Study Comparing Conversion to Sirolimus vs. Continued Use of Calcineurin Inhibitors in Kidney Transplant Recipients

Phase 3

Completed

• Conditions: Renal Transplantation
• Interventions: Drug: Sirolimus; Drug: tacrolimus; Drug: Cyclosporine A

• Registration Number: NCT00038948
• Lead Sponsor: Wyeth is now a wholly owned subsidiary of Pfizer

Brief Summary

The purpose of this study is to determine the effect of conversion from calcineurin inhibitor to sirolimus based therapy on renal function.

Detailed Description

Not available

Study Timeline

• Study Start: 2002-01
• Study First Submitted: 2002-06-05
• Study First Submitted QC: 2002-06-06
• Study First Posted: 2002-06-07
• Primary Completion: 2008-05
• Study Completion: 2008-05
• Results First Submitted: 2009-05-29
• Status Verified: 2010-04
• Results First Submitted QC: 2010-04-22
• Last Update Submitted: 2010-04-22
• Results First Posted: 2010-05-14
• Last Update Posted: 2010-05-14

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 830

Inclusion Criteria

• Age greater than or equal to 13 years.
• Receiving CsA or tacrolimus from the time of transplantation or within 2 weeks thereafter
• Patients with a functioning allograft and a Nankivell GFR greater than or equal to 20 mL/min, within 2 weeks before randomization

Exclusion Criteria

• Biopsy-confirmed acute rejection within 12 weeks before randomization, that was determined to require antirejection treatment
• Patients in whom kidney-pancreas or other multiple organ transplants have been performed

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
A	Sirolimus	Conversion from calcineurin inhibitor immunosuppression to Sirolimus-based immunosuppression
A	tacrolimus	Conversion from calcineurin inhibitor immunosuppression to Sirolimus-based immunosuppression
A	Cyclosporine A	Conversion from calcineurin inhibitor immunosuppression to Sirolimus-based immunosuppression
B	Cyclosporine A	Continued calcineurin inhibitor therapy
B	Sirolimus	Continued calcineurin inhibitor therapy
B	tacrolimus	Continued calcineurin inhibitor therapy

Primary Outcome Measures

Name	Time	Method
Nankivell Glomerular Filtration Rate (GFR)	52 weeks	Nankivell GFR: patients with baseline GFR of 20.0 to 40.0 mL/min and patients with baseline GFR of greater than 40.0 mL/min. GFR is an index of kidney function. A higher value means better kidney function.

Secondary Outcome Measures

Name	Time	Method
First Occurrence of Biopsy-confirmed Acute Rejection, Graft Loss, or Death.	52 and 104 weeks	Number of patients who experienced for the first time either biopsy-confirmed acute rejection, graft loss, or death by weeks 52 and 104. Assessed by individual endpoint and as composite endpoint (all combined).