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

Inflammation Clinical Trial

— Hercules  

Official title:

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

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT00169923
• Other study ID #: P06.108
• Status: Withdrawn
• Phase: Phase 2/Phase 3
• First received: September 13, 2005
• Last updated: September 30, 2008
• Start date: April 2007
• Est. completion date: May 2009

Study information

• Verified date: September 2008
• Source: Leiden University Medical Center
• Contact: n/a
• Is FDA regulated: No
• Health authority: Netherlands: Independent Ethics Committee
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 200
• Est. completion date: May 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Allocation: Randomized, Endpoint Classification: Pharmacodynamics Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Chronic Kidney Disease
• Inflammation
• Kidney Diseases
• Renal Insufficiency, Chronic

Intervention

Drug:
• rosiglitazone

Locations

Country	Name	City	State
Netherlands	Haga Ziekenhuis	Den Haag	Z-Holland
Netherlands	Medisch Centrum Haaglanden	Den Haag	Z-Holland

Sponsors (1)

Lead Sponsor	Collaborator
Leiden University Medical Center

Country where clinical trial is conducted

Netherlands, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	intima media thickness		48 weeks
Secondary	carotid artery calcifications		48 weeks
Secondary	inflammation		48 weeks
Secondary	lipid profile		48 weeks
Secondary	metabolic profile		48 weeks
Secondary	pulse wave velocity		48 weeks
Secondary	nutritional status		48 weeks
Secondary	bone density		48 weeks