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WithdrawnPhase 3
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
Key facts
- Who runs it
- Keryx Biopharmaceuticals
- Trial code
- Status
- Withdrawn
- Phase
- Phase 3
- Started
- Jan 2025
- Expected to end
- Mar 2027
- Type of study
- Interventional, 2 groupsOne group gets an existing treatment, for comparison.
- Treatments tested
- ferric citrate
- standard of care
- Record updated
- 20 November 2025
- Why it stopped
- PMR release
Who can take part
- Age
- 6 years to 18 years
- Sex
- Women and men
- Healthy volunteers
- Cannot take part
The registry criteria, word for word
Show all 15 criteriaShow less
Who can take part
- Age 6 years to <18 years at Screening
- Body Weight ≥12 kilograms (kg) at Screening
- Chronic kidney disease (CKD) stage 3 to 5, not on dialysis, with estimated glomerular filtration rate (eGFR) <60 milliliters per minute (mL/min)/1.73 meters squared (m\^2) utilizing the "Bedside Schwartz" equation
- Hemoglobin (Hgb) ≥8.5 and ≤11.5 grams per deciliter (g/dL) at Screening
- Transferrin saturation (TSAT) ≤25% at Screening
- Ferritin ≤200 nanograms per milliliter (ng/mL) at Screening
Who cannot take part
- Intravenous iron therapy or blood transfusion within 4 weeks before the Screening visit
- Participants with a functioning organ transplant
- Receipt of any investigational drug within 4 weeks before Screening
- Active significant gastrointestinal (GI) disorder, including overt gastrointestinal (GI) bleeding or active inflammatory bowel disease
- Serum phosphorus level at Screening:; 6 to <13 years: ≤4.0 milligrams per deciliter (mg/dL); 13 to <18 years: ≤2.7 mg/dL
- Liver transaminases (aspartate aminotransferase [AST] and/or alanine aminotransferase [ALT]) ˃3× the upper limit of normal at Screening
- Unable to swallow pills
- Anemia due to causes other than iron deficiency anemia (IDA) of CKD
- Phosphate binder use during the Screening period
About the trial
What the trial wants to find out
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).
The 2 groups in the trial
- Ferric citrateTreatment being tested
Participants aged 12 to \<18 years and 6 to \<12 years will receive ferric citrate for 24 weeks at a starting dose based on body weight categories.
- Standard of careExisting treatment, for comparison
Participants aged 12 to \<18 years and 6 to \<12 years will receive standard of care treatment for 24 weeks.
Data and sources
- Registry record
- Listed on ClinicalTrials.gov.
- Official title
- 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
- Record updated
- 20 November 2025