Anti-Inflammatory Effects of Pioglitazone in Non-Diabetic Patients with Stage 4 and 5 Chronic Kidney Disease - Article High blood pressure (hypertension)
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
|Chronic Kidney Disease |
| Drug: pioglitazone ||Phase II |
MedlinePlus related topics: Kidney Diseases
Study Type: Interventional
Study Design: Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment
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.
Location and Contact Information
Medisch Centrum Haaglanden, Den Haag, Z-Holland, 2512va, Netherlands
Haga Ziekenhuis, Den Haag, Z-Holland, 2545ch, Netherlands
Leiden University Medical Center, Leiden, Z-Holland, 2311AA, Netherlands
andré gaasbeek, Principal Investigator, Leiden University Medical Center
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
- High Blood Pressure and Kidney Disease (National Institute of Diabetes and Digestive and Kidney Diseases)