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

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.

Study Overview

• Status: Withdrawn
• Conditions: Inflammation; Chronic Kidney Disease
• Intervention / Treatment: Drug: rosiglitazone

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 Type: Interventional
• Enrollment (Anticipated): 200
• Phase: Phase 2; Phase 3

Contacts and Locations

Study Locations

• Netherlands
  • Z-Holland
    • Den Haag, Z-Holland, Netherlands, 2512va
      • Medisch Centrum Haaglanden
    • Den Haag, Z-Holland, Netherlands, 2545ch
      • Haga Ziekenhuis

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
intima media thickness	48 weeks

Secondary Outcome Measures

Outcome Measure	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

Collaborators and Investigators

• Sponsor: Leiden University Medical Center
• Investigators: Principal Investigator: andré gaasbeek, Leiden University Medical Center

Study record dates

Study Major Dates

• Study Start: April 1, 2007
• Study Completion (Anticipated): May 1, 2009

Study Registration Dates

• First Submitted: September 13, 2005
• First Submitted That Met QC Criteria: September 14, 2005
• First Posted (Estimate): September 15, 2005

Study Record Updates

• Last Update Posted (Estimate): October 1, 2008
• Last Update Submitted That Met QC Criteria: September 30, 2008
• Last Verified: September 1, 2008

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Urologic Diseases; Renal Insufficiency; Kidney Diseases; Renal Insufficiency, Chronic; Inflammation; Hypoglycemic Agents; Physiological Effects of Drugs; Rosiglitazone
• Other Study ID Numbers: P06.108