SuspendedPhase 3

Study to Evaluate the Safety and Tolerability of Ferric Citrate in Children With Hyperphosphatemia Related to Chronic Kidney Disease

Stopped: Sponsor decision

United States45 participantsStarted 2022-06-16

Plain-language summary

This study will be conducted to assess the safety and tolerability of ferric citrate in pediatric participants with hyperphosphatemia related to chronic kidney disease (CKD).

Who can participate

Age range

6 Years – 16 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 adequacy: single-pool Kt/V ≥1.2 for at least 1 hemodialysis session within 2 months.
. Peritoneal dialysis: At least 1Kt/V reading ≥1.8 within 4 months.

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

Number of participants with serious and non-serious treatment-emergent adverse events (TEAEs) including gastrointestinal (GI) AEs of special interest

Timeframe: up to Week 40

Number of participants with clinically significant laboratory abnormalities or changes in laboratory results

Timeframe: up to Week 40

Number of participants with TEAEs leading to the discontinuation of ferric citrate

Timeframe: up to Week 40

Trial details

NCT IDNCT04523727

SponsorKeryx Biopharmaceuticals

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2026-12

View on ClinicalTrials.gov More Hyperphosphatemia Related to Chronic Kidney Disease trials

Who can participate

Age range

6 Years – 16 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 adequacy: single-pool Kt/V ≥1.2 for at least 1 hemodialysis session within 2 months.
. Peritoneal dialysis: At least 1Kt/V reading ≥1.8 within 4 months.

What they're measuring

Number of participants with serious and non-serious treatment-emergent adverse events (TEAEs) including gastrointestinal (GI) AEs of special interest

Timeframe: up to Week 40

Number of participants with clinically significant laboratory abnormalities or changes in laboratory results

Timeframe: up to Week 40

Number of participants with TEAEs leading to the discontinuation of ferric citrate

Timeframe: up to Week 40