Chronic kidney disease
Conditions
Interventions
Trade Name: Avandia
Product Name: Rosiglitazon
Product Code: 1360
Pharmaceutical Form: Tablet
Pharmaceutical form of the placebo: Tablet
Route of administration of the placebo: Oral use
Sponsors
Leiden University Medical Center
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: - Willing and able to provide written consent; - Patients must 18 years of age or older; - Well-defined CKD for stage 4: GFR 15-30 ml/min/1.73m2 according to the abbreviated MDRD formula for stage 5: haemodialysis or peritoneal dialysis according to the K/DOQI guidelines Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: - A diagnosis of diabetes mellitus for which the patient uses insulin; - Significant co-morbidities which, according to the treating nephrologists, makes it unlikely that the patient will be able to complete the foreseen study period; - Significant cardiovascular co-morbidities which are likely to interfere with the objectives of the study (morbid obesity, family history of dyslipidemia, etc.); at the discretion of the treating nephrologists or the principal investigator; - Allergy for PPAR’s; - Cardiac disease with marked limitation of functional capacity (New York Heart Association III or IV clinical status); - Use of immunosuppressant agents; - History of renal transplant; - Hepatic insufficiency (defined as transaminase concentrations above > 2.5 times the upper limit of normal for the laboratories); - A history of alcohol abuse or excessive alcohol use defined as more than 21 consumptions per week; - For female patients: pregnancy, the intention to become pregnant within the study period, or lactating patients.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The primary objectives of the study are to assess the effect of rosiglitazone in patients with severe renal impairment on the change of carotid artery intima media thickness (IMT) and carotid artery calcifications and to assess the tolerability of rosiglitazone in this patient population.;Secondary Objective: Secondary objectives are to study the effects on (a) inflammation determined by measurement of the serum levels of inflammatory markers, nutrition state, erythropoietin resistance, insulin resistance and peritoneal membrane function in peritoneal dialysis patients and (b) the change of arterial stiffness determined by pulse wave velocity measurements over 48 weeks and (c) the drug safety profile (liver function parameters, weight changes, adverse events, etc.).;Primary end point(s): Intima-media thickness carotid artery | — |
Countries
Netherlands
Outcome results
None listed