Back to resultsSafety Assessment of Iron Sucrose (Venofer) in Patients With Chronic Kidney Disease Who Cannot Tolerate Ferumoxytol (Feraheme) or Iron Dextran (INFed or Dexferrum) (ASSURED)
Primary Purpose
Iron Deficiency Anemia
Status
Withdrawn
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
Iron Sucrose
Sponsored by
About this trial
This is an interventional treatment trial for Iron Deficiency Anemia focused on measuring Iron deficiency anemia in Chronic Kidney Disease Patients
Eligibility Criteria
Inclusion Criteria:
- Male or female subjects > or = to 18 years of age
- Determined by treating physician to have chronic kidney disease and require a course of intravenous iron
- Subject did not tolerate an intravenous iron containing a dextran or Ferumoxytol within the last year
- Subjects with hemodialysis-dependent or peritoneal dialysis chronic kidney disease should be receiving an erythropoiesis stimulating agent (ESA) as per the iron sucrose package insert
Exclusion Criteria:
- Known history of hypersensitivity or significant intolerance to iron sucrose
- Evidence of iron overload
- Hemochromatosis or other iron storage disorders
- Received an investigational drug within 30 days of screening
- Any other laboratory abnormality, medical condition or psychiatric disorder which would put the subject's disease management at risk or may result in the subject being unable to comply with study requirements
- Pregnant or sexually-active female subjects who are of childbearing potential and who are not willing to use an acceptable form of contraception
Sites / Locations
- Luitpold Pharmaceuticals, Inc.
Outcomes
Primary Outcome Measures
Incidence and severity of adverse events, overall and related from Day of first iron sucrose administration through the end of the study.
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01151592
Brief Title
Safety Assessment of Iron Sucrose (Venofer) in Patients With Chronic Kidney Disease Who Cannot Tolerate Ferumoxytol (Feraheme) or Iron Dextran (INFed or Dexferrum)
Acronym
ASSURED
Official Title
Assessment of Safety of Iron Sucrose (Venofer) in Patients With Chronic Kidney Disease Who Cannot Tolerate Ferumoxytol (Feraheme) or Iron Dextran (INFed or Dexferrum)
Study Type
Interventional
2. Study Status
Record Verification Date
January 2018
Overall Recruitment Status
Withdrawn
Why Stopped
Sponsor Decision
Study Start Date
undefined (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
undefined (undefined)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
American Regent, Inc.
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
The objective of this study is to assess the safety and tolerability of Venofer in patients with chronic kidney disease who cannot tolerate Ferumoxytol (Feraheme) or intravenous iron containing a dextran (INFed or Dexferrum).
Detailed Description
This is a Phase IV, multi-center, open label study that assesses the safety and tolerability of Iron Sucrose (Venofer) in subjects with CKD who require intravenous iron for the treatment of iron deficiency anemia (IDA) but cannot tolerate Ferumoxytol or Iron Dextran.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Iron Deficiency Anemia
Keywords
Iron deficiency anemia in Chronic Kidney Disease Patients
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
0 (Actual)
8. Arms, Groups, and Interventions
Intervention Type
Drug
Intervention Name(s)
Iron Sucrose
Other Intervention Name(s)
Venofer
Intervention Description
Iron Sucrose, 1000 mg cumulative dose to be administered per the US package insert.
Primary Outcome Measure Information:
Title
Incidence and severity of adverse events, overall and related from Day of first iron sucrose administration through the end of the study.
Time Frame
Day 0 through 30 days after the final administration of iron sucrose
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Male or female subjects > or = to 18 years of age
Determined by treating physician to have chronic kidney disease and require a course of intravenous iron
Subject did not tolerate an intravenous iron containing a dextran or Ferumoxytol within the last year
Subjects with hemodialysis-dependent or peritoneal dialysis chronic kidney disease should be receiving an erythropoiesis stimulating agent (ESA) as per the iron sucrose package insert
Exclusion Criteria:
Known history of hypersensitivity or significant intolerance to iron sucrose
Evidence of iron overload
Hemochromatosis or other iron storage disorders
Received an investigational drug within 30 days of screening
Any other laboratory abnormality, medical condition or psychiatric disorder which would put the subject's disease management at risk or may result in the subject being unable to comply with study requirements
Pregnant or sexually-active female subjects who are of childbearing potential and who are not willing to use an acceptable form of contraception
Facility Information:
Facility Name
Luitpold Pharmaceuticals, Inc.
City
Norristown
State/Province
Pennsylvania
ZIP/Postal Code
19403
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Safety Assessment of Iron Sucrose (Venofer) in Patients With Chronic Kidney Disease Who Cannot Tolerate Ferumoxytol (Feraheme) or Iron Dextran (INFed or Dexferrum)
We'll reach out to this number within 24 hrs