Conditions: Kidney Transplant
Keywords: CP-690,550 kidney transplant
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 28
Healthy volunteers: no

Brief summary:
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.

Detailed description:

Arms:
arm 1: None arm 2: None arm 3: None arm 4: None

Interventions: intervention 1: Placebo intervention 2: CP-690,550 5 mg BID intervention 3: CP-690,550 15 mg BID intervention 4: CP-690,550 30 mg BID
Intervention descriptions: intervention 1: Placebo tables twice daily (BID) for 28 days intervention 2: CP-690,550 5 mg BID for 28 days intervention 3: CP-690,550 15 mg BID for 28 days intervention 4: CP-690,550 30 mg BID for 28 days

Protocol document: