Iron Deficiency Anemia Associated With Non-Dialysis Dependent Chronic Kidney Disease
Conditions
Keywords
Iron Deficiency Anemia, Non-Dialysis Dependent Chronic Kidney Disease, CKD, ferric citrate, pediatric, dialysis
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).
Interventions
DRUGferric citrate
oral tablets
DRUGstandard of care
administered per the approved label and at the Investigator's discretion
Sponsors
Keryx Biopharmaceuticals
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
6 Years to 18 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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
| Measure | Time frame |
|---|---|
| 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 Bicarbonate 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 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 |
Outcome results
None listed