Diabetes Mellitus, Kidney Transplantation, Proteinuria
Conditions
Keywords
posttransplant diabetes mellitus, kidney transplantation, filtration fraction, proteinuria
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.
Interventions
DRUGpioglitazone
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.
Sponsors
Technische Universität Dresden
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
DOUBLE
Eligibility
Sex/Gender
ALL
Age
30 Years to 75 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| proteinuria | 12 weeks |
Secondary
| Measure | Time frame |
|---|---|
| efficacy: filtration fraction, renal nitric oxide bioavailability, insulin resistance, platelet function safety: tolerability, plasma glucose, body weight, edema | 12 weeks |
Countries
Germany
Outcome results
None listed