Influence of Pioglitazone for Renal Transplant Function in Diabetics

Technische Universität Dresden

Status and phase: Completed; Phase 3

Conditions: Proteinuria; Kidney Transplantation; Diabetes Mellitus

Treatments: Drug: pioglitazone

Study type: Interventional

Funder types: Other

Identifiers

NCT00507494

DNTx

Details and patient eligibility

About

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.

Full 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.

Sex: All

Ages: 30 to 75 years old

Volunteers: No 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Double Blind