NCT00254709
Completed
Phase 4
Open, Pilot, Comparative Study to Evaluate the Efficacy and Safety of Two Immunosuppressor Regimens, Anti Il-2, Sirolimus Mycophenolate, Mophetyl and Steroids Versus Sirolimus, Cyclosporine, and Withdrawal of Cyclosporine Since the Third Month and Steroids in Elderly Population
Wyeth is now a wholly owned subsidiary of Pfizer0 sites66 target enrollmentOctober 2002
DrugsSirolimus
Overview
- Phase
- Phase 4
- Intervention
- Not specified
- Conditions
- Kidney Failure
- Sponsor
- Wyeth is now a wholly owned subsidiary of Pfizer
- Enrollment
- 66
- Primary Endpoint
- Renal function at 3 and 12 months; measured by Cockroft-Gault formula or serum creatinine
- Status
- Completed
- Last Updated
- 14 years ago
Overview
Brief Summary
The purpose of this study is to test two different sirolimus-based immunosuppressive regimens for elderly kidney transplant recipients.
Investigators
Eligibility Criteria
Inclusion Criteria
- •End stage renal disease
- •Kidney transplantation
- •Both donor and recipient older than 60 years
Exclusion Criteria
- •Prior or concurrent transplant of any organ other than the kidney
- •Current clinically significant infections
Outcomes
Primary Outcomes
Renal function at 3 and 12 months; measured by Cockroft-Gault formula or serum creatinine
Secondary Outcomes
- Time to recover renal function (creatinine< 2 mg/dl)
- Incidence of acute rejections at 3 and 12 months
- Patient and graft survival at 3 and 12 months
- Incidence and duration of episodes of acute tubular necrosis
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