| Study of a JAK3 Inhibitor for the Prevention of Acute Rejection in Kidney Transplant Patients |
| 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 |
| 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. |
| Not Provided |
| Interventional |
| Phase 2 |
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention |
| Kidney Transplantation |
- 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
|
- 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
|
| Not Provided |
| |
| Completed |
| 338 |
| April 2010 |
| February 2010 (Final data collection date for primary outcome measure) |
|
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
|
| Sexes Eligible for Study: |
All |
|
| 18 Years to 70 Years (Adult, Senior) |
| No |
| Contact information is only displayed when the study is recruiting subjects |
| Australia, Belgium, Brazil, Canada, Czech Republic, France, Germany, Italy, Korea, Republic of, Netherlands, Norway, Poland, Portugal, Spain, United States |
| |
| |
| NCT00483756 |
| A3921030 |
| Yes |
| Not Provided |
| Not Provided |
| Pfizer |
| Pfizer |
| Not Provided |
| Study Director: |
Pfizer CT.gov Call Center |
Pfizer |
|
| Pfizer |
| February 2013 |
