Ignite Creation Date:
2025-12-24 @ 1:16 PM
Ignite Modification Date:
2026-02-20 @ 12:41 PM
Study NCT ID:
NCT02661295
Status:
TERMINATED
Last Update Posted:
2023-04-20
First Post:
2016-01-11
Is Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
A Study of Ferric Citrate to Improve Inflammation and Lipid Levels
Sponsor:
Winthrop University Hospital
Organization:
Study Overview
Official Title:
The Effect of Ferric Citrate on Inflammation and Lipid Levels in Patients on Hemodialysis
Status:
TERMINATED
Status Verified Date:
2023-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
38 enrolled, 19 completed the study when loss of funding occurred
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The risk of cardiovascular mortality in patients with end stage renal disease on hemodialysis is 10-100 times higher than the normal population. This is due in part to high levels of inflammation and vascular calcification found in these patients. Phosphate binders, particularly non-calcium based phosphate binders, may decrease cardiovascular risk by decreasing inflammation and vascular calcification. Ferric citrate a non-calcium based phosphate binder with approximately 210 mg of ferric iron has recently been approved for patients on hemodialysis. The effect of this phosphate binder on inflammation and lipid levels is unknown but investigators hypothesize that ferric citrate has the potential to improve inflammation and lipid levels in patients on hemodialysis by decreasing intravenous iron requirements and by improving lipid metabolism.
Detailed Description:
In patients with end stage renal disease (ESRD) receiving dialysis, the risk of cardiovascular death has been estimated to be 10-100 times higher than the general population without renal disease. This is due in part to high levels of inflammation and vascular calcification (large deposits of calcium in arteries) found in these patients. Chronic inflammation is particularly common in patients with ESRD. Parenteral iron therapy, which is common in patients on dialysis, may contribute to this inflammation and also a higher cardiovascular risk. Phosphate binders, particularly non-calcium based phosphate binders, may decrease cardiovascular risk by decreasing inflammation and vascular calcification. In a study of 10,044 hemodialysis patients, treatment with a phosphate binder was associated with improved survival. Ferric citrate a non-calcium based phosphate binder with approximately 210 mg of ferric iron has recently been approved for patients on hemodialysis. It has been shown to improve serum phosphorus levels and decrease intravenous iron requirements for patients on hemodialysis. The effect of this phosphate binder on inflammation and lipid levels is unknown but investigators hypothesize that ferric citrate has the potential to improve inflammation and lipid levels in patients on hemodialysis by decreasing intravenous iron requirements and by improving lipid metabolism.
Ferric citrate has the potential to decrease cardiovascular risk through multiple mechanisms:
1. acting as a non-calcium based binder to decrease serum phosphorus levels and vascular calcification,
2. decreasing intravenous iron requirements which in turn may decrease inflammation,
3. binding endotoxin (a harmful substance produced by microorganisms) in the gut and
4. improving lipid metabolism.
The purpose of this study is to examine the effect of ferric citrate on inflammatory markers and lipid levels.
Ferric citrate has the potential to decrease cardiovascular risk through multiple mechanisms:
1. acting as a non-calcium based binder to decrease serum phosphorus levels and vascular calcification,
2. decreasing intravenous iron requirements which in turn may decrease inflammation,
3. binding endotoxin (a harmful substance produced by microorganisms) in the gut and
4. improving lipid metabolism.
The purpose of this study is to examine the effect of ferric citrate on inflammatory markers and lipid levels.
Study Oversight
Has Oversight DMC:
False
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?: