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

Phase 3

Not yet recruiting

• Conditions: Iron Deficiency Anemia Associated With Non-Dialysis Dependent Chronic Kidney Disease
• Interventions: Drug: standard of care; Drug: ferric citrate

• Registration Number: NCT04649411
• Lead Sponsor: Keryx Biopharmaceuticals

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).

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2020-11-24
• Study First Submitted QC: 2020-11-24
• Study First Posted: 2020-12-02
• Status Verified: 2023-10
• Last Update Submitted: 2023-10-19
• Last Update Posted: 2023-10-23
• Study Start: 2025-01
• Primary Completion: 2027-01
• Study Completion: 2027-03

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 36

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Standard of care	standard of care	Participants aged 12 to \<18 years and 6 to \<12 years will receive standard of care treatment for 24 weeks.
Ferric citrate	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.

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
Change from Baseline in Transferrin Saturation (TSAT) 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 Hemoglobin 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 Calcium to Week 24/Early Termination Visit	Baseline; Week 24
Change from Baseline in Bicarbonate to Week 24/Early Termination Visit	Baseline; Week 24