Study Of JAK3 Inhibitor For The Prevention Of Acute Rejection In Kidney Transplant Patients
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 in addition to other standard transplant medications such as prednisone.
|Study Design:||Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
|Official Title:||A Pilot Randomized, Multicenter, Open-Label, Active Comparator-Controlled Trial Of A CP-690,550-Based Regimen In De Novo Kidney Allograft Recipients|
- Clinical biopsy proven acute rejection rate at 6 months [ Time Frame: 6 months ] [ Designated as safety issue: No ]
- Pharmacokinetics of CP-690,550 [ Time Frame: 12 months ] [ Designated as safety issue: No ]
- Lymphocyte subsets [ Time Frame: 12 months ] [ Designated as safety issue: No ]
- Posttransplant humoral alloreactivity [ Time Frame: 12 months ] [ Designated as safety issue: No ]
- Safety and tolerability of CP-690,550 [ Time Frame: 12 months ] [ Designated as safety issue: Yes ]
|Study Start Date:||August 2007|
Active Comparator: Treatment Arm 1
Treatment Arm 1 will also receive standard of care medications.
Standard of care
Experimental: Treatment Arm 2
Treatment Arm 2 will also receive select standard of care medications.
CP-690550 20 mg BID in Months 1-6 then 15 mg BID in Months 7-12