Influence of Pioglitazone for Renal Transplant Function in Diabetics

NCT00507494 | Completed Phase 3 DMC

• 1 other identifier: DNTx
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

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.

Conditions

Diabetes Mellitus; Kidney Transplantation; Proteinuria

Keywords

posttransplant diabetes mellitus; kidney transplantation; filtration fraction; proteinuria

Outcome Measures

Primary Outcomes (1)

• proteinuria

  12 weeks

Secondary Outcomes (1)

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

  12 weeks

Interventions

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.

Eligibility Criteria

• Age: 30 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• type 1 diabetes
• pregnant or breast feeding women
• congestive heart failure (\>stage 1 NYHA)
• creeping creatinin
• ALT, AST \> 2.5 fold the upper limit of normal
• uncontrolled hypertension
• hypo- or hyperthyroidism

Sponsors & Collaborators

• Technische Universität Dresden: lead

Study Sites (1)

Nephrology, Department of Medicine, university hospital Dresden

Dresden, 01307, Germany

Location

Related Publications (1)

• 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.

  PMID: 32803882 DERIVED

MeSH Terms

Conditions

Diabetes Mellitus; Proteinuria

Interventions

Pioglitazone

Condition Hierarchy (Ancestors)

Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Urination Disorders; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Urological Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Thiazolidinediones; Thiazoles; Sulfur Compounds; Organic Chemicals; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Study Officials

• Peter Gross, MD

  Nephrology, Department of Medicine, University hospital Dresden

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 25, 2007
• First Posted: July 26, 2007
• Study Start: July 1, 2007
• Primary Completion: September 1, 2009
• Study Completion: September 1, 2009
• Last Updated: October 28, 2011

Record last verified: 2011-10

Locations

DE (1)