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

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

Sponsors

Lead Sponsor: Keryx Biopharmaceuticals

Source Keryx Biopharmaceuticals
Brief Summary

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

Overall Status Not yet recruiting
Start Date November 2020
Completion Date June 2024
Primary Completion Date April 2024
Phase Phase 3
Study Type Interventional
Primary Outcome
Measure Time Frame
Number of participants with serious and non-serious treatment-emergent adverse events up to Week 40
Number of participants with clinically significant laboratory abnormalities up to Week 40
Number of participants with treatment-emergent adverse events leading to the discontinuation of ferric citrate up to Week 40
Secondary Outcome
Measure Time Frame
Change from baseline in serum phosphorus to Week 36/early termination (ET) Baseline; up to Week 36
Enrollment 40
Condition
Intervention

Intervention Type: Drug

Intervention Name: ferric citrate

Description: oral tablets

Arm Group Label: Ferric citrate

Other Name: KRX-0502

Eligibility

Criteria:

Inclusion Criteria:

- Weight ≥12 kg at Screening

- Chronic kidney disease (CKD) requiring 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

- At Screening:

a) If participant is on phosphate binder(s):

- At Visit 1, the participant, if eligible per all other inclusion and exclusion criteria, will discontinue phosphate binder(s) and proceed to the Washout period.

- After at least 1 week of washout (i.e., at Visit 1a or Visit 1b), serum phosphorus must be:

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

- 13 to <18 years: >4.5 mg/dl. b) If participant is not on a phosphate binder:

• At Visit 1, serum phosphorus must be:

- 6 to <13 years: >5.8 mg/dl;

- 13 to <18 years: >4.5 mg/dl.

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

- Parent/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

- 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

- Receiving immunosuppressive medication for 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)

Gender: All

Minimum Age: 6 Years

Maximum Age: 18 Years

Healthy Volunteers: No

Overall Contact

Last Name: Akebia Medical Information

Phone: 1-844-445-3799

Email: [email protected]

Verification Date

September 2020

Responsible Party

Type: Sponsor

Keywords
Has Expanded Access No
Condition Browse
Number Of Arms 1
Arm Group

Label: Ferric citrate

Type: Experimental

Description: Participants aged 12 to <18 years and 6 to <12 years will receive ferric citrate for 36 weeks at a starting dose based on body weight categories.

Patient Data No
Study Design Info

Allocation: N/A

Intervention Model: Single Group Assignment

Primary Purpose: Treatment

Masking: None (Open Label)

Source: ClinicalTrials.gov