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

Keryx Biopharmaceuticals

Status and phase: Withdrawn; Phase 3

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

Treatments: Drug: ferric citrate; Drug: standard of care

Study type: Interventional

Funder types: Industry

Identifiers

NCT04649411

KRX-0502-309

Details and patient eligibility

About

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).

Sex: All

Ages: 6 to 18 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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0 participants in 2 patient groups

Ferric citrate

Experimental group

Description:

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.

Treatment:

Drug: ferric citrate

Standard of care

Active Comparator group

Description:

Participants aged 12 to \<18 years and 6 to \<12 years will receive standard of care treatment for 24 weeks.

Treatment:

Drug: standard of care