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Influence of Pioglitazone for Renal Transplant Function in Diabetics

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Dresden University of Technology
ClinicalTrials.gov Identifier:
NCT00507494
First received: July 25, 2007
Last updated: October 27, 2011
Last verified: October 2011
History of Changes
  Purpose

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 Intervention Phase
Diabetes Mellitus
Kidney Transplantation
Proteinuria
 Drug: pioglitazone
 Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Crossover Assignment
Masking: Double-Blind
Primary Purpose: Treatment
Official Title: Influence of Pioglitazone for Renal Transplant Function in Diabetics - a Double Blind Randomised Placebo Controlled Cross Over Study

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Dresden University of Technology:

Primary Outcome Measures:
  • proteinuria [ Time Frame: 12 weeks ]

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

Study Start Date: July 2007
Study Completion Date: September 2009
Primary Completion Date: September 2009 (Final data collection date for primary outcome measure)
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.
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.

  Eligibility

Ages Eligible for Study:   30 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00507494

Locations
Germany
Nephrology, Department of Medicine, university hospital Dresden
Dresden, Germany, 01307
Sponsors and Collaborators
Dresden University of Technology
Investigators
Principal Investigator: Peter Gross, MD Nephrology, Department of Medicine, University hospital Dresden
  More Information

No publications provided

Responsible Party: Dresden University of Technology
ClinicalTrials.gov Identifier: NCT00507494     History of Changes
Other Study ID Numbers: DNTx
Study First Received: July 25, 2007
Last Updated: October 27, 2011
Health Authority: Germany: Federal Institute for Drugs and Medical Devices

Keywords provided by Dresden University of Technology:
posttransplant diabetes mellitus
kidney transplantation
filtration fraction
proteinuria

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

ClinicalTrials.gov processed this record on May 22, 2013