Influence of Pioglitazone for Renal Transplant Function in Diabetics

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Study Classification

INTERVENTIONAL

Study Start Date

2007-07-31

Study Completion Date

2009-09-30

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.

Conditions

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Diabetes Mellitus Kidney Transplantation Proteinuria

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Interventions

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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.

Intervention Type DRUG

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

Minimum Eligible Age

30 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Peter Gross, MD

Role: PRINCIPAL_INVESTIGATOR

Nephrology, Department of Medicine, University hospital Dresden

Locations

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Nephrology, Department of Medicine, university hospital Dresden

Dresden, , Germany

Site Status

Countries

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Germany

References

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Lo C, Toyama T, Oshima M, Jun M, Chin KL, Hawley CM, Zoungas S. Glucose-lowering agents for treating pre-existing and new-onset diabetes in kidney transplant recipients. Cochrane Database Syst Rev. 2020 Jul 30;8(8):CD009966. doi: 10.1002/14651858.CD009966.pub3.

Reference Type DERIVED

PMID: 32803882 (View on PubMed)

Other Identifiers

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DNTx

Identifier Type: -

Identifier Source: org_study_id