Extension Study Of Stage 1 Subjects Of Study A3921009 For The Prevention Of Acute Rejection In Kidney Transplant Patient

A Multicenter, Phase 2, Open-label, Controlled, Extension Study For Stage 1 Subjects Of Study A3921009 To Evaluate The Long-term Safety And Efficacy Of Cp-690,550 Versus Tacrolimus, When Co-administered With Mycophenolate Mofetil In 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 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.

Inclusion Criteria:

• Enrollment in Stage 1 of Study A3921009 and have completed 6-months of treatment with trial medications (CP-690,550 or tacrolimus)
• Recipient of a first-time kidney transplant

Exclusion Criteria:

• Subject with any untreated condition that may affect drug absorption (eg, gastrectomy or clinically significant diabetic gastroenteropathy).
• Subjects who are on the waiting list for a second kidney transplant or any non-renal organ transplants.