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NCT Number: NCT00507494

Influence of Pioglitazone for Renal Transplant Function in Diabetics

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.

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Key information

Conditions

Diabetes Mellitus Endocrine System Diseases Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Glucose Metabolism Disorders Kidney Transplantation Male Urogenital Diseases Metabolic Diseases Nutritional and Metabolic Diseases Pathological Conditions, Signs and Symptoms Proteinuria Signs and Symptoms Urination Disorders Urogenital Diseases Urologic Diseases Urological Manifestations

Age range

30 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Nephrology, Department of Medicine, university hospital Dresden

Dresden, 01307, Germany

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

pioglitazone

Drug

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 outcomes

  1. proteinuria

    Time frame: 12 weeks

Secondary outcomes

  1. efficacy: filtration fraction, renal nitric oxide bioavailability, insulin resistance, platelet function safety: tolerability, plasma glucose, body weight, edema

    Time frame: 12 weeks

Sponsors and collaborators

Lead sponsor

Technische Universität Dresden

Other

Registry information

Official study title

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

Important dates

Study start
2007
Primary completion
2009
Study completion
2009
First posted
Jul 26, 2007
Registry last updated
Oct 28, 2011

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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