Safety and Efficacy of Iron Sucrose in Children

Phase 4

Completed

• Conditions: Chronic Kidney Disease; Anemia
• Interventions: Drug: Venofer (iron sucrose injection)

• Registration Number: NCT00239642
• Lead Sponsor: American Regent, Inc.

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 efficacy (clinical success)

Study Timeline

• Study Start: 2005-07
• Study First Submitted: 2005-10-13
• Study First Submitted QC: 2005-10-13
• Study First Posted: 2005-10-17
• Primary Completion: 2009-01
• Study Completion: 2010-04
• Results First Submitted: 2011-12-05
• Results First Submitted QC: 2011-12-05
• Results First Posted: 2012-01-10
• Status Verified: 2021-10
• Last Update Submitted: 2021-10-19
• Last Update Posted: 2021-11-17

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 141

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Venofer (2.0 mg/kg)	Venofer (iron sucrose injection)	2.0 mg/kg of Venofer (iron sucrose) up to 100 mg administered intravenously
Venofer (0.5 mg/kg)	Venofer (iron sucrose injection)	0.5 mg/kg of Venofer (iron sucrose) up to 100 mg administered intravenously
Venofer (1.0 mg/kg)	Venofer (iron sucrose injection)	1.0 mg/kg of Venofer (iron sucrose) up to 100 mg administered intravenously

Primary Outcome Measures

Name	Time	Method
Safety Profile: Number of Subjects Experiencing at Least 1 Adverse Event	baseline through week 12	Safety Profile: Number of subjects who experienced at least 1 adverse event in each arm

Secondary Outcome Measures

Name	Time	Method
Number of Subjects Achieving Clinical Success	anytime during the 12 week post-baseline period	Summary of the Number of Subjects Achieving Clinical Success During the 12-Week Study Period - Hemoglobin between 10.5 g/dL and 14.0 g/dL, Inclusive, TSAT between 20% and 50%, Inclusive, and Stable EPO Dosing (±25% of Baseline Dose)
Percentage (%) of Subjects Achieving Clinical Success	anytime during the 12 week post-baseline period	Summary of the Percentage (%) of Subjects Achieving Clinical Success During the 12-Week Study Period - Hemoglobin between 10.5 g/dL and 14.0 g/dL, Inclusive, TSAT between 20% and 50%, Inclusive, and stable EPO Dosing (±25% of Baseline Dose)
Number of Subjects With Hemoglobin Between 10.5 g/dL and 14.0 g/dL, Inclusive	anytime during the 12-week post-baseline period	Summary of the Number of Subjects with Hemoglobin between 10.5 g/dL and 14.0 g/dL, Inclusive
Percentage (%) of Subjects With Hemoglobin Between 10.5 g/dL and 14.0 g/dL, Inclusive	anytime during the 12 week post-baseline period	Summary of the Percentage (%) of Subjects with Hemoglobin Between 10.5 g/dL and 14.0 g/dL, Inclusive
Proportion of Subjects With Transferrin Saturation (TSAT) Between 20% and 50%, Inclusive	anytime during the 12 week post-baseline period	Summary of the Proportion of Subjects with transferrin saturation (TSAT) between 20% and 50%, Inclusive
Percentage (%) of Subjects With TSAT Between 20% and 50%, Inclusive	anytime during the 12 week post-baseline period	Summary of the Percentage (%) of Subjects with TSAT between 20% and 50%, Inclusive
Proportion of Subjects With Stable Erythropoietin (EPO) Dosing or a Decrease >25% in EPO Dose From Baseline	anytime during the 12 week post-baseline period	Summary of the Proportion of Subjects with Stable erythropoietin (EPO) Dosing or a Decrease \>25% in EPO dose from Baseline
Percentage (%) of Subjects With Stable EPO Dosing or a Decrease >25% in EPO Dose From Baseline	anytime during the 12 week post-baseline period	Summary of the Percentage (%) of Subjects with Stable EPO Dosing or a Decrease \>25% in EPO Dose from Baseline

Trial Locations

Locations (1)

Luitpold Pharmaceutials; 🇺🇸 Norristown, Pennsylvania, United States