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

NCT ID: NCT04649411

Last Updated: 2025-11-20

Basic Information

• Recruitment Status: WITHDRAWN
• Clinical Phase: PHASE3
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-01-31
• Study Completion Date: 2027-03-31

Brief 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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Ferric citrate

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.

Group Type: EXPERIMENTAL

ferric citrate

Intervention Type: DRUG

oral tablets

Standard of care

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

Group Type: ACTIVE_COMPARATOR

standard of care

Intervention Type: DRUG

administered per the approved label and at the Investigator's discretion

Interventions

ferric citrate

oral tablets

Intervention Type: DRUG

standard of care

administered per the approved label and at the Investigator's discretion

Intervention Type: DRUG

Other Intervention Names

KRX-0502

Eligibility 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

• Minimum Eligible Age: 6 Years
• Maximum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Keryx Biopharmaceuticals

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Chief Medical Officer

Role: STUDY_DIRECTOR

Akebia Therapeutics Inc.

Other Identifiers

KRX-0502-309

Identifier Type: -

Identifier Source: org_study_id