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Study of 2 Dose Levels of a JAK3 Inhibitor for the Prevention of Acute Rejection in Kidney Transplant Patients
Official Title:
A 6-Month, Phase 2, Multicenter, Randomized, Open-Label, Comparative Study of 2 Dose Levels of CP-690,550 Administered Concomitantly With il-2 Receptor Antagonist Induction Therapy, Mycophenolate Mofetil and Corticosteroids Versus a Tacrolimus-Based Immunosuppressive Regimen for the Prevention of Allograft Rejection in de Novo Renal Allograft RecipientsBasic Trial Information
| Phase | Type | Age | Sponsor | Protocol IDs | Status |
|---|---|---|---|---|---|
| Phase 2 | Interventional | 18 - 70 Years | Pfizer |
A3921009 NCT00106639 |
Active, but closed to enrollment |
Study Design:
Prevention, Randomized, Open Label, Active Control, 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 tacrolimus will be given to new kidney transplant
patients for 6 months. Patients who respond well will be offered the opportunity to
participate in an additional study to receive the JAK3 inhibitor or tacrolimus long-term.
There will be 2 stages of enrollment in this study. In both stages of this research study,
patients will be assigned to one of three treatment groups from the day after receiving a
kidney transplant. Two of the treatment groups will be 2 different dose levels of the JAK3
inhibitor that will be taken by mouth. The third treatment group will be twice daily
tacrolimus (Prograf). Patients will continue to take the assigned study medication (JAK3
inhibitor or tacrolimus) for 6 months as well as other standard transplant medications such
as Cellcept and 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:
Esterlina Gurion, RN
415-353-8380
Esterlina.Gurion@ucsfmedctr.org