Conversion From Tacrolimus to Cyclosporine Microemulsion in Liver Transplant Patients With New Onset Diabetes After the 3rd Month Post-transplant
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.
Maintenance Liver Transplant Patients With New Onset Diabetes
Drug: Cyclosporine - cyclosporine microemulsion
|Study Design:||Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|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.|
- % of patients whose diabetes resolves 6 months after the conversion (fasting glucose < 1.26 g/L without hypoglycemic treatment).
- % 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.
|Study Start Date:||February 2004|
|Study Completion Date:||December 2005|
|Primary Completion Date:||December 2005 (Final data collection date for primary outcome measure)|