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

This study has been withdrawn prior to enrollment.
(it was not possible to recruit any patient in the study)
Sponsor:
Information provided by:
Leiden University Medical Center
ClinicalTrials.gov Identifier:
NCT00169923
First received: September 13, 2005
Last updated: September 30, 2008
Last verified: September 2008
  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 2
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Pharmacodynamics Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
Primary Purpose: Treatment
Official Title: Anti-Inflammatory Effects of Rosiglitazone in Patients With Stage 4 and 5 Chronic Kidney Disease

Resource links provided by NLM:


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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

Locations
Netherlands
Medisch Centrum Haaglanden
Den Haag, Z-Holland, Netherlands, 2512va
Haga Ziekenhuis
Den Haag, Z-Holland, Netherlands, 2545ch
Sponsors and Collaborators
Leiden University Medical Center
Investigators
Principal Investigator: andré gaasbeek Leiden University Medical Center
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00169923     History of Changes
Other Study ID Numbers: P06.108
Study First Received: September 13, 2005
Last Updated: September 30, 2008
Health Authority: Netherlands: Independent Ethics Committee

Additional relevant MeSH terms:
Inflammation
Kidney Diseases
Renal Insufficiency, Chronic
Pathologic Processes
Urologic Diseases
Renal Insufficiency
Anti-Inflammatory Agents
Rosiglitazone
Therapeutic Uses
Pharmacologic Actions
Hypoglycemic Agents
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on August 27, 2014