Effects of rosiglitazone on renal hemodynamics and proteinuria of type 2 diabetic patients with renal insufficiency due to overt diabetic nephropathy
- Conditions
- type 2 diabetic patients with proteinuria and chronic renal failure due to overt diabetic nephropathy
- Registration Number
- EUCTR2005-002407-17-DE
- Lead Sponsor
- Technical University Dresden
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 38
-type 2 diabetes mellitus
-age between 40 and 70 years
-well controlled HbA1c (< 7.5%)
-chronic renal failure (creatinin clearance between 70 and 30 mL/(min x 1.73 m²) according to the Cockroft equation)
-proteinuria > 300 mg / 24 hours
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
-type 1 diabetes
-poorly controlled type 2 diabetes (HbA1c > 7.5%) or unstable blood glucose during the day (capillary blood glucose self monitoring)
-elevation of ALT, AST or GGT more than 2.5 fold the upper normal value
-CHF (more than grade 1 of NYHA)
-uncontrolled hypertension
-malignant tumorous disorder
-hyper- or hypothyroidism
-pregnant women
-nursing women
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Main Objective: Investigation of the efficacy of rosiglitazone on urinary protein excretion in type 2 diabetic patients with renal insufficiency due to overt diabetic nephropathy.;Secondary Objective: Investigation of the efficacy of rosiglitazone on glomerular filtration rate, renal plasma flow and insulin sensitivity index in type 2 diabetic patients with renal insufficiency due to overt diabetic nephropathy.<br>Investigation of the safety of rosiglitazone treatment in type 2 diabetic patients with renal insufficiency due to overt diabetic nephropathy.<br>;Primary end point(s): urinary protein excretion within 24 hours after 52 weeks of treatment
- Secondary Outcome Measures
Name Time Method