A Study of Ferric Citrate to Improve Inflammation and Lipid Levels

• Status: Unknown status
• Trial end date: 2016-06-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Winthrop University Hospital
• Collaborator: Keryx Biopharmaceuticals
• Treatments: Citric Acid; Ferric Compounds

Criteria

Inclusion Criteria:

• Hemodialysis treatment for ≥ 6 months

• Phosphate binder treatment for ≥ to 1 month

• Maintenance iron therapy with no more than 125mg IV iron weekly≥ to 1 month

• Serum phosphorus levels between 2.5 and 8 at screening

• Serum phosphorus ≥ to 6.0 mg/dL after a 2 week washout period.

• Serum ferritin ≥ 200 and < 600ng/ml after a 2 week washout period

• Serum calcium levels within normal range

• Predicted survival greater than 6 months

Exclusion Criteria:

• Intact PTH< 70 pg/ml or > 1,000 pg/ml

• Oral iron use

• Vitamin C supplement use

• Parathyroidectomy

• Active malignancy

• Hemodialysis via an intravenous catheter or arteriovenous (AV) graft

• Received > 250mg of IV iron over the two weeks prior to screening

• Whole blood transfusion within 3 months prior to screening

• Active bleeding other than from the dialysis access

• Hospitalization within one month prior to screening

• current infection

• Ongoing or uncontrolled inflammatory disorder

• Liver cirrhosis

• Likelihood of imminent renal transplantation