A Randomized Open-Label Study Comparing the Efficacy and Safety of Sirolimus Combined With Daclizumab, Mycophenolate and Corticosteroids vs Cyclosporine, Mycophenolate and Corticosteroids in Renal Allograft Recipients Receiving Kidneys From Older Donors
Overview
- Phase
- Phase 3
- Intervention
- sirolimus
- Conditions
- Graft vs Host Disease
- Sponsor
- Wyeth is now a wholly owned subsidiary of Pfizer
- Enrollment
- 61
- Primary Endpoint
- Mean Creatinine Clearance Rate
- Status
- Completed
- Last Updated
- 16 years ago
Overview
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.
Investigators
Eligibility Criteria
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.
Arms & Interventions
1
Sirolimus + Daclizumab + Mycophenolate + Corticosteroids
Intervention: sirolimus
1
Sirolimus + Daclizumab + Mycophenolate + Corticosteroids
Intervention: mycophenolate mofetil
1
Sirolimus + Daclizumab + Mycophenolate + Corticosteroids
Intervention: corticosteroids
1
Sirolimus + Daclizumab + Mycophenolate + Corticosteroids
Intervention: daclizumab
2
Cyclosporine + Mycophenolate + Corticosteroids
Intervention: cyclosporine
2
Cyclosporine + Mycophenolate + Corticosteroids
Intervention: mycophenolate mofetil
2
Cyclosporine + Mycophenolate + Corticosteroids
Intervention: corticosteroids
Outcomes
Primary Outcomes
Mean Creatinine Clearance Rate
Time Frame: 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 Outcomes
- Number of Patients With Acute Rejection(3 and 12 months)
- Patient and Graft Survival(12 months)
- Mean Creatinine Clearance Rate - 3 Months(3 months)