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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00169923
Recruitment Status : Withdrawn (it was not possible to recruit any patient in the study)
First Posted : September 15, 2005
Last Update Posted : October 1, 2008
Information provided by:
Leiden University Medical Center

Brief 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.

Condition or disease Intervention/treatment Phase
Chronic Kidney Disease Inflammation Drug: rosiglitazone Phase 2 Phase 3

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  (Clinical Trial)
Estimated Enrollment : 200 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
Primary Purpose: Treatment
Official Title: Anti-Inflammatory Effects of Rosiglitazone in Patients With Stage 4 and 5 Chronic Kidney Disease
Study Start Date : April 2007
Estimated Study Completion Date : May 2009

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Kidney Diseases
U.S. FDA Resources

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

Secondary Outcome Measures :
  1. carotid artery calcifications [ Time Frame: 48 weeks ]
  2. inflammation [ Time Frame: 48 weeks ]
  3. lipid profile [ Time Frame: 48 weeks ]
  4. metabolic profile [ Time Frame: 48 weeks ]
  5. pulse wave velocity [ Time Frame: 48 weeks ]
  6. nutritional status [ Time Frame: 48 weeks ]
  7. bone density [ Time Frame: 48 weeks ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00169923

Medisch Centrum Haaglanden
Den Haag, Z-Holland, Netherlands, 2512va
Haga Ziekenhuis
Den Haag, Z-Holland, Netherlands, 2545ch
Sponsors and Collaborators
Leiden University Medical Center
Principal Investigator: andré gaasbeek Leiden University Medical Center Identifier: NCT00169923     History of Changes
Other Study ID Numbers: P06.108
First Posted: September 15, 2005    Key Record Dates
Last Update Posted: October 1, 2008
Last Verified: September 2008

Additional relevant MeSH terms:
Kidney Diseases
Renal Insufficiency, Chronic
Pathologic Processes
Urologic Diseases
Renal Insufficiency
Anti-Inflammatory Agents
Hypoglycemic Agents
Physiological Effects of Drugs