Influence of Pioglitazone for Renal Transplant Function in Diabetics

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00507494
Recruitment Status : Completed
First Posted : July 26, 2007
Last Update Posted : October 28, 2011
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment Phase
Diabetes Mellitus Kidney Transplantation Proteinuria Drug: pioglitazone Phase 3

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 Type : Interventional  (Clinical Trial)
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double
Primary Purpose: Treatment
Official Title: Influence of Pioglitazone for Renal Transplant Function in Diabetics - a Double Blind Randomised Placebo Controlled Cross Over Study
Study Start Date : July 2007
Actual Primary Completion Date : September 2009
Actual Study Completion Date : September 2009

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Intervention Details:
    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.

Primary Outcome Measures :
  1. proteinuria [ Time Frame: 12 weeks ]

Secondary Outcome Measures :
  1. efficacy: filtration fraction, renal nitric oxide bioavailability, insulin resistance, platelet function safety: tolerability, plasma glucose, body weight, edema [ Time Frame: 12 weeks ]

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Ages Eligible for Study:   30 Years to 75 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00507494

Nephrology, Department of Medicine, university hospital Dresden
Dresden, Germany, 01307
Sponsors and Collaborators
Technische Universität Dresden
Principal Investigator: Peter Gross, MD Nephrology, Department of Medicine, University hospital Dresden

Responsible Party: Technische Universität Dresden Identifier: NCT00507494     History of Changes
Other Study ID Numbers: DNTx
First Posted: July 26, 2007    Key Record Dates
Last Update Posted: October 28, 2011
Last Verified: October 2011

Keywords provided by Technische Universität Dresden:
posttransplant diabetes mellitus
kidney transplantation
filtration fraction

Additional relevant MeSH terms:
Diabetes Mellitus
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Urination Disorders
Urologic Diseases
Urological Manifestations
Signs and Symptoms
Hypoglycemic Agents
Physiological Effects of Drugs