Clinical trial

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

Name

KRX-0502-309

Description

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).

Trial arms

Trial start

2025-01-01

Estimated PCD

2027-01-01

Trial end

2027-03-01

Status

Not yet recruiting

Phase

Early phase I

Treatment

ferric citrate

oral tablets

Arms:

Ferric citrate

Other names:

KRX-0502

standard of care

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

Arms:

Standard of care

Size

Primary endpoint

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

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

Protocol

{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE3'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'NONE'}}, 'enrollmentInfo': {'count': 36, 'type': 'ESTIMATED'}}

Updated at

2023-10-23

1 organization

Organization

Keryx Biopharmaceuticals