search
Back to results

Influence of Pioglitazone for Renal Transplant Function in Diabetics

Primary Purpose

Diabetes Mellitus, Kidney Transplantation, Proteinuria

Status
Completed
Phase
Phase 3
Locations
Germany
Study Type
Interventional
Intervention
pioglitazone
Sponsored by
Technische Universität Dresden
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Diabetes Mellitus focused on measuring posttransplant diabetes mellitus, kidney transplantation, filtration fraction, proteinuria

Eligibility Criteria

30 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Nephrology, Department of Medicine, university hospital Dresden

Outcomes

Primary Outcome Measures

proteinuria

Secondary Outcome Measures

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

Full Information

First Posted
July 25, 2007
Last Updated
October 27, 2011
Sponsor
Technische Universität Dresden
search

1. Study Identification

Unique Protocol Identification Number
NCT00507494
Brief Title
Influence of Pioglitazone for Renal Transplant Function in Diabetics
Official Title
Influence of Pioglitazone for Renal Transplant Function in Diabetics - a Double Blind Randomised Placebo Controlled Cross Over Study
Study Type
Interventional

2. Study Status

Record Verification Date
October 2011
Overall Recruitment Status
Completed
Study Start Date
July 2007 (undefined)
Primary Completion Date
September 2009 (Actual)
Study Completion Date
September 2009 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Technische Universität Dresden

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Diabetes Mellitus, Kidney Transplantation, Proteinuria
Keywords
posttransplant diabetes mellitus, kidney transplantation, filtration fraction, proteinuria

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Crossover Assignment
Masking
Double
Allocation
Randomized

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
pioglitazone
Intervention Description
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 Measure Information:
Title
proteinuria
Time Frame
12 weeks
Secondary Outcome Measure Information:
Title
efficacy: filtration fraction, renal nitric oxide bioavailability, insulin resistance, platelet function safety: tolerability, plasma glucose, body weight, edema
Time Frame
12 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
30 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Peter Gross, MD
Organizational Affiliation
Nephrology, Department of Medicine, University hospital Dresden
Official's Role
Principal Investigator
Facility Information:
Facility Name
Nephrology, Department of Medicine, university hospital Dresden
City
Dresden
ZIP/Postal Code
01307
Country
Germany

12. IPD Sharing Statement

Citations:
PubMed Identifier
32803882
Citation
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.
Results Reference
derived

Learn more about this trial

Influence of Pioglitazone for Renal Transplant Function in Diabetics

We'll reach out to this number within 24 hrs