At a glance
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A Phase 2 Randomized, Multicenter, Active Comparator-Controlled Trial to Evaluate the Safety and Efficacy of Co-administration of CP-690,550 and Mycophenolate Mofetil / Mycophenolate Sodium in De Novo Renal Allograft Recipients
In Brief
A Phase 2 clinical trial evaluating Cyclosporine and CP-690,550 for Kidney Transplantation. Completed, enrolled 338 participants across 69 sites in 15 countries.
Detailed 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 this research study, a JAK3 inhibitor or cyclosporine will be given to new kidney transplant patients for 12 months. Patients will be assigned to one of three treatment groups after receiving a kidney transplant. Two of the treatment groups will receive 2 different dosing regimens of the JAK3 inhibitor that will be taken by mouth. The third treatment group will be a standard-of-care control arm. Patients will continue to take the assigned study medication for 12 months as well as other standard transplant medications such as prednisone.
Study Details
Timeline
Interventions
Standard of care
CP-690,550 15 mg BID for Months 1-6, then 10 mg BID for Months 7-12
CP-690,550 15 mg BID for Months 1-3, then 10 mg BID for Months 4-12