A Six-month Open Label, Multicenter, Randomized Study to Evaluate the Incidence of New Onset Diabetes Mellitus and Glucose Metabolism in Patients Receiving Cyclosporine Microemulsion With C-2 Monitoring Versus Tacrolimus After de Novo Kidney Transplantation

Novartis0 sites693 target enrollmentOctober 2003

ConditionsKidney Transplant

InterventionsCyclosporine microemulsion Tacrolimus

DrugsCyclosporine microemulsion Tacrolimus

Overview

Phase: Phase 4
Intervention: Cyclosporine microemulsion
Conditions: Kidney Transplant
Sponsor: Novartis
Enrollment: 693
Primary Endpoint: 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.
Status: Completed
Last Updated: 9 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Similar Trials

Overview

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

Registry

clinicaltrials.gov

Start Date

October 2003

End Date

March 2006

Last Updated

9 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

Novartis

Eligibility Criteria

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

Arms & Interventions

Cyclosporine microemulsion

Intervention: Cyclosporine microemulsion

Tacrolimus

Intervention: Tacrolimus

Outcomes

Primary Outcomes

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 Outcomes

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.