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

Phase 4 Completed 39 enrolled Novartis

Non-randomizedSingle-groupOpen-labelTreatment

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.

Timeline

Start: 2004-02
Primary completion: 2005-12
Completion: 2005-12

Publications

Lorho R, Hardwigsen J, Dumortier J, Pageaux GP, Durand F, Bizollon T, Blanc AS, Di Giambattista F, Duvoux C. Regression of new-onset diabetes mellitus after conversion from tacrolimus to cyclosporine in liver transplant patients: results of a pilot study. Clin Res Hepatol Gastroenterol. 2011 Jun;35(6-7):482-8. doi: 10.1016/j.clinre.2011.03.008. Epub 2011 May 6.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Cyclosporine	Peptide	—	—

Indications

No indication recorded.