Anti-inflammatory effects of rosiglitazone in patients with stage 4 and 5 chronic kidney disease - Hercules
- Conditions
- Chronic kidney disease
- Registration Number
- EUCTR2006-003001-49-NL
- Lead Sponsor
- eiden University Medical Center
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Authorised-recruitment may be ongoing or finished
- Sex
- All
- Target Recruitment
- 200
- 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
- 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.
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 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
- Secondary Outcome Measures
Name Time Method