A Study to Evaluate the Safety and Efficacy of Prograf/FK778 and Prograf/MMF in de Novo Kidney Transplant Recipients
Phase 2
Terminated
- Conditions
- Kidney Transplantation
- Registration Number
- NCT00282230
- Lead Sponsor
- Astellas Pharma Inc
- Brief Summary
A study to evaluate the safety and efficacy of Prograf/FK778 in de novo kidney transplant patients
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- TERMINATED
- Sex
- All
- Target Recruitment
- 150
Inclusion Criteria
- Patient is a recipient of a primary or retransplanted cadaveric or non-HLA-identical living donor kidney.
- Patient must receive first oral dose of randomized study drug within 48 hours of transplant procedure.
Exclusion Criteria
- Patient has received or is receiving an organ transplant other than kidney
- Patient has received a kidney transplant from a cadaveric donor >= 60 years of age.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Primary Outcome Measures
Name Time Method Incidence of biopsy confirmed acute rejection (Banff Grade ≥ I) at 6 months.
- Secondary Outcome Measures
Name Time Method quantitation of CMV and polyomavirus viral load renal function (SrCl and CrCl) time to first biopsy confirmed acute rejection clinically treated acute rejection episodes treatment failure (up to 6 months) 6 month patient and graft survival rates