New onset diabetes mellitus after renal transplantation.
Conditions
Interventions
Trade Name: Neoral
Product Name: Neoral
Pharmaceutical Form: Capsule*
INN or Proposed INN: cyclosporine
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 25-
Trade N
Sponsors
UZ Brussel
Eligibility
Sex/Gender
All
Inclusion criteria
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
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The main objective of the study is to assess whether conversion from tacrolimus (Prograft) to cyclosporine (Neoral) can cause remission of diabetes in at least 20% of the patients in excess of the control group;Secondary Objective: Effect of the conversion from tacrolimus (Prograft) to cyclosporin (Neoral) on fasting blood glucose levels, glucose levels 2 hours after administration of 75g of glucose in an oral glucose tolerance test, HbA1c levels, markers of insulin secretion and sensitivity. Effect of the conversion from tacrolimus (Prograft) to cyclosporin (Neoral) on the need for glucose-lowering agents. Effect of the conversion from tacrolimus (Prograft) to cyclosporin (Neoral) on hepatitis C virus replication in HCV positive patients. Incidence of treated acute rejection episodes , biopsy proven acute rejection in the two groups. Creatinine clearance assessed by the Cockroft and Gault formula, proteinuria in the two groups. ;Primary end point(s): Proportion of patients with remission of diabetes one year after randomization, defined as a fasting plasma glucose <126mg/dl and a plama glucose level 2 hours after a 75g OGTT<200 mg/dl in the absence of glucose lowering therapy. The main objective of the study is to assess whether conversion to CsA can cause remission of diabetes in at least 20% of the patients in excess of the control group. | — |
Countries
Belgium, Germany
Outcome results
None listed