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Trial record 1 of 1 for:    NCT00483756
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Study of a JAK3 Inhibitor for the Prevention of Acute Rejection in Kidney Transplant Patients

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00483756
First Posted: June 7, 2007
Last Update Posted: March 14, 2013
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 evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Pfizer
Results First Submitted: December 3, 2012  
Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Prevention
Condition: Kidney Transplantation
Interventions: Drug: Cyclosporine
Drug: CP-690,550

  Participant Flow
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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 
Other                2                4                3 
Randomized, Not Treated                1                4                4 



  Baseline Characteristics
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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 
Overall Participants Analyzed 
[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 reported.   Anticipated Reporting Date:   No text entered.  


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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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
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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



Responsible Party: Pfizer
ClinicalTrials.gov Identifier: NCT00483756     History of Changes
Other Study ID Numbers: A3921030
First Submitted: June 6, 2007
First Posted: June 7, 2007
Results First Submitted: December 3, 2012
Results First Posted: March 14, 2013
Last Update Posted: March 14, 2013