A Phase 2/3 interventional study of rosiglitazone in Chronic Kidney Disease and Inflammation, sponsored by Leiden University Medical Center. Withdrawn at 2 sites in Netherlands. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2008-10-01.
Sponsored by Leiden University Medical Center · Phase 2/3, Interventional, and Treatment
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.
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.
3,840 studies on the registry are indexed under Kidney Diseases; 500 are open to participants now.
This study's planned enrollment of 200 is above the median of 70 across 2,640 interventional studies indexed under Kidney Diseases.
Browse Kidney Diseases studies →Leiden University Medical Center is the lead sponsor of 326 studies on the registry; 106 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
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
This study is withdrawn, as verified in Sep 2008. You cannot join it, but the record below documents what was studied.
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Leiden University Medical Center