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: Not yet recruiting
• Trial end date: 2025-02-01
• Target enrollment: 0
• Participant gender: All

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).

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Keryx Biopharmaceuticals

Criteria

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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

• Active significant gastrointestinal (GI) disorder, including overt gastrointestinal (GI) bleeding or active inflammatory bowel disease

• Unable to swallow pills

• Anemia due to causes other than iron deficiency anemia (IDA) of CKD

• 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

• Phosphate binder use during the Screening period