Study Evaluating Sirolimus in Kidney Transplant Recipients

Phase 3

Completed

• Conditions: Graft vs Host Disease; Kidney Transplantation
• Interventions: Drug: sirolimus; Drug: cyclosporine; Drug: mycophenolate mofetil; Drug: corticosteroids; Drug: daclizumab

• Registration Number: NCT00195273
• Lead Sponsor: Wyeth is now a wholly owned subsidiary of Pfizer

Brief Summary

The purpose of this study is to compare the kidney function in patients who have received a transplanted kidney and were treated with the combination of sirolimus, daclizumab, mycophenolate and corticosteroids versus transplanted patients treated with cyclosporine, mycophenolate and corticosteroids.

Detailed Description

Not available

Study Timeline

• Study Start: 2004-11
• Study First Submitted: 2005-09-12
• Study First Submitted QC: 2005-09-12
• Study First Posted: 2005-09-19
• Primary Completion: 2008-07
• Study Completion: 2008-07
• Results First Submitted: 2009-07-31
• Results First Submitted QC: 2009-07-31
• Results First Posted: 2009-09-07
• Status Verified: 2010-04
• Last Update Submitted: 2010-04-22
• Last Update Posted: 2010-04-28

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 61

Inclusion Criteria

• Kidney transplantation
• Donor must be at least 60 years old.

Exclusion Criteria

• Current systemic infection
• Unstable angina or treatment for serious arrhythmia.
• Cancer within the previous 5 years.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
1	corticosteroids	Sirolimus + Daclizumab + Mycophenolate + Corticosteroids
2	corticosteroids	Cyclosporine + Mycophenolate + Corticosteroids
1	sirolimus	Sirolimus + Daclizumab + Mycophenolate + Corticosteroids
1	mycophenolate mofetil	Sirolimus + Daclizumab + Mycophenolate + Corticosteroids
1	daclizumab	Sirolimus + Daclizumab + Mycophenolate + Corticosteroids
2	cyclosporine	Cyclosporine + Mycophenolate + Corticosteroids
2	mycophenolate mofetil	Cyclosporine + Mycophenolate + Corticosteroids

Primary Outcome Measures

Name	Time	Method
Mean Creatinine Clearance Rate	12 months	Creatinine clearance is a measure of kidney function. Creatinine clearance rate is the volume of blood plasma that is cleared of creatinine by the kidneys per unit time. Creatinine clearance can be measured directly or estimated using established formulas. For this study, the creatinine clearance rate was calculated using the Nankivell formula. Normal values for healthy, young males are in the range of 100-135 ml/min and for females 90-125 ml/min. A low creatinine clearance indicates poor kidney function.

Secondary Outcome Measures

Name	Time	Method
Number of Patients With Acute Rejection	3 and 12 months	The diagnosis of acute rejection was made via kidney biopsy (Banff criteria). The Banff criteria are standardized diagnostic categories based on histological assessments (e.g., cell types and distributions). Biopsy was performed before initiation of anti-rejection therapy, or at least within 24 hours of the start of therapy.
Patient and Graft Survival	12 months	Graft survival is measured by graft loss which is defined as removal of the transplant.
Mean Creatinine Clearance Rate - 3 Months	3 months	Creatinine clearance is a measure of kidney function. Creatinine clearance rate is the volume of blood plasma that is cleared of creatinine by the kidneys per unit time. Creatinine clearance can be measured directly or estimated using established formulas. For this study, the creatinine clearance rate was calculated using the Nankivell formula. Normal values for healthy, young males are in the range of 100-135 ml/min and for females 90-125 ml/min. A low creatinine clearance indicates poor kidney function.