Safety and Efficacy of Iron Sucrose in Children
October 19, 2021 updated by: American Regent, Inc.
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
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
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Pennsylvania
-
Norristown, Pennsylvania, United States, 19403
- Luitpold Pharmaceutials
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
1 year to 17 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
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
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
|
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
|
|
Experimental: Venofer (1.0 mg/kg)
1.0 mg/kg of Venofer (iron sucrose) up to 100 mg administered intravenously
|
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
|
|
Experimental: Venofer (2.0 mg/kg)
2.0 mg/kg of Venofer (iron sucrose) up to 100 mg administered intravenously
|
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
|
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
Time Frame: baseline through week 12
|
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
Time Frame: 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)
|
anytime during the 12 week post-baseline period
|
|
Percentage (%) of Subjects Achieving Clinical Success
Time Frame: 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)
|
anytime during the 12 week post-baseline period
|
|
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
|
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
Time Frame: 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
|
anytime during the 12 week post-baseline period
|
|
Proportion of Subjects With Transferrin Saturation (TSAT) Between 20% and 50%, Inclusive
Time Frame: anytime during the 12 week post-baseline period
|
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
Time Frame: anytime during the 12 week post-baseline period
|
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
Time Frame: 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
|
anytime during the 12 week post-baseline period
|
|
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
|
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
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
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
Additional Relevant MeSH Terms
Other Study ID Numbers
- 1VEN03017
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