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

Sponsor

Keryx Biopharmaceuticals (Industry)

Overall Status

Not yet recruiting

CT.gov ID

NCT04649411

Collaborator

(none)

Enrollment

Arms

31.1

Anticipated Duration (Months)

Study Details

Study Description

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).

Condition or Disease	Intervention/Treatment	Phase
Iron Deficiency Anemia Associated With Non-Dialysis Dependent Chronic Kidney Disease	Drug: ferric citrate Drug: standard of care	Phase 3

Study Design

Study Type:

Interventional

Anticipated Enrollment :

36 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

A 24-Week, Open-Label, Randomized, 2-Arm 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

Anticipated Study Start Date :

Jul 1, 2022

Anticipated Primary Completion Date :

Aug 1, 2024

Anticipated Study Completion Date :

Feb 1, 2025

Arms and Interventions

Arm	Intervention/Treatment
Experimental: 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.	Drug: ferric citrate oral tablets Other Names: KRX-0502
Active Comparator: Standard of care Participants aged 12 to <18 years and 6 to <12 years will receive standard of care treatment for 24 weeks.	Drug: standard of care administered per the approved label and at the Investigator's discretion

Arm

Intervention/Treatment

Experimental: 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.

Drug: ferric citrate

oral tablets

Other Names:

KRX-0502

Active Comparator: Standard of care

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

Drug: standard of care

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

Outcome Measures

Primary Outcome Measures

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

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]
Change from Baseline in Bicarbonate to Week 24/Early Termination Visit [Baseline; Week 24]

Eligibility Criteria

Criteria

Ages Eligible for Study:

6 Years to 18 Years

Sexes Eligible for Study:

All

Accepts 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