RECRUITING

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

Conditions

Hyperphosphatemia Related to Chronic Kidney Disease hyperphosphatemia chronic kidney disease CKD ferric citrate pediatric dialysis

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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).

Official Title

A 36-week, Single-Arm, Open-label Study to Evaluate the Safety and Tolerability of Ferric Citrate in Children With Hyperphosphatemia Related to Chronic Kidney Disease

Quick Facts

Study Start:2023-06-08

Study Completion:2025-06

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT04523727

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:6 Years to 16 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:CHILD

Inclusion Criteria	Exclusion 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%. * 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.	* 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. * 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).

Inclusion Criteria

Exclusion 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%.
* 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.

* 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.
* 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).

Contacts and Locations

Study Contact

Akebia Medical Information

CONTACT

1-844-445-3799

medicalinfo@akebia.com

Principal Investigator

Chief Medical Officer

STUDY_DIRECTOR

Akebia Therapeutics Inc.

Study Locations (Sites)

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

Birmingham, Alabama, 35233

United States

Phoenix Childrens Hospital

Phoenix, Arizona, 85016

United States

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

San Francisco, California, 94158

United States

Stanford University Medical Center

Stanford, California, 94305

United States

Children's Hospital Colorado

Aurora, Colorado, 80045

United States

University of South Florida

Tampa, Florida, 33606

United States

Johns Hopkins Hospital

Baltimore, Maryland, 21287

United States

University of Minnesota

Minneapolis, Minnesota, 55455

United States

Children's Mercy Hospital - Kansas City

Kansas City, Missouri, 64108

United States

University of New Mexico

Albuquerque, New Mexico, 87110

United States

Cincinnati Children's Hospital Medical Center

Cincinnati, Ohio, 45229

United States

University of Utah

Salt Lake City, Utah, 84113

United States

Seattle Children's Hospital

Seattle, Washington, 98105

United States

Collaborators and Investigators

Sponsor: Keryx Biopharmaceuticals

Chief Medical Officer, STUDY_DIRECTOR, Akebia Therapeutics Inc.

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2023-06-08

Study Completion Date2025-06

Study Record Updates

Study Start Date2023-06-08

Study Completion Date2025-06

Terms related to this study

Keywords Provided by Researchers

hyperphosphatemia
chronic kidney disease
CKD
ferric citrate
pediatric
dialysis

Additional Relevant MeSH Terms

Hyperphosphatemia Related to Chronic Kidney Disease