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

Sponsor:	Novartis
Information provided by:	Novartis
ClinicalTrials.gov Identifier:	NCT00171496

Purpose

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

Condition	Intervention	Phase
Kidney Transplant	Drug: Cyclosporine microemulsion; Tacrolimus	Phase IV

Study Type:	Interventional
Study Design:	Allocation: Randomized Control: Active Control Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Prevention
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

Resource links provided by NLM:

MedlinePlus related topics: Diabetes Kidney Transplantation

Drug Information available for: Cyclosporine Cyclosporin Tacrolimus anhydrous Tacrolimus

U.S. FDA Resources

Further study details as provided by Novartis:

Primary Outcome Measures:

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 Measures:

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.

Estimated Enrollment:	702
Study Start Date:	October 2004

Eligibility

Ages Eligible for Study:	18 Years to 70 Years
Genders Eligible for Study:	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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00171496

Sponsors and Collaborators

Novartis

Investigators

Study Director:

Novartis

More Information

No publications provided

Study ID Numbers:	COLO400A2419
Study First Received:	September 12, 2005
Last Updated:	July 21, 2008
ClinicalTrials.gov Identifier:	NCT00171496 History of Changes
Health Authority:	Germany: Federal Institute for Drugs and Medical Devices

Keywords provided by Novartis:

Kidney transplant, adults, new onset diabetes mellitus, immunosuppressants

Additional relevant MeSH terms:

Anti-Infective Agents
Metabolic Diseases
Cyclosporine
Molecular Mechanisms of Pharmacological Action
Immunologic Factors
Physiological Effects of Drugs
Diabetes Mellitus
Endocrine System Diseases
Enzyme Inhibitors

Tacrolimus
Cyclosporins
Immunosuppressive Agents
Pharmacologic Actions
Therapeutic Uses
Antifungal Agents
Antirheumatic Agents
Glucose Metabolism Disorders
Dermatologic Agents

ClinicalTrials.gov processed this record on March 18, 2010