Conditions: Kidney Transplantation
Keywords: immunosuppression JAK3 inhibitor kidney transplant tofacitinib Xeljanz CP-690 550 tacromilus mycophenolate mofetil
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 46
Healthy volunteers: no

Brief summary:
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 study A3921009, kidney transplant patients were given a JAK inhibitor or tacrolimus for 6 months posttransplant. Patients who completed study A3921009 were offered the opportunity to participate in study A3921021 which will extend the evaluation of safety and efficacy of CP-690,550 versus tacrolimus through 8 years posttransplant. In treatment group 1 (control arm), subjects will continue to receive tacrolimus. In treatment groups 2 and 3, subjects will continue to receive CP-690,550. Per Amendment 4, the tacrolimus comparator arm will be discontinued.

Detailed description:

Arms:
arm 1: Standard of care arm 2: Treatment group 2 also receives mycophenolate mofetil arm 3: Treatment group 3 does not receive mycophenolate mofetil

Interventions: intervention 1: Tacrolimus intervention 2: CP-690,550 intervention 3: CP-690,550
Intervention descriptions: intervention 1: Standard of care intervention 2: CP-690,550 5 mg BID intervention 3: CP-690,550 10 mg BID

Protocol document: