Maintenance Liver Transplant Patients With New Onset Diabetes
Conditions
Keywords
Cyclosporine, liver transplantation, maintenance, diabetes
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.
Interventions
DRUGCyclosporine - cyclosporine microemulsion
Sponsors
Novartis
Study design
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 70 Years
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 /
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| % of patients whose diabetes resolves 6 months after the conversion (fasting glucose < 1.26 g/L without hypoglycemic treatment). | — |
Secondary
| Measure | Time frame |
|---|---|
| % 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 whose diabetes has resolved 1 year after the conversion (fasting glucose < 1.26 g/L without hypoglycemic 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. | — |
| % of patients receiving antihypertensive treatment), | — |
Outcome results
None listed