Evaluation of Cyclosporine Microemulsion and Tacrolimus on the Rate of New Onset Diabetes Mellitus in Kidney Transplantation Recipients
Information source: Novartis
Information obtained from ClinicalTrials.gov on June 20, 2008
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Kidney Transplant
Intervention: Cyclosporine microemulsion; Tacrolimus (Drug)
Phase: Phase 4
Status: Active, not recruiting
Sponsored by: Novartis Official(s) and/or principal investigator(s):
Novartis, Study Director, Affiliation: Novartis
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
Clinical Details
Official title: 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
Study design: Prevention, Randomized, Open Label, Active Control, Parallel Assignment, Safety/Efficacy Study
Primary outcome: Incidence of NODM or impaired fasting glucose (IFG) in de novo kidney transplant patients receiving Neoral 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: Effects Neoral & tacrolimus on glucose metabolism de novo kidney transplant patients assessed by:incidence of NODM or IFG within the first 3 mths post-transplantation in pts treated with Neoral 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) performed at 3 &6 months post-transplantation. Blood pressure at Months 3& 6 post-transplantation in de novo kidney transplant recipients treated w/ Neoral or tacrolimus. Efficacy of Neoral &tacrolimus in de novo kidney transplant pts by the 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.
Eligibility
Minimum age: 18 Years.
Maximum age: 70 Years.
Gender(s): Both.
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
Locations and Contacts
Additional Information
Starting date: October 2004
Last updated: July 18, 2007
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