Safety and Efficacy of Converting Maintenance Kidney and Liver Transplant Recipients With Abnormal Glucose Metabolism From Tacrolimus to Cyclosporine Micro-Emulsion - Full Text View

Sponsored by:	Novartis
Information provided by:	Novartis
ClinicalTrials.gov Identifier:	NCT00150085

Purpose

New onset diabetes mellitus (NODM) post- transplantation decreases patient and graft survival. Some immunosuppressive agents are associated with a higher incidence of NODM. This study evaluates the safety and efficacy of converting patients with NODM from tacrolimus to cyclosporine micro-emulsion as a primary immunosuppressant for kidney and liver recipients.

Condition	Intervention	Phase
Tacrolimus-Associated Abnormal Glucose Metabolism in Kidney and Liver Transplant Recipients	Drug: cyclosporine micro-emulsion	Phase IV

MedlinePlus related topics: Diabetes Liver Transplantation

Drug Information available for: Tacrolimus Cyclosporin Cyclosporine Dextrose Tacrolimus anhydrous

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Safety/Efficacy Study
Official Title:	A Prospective, Randomized, Open-Label, Twenty-Six Week Study of the Efficacy and Safety of Converting Kidney and Liver Transplant Recipients With Tacrolimus-Associated Abnormal Glucose Metabolism to Cyclosporine Micro-Emulsion With C2 Monitoring

Further study details as provided by Novartis:

Primary Outcome Measures:

Proportion of patients who no longer require a hypoglycemic agent, or who move from insulin to an oral agent, or who no longer meet the American Diabetes Association criteria, or a relative improvement in mean glycosylated hemoglobin at 12 and 26 weeks

Secondary Outcome Measures:

Safety assessed by death, graft loss, biopsy supported clinically manifested acute rejection, change in kidney function, change in liver function, serious adverse events and adverse events at 12 and 26 weeks

Study Start Date:

February 2004

Eligibility

Ages Eligible for Study:	18 Years to 75 Years
Genders Eligible for Study:	Both

Criteria

Inclusion Criteria:

Recipients of first or second cadaveric or living donor kidney transplantation or first cadaveric or living donor liver transplantation
Receiving tacrolimus as a primary immunosuppressant
Currently on any diabetic agent or meets the American Diabetes Association definition of diabetes mellitus

Exclusion Criteria:

History of treated diabetes mellitus prior to transplantation
Less than 2 weeks post-transplantation for kidney and less than 8 weeks for liver
Greater than 36 months post-transplantation
Onset of diabetes is greater than 12 months prior to time of study entry
Has unacceptable or unstable graft function

Other protocol-defined inclusion/exclusion criteria may apply.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00150085

Sponsors and Collaborators

Novartis

Investigators

Study Director:

Novartis

More Information

Responsible Party:	Novartis ( Novartis )
Study ID Numbers:	COLO400AUS06
Study First Received:	September 6, 2005
Last Updated:	September 17, 2008
ClinicalTrials.gov Identifier:	NCT00150085
Health Authority:	United States: Institutional Review Board

Keywords provided by Novartis:

diabetes, glucose, tacrolimus, cyclosporine micro-emulsion, liver, kidney, renal

Study placed in the following topic categories:

Cyclosporine
Clotrimazole
Miconazole
Tioconazole

Diabetes Mellitus
Tacrolimus
Cyclosporins

Additional relevant MeSH terms:

Anti-Infective Agents
Immunologic Factors
Molecular Mechanisms of Pharmacological Action
Therapeutic Uses
Antifungal Agents
Physiological Effects of Drugs

Enzyme Inhibitors
Antirheumatic Agents
Dermatologic Agents
Immunosuppressive Agents
Pharmacologic Actions

ClinicalTrials.gov processed this record on January 16, 2009