NCT00507793
Completed
Phase 4
An Open-Label Study to Evaluate the Efficacy and Safety of Cyclosporine Reduction in de Novo Renal Allograft Recipients Receiving Sirolimus: a Dose Comparative Study
Wyeth is now a wholly owned subsidiary of Pfizer0 sites385 target enrollmentApril 2000
ConditionsKidney Transplantation
Overview
- Phase
- Phase 4
- Intervention
- Not specified
- Conditions
- Kidney Transplantation
- Sponsor
- Wyeth is now a wholly owned subsidiary of Pfizer
- Enrollment
- 385
- Primary Endpoint
- A dose response model using the average cyclosporine blood levels correlated to graft rejection rates and renal function will be used to compare efficacy and safety of different doses of cyclosporine.
- Status
- Completed
- Last Updated
- 18 years ago
Overview
Brief Summary
To evaluate the safety and efficacy of different doses of cyclosporine given concomitantly with a fixed dose of sirolimus in kidney transplant recipients.
Detailed Description
To evaluate the safety and efficacy of different doses of cyclosporine given concomitantly with a fixed dose of sirolimus in kidney transplant recipients. Cyclosporine blood levels, graft rejection rates and renal function will be assessed.
Investigators
Eligibility Criteria
Inclusion Criteria
- Not provided
Exclusion Criteria
- Not provided
Outcomes
Primary Outcomes
A dose response model using the average cyclosporine blood levels correlated to graft rejection rates and renal function will be used to compare efficacy and safety of different doses of cyclosporine.
Secondary Outcomes
- Safety evaluations will include physical exams, vital signs, CBC with differential, platelet count, blood chemistries, fasting lipid profiles, BUN or urea, serum creatinine, adverse event monitoring and calculated creatinine clearance.
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