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.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
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.
Nephrology, Department of Medicine, university hospital Dresden
Dresden, Germany
proteinuria
Time frame: 12 weeks
efficacy: filtration fraction, renal nitric oxide bioavailability, insulin resistance, platelet function safety: tolerability, plasma glucose, body weight, edema
Time frame: 12 weeks
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