Evaluation of Cyclosporine Microemulsion and Tacrolimus on the Rate of New Onset Diabetes Mellitus in Kidney Transplantation Recipients

Novartis693 enrolled

Overview

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

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

NONE

Enrollment

693

Conditions

Kidney Transplant

Interventions

Cyclosporine microemulsionDRUG

TacrolimusDRUG

Eligibility

Sex: ALLMin age: 18 YearsMax age: 70 Years

Medical Language ↔ Plain English

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

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

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

incidence of impaired glucose tolerance (IGT) as assessed by an oral glucose tolerance test (OGTT)

Time frame: 6 months

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.

Data from ClinicalTrials.gov

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