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

• Status: Not yet recruiting
• Trial end date: 2024-06-01
• Target enrollment: 0
• Participant gender: All

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).

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Keryx Biopharmaceuticals

Criteria

Inclusion Criteria:

• Weight ≥12 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 of/secondary to CKD, with at least 1 of the following:

1. Serum phosphorus level at Screening:

• 6 to <13 years: >5.8 milligrams per deciliter (mg/dl).

• 13 to <18 years: >4.5 mg/dl, and/or:

2. Current use of phosphate binders for treatment of hyperphosphatemia

• Transferrin saturation (TSAT) <50% at Screening

• Serum ferritin <500 nanograms per milliliter (ng/ml) at Screening

• 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 at Screening.

Exclusion Criteria:

• Active significant gastrointestinal (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, or tube feeding required (Note: 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 of childbearing potential who are unwilling to use adequate contraception

• Pregnant or breast-feeding, if female

• 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)