Study Comparing Graft Function in Renal Allograft Recepients Receiving Reduced or Standard Dose CsA With Sirolimus
- Conditions
- Kidney Transplantation
- Registration Number
- NCT00518375
- Lead Sponsor
- Wyeth is now a wholly owned subsidiary of Pfizer
- Brief Summary
This study evaluated renal graft function (based on calcuated creatinine clearance) 12 months after transplantation in patients receiving either a regimen of reduced dose or standard dose cyclosporine in combination with sirolimus and corticosteroids. The incidence of acute graft rejection at 6 and 12 months following transplantation and patient and graft survival at 12 months were evaluated also.
- Detailed Description
This study evaluated renal graft function (based on calcuated creatinine clearance) 12 months after kidney transplantation in patients receiving either a regimen of reduced dose or standard dose cyclosporine (CsA) in combination with sirolimus and corticosteroids. The incidence of acute graft rejection at 6 and 12 months following transplantation and patient and graft survival at 12 months after transplantation were evaluated also.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 250
- Adults more than 18 years of age
- End-stage renal disease, with patients receiving a primary or secondary renal allograft from a cadaveric, living-unrelated or living-related mismatched donor
- Patients with a secondary transplant must have maintained their primary graft for at least 6 months
- Planned antibody induction therapy
- Multiple organ transplants
- Patients at a high risk of acute rejection
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Primary Outcome Measures
Name Time Method Calculated creatinine clearance to evaluate renal function at 12 months post transplantation 12 months
- Secondary Outcome Measures
Name Time Method Incidence of acute graft rejection at 6 and 12 months post transplantation and patient and graft survival at 12 months post transplantation 12 months