A prospective and randomized study of conversion from tacrolimus to cyclosporine A to improve glucose metabolism in patients with new-onset diabetes mellitus after renal transplantation (REVERSE study) - REVERSE

Phase 1

• Conditions: ew onset diabetes mellitus after renal transplantation.

• Registration Number: EUCTR2006-001765-42-DE
• Lead Sponsor: B Erasme

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2008-05-27
• Last Update Posted: 20 August 2018

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 200

Inclusion Criteria

Diabetes mellitus difined by: At least 2 fasting blood glucose levels >= 126mg/dl or any glucose level >= 200 mg/dl in presence of polyuria/polydipsia or a glucose level 2 hours after a 75g OGTT>=200mg/dl during the three months before inclusion or ongoing treatment with oral agents and/or insulin at inclusion.
first or second renal transplantation more than 6 monthes before inclusion
Minimal clinically acceptable steroid dose during the last 3 months before inclusion.
Treatment with tacrolimus
Patients 18 years or older.
Women must be willing to use efficient contraception for the duration of the study.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

Medical history of diabetes before renal transplantation
Multi-organ transplants
Uncontrolled arterial hypertension
Hypercholiesterolemia that is not controlled by medical therapy.
Acute rejection treated with bolus corticosteroids during the previous 3 months
history of more than two episodes of treated acute rejection.
Monotherapy with tacrolimus
Treatment with tacrolimus in combination with sirolimus.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified