Influence of Pioglitazone for Renal Transplant Function in Diabetics

Phase 3

Completed

• Conditions: Diabetes Mellitus; Kidney Transplantation; Proteinuria

• Registration Number: NCT00507494
• Lead Sponsor: Technische Universität Dresden

Brief Summary

The purpose of this study is to test whether pioglitazone is able to prevent the progression of diabetic nephropathy in kidney transplant recipients with diabetes mellitus.

Detailed Description

About 30 % of kidney transplant recipients will develop diabetes mellitus. This condition is a risk factor for graft dysfunction, graft loss and increased mortality of patients. Inflammatory reactions within the graft and proteinuria are considered as pathogenetic mechanisms.

Recent studies indicated that pioglitazone might have beneficial effects on the urinary protein excretion of type 2 diabetic patients with diabetic nephropathy and was able to reduce systemic inflammation.

This lead to the hypothesis that pioglitazone could improve proteinuria of kidney transplant patients with diabetes.

Comparison: Effects of pioglitazone vs. placebo on proteinuria and renal function of kidney transplant recipients in a cross over study.

Study Timeline

• Study Start: 2007-07
• Study First Submitted: 2007-07-25
• Study First Submitted QC: 2007-07-25
• Study First Posted: 2007-07-26
• Primary Completion: 2009-09
• Study Completion: 2009-09
• Status Verified: 2011-10
• Last Update Submitted: 2011-10-27
• Last Update Posted: 2011-10-28

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

• kidney transplantation(> 6 months ago) ; stable graft function
• diabetes mellitus type 2
• acceptable glycemia (HbA1c < 8%)
• creatinin clearance (MDRD)>30 ml/min 1,73m²)
• proteinuria > 30 mg/24 hr

Exclusion Criteria

• type 1 diabetes
• pregnant or breast feeding women
• congestive heart failure (>stage 1 NYHA)
• creeping creatinin
• treatment for rejection within 3 months prior to inclusion
• ALT, AST > 2.5 fold the upper limit of normal
• uncontrolled hypertension
• hypo- or hyperthyroidism

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Primary Outcome Measures

Name	Time	Method
proteinuria	12 weeks

Secondary Outcome Measures

Name	Time	Method
efficacy: filtration fraction, renal nitric oxide bioavailability, insulin resistance, platelet function safety: tolerability, plasma glucose, body weight, edema	12 weeks

Trial Locations

Locations (1)

Nephrology, Department of Medicine, university hospital Dresden; 🇩🇪 Dresden, Germany