Phase 4 N=145 Randomized Treatment

Safety and Efficacy of Iron Sucrose in Children

Anemia · Chronic Kidney Disease

Bottom Line

View on ClinicalTrials.gov: NCT00239642 ↗

Enrolled (actual)

145

Serious AEs

17.7%

Results posted

Jan 2012

Primary outcome: Primary: Safety Profile: Number of Subjects Experiencing at Least 1 Adverse Event — 27; 25; 26 participants

Study Design & Population

Study type: Interventional
Phase: Phase 4
Interventions: Venofer (iron sucrose injection) (Drug)
Age: Pediatric, Adult · 2+ yrs
Sex: All
Sponsor: American Regent, Inc.
Primary completion: Jan 2009

Outcome Measures

Outcome	Result	p-value
PRIMARY Safety Profile: Number of Subjects Experiencing at Least 1 Adverse Event	27; 25; 26	—
SECONDARY Number of Subjects Achieving Clinical Success	44; 40; 33	—
SECONDARY Percentage (%) of Subjects Achieving Clinical Success	95.7; 88.9; 82.5	—
SECONDARY Number of Subjects With Hemoglobin Between 10.5 g/dL and 14.0 g/dL, Inclusive	46; 43; 38	—
SECONDARY Percentage (%) of Subjects With Hemoglobin Between 10.5 g/dL and 14.0 g/dL, Inclusive	100.0; 95.6; 95.0	—
SECONDARY Proportion of Subjects With Transferrin Saturation (TSAT) Between 20% and 50%, Inclusive	44; 42; 37	—
SECONDARY Percentage (%) of Subjects With TSAT Between 20% and 50%, Inclusive	95.7; 93.3; 92.5	—
SECONDARY Proportion of Subjects With Stable Erythropoietin (EPO) Dosing or a Decrease >25% in EPO Dose From Baseline	46; 45; 39	—
SECONDARY Percentage (%) of Subjects With Stable EPO Dosing or a Decrease >25% in EPO Dose From Baseline	100.0; 100.0; 97.5	—

Summary

Comparison of three potential iron sucrose maintenance regimens in pediatric chronic kidney disease (CKD) patients

Eligibility Criteria

Inclusion Criteria

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 Criteria

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

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT00239642). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.