Conditions: Kidney Transplantation
Keywords: Immunosuppression JAK3 inhibitor kidney transplantation.
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 338
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 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.

Detailed description:

Arms:
arm 1: Treatment Arm 1 will also receive standard of care medications arm 2: Treatment Arm 2 will also receive standard of care medications arm 3: Treatment Arm 3 will also receive standard of care medications

Interventions: intervention 1: Cyclosporine intervention 2: CP-690,550 intervention 3: CP-690,550
Intervention descriptions: intervention 1: Standard of care intervention 2: CP-690,550 15 mg BID for Months 1-6, then 10 mg BID for Months 7-12 intervention 3: CP-690,550 15 mg BID for Months 1-3, then 10 mg BID for Months 4-12

Protocol document: