Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
American Regent, Inc.
Randomized, controlled, open label trial of pediatric CKD patients on stable erythropoietin (EPO) therapy. Patients will be followed for 12 weeks to assess safety (incidence of adverse events) and efficacy (clinical success)
Age
2–21
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible if
Patients between 2 to 21 years of age
Patients on stable hemodialysis (HD) or peritoneal dialysis (PD) regimen for 3 months for ≥ 3 months
Non-dialysis dependent (NDD) patients with glomerular filtration rate (GFR) \<60
Hemoglobin (Hgb) ≥ 11g/dL to ≤ 13.5g/dL
Ferritin ≤ 800 ng/mL
Transferrin saturation (TSAT) ≥ 20% to ≤ 50%
Received stable erythropoietin (EPO) regimen for ≥ 8 weeks prior to the qualifying screening visit
You may not be if
Known hypersensitivity to iron sucrose
Severe diseased of the liver, cardiovascular system, or hemopoietic system
Serious infection requiring hospitalization
Significant blood loss within the last 3 months
Bleeding disorders
Pregnancy / Lactation
Actively being treated for asthma
Hemoglobinopathy
Receiving a myelosuppressive drug
Clareo Health | Safety and Efficacy of Iron Sucrose in Children
