Ignite Creation Date:
2024-05-05 @ 11:53 AM
Last Modification Date:
2024-10-26 @ 9:16 AM
Study NCT ID:
NCT00169923
Status:
WITHDRAWN
Last Update Posted:
2008-10-01
First Post:
2005-09-13
Brief Title:
Anti-Inflammatory Effects of Rosiglitazone in Patients With Stage 4 and 5 Chronic Kidney Disease
Sponsor:
Leiden University Medical Center
Organization:
Leiden University Medical Center
Study Overview
Official Title:
Anti-Inflammatory Effects of Rosiglitazone in Patients With Stage 4 and 5 Chronic Kidney Disease
Status:
WITHDRAWN
Status Verified Date:
2008-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
it was not possible to recruit any patient in the study
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
Hercules
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
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 profileiron status glucose and insulin will be measured Intima media thickness pulse wave velocity bone densitometrysubjective global assessment will be performed at 0 24 and 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 profileiron status glucose and insulin will be measured Intima media thickness pulse wave velocity bone densitometrysubjective global assessment will be performed at 0 24 and 48 weeks
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None