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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

WITHDRAWN

Clinical Phase

PHASE2/PHASE3

Total Enrollment

200 participants

Study Classification

INTERVENTIONAL

Study Start Date

2007-04-30

Study Completion Date

2009-05-31

Brief Summary

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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

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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.

Conditions

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Chronic Kidney Disease Inflammation

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Interventions

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rosiglitazone

Intervention Type DRUG

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Principal Investigators

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andré gaasbeek

Role: PRINCIPAL_INVESTIGATOR

Leiden University Medical Center

Locations

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Medisch Centrum Haaglanden

The Hague, Z-Holland, Netherlands

Site Status

Haga Ziekenhuis