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

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

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.

Study Overview

• Status: Terminated
• Conditions: Tacrolimus-associated Abnormal Glucose Metabolism in Kidney and Liver Transplant Recipients
• Intervention / Treatment: Drug: cyclosporine micro-emulsion

• Study Type: Interventional
• Enrollment (Actual): 50
• Phase: Phase 4

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: N/A
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
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

Outcome Measure
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

Collaborators and Investigators

• Sponsor: Novartis

Study record dates

Study Major Dates

• Study Start: February 1, 2004
• Primary Completion (Actual): October 1, 2005
• Study Completion (Actual): October 1, 2005

Study Registration Dates

• First Submitted: September 6, 2005
• First Submitted That Met QC Criteria: September 7, 2005
• First Posted (Estimate): September 8, 2005

Study Record Updates

• Last Update Posted (Estimate): February 18, 2011
• Last Update Submitted That Met QC Criteria: February 17, 2011
• Last Verified: February 1, 2011

More Information

Terms related to this study

• Keywords: diabetes, glucose, tacrolimus, cyclosporine micro-emulsion, liver, kidney, renal
• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Anti-Infective Agents; Enzyme Inhibitors; Antirheumatic Agents; Immunosuppressive Agents; Immunologic Factors; Dermatologic Agents; Antifungal Agents; Calcineurin Inhibitors; Cyclosporine; Cyclosporins
• Other Study ID Numbers: COLO400AUS06