Study Evaluating Cyclosporine Dose Reduction and Cyclosporine Elimination in Chinese Kidney Transplants

Phase 1

Completed

• Conditions: Kidney Transplant

• Registration Number: NCT00257387
• Lead Sponsor: Wyeth is now a wholly owned subsidiary of Pfizer

Brief Summary

Evaluate the incidence of acute rejection at 12 months after transplantation in subjects receiving induction therapy with cyclosporine microemulsion (CsA) and Rapamune followed by CsA dose reduction (Phase I) with subjects receiving induction therapy with CsA and Rapamune followed by CsA discontinuation (Phase II) in Chinese de novo renal allograft recipients.

Detailed Description

Not available

Study Timeline

• Study Start: 2004-06
• Study First Submitted: 2005-11-04
• Study First Submitted QC: 2005-11-21
• Study First Posted: 2005-11-22
• Study Completion: 2006-08
• Status Verified: 2007-06
• Last Update Submitted: 2011-02-01
• Last Update Posted: 2011-02-02

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 120

Inclusion Criteria

• Subjects with end-stage renal disease scheduled to receive a primary renal allograft from a cadaveric donor, from a living-unrelated donor, or a living-related HLA-mismatched donor.
• Subjects must be at least 18 years of age.

Exclusion Criteria

• Subjects with active major infection, including active hepatitis B or C infection, HIV, decreased platelets, elevated lipids, or multiple organ transplants.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
The incidence and severity of acute rejection in renal allograft recipients at 6 months post-transplantation.

Secondary Outcome Measures

Name	Time	Method
To evaluate the treatment groups with respect to incidence of adverse events, renal function, subject and graft survival at 6 and 12 months, and the incidence and severity of acute rejection at 12 months post-transplantation.