Conversion From Tacrolimus to Cyclosporine Microemulsion in Liver Transplant Patients With New Onset Diabetes After the 3rd Month Post-transplant

Novartis

Status and phase: Completed; Phase 4

Conditions: Maintenance Liver Transplant Patients With New Onset Diabetes

Treatments: Drug: Cyclosporine - cyclosporine microemulsion

Study type: Interventional

Funder types: Industry

Identifiers

NCT00171717

COLO400AFR04

Details and patient eligibility

About

The trial is conducted in patients who have received a liver transplant, were prescribed tacrolimus to prevent organ rejection and developed diabetes from 3 month post-transplantation onwards. The goal of the trial is to assess the percentage of patients in whom diabetes will resolve 6 month after conversion from tacrolimus to cyclosporine micro-emulsion as measured by a fasting blood glucose < 1,26 g/l without the need of hypoglycemic treatment.

Enrollment: 39 patients

Sex: All

Ages: 18 to 70 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

Inclusion Criteria:

• • Patients who have received a first liver transplantation and who are 18 to 70 year old
• Patients who are treated with tacrolimus post-transplant for at least 3 months and for a maximum of 36 months
• Patients without any known diabetes before transplantation and in whom diabetes mellitus was diagnosed for the first time at least 3 months post-transplantation

Exclusion Criteria

• Re-transplantation or multi-organ transplantation,
• Diabetes before the transplantation,
• Type I diabetes mellitus.

Other protocol-defined inclusion / exclusion criteria may apply

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)