Safety and Efficacy of Iron Sucrose in Children

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

Detailed Description
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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)

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

Conditions
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Anemia, Chronic Kidney Disease

Intervention / Treatment
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* Drug: Venofer (iron sucrose injection)
* Drug: Venofer (iron sucrose injection)
* Drug: Venofer (iron sucrose injection)


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 2 Years
Maximum Age: 21 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Venofer (0.5 mg/kg)<br>0.5 mg/kg of Venofer (iron sucrose) up to 100 mg administered intravenously | Drug: Venofer (iron sucrose injection)<br>* 0.5 mg/kg of Venofer (iron sucrose) up to 100 mg administered intravenously<br>|
| Experimental: Venofer (1.0 mg/kg)<br>1.0 mg/kg of Venofer (iron sucrose) up to 100 mg administered intravenously | Drug: Venofer (iron sucrose injection)<br>* 1.0 mg/kg of Venofer (iron sucrose) up to 100 mg administered intravenously<br>|
| Experimental: Venofer (2.0 mg/kg)<br>2.0 mg/kg of Venofer (iron sucrose) up to 100 mg administered intravenously | Drug: Venofer (iron sucrose injection)<br>* 2.0 mg/kg of Venofer (iron sucrose) up to 100 mg administered intravenously<br>|

What is the study measuring?
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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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Iron, Anemia, CKD