Clinical Trial: Anti-Inflammatory Effects of Pioglitazone in Non-Diabetic Patients with Stage 4 and 5 Chronic Kidney Disease

This study is not yet open for patient recruitment.
Verified by Leiden University Medical Center June 2005

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

Purpose

The purpose of this study in non-diabetic patients with stage 4 and 5 chronic kidney disease is to determine whether pioglitazone can reduce inflammatory markers and to investigate its effect on intima media thickness and pulse wave velocity.
Condition Intervention Phase
Chronic Kidney Disease
Inflammation
 Drug: pioglitazone
Phase II
Phase III

MedlinePlus related topics:  Kidney Diseases

Study Type: Interventional
Study Design: Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment

Further Study Details: 

Expected Total Enrollment:  150

This is a double-blind randomised placebo-controlled clinical multicenter trial in non-diabetic 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 pioglitazone (30 mg 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 3,6,12,18,24 and 48 weeks during follow-upinflammatory parameters (CRP, hs CRP, IL-6, fetuin,fibrinogen, serum amyloid A), lipid profile, glucose and insulin will be measured. Intima media thickness, pulse wave velocity, subjective global assessment will be performed at 0,24 and 48 weeks.

Eligibility

Ages Eligible for Study:  18 Years and above,  Genders Eligible for Study:  Both
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)

Location and Contact Information

Please refer to this study by ClinicalTrials.gov identifier  NCT00169923

andré gaasbeek      +31715262148    a.gaasbeek@lumc.nl

Netherlands, Z-Holland
      Medisch Centrum Haaglanden, Den Haag,  Z-Holland,  2512va,  Netherlands
a gaasbeek  +31715262148    a.gaasbeek@lumc.nl 

      Haga Ziekenhuis, Den Haag,  Z-Holland,  2545ch,  Netherlands
a gaasbeek  +31715269111    a.gaasbeek@lumc.nl 

      Leiden University Medical Center, Leiden,  Z-Holland,  2311AA,  Netherlands
a gaasbeek  +31715262148    a.gaasbeek@lumc.nl 

Study chairs or principal investigators

andré gaasbeek,  Principal Investigator,  Leiden University Medical Center   

More Information

Study ID Numbers:  P05.020
Last Updated:  September 14, 2005
Record first received:  September 13, 2005
ClinicalTrials.gov Identifier:  NCT00169923
Health Authority: Netherlands: Independent Ethics Committee
ClinicalTrials.gov processed this record on 2005-09-20

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