nephropathy after renal transplantation in patients with type 2 diabetes MedDRA version: 8.1 Level: LLT Classification code 10061835 Term: Diabetic nephropathy
Conditions
Interventions
Trade Name: Actos
Pharmaceutical Form: Tablet
Pharmaceutical form of the placebo: Tablet
Route of administration of the placebo: Oral use
Sponsors
Technical University Dresden
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: -renal transplant recipient (> 6 months after renal transplantation) with stable renal function (fluctuations of serum creatinin 30 ml/min (MDRD formula) -albuminuria > 30 mg / day 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) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: - type 1 diabetes mellitus - HbA1c > 8 % - unstable renal function (any acute rejection episode within 3 months prior to the screening or chronic allograft nephropathy with fluctuation of serum creatinin > 20 %) - pregnant or breastfeeeding women - congestive heart failure > stage 1 NYHA - uncontrolled hypertension - hypo- or hyperthyreoidism
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: Influence of pioglitazone (Actos) on proteinuria and filtration fraction of renal transplant recipients with diabetes mellitus;Secondary Objective: Influence of pioglitazone on intra-renal NO-bio-availability of renal transplant recipients with diabetes mellitus. Safety of pioglitazone in renal transplant recipients with proteinurie and diabetes mellitus.;Primary end point(s): Proteinuria | — |
Countries
Germany
Outcome results
None listed