Clinical trial NCT00171717: Conversion From Tacrolimus to Cyclosporine Microemulsion in Liver Transplant Patients With New Onset Diabetes After the 3rd Month Post-transplant
Official title: 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.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Maintenance Liver Transplant Patients With New Onset Diabetes
Keywords: Cyclosporine, liver transplantation, maintenance, diabetes
Lead sponsor: Novartis
Sponsor class: INDUSTRY
First posted: 2005-09-15
Enrollment: 39
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.


Eligibility criteria: 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

Primary outcomes:
measure: % of patients whose diabetes resolves 6 months after the conversion (fasting glucose < 1.26 g/L without hypoglycemic treatment).
Secondary outcomes:
measure: % of patients whose diabetes has resolved 1 year after the conversion (fasting glucose < 1.26 g/L without hypoglycemic treatment).
measure: % of patients treated with insulin and oral ant diabetics and status of the drug doses 6 months and 1 year after the conversion.
measure: % of patients with HbA1c ≤ 7% 6 months and 1 year after the conversion.
measure: Blood pressure % of patients with a diastolic value ≥ 90 mmHg, mean systolic and diastolic values,
measure: % of patients receiving antihypertensive treatment),
measure: BMI, kidney function (creatinine and creatinine clearance), microalbuminuria, hyperlipidemia, adverse events, serious adverse events, dropouts, at 6 months and at 1 year.
measure: Incidence of acute and chronic rejection treated at 6 months and at 1 year.
Other outcomes:
Locations:
Study officials:
affiliation: Novartis
name: Novartis
role: STUDY_DIRECTOR
References:
citation: 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.