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

What this study involves

The registry does not currently label this study as recruiting. Ask about its status before planning a screening visit.

Study type

Interventional

Phase

Phase 3

Age range

6 years - 16 years

Sex eligible

All sexes

Healthy volunteers

Not accepted

Participants

45 Estimated

These are starting points, not an eligibility decision. The research team must review the full requirements.

About the research

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 may be able to participate?

The list below is the sponsor’s full registry wording. It can include conditions, prior treatment, test results and other requirements. A match in search does not mean you qualify.

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).

Treatment, groups and participation

The registry may describe treatments and study duration without a complete visit calendar. Ask the study team for the exact schedule, procedures, risks, costs and alternatives. Keep your usual care plan unless your treating clinician tells you otherwise.

Assignment

Not applicable

Masking

No masking

What researchers are measuring

Outcome measures describe what is being studied. They are not proof that a treatment works.

Primary measures

Secondary measures

Research locations (14)

The overall study status and a local site’s status can differ. Confirm that location’s availability before traveling.

14 locations

Study team and timeline

Lead sponsor

Keryx Biopharmaceuticals

Study start

Jun 16, 2022 Actual

Primary completion

2027-02 Estimated

Study completion

2027-10 Estimated

First posted

Aug 24, 2020 Actual

Last updated

Nov 10, 2026 Actual

Official study contacts

No central contact is listed. Check the locations and the official record.