months 1 to 6 CP-690,550 15 milligram (mg) tablet orally twice daily for Month 1 to 6, then 10 mg tablet orally twice daily for Month 7 to 12. Participants also received mycophenolate mofetil 1 gram tablet orally twice daily for 12 months.
CP-690,550 15 mg for Months 1 to 3 CP-690,550 15 mg tablet orally twice daily for Month 1 to 3, then 10 mg tablet orally twice daily for Month 4 to 12. Participants also received mycophenolate mofetil 1 gram tablet orally twice daily for 12 months.
Total Total of all reporting groups

Baseline Measures
    Cyclosporine     CP-690,550 15 mg for Months 1 to 6     CP-690,550 15 mg for Months 1 to 3     Total  
Number of Participants  
[units: participants]
  109     106     107     322  
Age, Customized  
[units: participants]
       
18 to 44 Years     45     43     46     134  
45 to 64 Years     57     54     56     167  
Greater Than or Equal to (>=) 65 Years     7     9     5     21  
Gender  
[units: participants]
       
Female     39     24     27     90  
Male     70     82     80     232  



  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Number of Participants With First Clinical Biopsy Proven Acute Rejection (BPAR) Episode 6 Months Post-Transplant   [ Time Frame: Baseline up to Month 6 ]

2.  Primary:   Glomerular Filtration Rate (GFR) at Month 12   [ Time Frame: 2, 3, 4, and 5 hrs post iohexol intravenous bolus at Month 12 ]

3.  Secondary:   Glomerular Filtration Rate (GFR) at Month 6   [ Time Frame: 2, 3, 4, and 5 hrs post iohexol intravenous bolus at Month 6 ]

4.  Secondary:   Number of Participants With Progression of Chronic Allograft Lesions at Month 12   [ Time Frame: Month 12 ]

5.  Secondary:   Number of Participants With First Clinical Biopsy Proven Acute Rejection (BPAR) 12 Months Post Transplant   [ Time Frame: Baseline up to Month 12 ]

6.  Secondary:   Number of Participants With Treated Clinical Acute Rejection   [ Time Frame: Month 6, 12 ]

7.  Secondary:   Number of Participants With Combined Banff Rejection Categories (Categories 2, 3, and 4)   [ Time Frame: Month 6, 12 ]

8.  Secondary:   Number of Participants With Graft Loss   [ Time Frame: Month 6, 12 ]

9.  Secondary:   Number of Participants With Efficacy Failure   [ Time Frame: Month 6, 12 ]

10.  Secondary:   Number of Participants Who Died   [ Time Frame: Month 6, 12 ]

11.  Secondary:   Lymphocyte Subset   [ Time Frame: Month 1, 3, 6, 12 ]

12.  Secondary:   Glomerular Filtration Rate (GFR) by The Nankivell Equation   [ Time Frame: Month 1, 3, 6, 9, 12 ]

13.  Secondary:   Glomerular Filtration Rate (GFR) by The Cockcroft-Gault Equation   [ Time Frame: Month 1, 3, 6, 9, 12 ]

14.  Secondary:   Glomerular Filtration Rate (GFR) by The Modification of Diet in Renal Disease (MDRD) Equation   [ Time Frame: Month 1, 3, 6, 9, 12 ]

15.  Secondary:   Glomerular Filtration Rate (GFR) by The Abbreviated Modification of Diet in Renal Disease (MDRD) Equation   [ Time Frame: Month 1, 3, 6, 9, 12 ]

16.  Secondary:   Number of Participants With Clinically Significant Infections   [ Time Frame: Baseline up to Month 12 ]

17.  Secondary:   36-Item Short-Form Health Survey (SF-36)   [ Time Frame: Baseline, Month 6, 12 ]

18.  Secondary:   End-Stage Renal Disease Symptom Checklist Transplantation Module (ESRD-SCL)   [ Time Frame: Baseline, Month 6, 12 ]

19.  Secondary:   Severity of Dyspepsia Assessment (SODA)   [ Time Frame: Baseline, Month 6, 12 ]

20.  Secondary:   Population Pharmacokinetics (PK)   [ Time Frame: 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 ]
Results not yet posted.   Anticipated Posting Date:   No text entered.   Safety Issue:   No


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
  Hide Limitations and Caveats

Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
No text entered.


  More Information
  Hide More Information

Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
The agreement is:
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.


Results Point of Contact:  
Name/Title: Pfizer ClinicalTrials.gov Call Center
Organization: Pfizer, Inc.
phone: 1-800-718-1021
e-mail: ClinicalTrials.gov_Inquiries@pfizer.com


No publications provided


Responsible Party: Pfizer
ClinicalTrials.gov Identifier: NCT00483756     History of Changes
Other Study ID Numbers: A3921030
Study First Received: June 6, 2007
Results First Received: December 3, 2012
Last Updated: February 8, 2013
Health Authority: United States: Food and Drug Administration