Study Evaluating the Efficacy and Safety of Cyclosporine Reduction in Kidney Transplant Recipients Receiving Sirolimus

Phase 4

Completed

• Conditions: Kidney Transplantation

• Registration Number: NCT00507793
• Lead Sponsor: Wyeth is now a wholly owned subsidiary of Pfizer

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.

Study Timeline

• Study Start: 2000-04
• Study Completion: 2002-06
• Status Verified: 2007-07
• Study First Submitted: 2007-07-26
• Study First Submitted QC: 2007-07-26
• Last Update Submitted: 2007-07-26
• Study First Posted: 2007-07-27
• Last Update Posted: 2007-07-27

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 385

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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.