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

eiden University Medical Center0 个研究点目标入组 200 人开始时间: 2006年6月1日最近更新: 2012年3月19日

适应症

试验速览

暂无简介。

•- 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.

发起方

eiden University Medical Center