Clareo Health | 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 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
Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
Keryx Biopharmaceuticals
Age
6–18
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible if
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
You may not be if
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
