Anti-Inflammatory Effects of Rosiglitazone in Patients With Stage 4 and 5 Chronic Kidney Disease

Phase 2

Withdrawn

• Conditions: Chronic Kidney Disease; Inflammation

• Registration Number: NCT00169923
• Lead Sponsor: Leiden University Medical Center

Brief Summary

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.

Detailed Description

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.

Study Timeline

• Study First Submitted: 2005-09-13
• Study First Submitted QC: 2005-09-14
• Study First Posted: 2005-09-15
• Study Start: 2007-04
• Status Verified: 2008-09
• Last Update Submitted: 2008-09-30
• Last Update Posted: 2008-10-01
• Study Completion: 2009-05

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: 200

Inclusion Criteria

• Written consent
• Over 18 years of age
• Stage 4 or 5 chronic kidney disease according the K/DOQI guidelines

Exclusion Criteria

• Life span of less than one year
• Alcohol abuse
• Transaminases > 2.5 times the upper limit
• Diabetes mellitus
• Pregnancy
• Cardiac disease with marked limitation of functional capacity (NYHA III or IV)
• Use of immunosuppressant agents

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
intima media thickness	48 weeks

Secondary Outcome Measures

Name	Time	Method
nutritional status	48 weeks
bone density	48 weeks
carotid artery calcifications	48 weeks
inflammation	48 weeks
lipid profile	48 weeks
metabolic profile	48 weeks
pulse wave velocity	48 weeks

Trial Locations

Locations (2)

Medisch Centrum Haaglanden; 🇳🇱 Den Haag, Z-Holland, Netherlands

Haga Ziekenhuis; 🇳🇱 Den Haag, Z-Holland, Netherlands