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

NCT04649411 | Withdrawn Phase 3 FDA Drug

• 1 other identifier: KRX-0502-309
• Study Type: interventional
• Target: N/A
• Locations: 0 countries
• Sites: N/A

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

Keywords

Iron Deficiency Anemia; Non-Dialysis Dependent Chronic Kidney Disease; CKD; ferric citrate; pediatric; dialysis

Outcome Measures

Primary Outcomes (3)

• Number of Participants with Serious and Non-serious Treatment-emergent Adverse Events

  up to Week 28

• Number of Participants with Clinically Significant Laboratory Abnormalities or Changes in Laboratory Results

  up to Week 24

• Number of Participants with Treatment-emergent Adverse Events Leading to the Discontinuation of Ferric Citrate

  up to Week 28

Secondary Outcomes (6)

• Change from Baseline in Hemoglobin to Week 24/Early Termination Visit

  Baseline; Week 24

• Change from Baseline in Transferrin Saturation (TSAT) to Week 24/Early Termination Visit

  Baseline; Week 24

• Change from Baseline in Ferritin to Week 24/Early Termination Visit

  Baseline; Week 24

• Change from Baseline in Serum Phosphorus to Week 24/Early Termination Visit

  Baseline; Week 24

• Change from Baseline in Calcium to Week 24/Early Termination Visit

  Baseline; Week 24

Study Arms (2)

Ferric citrate

EXPERIMENTAL

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.

Drug: ferric citrate

Standard of care

ACTIVE COMPARATOR

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

Drug: standard of care

Interventions

ferric citrate DRUG

oral tablets

Also known as: KRX-0502

Ferric citrate

standard of care DRUG

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

Standard of care

Eligibility Criteria

• Age: 6 Years - 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• Serum phosphorus level at Screening:
• to \<13 years: ≤4.0 milligrams per deciliter (mg/dL);
• 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

Sponsors & Collaborators

• Keryx Biopharmaceuticals: lead

MeSH Terms

Conditions

Anemia, Iron-Deficiency

Interventions

ferric citrate; Standard of Care

Condition Hierarchy (Ancestors)

Anemia, Hypochromic; Anemia; Hematologic Diseases; Hemic and Lymphatic Diseases; Iron Deficiencies; Iron Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

Quality Indicators, Health Care; Quality of Health Care; Health Services Administration; Health Care Quality, Access, and Evaluation

Study Officials

• Chief Medical Officer

  Akebia Therapeutics Inc.

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 24, 2020
• First Posted: December 2, 2020
• Study Start: January 1, 2025
• Primary Completion (Estimated): January 1, 2027
• Study Completion (Estimated): March 1, 2027
• Last Updated: November 20, 2025

Record last verified: 2025-11

Data Sharing

• IPD Sharing: Will not share