Influence of Pioglitazone for Renal Transplant Function in Diabetics

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Diabetes Mellitus, Kidney Transplantation, Proteinuria

Intervention / Treatment
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* Drug: pioglitazone


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 30 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double


Arms and Interventions

| Intervention/Treatment |
| --- |
|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.|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| proteinuria |  | 12 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| efficacy: filtration fraction, renal nitric oxide bioavailability, insulin resistance, platelet function safety: tolerability, plasma glucose, body weight, edema |  | 12 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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posttransplant diabetes mellitus, kidney transplantation, filtration fraction, proteinuria