E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
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MedDRA Classification |
E.1.3 | Condition being studied is a rare disease | No |
E.2 Objective of the trial |
E.2.1 | Main objective of the trial |
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. |
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E.2.2 | Secondary objectives of the trial |
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.). |
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E.2.3 | Trial contains a sub-study | Information not present in EudraCT |
E.3 | Principal 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
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E.4 | Principal 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.
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E.5 End points |
E.5.1 | Primary end point(s) |
Intima-media thickness carotid artery |
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E.6 and E.7 Scope of the trial |
E.6 | Scope of the trial |
E.6.1 | Diagnosis | No |
E.6.2 | Prophylaxis | No |
E.6.3 | Therapy | Yes |
E.6.4 | Safety | Yes |
E.6.5 | Efficacy | Yes |
E.6.6 | Pharmacokinetic | No |
E.6.7 | Pharmacodynamic | Yes |
E.6.8 | Bioequivalence | No |
E.6.9 | Dose response | No |
E.6.10 | Pharmacogenetic | Information not present in EudraCT |
E.6.11 | Pharmacogenomic | No |
E.6.12 | Pharmacoeconomic | No |
E.6.13 | Others | No |
E.7 | Trial type and phase |
E.7.1 | Human pharmacology (Phase I) | No |
E.7.1.1 | First administration to humans | No |
E.7.1.2 | Bioequivalence study | No |
E.7.1.3 | Other | No |
E.7.1.3.1 | Other trial type description | |
E.7.2 | Therapeutic exploratory (Phase II) | Yes |
E.7.3 | Therapeutic confirmatory (Phase III) | No |
E.7.4 | Therapeutic use (Phase IV) | No |
E.8 Design of the trial |
E.8.1 | Controlled | Yes |
E.8.1.1 | Randomised | Yes |
E.8.1.2 | Open | No |
E.8.1.3 | Single blind | No |
E.8.1.4 | Double blind | Yes |
E.8.1.5 | Parallel group | Yes |
E.8.1.6 | Cross over | No |
E.8.1.7 | Other | No |
E.8.2 | Comparator of controlled trial |
E.8.2.1 | Other medicinal product(s) | No |
E.8.2.2 | Placebo | Yes |
E.8.2.3 | Other | No |
E.8.3 |
The trial involves single site in the Member State concerned
| No |
E.8.4 | The trial involves multiple sites in the Member State concerned | Yes |
E.8.5 | The trial involves multiple Member States | No |
E.8.6 Trial involving sites outside the EEA |
E.8.6.1 | Trial being conducted both within and outside the EEA | No |
E.8.6.2 | Trial being conducted completely outside of the EEA | Information not present in EudraCT |
E.8.7 | Trial has a data monitoring committee | Information not present in EudraCT |
E.8.8 |
Definition of the end of the trial and justification where it is not the last
visit of the last subject undergoing the trial
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48 weeks treatment period |
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E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | 1 |
E.8.9.1 | In the Member State concerned months | 6 |
E.8.9.1 | In the Member State concerned days | |
E.8.9.2 | In all countries concerned by the trial years | 1 |
E.8.9.2 | In all countries concerned by the trial months | 6 |