NCT02661295

A Study of Ferric Citrate to Improve Inflammation and Lipid Levels

The Effect of Ferric Citrate on Inflammation and Lipid Levels in Patients on Hemodialysis

• Status: Terminated
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 38 (actual)
• Sponsor: Winthrop University Hospital · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• End Stage Renal Disease
• Hyperphosphatemia
• Chronic Inflammation

Interventions

Type	Name	Description
DRUG	Ferric Citrate	Study participants will receive ferric citrate at a starting dose of 2 tablets with each meal if serum phosphorus levels are ≥ 6.0 mg/dL calcium levels are in the normal range, Tsat ≥ 20 and \< 50% and ferritin ≥ 200 and \< 500 ng/ml after a 2 week wash out period.

Timeline

• Start date: 2015-07-01
• Primary completion: 2017-09-29
• Completion: 2018-03-15
• First posted: 2016-01-22
• Last updated: 2023-04-20
• Results posted: 2023-04-20

Locations

1 site across 1 country: United States