Clinical trial NCT04649411: 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
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
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: PHASE3
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
Lead sponsor: Keryx Biopharmaceuticals
Sponsor class: INDUSTRY
First posted: 2020-12-02
Enrollment: 36
Sex: ALL
Minimum age (years): 6
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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).


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

Primary outcomes:
measure: Number of Participants with Serious and Non-serious Treatment-emergent Adverse Events
timeFrame: up to Week 28
measure: Number of Participants with Clinically Significant Laboratory Abnormalities or Changes in Laboratory Results
timeFrame: up to Week 24
measure: Number of Participants with Treatment-emergent Adverse Events Leading to the Discontinuation of Ferric Citrate
timeFrame: up to Week 28
Secondary outcomes:
measure: Change from Baseline in Hemoglobin to Week 24/Early Termination Visit
timeFrame: Baseline; Week 24
measure: Change from Baseline in Transferrin Saturation (TSAT) to Week 24/Early Termination Visit
timeFrame: Baseline; Week 24
measure: Change from Baseline in Ferritin to Week 24/Early Termination Visit
timeFrame: Baseline; Week 24
measure: Change from Baseline in Serum Phosphorus to Week 24/Early Termination Visit
timeFrame: Baseline; Week 24
measure: Change from Baseline in Calcium to Week 24/Early Termination Visit
timeFrame: Baseline; Week 24
measure: Change from Baseline in Bicarbonate to Week 24/Early Termination Visit
timeFrame: Baseline; Week 24
Other outcomes:
Locations:
Study officials:
affiliation: Akebia Therapeutics Inc.
name: Chief Medical Officer
role: STUDY_DIRECTOR
References: