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

This study is currently recruiting participants.
Verified by Leiden University Medical Center, March 2007

Sponsored by: Leiden University Medical Center
Information provided by: Leiden University Medical Center
ClinicalTrials.gov Identifier: NCT00169923
  Purpose

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.


Condition Intervention Phase
Chronic Kidney Disease
Inflammation
Drug: rosiglitazone
Phase II
Phase III

ChemIDplus related topics:   Rosiglitazone    Rosiglitazone Maleate   

U.S. FDA Resources

Study Type:   Interventional
Study Design:   Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Pharmacodynamics Study
Official Title:   Anti-Inflammatory Effects of Rosiglitazone in Patients With Stage 4 and 5 Chronic Kidney Disease

Further study details as provided by Leiden University Medical Center:

Primary Outcome Measures:
  • intima media thickness [ Time Frame: 48 weeks ]

Secondary Outcome Measures:
  • carotid artery calcifications [ Time Frame: 48 weeks ]
  • inflammation [ Time Frame: 48 weeks ]
  • lipid profile [ Time Frame: 48 weeks ]
  • metabolic profile [ Time Frame: 48 weeks ]
  • pulse wave velocity [ Time Frame: 48 weeks ]
  • nutritional status [ Time Frame: 48 weeks ]
  • bone density [ Time Frame: 48 weeks ]

Estimated Enrollment:   200
Study Start Date:   April 2007
Estimated Study Completion Date:   May 2009

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.

  Eligibility
Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No

Criteria

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
  Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00169923

Contacts
Contact: andré gaasbeek     +31715262148     a.gaasbeek@lumc.nl    

Locations
Netherlands, Z-Holland
Medisch Centrum Haaglanden     Not yet recruiting
      Den Haag, Z-Holland, Netherlands, 2512va
      Contact: a gaasbeek     +31715262148     a.gaasbeek@lumc.nl    
Haga Ziekenhuis     Not yet recruiting
      den haag, Z-Holland, Netherlands, 2545ch
      Contact: a gaasbeek     +31715269111     a.gaasbeek@lumc.nl    
Leiden University Medical Center     Recruiting
      leiden, Z-Holland, Netherlands, 2311AA
      Contact: a gaasbeek     +31715262148     a.gaasbeek@lumc.nl    

Sponsors and Collaborators
Leiden University Medical Center

Investigators
Principal Investigator:     andré gaasbeek     Leiden University Medical Center    
  More Information


Study ID Numbers:   P06.108
First Received:   September 13, 2005
Last Updated:   April 30, 2007
ClinicalTrials.gov Identifier:   NCT00169923
Health Authority:   Netherlands: Independent Ethics Committee

Study placed in the following topic categories:
Renal Insufficiency
Urologic Diseases
Renal Insufficiency, Chronic
Kidney Failure, Chronic
Kidney Diseases
Rosiglitazone
Kidney Failure
Inflammation

Additional relevant MeSH terms:
Hypoglycemic Agents
Pathologic Processes
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on September 22, 2008




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