Anti-Inflammatory Effects of Rosiglitazone in Patients With Stage 4 and 5 Chronic Kidney Disease (Hercules)
The purpose of this study in patients with stage 4 and 5 chronic kidney disease is to determine whether rosiglitazone can reduce inflammatory markers and to investigate its effect on intima media thickness, calcification and pulse wave velocity.
Chronic Kidney Disease
|Study Design:||Allocation: Randomized
Endpoint Classification: Pharmacodynamics Study
Intervention Model: Parallel Assignment
Primary Purpose: Treatment
|Official Title:||Anti-Inflammatory Effects of Rosiglitazone in Patients With Stage 4 and 5 Chronic Kidney Disease|
- intima media thickness [ Time Frame: 48 weeks ]
- carotid artery calcifications [ Time Frame: 48 weeks ]
- inflammation [ Time Frame: 48 weeks ]
- lipid profile [ Time Frame: 48 weeks ]
- metabolic profile [ Time Frame: 48 weeks ]
- pulse wave velocity [ Time Frame: 48 weeks ]
- nutritional status [ Time Frame: 48 weeks ]
- bone density [ Time Frame: 48 weeks ]
|Study Start Date:||April 2007|
|Estimated Study Completion Date:||May 2009|
This is a double-blind randomised placebo-controlled clinical multicenter trial in patients with stage 4 and 5 chronic kidney disease. Eligible patients in the outpatient kidney clinic and patients at the dialysis department will be informed by their treating physician about the study and they will be asked to join the study. Following informed consent the eligible patients will undergo baseline evaluation and will then be followed for a period of 48 weeks. Patients will be randomly divided in two groups: one group will take rosiglitazone (4 mg during the first 8 weeks once daily and 8 mg during the next 40 weeks once daily) and the other group will get placebo. The original medication will be continued. The total follow-up will be 48 weeks.
At the start of the study and at 4, 8, 12, 18, 24 and 48 weeks during follow-up inflammatory parameters (CRP, hs CRP, fetuin, fibrinogen), lipid profile,iron status, glucose and insulin will be measured. Intima media thickness, pulse wave velocity, bone densitometry,subjective global assessment will be performed at 0, 24 and 48 weeks.
|Medisch Centrum Haaglanden|
|Den Haag, Z-Holland, Netherlands, 2512va|
|Den Haag, Z-Holland, Netherlands, 2545ch|
|Principal Investigator:||andré gaasbeek||Leiden University Medical Center|