Study Comparing Cyclosporin Dose Reduction With Cyclosporin Elimination in Kidney Transplant Recipients Taking Sirolimus
NCT00248313 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 470
Last updated 2010-03-10
Summary
To assess equivalence in the rates of functional graft survival at 12 months after transplantation in patients receiving induction therapy with cyclosporin (CsA, Neoral) and Rapamune® followed by CsA dose reduction and concentration-controlled Rapamune® versus induction with CsA and Rapamune® followed by discontinuation of CsA and concentration-controlled Rapamune®.
Conditions
Interventions
- DRUG
-
Rapamune®
Sponsors & Collaborators
-
Wyeth is now a wholly owned subsidiary of Pfizer
lead INDUSTRY
Principal Investigators
-
Medical Monitor, MD · Wyeth is now a wholly owned subsidiary of Pfizer
Study Design
- Allocation
- RANDOMIZED
- Purpose
- PREVENTION
- Masking
- NONE
- Model
- PARALLEL
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2000-07-31
- Completion
- 2007-10-31
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