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A Study to Assess the Safety and Efficacy of Alefacept in Kidney Transplant Recipients
Official Title:
A Phase 2, Randomized, Open-Label, Parallel Group, Multi-Center Study to Assess the Safety and Efficacy of Alefacept in de Novo Kidney Transplant RecipientsBasic Trial Information
| Phase | Type | Age | Sponsor | Protocol IDs | Status |
|---|---|---|---|---|---|
| Phase 2 | Interventional | 18 Years and older | Astellas Pharma Inc |
0485-CL-U201 NCT00543569 |
Recruiting |
Study Design:
Treatment, 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 study to assess the safety and efficacy of Alefacept in de novo kidney transplant
patients.
Eligibility
Inclusion Criteria:
- Subject is anticipated to receive first oral dose of tacrolimus within 48 hours of
transplant procedure - Subject is a recipient of a de novo kidney transplant
- Subject is a recipient of a kidney from a non-HLA identical related living donor, a
non-related living donor, or a deceased donor
Exclusion Criteria:
- Subject has a screening (pre-operative)estimated CD4+ T cell count of <250 cells/uL
- Subject will receive a kidney with an anticipated cold ischemia time (CIT) of > 30
hours - Recipient has a positive T or B cell cross match by investigational site's standard
method of determination - Subject will receive a kidney from a 50-65 year old deceased donor with one of the
following:
- History of hypertension and a terminal serum creatinine > 1.5 mg/dl
- Cerebrovascular accident as cause of death and a terminal serum creatinine > 1.5
mg/dl
- History of hypertension and cerebrovascular accident as cause of death and a
terminal serum creatinine > 1.5 mg/dl
Detailed Description
This is a 4 arm (all active) study to determine the safety and efficacy of Alefacept in de
novo kidney transplant recipients.
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:
JoAnn Zlatunich, RN
(415) 353-8380
JoAnn.Zlatunich@ucsfmedctr.org