Safety and Efficacy of Iron Sucrose in Children

American Regent, Inc.141 enrolled

Overview

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

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

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

141

Conditions

Anemia Chronic Kidney Disease

Interventions

Venofer (iron sucrose injection)DRUG

0.5 mg/kg of Venofer (iron sucrose) up to 100 mg administered intravenously

Venofer (iron sucrose injection)DRUG

1.0 mg/kg of Venofer (iron sucrose) up to 100 mg administered intravenously

Venofer (iron sucrose injection)DRUG

2.0 mg/kg of Venofer (iron sucrose) up to 100 mg administered intravenously

Eligibility

Sex: ALLMin age: 2 YearsMax age: 21 Years

Medical Language ↔ Plain English

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

Locations (1)

Luitpold Pharmaceutials

Norristown, Pennsylvania, United States

Outcomes

Primary Outcomes

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

Time frame: baseline through week 12

Secondary Outcomes

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)

Time frame: 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)

Time frame: 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

Time frame: 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

Time frame: 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

Data from ClinicalTrials.gov

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