NCT00507494

Influence of Pioglitazone for Renal Transplant Function in Diabetics

Influence of Pioglitazone for Renal Transplant Function in Diabetics - a Double Blind Randomised Placebo Controlled Cross Over Study

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: —
• Sponsor: Technische Universität Dresden · Academic / Other
• Sex: All
• Age: 30 Years – 75 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Diabetes Mellitus
• Kidney Transplantation
• Proteinuria

Interventions

Type	Name	Description
DRUG	pioglitazone	Pioglitazone 30 mg o.d. tablet for 12 weeks or placebo o.d. tablet for 12 weeks in random order. After 12 wk treatment there is a 4 wk washout out which is followed by switch of study medication in a cross over fashion and a further 12 wk treatment.

Timeline

• Start date: 2007-07-01
• Primary completion: 2009-09-01
• Completion: 2009-09-01
• First posted: 2007-07-26
• Last updated: 2011-10-28

Locations

1 site across 1 country: Germany