Back to resultsSafety and Efficacy of Iron Sucrose in Children
Primary Purpose
Anemia, Chronic Kidney Disease
Status
Completed
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
Venofer (iron sucrose injection)
Venofer (iron sucrose injection)
Venofer (iron sucrose injection)
Sponsored by
About this trial
This is an interventional treatment trial for Anemia focused on measuring Iron, Anemia, CKD
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
Sites / Locations
- Luitpold Pharmaceutials
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Experimental
Experimental
Experimental
Arm Label
Venofer (0.5 mg/kg)
Venofer (1.0 mg/kg)
Venofer (2.0 mg/kg)
Arm Description
0.5 mg/kg of Venofer (iron sucrose) up to 100 mg administered intravenously
1.0 mg/kg of Venofer (iron sucrose) up to 100 mg administered intravenously
2.0 mg/kg of Venofer (iron sucrose) up to 100 mg administered intravenously
Outcomes
Primary Outcome Measures
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
Secondary Outcome Measures
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)
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)
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
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
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
Percentage (%) of Subjects With TSAT Between 20% and 50%, Inclusive
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
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
Summary of the Percentage (%) of Subjects with Stable EPO Dosing or a Decrease >25% in EPO Dose from Baseline
Full Information
NCT ID
NCT00239642
First Posted
October 13, 2005
Last Updated
October 19, 2021
Sponsor
American Regent, Inc.
1. Study Identification
Unique Protocol Identification Number
NCT00239642
Brief Title
Safety and Efficacy of Iron Sucrose in Children
Official Title
Comparison of the Safety and Efficacy of Three Iron Sucrose Maintenance Regimens in Pediatric Chronic Kidney Disease (CKD) Patients
Study Type
Interventional
2. Study Status
Record Verification Date
October 2021
Overall Recruitment Status
Completed
Study Start Date
July 2005 (undefined)
Primary Completion Date
January 2009 (Actual)
Study Completion Date
April 2010 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
American Regent, Inc.
4. Oversight
5. Study Description
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)
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Anemia, Chronic Kidney Disease
Keywords
Iron, Anemia, CKD
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
141 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Venofer (0.5 mg/kg)
Arm Type
Experimental
Arm Description
0.5 mg/kg of Venofer (iron sucrose) up to 100 mg administered intravenously
Arm Title
Venofer (1.0 mg/kg)
Arm Type
Experimental
Arm Description
1.0 mg/kg of Venofer (iron sucrose) up to 100 mg administered intravenously
Arm Title
Venofer (2.0 mg/kg)
Arm Type
Experimental
Arm Description
2.0 mg/kg of Venofer (iron sucrose) up to 100 mg administered intravenously
Intervention Type
Drug
Intervention Name(s)
Venofer (iron sucrose injection)
Intervention Description
0.5 mg/kg of Venofer (iron sucrose) up to 100 mg administered intravenously
Intervention Type
Drug
Intervention Name(s)
Venofer (iron sucrose injection)
Intervention Description
1.0 mg/kg of Venofer (iron sucrose) up to 100 mg administered intravenously
Intervention Type
Drug
Intervention Name(s)
Venofer (iron sucrose injection)
Intervention Description
2.0 mg/kg of Venofer (iron sucrose) up to 100 mg administered intravenously
Primary Outcome Measure Information:
Title
Safety Profile: Number of Subjects Experiencing at Least 1 Adverse Event
Description
Safety Profile: Number of subjects who experienced at least 1 adverse event in each arm
Time Frame
baseline through week 12
Secondary Outcome Measure Information:
Title
Number of Subjects Achieving Clinical Success
Description
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
Title
Percentage (%) of Subjects Achieving Clinical Success
Description
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
Title
Number of Subjects With Hemoglobin Between 10.5 g/dL and 14.0 g/dL, Inclusive
Description
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
Title
Percentage (%) of Subjects With Hemoglobin Between 10.5 g/dL and 14.0 g/dL, Inclusive
Description
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
Title
Proportion of Subjects With Transferrin Saturation (TSAT) Between 20% and 50%, Inclusive
Description
Summary of the Proportion of Subjects with transferrin saturation (TSAT) between 20% and 50%, Inclusive
Time Frame
anytime during the 12 week post-baseline period
Title
Percentage (%) of Subjects With TSAT Between 20% and 50%, Inclusive
Description
Summary of the Percentage (%) of Subjects with TSAT between 20% and 50%, Inclusive
Time Frame
anytime during the 12 week post-baseline period
Title
Proportion of Subjects With Stable Erythropoietin (EPO) Dosing or a Decrease >25% in EPO Dose From Baseline
Description
Summary of the Proportion of Subjects with Stable erythropoietin (EPO) Dosing or a Decrease >25% in EPO dose from Baseline
Time Frame
anytime during the 12 week post-baseline period
Title
Percentage (%) of Subjects With Stable EPO Dosing or a Decrease >25% in EPO Dose From Baseline
Description
Summary of the Percentage (%) of Subjects with Stable EPO Dosing or a Decrease >25% in EPO Dose from Baseline
Time Frame
anytime during the 12 week post-baseline period
10. Eligibility
Sex
All
Minimum Age & Unit of Time
2 Years
Maximum Age & Unit of Time
21 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Mark A Falone, MD
Organizational Affiliation
American Regent, Inc.
Official's Role
Study Director
Facility Information:
Facility Name
Luitpold Pharmaceutials
City
Norristown
State/Province
Pennsylvania
ZIP/Postal Code
19403
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Safety and Efficacy of Iron Sucrose in Children
We'll reach out to this number within 24 hrs