| Study of a JAK3 Inhibitor for the Prevention of Acute Rejection in Kidney Transplant Patients
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| 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
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| A new immunosuppressive drug, based on the inhibition of an important enzyme in the immune system called JAK3, is being developed by Pfizer to prevent transplant rejection. In this research study, a JAK3 inhibitor or cyclosporine will be given to new kidney transplant patients for 12 months. Patients will be assigned to one of three treatment groups after receiving a kidney transplant. Two of the treatment groups will receive 2 different dosing regimens of the JAK3 inhibitor that will be taken by mouth. The third treatment group will be a standard-of-care control arm. Patients will continue to take the assigned study medication for 12 months as well as other standard transplant medications such as prednisone.
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| Not Provided
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| Interventional
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| Phase 2
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Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
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| Kidney Transplantation
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- Drug: Cyclosporine
Standard of care
- Drug: CP-690,550
CP-690,550 15 mg BID for Months 1-6, then 10 mg BID for Months 7-12
- Drug: CP-690,550
CP-690,550 15 mg BID for Months 1-3, then 10 mg BID for Months 4-12
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- Active Comparator: 1
Treatment Arm 1 will also receive standard of care medications
Intervention: Drug: Cyclosporine
- Experimental: 2
Treatment Arm 2 will also receive standard of care medications
Intervention: Drug: CP-690,550
- Experimental: 3
Treatment Arm 3 will also receive standard of care medications
Intervention: Drug: CP-690,550
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| Not Provided
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| |
| Completed
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| 338
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| 300
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| April 2010
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| February 2010 (Final data collection date for primary outcome measure)
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Inclusion Criteria:
- Recipient of a first-time kidney transplant
- Between the ages of 18 and 70 years, inclusive
Exclusion Criteria:
- Recipient of any non-kidney transplant
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| Sexes Eligible for Study: |
All |
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| 18 Years to 70 Years (Adult, Older Adult)
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| No
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Contact information is only displayed when the study is recruiting subjects
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| Australia, Belgium, Brazil, Canada, Czech Republic, France, Germany, Italy, Korea, Republic of, Netherlands, Norway, Poland, Portugal, Spain, United States
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| NCT00483756
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| A3921030
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| Yes
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| Not Provided
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| Not Provided
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| Pfizer
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| Pfizer
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| Not Provided
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| Study Director: |
Pfizer CT.gov Call Center |
Pfizer |
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| Pfizer
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| February 2013
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