Study Comparing Two Sirolimus Regimens vs. Tacrolimus and Mycophenolate Mofetil Regimen in Kidney Transplant Recipients
NCT00266123 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 420
Last updated 2007-12-27
Summary
To demonstrate the superiority of SRL + TAC elimination + corticosteroids (Group I) and SRL + MMF + corticosteroids (Group II) to TAC + MMF + corticosteroids (Group III) with respect to renal allograft function at month 12 post-transplantation.
Conditions
- Graft Rejection
- Kidney Failure
- Kidney Transplant
Interventions
- DRUG
-
Sirolimus
Sponsors & Collaborators
-
Wyeth is now a wholly owned subsidiary of Pfizer
lead INDUSTRY
Principal Investigators
-
Medical Monitor · Wyeth Reseach
-
Trial Manager · For Belgium, [email protected]
-
Trial Manager · For France, [email protected]
-
Trial Manager · For Germany, [email protected]
-
Trial Manager · For Italy, [email protected]
-
Trial Manager · For Poland, [email protected]
-
Trial Manager · For Spain, [email protected]
-
Trial Manager · For Switzerland, [email protected]
-
Trial Manager · For United Kingdom, [email protected]
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- PARALLEL
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2004-03-31
- Completion
- 2007-07-31
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