Study Comparing Two Immunosuppressive Regimens in De Novo Renal Allograft Recipients

Phase 4

Completed

• Conditions: Graft Rejection; Kidney Failure; Kidney Transplantation

• Registration Number: NCT00261820
• Lead Sponsor: Wyeth is now a wholly owned subsidiary of Pfizer

Brief Summary

Evaluate renal graft function (based on the calculated Glomerular Filtration Rate) at 12 months after transplantation in patients receiving either a regimen of sirolimus plus mycophenolate mofetil following an antibody induction (RATG) or a standard regimen combining tacrolimus plus mycophenolate mofetil, both regimens including corticosteroids in patients undergoing renal allograft transplantation. In addition, the two treatment groups will be compared with respect to the incidence of acute rejection at 3, 6 and 12 months following transplantation, and the patient and graft survival at 6 and 12 months after transplantation. The safety of sirolimus plus mycophenolate mofetil following an antibody induction (ATG) will be evaluated beginning in the immediate post-operative period.

Detailed Description

Not available

Study Timeline

• Study Completion: 2005-01
• Study First Submitted: 2005-12-02
• Study First Submitted QC: 2005-12-02
• Study First Posted: 2005-12-05
• Status Verified: 2006-05
• Last Update Submitted: 2006-05-17
• Last Update Posted: 2006-05-19

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 160

Inclusion Criteria

• Age: 18 and < 65 years
• End-stage renal disease, with patients scheduled to receive a primary renal allograft from a cadaveric donor
• Patients receiving a second transplant without an immunological loss of their first graft in the first six months of transplant

Exclusion Criteria

• Evidence of active systemic or localized major infection at the time of initial sirolimus administration
• Evidence of infiltrate, cavitation, or consolidation on chest x-ray obtained during pre-study screening
• Use of any investigational drug or treatment up to 4 weeks prior to enrollment to the study and during the 12-month treatment phase

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
- Graft function as measured by Glomerular Filtration Rate (GFR) by Nankivell formula at Month 12 post-
transplantation.

Secondary Outcome Measures

Name	Time	Method
Incidence of occurrence of primary acute rejection biopsy confirmed by a local pathologist using the 1997 Banff
criteria at 3, 6 and 12 Months following transplantation
One year graft biopsy status
Incidence of document infection