Influence of Pioglitazone for Renal Transplant Function in Diabetics

Diabetes Mellitus Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00507494
• Other study ID #: DNTx
• Status: Completed
• Phase: Phase 3
• First received: July 25, 2007
• Last updated: October 27, 2011
• Start date: July 2007
• Est. completion date: September 2009

Study information

• Verified date: October 2011
• Source: Technische Universität Dresden
• Contact: n/a
• Is FDA regulated: No
• Health authority: Germany: Federal Institute for Drugs and Medical Devices
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 0
• Est. completion date: September 2009
• Est. primary completion date: September 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 30 Years to 75 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Crossover Assignment, Masking: Double-Blind, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Diabetes Mellitus
• Kidney Transplantation
• Proteinuria

Intervention

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.

Locations

Country	Name	City	State
Germany	Nephrology, Department of Medicine, university hospital Dresden	Dresden

Sponsors (1)

Lead Sponsor	Collaborator
Technische Universität Dresden

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	proteinuria		12 weeks
Secondary	efficacy: filtration fraction, renal nitric oxide bioavailability, insulin resistance, platelet function safety: tolerability, plasma glucose, body weight, edema		12 weeks