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Not recruiting
Phase 3

Ferric Citrate

Sponsor:

Keryx Biopharmaceuticals

Code:

NCT04523727

Conditions

Hyperphosphatemia Related to Chronic Kidney Disease

Eligibility Criteria

Sex: All

Age: 6 - 16

Healthy Volunteers: Not accepted

Interventions

ferric citrate

Study Details

Brief 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).

Conditions

Hyperphosphatemia Related to Chronic Kidney Disease

Study ID

NCT04523727

Start date

Jun 16, 2022

Status verified date

Sep, 2025

Completion date

Oct, 2026

Anticipated

Primary completion date

Dec, 2025

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 6 - 16

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • Age 6 years to <17 years at Screening.
  • Weight ≥ 20 kilograms (kg) (dry weight for dialysis participants) at Screening.
  • Chronic kidney disease (CKD) requiring chronic dialysis (i.e., hemodialysis or peritoneal dialysis), or CKD not on dialysis with an estimated glomerular filtration rate (eGFR) <30 milliliters per minute (mL/min)/1.73 meters squared (m\^2) at Screening.
  • Documented history of CKD-related hyperphosphatemia for at least 3 months prior to the screening visit.
  • If participant is or is not on phosphate binder(s) at Visit 1, serum phosphorus must be:

  • 6 to <13 years: >5.8 milligrams per deciliter (mg/dL).
  • 13 to <17 years: >4.5 mg/dL.
  • If participant is on phosphate binder(s) at Visit 1, and serum phosphorus is not greater than the above stated age-limit criteria, approximately 1 to 4-weeks of washout period is required and at Visit 1a or Visit 1b, serum phosphorus must be greater than the age above stated age-limit criteria.
  • Transferrin saturation (TSAT) <50%.
  • Serum ferritin of <650 nanograms per milliliter (ng/mL).
  • Parent/legal guardian must be willing and able to give written informed consent, and child (participant) willing and able to give age-appropriate assent according to local regulatory requirements.
  • Female participants of childbearing potential, defined as post menarche and not surgically sterile, must have a negative serum pregnancy test.
  • Dialysis adequacy stable on current mode of dialysis prior to screening and agree to maintain dialysis prescription for the duration of the pharmacodynamic assessment period unless changes are needed for safety. A minimum dialysis adequacy (dialysis clearance of urea-dialysis time/volume of distribution of urea \[Kt/V\]), defined by the following:

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

Exclusion Criteria:

  • Active significant GI disorder, including overt GI bleeding or active inflammatory bowel disease.
  • Liver transaminases (aspartate aminotransferase \[AST\] or alanine aminotransferase \[ALT\]) >3× the upper limit of normal at Screening.
  • Unable to swallow pills, if participant requires tube feeding, ferric citrate must be taken orally and not administered via feeding tube.
  • Non-renal cause of hyperphosphatemia.
  • Active drug or alcohol dependence or abuse (excluding tobacco use or medicinal marijuana) within the 12 months prior to Screening or evidence of such abuse (in the opinion of the Investigator).
  • Malignancy, except for participants who have been disease-free for at least 2 years after curative therapy.
  • Participants with a functioning organ transplant.
  • A known allergy or intolerance to ferric citrate or any of its constituents.
  • Female participants who do not agree to remain abstinent or assent to use a combination of 2 of the following highly effective birth control methods for at least 28 days before the first dose, during the study (including during dose interruptions), and for at least 30 days after the last dose:

  • Barrier method of contraception: condoms (female or male) with or without a spermicidal agent, diaphragm, or cervical cap with spermicide.
  • Intrauterine device (IUD).
  • Hormone-based contraceptives which are associated with inhibition of ovulation.
  • Females who are pregnant or breast-feeding other children. Participants who are being breastfed are eligible to participate in this study.
  • Any other medical condition that, in the opinion of the Investigator, renders the participant unable to or unlikely to complete the trial or that would interfere with optimal participation in the trial or produce significant risk to the participant.
  • The participant, in the opinion of the Investigator, is unable to adhere to the requirements of the study.
  • Receipt of any investigational drug within 4 weeks before Screening.
  • History of hemochromatosis or iron overload syndrome (e.g, hereditary sideroblastic anemia, thalassemia).

Study Design

Enrollment

45 participants

Anticipated

Intervention Model

Single group

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Ferric citrate

Participants aged 6 to < 17 years will receive ferric citrate for 36 weeks at a starting dose based on body weight categories.

Interventions

ferric citrate

oral tablets

Primary outcome measure

  • Number of participants with serious and non-serious treatment-emergent adverse events (TEAEs) including gastrointestinal (GI) AEs of special interest [ Time Frame: up to Week 40 ]
  • Number of participants with clinically significant laboratory abnormalities or changes in laboratory results [ Time Frame: up to Week 40 ]
  • Number of participants with TEAEs leading to the discontinuation of ferric citrate [ Time Frame: up to Week 40 ]

Central Contacts and Locations

Central contacts

Akebia Medical Information

1-844-445-3799medicalinfo@akebia.com

Locations

University of Alabama at Birmingham (UAB) - Children's of Alabama

Recruiting

Birmingham, Alabama, United States, 35233

Phoenix Childrens Hospital

Recruiting

Phoenix, Arizona, United States, 85016

University of California, San Francisco (UCSF) - Department of Nephrology

Recruiting

San Francisco, California, United States, 94158

Stanford University Medical Center

Recruiting

Stanford, California, United States, 94305

Children's Hospital Colorado

Recruiting

Aurora, Colorado, United States, 80045

University of Minnesota

Recruiting

Minneapolis, Minnesota, United States, 55455

University of New Mexico

Recruiting

Albuquerque, New Mexico, United States, 87110

Cincinnati Children's Hospital Medical Center

Recruiting

Cincinnati, Ohio, United States, 45229

Seattle Children's Hospital

Recruiting

Seattle, Washington, United States, 98105

More Information

Sponsor

Keryx Biopharmaceuticals

Last update posted

Sep 9, 2025

Last verified

Sep, 2025

Keywords

  • hyperphosphatemia
  • chronic kidney disease
  • CKD
  • ferric citrate
  • pediatric
  • dialysis

Trial information was received from ClinicalTrials.gov and was last updated on 2026-10-05. This information was provided to ClinicalTrials.gov by Keryx Biopharmaceuticals on 2025-09-09. Recruitment status is synced daily from ClinicalTrials.gov and may not reflect the sponsor's current status. Confirm during your call.