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

Phase 4

Terminated

• Conditions: Tacrolimus-associated Abnormal Glucose Metabolism in Kidney and Liver Transplant Recipients

• Registration Number: NCT00150085
• Lead Sponsor: Novartis

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2004-02
• Study First Submitted: 2005-09-06
• Study First Submitted QC: 2005-09-07
• Study First Posted: 2005-09-08
• Primary Completion: 2005-10
• Study Completion: 2005-10
• Status Verified: 2011-02
• Last Update Submitted: 2011-02-17
• Last Update Posted: 2011-02-18

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 50

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
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