TerminatedPhase 4

A Study of Ferric Citrate to Improve Inflammation and Lipid Levels

Stopped: 38 enrolled, 19 completed the study when loss of funding occurred

United States38 participantsStarted 2015-07

Plain-language 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.

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Percent Change in Total Cholesterol

Timeframe: Baseline, Month 6

Percent Change in LDL-Cholesterol

Timeframe: Baseline, Month 6

Percent Change in HDL Cholesterol

Timeframe: Baseline, Month 6

Percent Change in Triglycerides

Timeframe: Baseline, Month 6

Percent Change in TNF-alpha

Timeframe: Baseline, Month 6

Percent Change in IL-6

Timeframe: Baseline, Month 6

Percent Change in IL-8

Timeframe: Baseline, Month 6

Percent Change in Ferritin

Timeframe: Baseline, Month 6

Trial details

NCT IDNCT02661295

SponsorWinthrop University Hospital

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2017-09-29

Results submitted2023-03-30

View on ClinicalTrials.gov More End Stage Renal Disease trials

Plain-language summary

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

What they're measuring

Percent Change in Total Cholesterol

Timeframe: Baseline, Month 6

Percent Change in LDL-Cholesterol

Timeframe: Baseline, Month 6

Percent Change in HDL Cholesterol

Timeframe: Baseline, Month 6

Percent Change in Triglycerides

Timeframe: Baseline, Month 6

Percent Change in TNF-alpha

Timeframe: Baseline, Month 6

Percent Change in IL-6

Timeframe: Baseline, Month 6

Percent Change in IL-8

Timeframe: Baseline, Month 6

Percent Change in Ferritin

Timeframe: Baseline, Month 6