Inflammation Clinical Trial
Official title:
Anti-Inflammatory Effects of Rosiglitazone in Patients With Stage 4 and 5 Chronic Kidney Disease
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.
;
Allocation: Randomized, Endpoint Classification: Pharmacodynamics Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment
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