Effects of Rosiglitazone on Renal Hemodynamics and Proteinuria of Type 2 Diabetic Patients With Renal Insufficiency Due to Overt Diabetic Nephropathy

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Technische Universität Dresden
ClinicalTrials.gov Identifier:
NCT00324675
First received: May 9, 2006
Last updated: October 27, 2011
Last verified: October 2011

May 9, 2006
October 27, 2011
August 2006
December 2008   (final data collection date for primary outcome measure)
Proteinuria [ Time Frame: at baseline and after 6 and 12 mo of treatment ] [ Designated as safety issue: No ]
Not Provided
Complete list of historical versions of study NCT00324675 on ClinicalTrials.gov Archive Site
  • Renal Hemodynamic [ Time Frame: at baseline and after 6 and 12 mo of tretament ] [ Designated as safety issue: No ]
  • Renal Function [ Time Frame: at abseline and after 6 and 12 mo ] [ Designated as safety issue: Yes ]
  • Adverse Event [ Time Frame: every month or at occurence ] [ Designated as safety issue: Yes ]
  • HbA1c [ Time Frame: at baseline and after 6 and 12 mo ] [ Designated as safety issue: Yes ]
Not Provided
Not Provided
Not Provided
 
Effects of Rosiglitazone on Renal Hemodynamics and Proteinuria of Type 2 Diabetic Patients With Renal Insufficiency Due to Overt Diabetic Nephropathy
Effects of Rosiglitazone on Renal Hemodynamics and Proteinuria of Type 2 Diabetic Patients With Renal Insufficiency Due to Overt Diabetic Nephropathy

Objective:

To evaluate how rosiglitazone does influence the renal plasma flow, the glomerular filtration rate and the degree of proteinuria in type 2 diabetic patients with renal insufficiency due to overt diabetic nephropathy.

Background:

Diabetic nephropathy is a world wide public health concern of increasing proportions. It has become the most common single cause of end-stage renal disease in the United States and in Europe. Previous studies have already found agents modifying the renin-angiotensin-system (ACE inhibitors and angiotensin receptor blocker) to retard diabetic nephropathy. These agents are likely to exert multiple effects in the kidney. One of them appear to be their known ability to improve endothelial function and to change renal glomerular hemodynamics.

In a previous study we demonstrated an improvement of renal endothelial dysfunction in type 2 diabetic patients without end organ damage after treatment with rosiglitazone. In that study, rosiglitazone significantly reduced glomerular hyperfiltration. This was associated with a reduction of urinary albumin excretion. The observed effects are potentially important in the context of renal protection, provided that a similar beneficial effect of rosiglitazone is demonstrable in overt diabetic nephropathy (renal insufficiency, hypertension, proteinuria).

Hypothesis Rosiglitazone decreases proteinuria and improves renal hemodynamic function in patients with chronic renal insufficiency due to overt diabetic nephropathy.

Not Provided
Interventional
Not Provided
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
  • Type 2 Diabetes
  • Overt Diabetic Nephropathy
  • Drug: Rosiglitazone
    4 mg tablets, bid, 12 months
  • Drug: Placebo
    2 tablets per day
  • Active Comparator: Rosiglitazone
    Intervention: Drug: Rosiglitazone
  • Placebo Comparator: placebo
    Intervention: Drug: Placebo
Pistrosch F, Passauer J, Herbrig K, Schwanebeck U, Gross P, Bornstein SR. Effect of thiazolidinedione treatment on proteinuria and renal hemodynamic in type 2 diabetic patients with overt nephropathy. Horm Metab Res. 2012 Nov;44(12):914-8. doi: 10.1055/s-0032-1314836. Epub 2012 Jun 21.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
28
December 2010
December 2008   (final data collection date for primary outcome measure)

Inclusion Criteria:

type 2 diabetes mellitus -age between 40 and 75 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

Exclusion Criteria:

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

Both
40 Years to 75 Years
No
Contact information is only displayed when the study is recruiting subjects
Germany
 
NCT00324675
DN 2
Yes
Technische Universität Dresden
Technische Universität Dresden
Not Provided
Principal Investigator: Frank Pistrosch, M.D. Nephrology, Department of Medicine, University hospital Dresden
Technische Universität Dresden
October 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP