Status:
COMPLETED
Safety and Efficacy of Iron Sucrose in Children
Lead Sponsor:
American Regent, Inc.
Conditions:
Anemia
Chronic Kidney Disease
Eligibility:
All Genders
2-21 years
Phase:
PHASE4
Brief Summary
Comparison of three potential iron sucrose maintenance regimens in pediatric chronic kidney disease (CKD) patients
Detailed Description
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 eff...
Eligibility Criteria
Inclusion
- 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
Exclusion
- 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
Key Trial Info
Start Date :
July 1 2005
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 1 2010
Estimated Enrollment :
141 Patients enrolled
Trial Details
Trial ID
NCT00239642
Start Date
July 1 2005
End Date
April 1 2010
Last Update
November 17 2021
Active Locations (1)
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1
Luitpold Pharmaceutials
Norristown, Pennsylvania, United States, 19403