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 6 month patient and graft survival rates clinically treated acute rejection episodes treatment failure (up to 6 months)