A Study of Ferric Citrate to Improve Inflammation and Lipid Levels

NCT ID: NCT02661295

Last Updated: 2023-04-20

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE4
• Total Enrollment: 38 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-07-31
• Study Completion Date: 2018-03-15

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.

Conditions

End Stage Renal Disease; Hyperphosphatemia; Chronic Inflammation

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: OTHER
• Blinding Strategy: NONE

Study Groups

Ferric Citrate

Ferric citrate at a starting dose of 2 tablets with each meal will be given to all participants.

Group Type: OTHER

Ferric Citrate

Intervention Type: DRUG

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.

Interventions

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.

Intervention Type: DRUG

Other Intervention Names

Auryxia

Eligibility 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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Keryx Biopharmaceuticals

INDUSTRY

Sponsor Role: collaborator

Winthrop University Hospital

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Candace Grant, MD

Role: PRINCIPAL_INVESTIGATOR

NYU Winthrop

Locations

Winthrop University Hospital

Mineola, New York, United States

Countries

United States

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

WUH 756275-1

Identifier Type: -

Identifier Source: org_study_id