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

Novartis

Status and phase: Terminated; Phase 4

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

Treatments: Drug: cyclosporine micro-emulsion

Study type: Interventional

Funder types: Industry

Identifiers

NCT00150085

COLO400AUS06

Details and patient eligibility

About

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.

Enrollment: 50 patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)