NCT04649411

Study to Evaluate the Safety and Tolerability of KRX-0502 (Ferric Citrate) in Children With Iron Deficiency Anemia Associated With Non-Dialysis Dependent Chronic Kidney Disease

A 24-Week, Open-Label, Randomized, 2-Arm Study to Evaluate the Safety and Tolerability of KRX-0502 (Ferric Citrate) in Children With Iron Deficiency Anemia Associated With Non-Dialysis Dependent Chronic Kidney Disease

• Status: Withdrawn
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 0 (actual)
• Sponsor: Keryx Biopharmaceuticals · Industry
• Sex: All
• Age: 6 Years – 18 Years
• Healthy volunteers: Not accepted

Summary

This study will be conducted to evaluate the safety and tolerability of ferric citrate in pediatric participants with iron deficiency anemia (IDA) associated with non-dialysis dependent chronic kidney disease (NDD-CKD).

Conditions

• Iron Deficiency Anemia Associated With Non-Dialysis Dependent Chronic Kidney Disease

Interventions

Type	Name	Description
DRUG	ferric citrate	oral tablets
DRUG	standard of care	administered per the approved label and at the Investigator's discretion

Timeline

• Start date: 2025-01-01
• Primary completion: 2027-01-01
• Completion: 2027-03-01
• First posted: 2020-12-02
• Last updated: 2025-11-20

Regulatory

• FDA-regulated drug study