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Kidney Week

Abstract: INFO12-TH

Safety and Tolerability of Auryxia® (Ferric Citrate) in Children with Hyperphosphatemia Related to CKD

Session Information

  • Informational Posters - I
    November 02, 2023 | Location: Exhibit Hall, Pennsylvania Convention Center
    Abstract Time: 10:00 AM - 12:00 PM

Category: Pediatric Nephrology

  • No subcategory defined

Authors

  • Ullah, Irfan, Akebia Therapeutics Inc, Cambridge, Massachusetts, United States
  • Nayak, Anjali B., Phoenix Children's Hospital, Phoenix, Arizona, United States
  • Zhang, Zhiqun, Akebia Therapeutics Inc, Cambridge, Massachusetts, United States
Description

Background
Ferric citrate (Auryxia®) is an oral phosphate binder indicated for the control of serum phosphorus levels in adult patients with chronic kidney disease (CKD) on dialysis. This study aims to assess the safety and tolerability of ferric citrate in pediatric patients with hyperphosphatemia related to CKD (ClinicalTrials.gov Identifier: NCT04523727).

Methods
This phase 3, single-arm, open-label study will evaluate 3-times-daily oral ferric citrate for treatment of pediatric patients with hyperphosphatemia-related CKD for up to 36 weeks (Figure). Key inclusion criteria include patients 2 to <17 years of age with dialysis-dependent or non–dialysis-dependent CKD (eGFR <30 mL/min/1.73 m2), a documented history of CKD-related hyperphosphatemia for at least 3 months, serum phosphorus levels of >5.8 mg/dL for patients aged 12 years and >4.5 mg/dL for those aged 13 to <17 years, serum ferritin <500 ng/mL, and transferrin saturation <50%. The study consists of a screening period for up to 6 weeks, which includes a washout period for patients currently on phosphate binder(s), followed by a 36-week treatment period and a 30-day safety follow-up period after the last dose of study drug. Primary endpoints to assess safety and tolerability are based on incidence and severity of treatment-emergent adverse events (TEAEs), including gastrointestinal AEs of special interest, clinically significant laboratory abnormalities, and TEAEs leading to discontinuation of ferric citrate. Change from baseline in serum phosphorus to week 12/early termination will be assessed as a secondary endpoint.
Results
This study is in progress and actively screening and enrolling patients. The results will be presented in subsequent publications.
Conclusion
This study will offer valuable insights into the safety and tolerability of ferric citrate in a pediatric population and advance our understanding of the benefits/risks associated with ferric citrate.

Figure. Study Design

Funding

  • Akebia Therapeutics, Inc.