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Study of a JAK3 Inhibitor for the Prevention of Acute Rejection in Kidney Transplant Patients
Official Title:
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 RecipientsBasic Trial Information
| Phase | Type | Age | Sponsor | Protocol IDs | Status |
|---|---|---|---|---|---|
| Phase 2 | Interventional | 18 - 70 Years | Pfizer |
A3921030 NCT00483756 |
Active, but closed to enrollment |
Study Design:
Prevention, Randomized, Open Label, Parallel Assignment, Safety/Efficacy StudyPrincipal Investigator
Flavio Vincenti, M.D.
Professor of Clinical Medicine
Division of Nephrology
Departments of Medicine and Surgery
Trial 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.
Eligibility
Inclusion Criteria:
- Recipient of a first-time kidney transplant
- Between the ages of 18 and 70 years, inclusive
Exclusion Criteria:
- Recipient of any non-kidney transplant
Important
Final eligibility is determined by the health professionals conducting the trial and the protocol approved by the Committee on Human Resources (CHR) at the University of California, San Francisco (UCSF). The Patient Consent Form for this trial is available upon request. For more information about this trial, please see the full posting at ClinicalTrials.gov.
For More Information
For questions about this trial or eligibility, contact:
Clarina Mendoza, RN
(415) 353-8380
Clarina.Mendoza@ucsfmedctr.org