Anti-inflammatory effects of rosiglitazone in patients with stage 4 and 5 chronic kidney disease

INTERVENTION: 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 CONDITION: Chronic kidney disease PRIMARY OUTCOME: 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. Primary end point(s): Intima‐media thickness carotid artery 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.). 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