Conditions: Kidney Transplantation
Keywords: tofacitinib CP-690550 kidney transplant
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 61
Healthy volunteers: no

Brief summary:
This Phase 2 study was designed to evaluate the safety and efficacy of 2 dose levels of CP-690,550 (15 mg twice daily and 30 mg twice) against tacrolimus, in combination with basiliximab induction, mycophenolate mofetil and corticosteroids, in kidney transplant patients. Stage 1 was to randomize approximately 54 subjects. After all Stage 1 subjects had completed 6 months of treatment, Stage 2 was to randomize an additional 195 subjects to the same treatment groups.

Detailed description:

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

Interventions: intervention 1: CP-690,550 intervention 2: CP-690,550 intervention 3: tacrolimus
Intervention descriptions: intervention 1: 15 mg twice daily intervention 2: 30 mg twice daily intervention 3: dose adjusted according to level

Protocol document: