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

Tracking Information

First Received Date ^ICMJE

September 12, 2005

Last Updated Date

July 21, 2008

Start Date ^ICMJE

October 2004

Primary Completion Date

Current Primary Outcome Measures ^ICMJE

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.

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT00171496 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

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.

Original Secondary Outcome Measures ^ICMJE

Same as current

Descriptive Information

Brief Title ^ICMJE

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

Official Title ^ICMJE

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

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

Study Phase

Phase IV

Study Type ^ICMJE

Interventional

Study Design ^ICMJE

Prevention, Randomized, Open Label, Active Control, Parallel Assignment, Safety/Efficacy Study

Condition ^ICMJE

Kidney Transplant

Intervention ^ICMJE

Drug: Cyclosporine microemulsion; Tacrolimus

Study Arms / Comparison Groups

Publications *

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Active, not recruiting

Enrollment ^ICMJE

702

Completion Date

Primary Completion Date

Eligibility Criteria ^ICMJE

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

Gender

Both

Ages

18 Years to 70 Years

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

Administrative Information

NCT ID ^ICMJE

NCT00171496

Responsible Party

Study ID Numbers ^ICMJE

COLO400A2419

Study Sponsor ^ICMJE

Novartis

Collaborators ^ICMJE

Investigators ^ICMJE

Study Director:

Novartis

Information Provided By

Novartis

Verification Date

July 2008

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP