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

Study Overview
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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.

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

Conditions
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Chronic Kidney Disease, Inflammation

Intervention / Treatment
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* Drug: rosiglitazone


Participation Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: rosiglitazone|nan|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| intima media thickness |  | 48 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| carotid artery calcifications |  | 48 weeks | 
| inflammation |  | 48 weeks | 
| lipid profile |  | 48 weeks | 
| metabolic profile |  | 48 weeks | 
| pulse wave velocity |  | 48 weeks | 
| nutritional status |  | 48 weeks | 
| bone density |  | 48 weeks |