Safety and Efficacy of Iron Sucrose in Children

Comparison of the Safety and Efficacy of Three Iron Sucrose Maintenance Regimens in Pediatric Chronic Kidney Disease (CKD) Patients

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

Study Overview

• Status: Completed
• Conditions: Anemia; Chronic Kidney Disease
• Intervention / Treatment: Drug: Venofer (iron sucrose injection); Drug: Venofer (iron sucrose injection); Drug: Venofer (iron sucrose injection)

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 Type: Interventional
• Enrollment (Actual): 141
• Phase: Phase 4

Contacts and Locations

Study Locations

• United States
  • Pennsylvania
    • Norristown, Pennsylvania, United States, 19403
      • Luitpold Pharmaceutials

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 7 months to 19 years (Child, Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Venofer (0.5 mg/kg); 0.5 mg/kg of Venofer (iron sucrose) up to 100 mg administered intravenously	Drug: Venofer (iron sucrose injection); 0.5 mg/kg of Venofer (iron sucrose) up to 100 mg administered intravenously; Drug: Venofer (iron sucrose injection); 1.0 mg/kg of Venofer (iron sucrose) up to 100 mg administered intravenously; Drug: Venofer (iron sucrose injection); 2.0 mg/kg of Venofer (iron sucrose) up to 100 mg administered intravenously
Experimental: Venofer (1.0 mg/kg); 1.0 mg/kg of Venofer (iron sucrose) up to 100 mg administered intravenously	Drug: Venofer (iron sucrose injection); 0.5 mg/kg of Venofer (iron sucrose) up to 100 mg administered intravenously; Drug: Venofer (iron sucrose injection); 1.0 mg/kg of Venofer (iron sucrose) up to 100 mg administered intravenously; Drug: Venofer (iron sucrose injection); 2.0 mg/kg of Venofer (iron sucrose) up to 100 mg administered intravenously
Experimental: Venofer (2.0 mg/kg); 2.0 mg/kg of Venofer (iron sucrose) up to 100 mg administered intravenously	Drug: Venofer (iron sucrose injection); 0.5 mg/kg of Venofer (iron sucrose) up to 100 mg administered intravenously; Drug: Venofer (iron sucrose injection); 1.0 mg/kg of Venofer (iron sucrose) up to 100 mg administered intravenously; Drug: Venofer (iron sucrose injection); 2.0 mg/kg of Venofer (iron sucrose) up to 100 mg administered intravenously

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of Subjects Achieving Clinical Success	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)	anytime during the 12 week post-baseline period
Percentage (%) of Subjects Achieving Clinical Success	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)	anytime during the 12 week post-baseline period
Number of Subjects With Hemoglobin Between 10.5 g/dL and 14.0 g/dL, Inclusive	Summary of the Number of Subjects with Hemoglobin between 10.5 g/dL and 14.0 g/dL, Inclusive	anytime during the 12-week post-baseline period
Percentage (%) of Subjects With Hemoglobin Between 10.5 g/dL and 14.0 g/dL, Inclusive	Summary of the Percentage (%) of Subjects with Hemoglobin Between 10.5 g/dL and 14.0 g/dL, Inclusive	anytime during the 12 week post-baseline period
Proportion of Subjects With Transferrin Saturation (TSAT) Between 20% and 50%, Inclusive	Summary of the Proportion of Subjects with transferrin saturation (TSAT) between 20% and 50%, Inclusive	anytime during the 12 week post-baseline period
Percentage (%) of Subjects With TSAT Between 20% and 50%, Inclusive	Summary of the Percentage (%) of Subjects with TSAT between 20% and 50%, Inclusive	anytime during the 12 week post-baseline period
Proportion of Subjects With Stable Erythropoietin (EPO) Dosing or a Decrease >25% in EPO Dose From Baseline	Summary of the 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
Percentage (%) of Subjects With Stable EPO Dosing or a Decrease >25% in EPO Dose From Baseline	Summary of the Percentage (%) of Subjects with Stable EPO Dosing or a Decrease >25% in EPO Dose from Baseline	anytime during the 12 week post-baseline period

Collaborators and Investigators

• Sponsor: American Regent, Inc.

Study record dates

Study Major Dates

• Study Start: July 1, 2005
• Primary Completion (Actual): January 1, 2009
• Study Completion (Actual): April 1, 2010

Study Registration Dates

• First Submitted: October 13, 2005
• First Submitted That Met QC Criteria: October 13, 2005
• First Posted (Estimate): October 17, 2005

Study Record Updates

• Last Update Posted (Actual): November 17, 2021
• Last Update Submitted That Met QC Criteria: October 19, 2021
• Last Verified: October 1, 2021

More Information

Terms related to this study

• Keywords: Anemia; Iron; CKD
• Additional Relevant MeSH Terms: Urologic Diseases; Renal Insufficiency; Kidney Diseases; Renal Insufficiency, Chronic; Physiological Effects of Drugs; Trace Elements; Micronutrients; Hematinics; Iron; Ferric Oxide, Saccharated
• Other Study ID Numbers: 1VEN03017