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

Novartis39 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

NON_RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Maintenance Liver Transplant Patients With New Onset Diabetes

Interventions

Cyclosporine - cyclosporine microemulsionDRUG

Eligibility

Sex: ALLMin age: 18 YearsMax age: 70 Years

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

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

Secondary Outcomes

% 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.

Data from ClinicalTrials.gov

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