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

Phase 4

Completed

• Conditions: Maintenance Liver Transplant Patients With New Onset Diabetes

• Registration Number: NCT00171717
• Lead Sponsor: Novartis

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2004-02
• Study First Submitted: 2005-09-13
• Study First Submitted QC: 2005-09-13
• Study First Posted: 2005-09-15
• Primary Completion: 2005-12
• Study Completion: 2005-12
• Status Verified: 2011-01
• Last Update Submitted: 2011-01-31
• Last Update Posted: 2011-02-01

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 39

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

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
% of patients whose diabetes resolves 6 months after the conversion (fasting glucose < 1.26 g/L without hypoglycemic treatment).

Secondary Outcome Measures

Name	Time	Method
% of patients whose diabetes has resolved 1 year after the conversion (fasting glucose < 1.26 g/L without hypoglycemic treatment).
% of patients treated with insulin and oral ant diabetics and status of the drug doses 6 months and 1 year after the conversion.
% of patients with HbA1c ≤ 7% 6 months and 1 year after the conversion.
Blood pressure % of patients with a diastolic value ≥ 90 mmHg, mean systolic and diastolic values,
% of patients receiving antihypertensive treatment),
BMI, kidney function (creatinine and creatinine clearance), microalbuminuria, hyperlipidemia, adverse events, serious adverse events, dropouts, at 6 months and at 1 year.
Incidence of acute and chronic rejection treated at 6 months and at 1 year.