Evaluation of Cyclosporine Microemulsion and Tacrolimus on the Rate of New Onset Diabetes Mellitus in Kidney Transplantation Recipients
Phase 4
Completed
- Conditions
- Kidney Transplant
- Interventions
- Registration Number
- NCT00171496
- Lead Sponsor
- Novartis
- Brief Summary
The purpose of this study is to evaluate the impact of tacrolimus and cyclosporine microemulsion on glucose metabolism in kidney transplant recipients and the efficacy and safety in preventing organ rejection
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 693
Inclusion Criteria
- First or second transplant, cadaveric or living donor
Exclusion Criteria
- Multi-organ or dual kidney transplants
- Panel reactive antibodies >50%
Other protocol-defined inclusion/exclusion criteria applied
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Tacrolimus Tacrolimus - Cyclosporine microemulsion Cyclosporine microemulsion -
- Primary Outcome Measures
Name Time Method Incidence of NODM or impaired fasting glucose (IFG) in de novo kidney transplant patients receiving cyclosporine microemulsion versus in patients receiving tacrolimus within the first 6 months post-transplantation. Incidence of biopsy-proven acute rejection (BPAR) or graft loss or death within the first 6 months post-transplantation.
- Secondary Outcome Measures
Name Time Method incidence of NODM or IFG within the first 3 mths post-transplantation in pts treated with cyclosporine microemulsion or tacrolimus percentage of pts with preexisting diabetes at transplantation who have a glycosylated hemoglobin level >7% at Mths 3 &6 post-transplantation incidence of impaired glucose tolerance (IGT) as assessed by an oral glucose tolerance test (OGTT) 6 months Change over time of mean HbA1c at mths 3 &6 post-transplantation in pts w/ preexisting diabetes at transplantation percentage of pts who switched from oral hypoglycemic agents to insulin within 3 &6 mths post-transplantation Blood pressure at Months 3& 6 post-transplantation incidence of BPAR or graft loss or death within the first 3 months post-transplantation, as well as the incidence of each individual event within 3 and 6 months post-transplantation.