A Study Of CP-690,550 In Stable Kidney Transplant Patients

Phase 1, Placebo-controlled, Randomized, Sequential, Parallel-group, Dose Escalation Study to Evaluate 28-day Multiple Dose Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of CP-690,550 in Stable Renal Allograft Recipients

This was a Phase 1 dose escalation study to evaluate the safety, tolerability and pharmacokinetics of 28-day treatment of CP-690,550 in stable renal allograft recipients. In Stage 1, ascending doses of CP-690,550 were to be administered sequentially to 3-4 cohorts of subjects. After Stage 1, one dose level was to be selected for dosing in an expanded cohort in Stage 2.

Inclusion Criteria:

• Medically stable kidney transplant patients 6 or more months after transplantation.
• Subjects must be on mycophenolate mofetil 1-2 gm daily
• In Cohort 3 (and 4, if conducted) in Stage 1 and the expanded cohort in Stage 2, subjects must be on a calcineurin inhibitor-free regimen.

Exclusion Criteria:

• Any rejection episodes in the preceding 3 months.
• Treated with Thymoglobulin or OKT3 for acute rejection in the past 6 months.