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

Novartis0 个研究点目标入组 39 人开始时间: 2004年2月1日最近更新: 2011年2月1日

适应症

试验速览

阶段: 4 期
状态: 已完成
发起方: Novartis
入组人数: 39
主要终点: % of patients whose diabetes resolves 6 months after the conversion (fasting glucose < 1.26 g/L without hypoglycemic treatment).

研究概览研究设计入排标准结局指标研究者记录与标识符相似试验

研究概览

简要总结

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.

研究设计

研究类型: Interventional
分配方式: Non Randomized
干预模型: Single Group
主要目的: Treatment
盲法: None

入排标准

年龄范围: 18 Years 至 70 Years（Adult, Older Adult）
性别: All
接受健康志愿者: 否

入选标准

•- 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

排除标准

•Re-transplantation or multi-organ transplantation,
•Diabetes before the transplantation,
•Type I diabetes mellitus.
•Other protocol-defined inclusion / exclusion criteria may apply

结局指标

主要结局

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

次要结局

% 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.

研究者

发起方

Novartis

申办方类型

Industry

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