Back to resultsA Randomized Study to Compare the Dosing Schedule of INFeD in Anemic Patients.
Primary Purpose
Anemia, Iron Deficiency
Status
Withdrawn
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
IV iron
Sponsored by
About this trial
This is an interventional treatment trial for Anemia, Iron Deficiency
Eligibility Criteria
Inclusion Criteria:
- Patients over the age of 18 years old.
- Being treated by a Sutter Health Physician.
- Hemoglobin of < 10mg/dl for Men and Women
- Ferritin </= 10ng/ml
- Patients in whom oral administration is unsatisfactory or impossible.
Exclusion Criteria:
- Patients with a history of receiving iron or other hematinic in the preceding 3 months, oral iron is allowable.
- Anemia due to acute blood loss; menorrhagia is allowed.
- Patients with a current illness known to interact with iron status.
- Patients unwilling to consent to required blood draws.
- Patients who are viewed as unable to complete treatment, based on PI recommendation.
Sites / Locations
- Sutter Gould Medical Foundation
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Active Comparator
Arm Label
Weekly Dosage
3 week dosage
Arm Description
weekly dose of 100mg
every 3 week dosage.
Outcomes
Primary Outcome Measures
superior dosing regimen exists for INfed
shown by a 2gm/dl increase in HgB
High Dose Effect
INfed can be given at high dose without an increase in AE and/or SAEs frequency
Secondary Outcome Measures
Full Information
NCT ID
NCT03286205
First Posted
September 14, 2017
Last Updated
June 3, 2019
Sponsor
Sutter Gould Medical Foundation
1. Study Identification
Unique Protocol Identification Number
NCT03286205
Brief Title
A Randomized Study to Compare the Dosing Schedule of INFeD in Anemic Patients.
Official Title
A Randomized Study to Compare the Dosing Schedule of INFeD in Anemic Patients.
Study Type
Interventional
2. Study Status
Record Verification Date
June 2019
Overall Recruitment Status
Withdrawn
Why Stopped
IP unavailable at site.
Study Start Date
April 14, 2015 (Actual)
Primary Completion Date
August 31, 2018 (Actual)
Study Completion Date
August 31, 2018 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Sutter Gould Medical Foundation
4. Oversight
Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
The purpose of this study is to establish which dosing schedule of INfed (Iron dextrose) is superior for the treatment of iron deficient anemia.
Detailed Description
The purpose of this study is to establish which dosing schedule of INfed (Iron dextrose) is superior for the treatment of iron deficient anemia. The two dosing regimens under review are a low dose weekly or a larger dose given every three weeks.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Anemia, Iron Deficiency
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
0 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Weekly Dosage
Arm Type
Active Comparator
Arm Description
weekly dose of 100mg
Arm Title
3 week dosage
Arm Type
Active Comparator
Arm Description
every 3 week dosage.
Intervention Type
Drug
Intervention Name(s)
IV iron
Intervention Description
IV iron infusion based on weekly or every 3 week dosage.
Primary Outcome Measure Information:
Title
superior dosing regimen exists for INfed
Description
shown by a 2gm/dl increase in HgB
Time Frame
3 years
Title
High Dose Effect
Description
INfed can be given at high dose without an increase in AE and/or SAEs frequency
Time Frame
3 years
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
Patients over the age of 18 years old.
Being treated by a Sutter Health Physician.
Hemoglobin of < 10mg/dl for Men and Women
Ferritin </= 10ng/ml
Patients in whom oral administration is unsatisfactory or impossible.
Exclusion Criteria:
Patients with a history of receiving iron or other hematinic in the preceding 3 months, oral iron is allowable.
Anemia due to acute blood loss; menorrhagia is allowed.
Patients with a current illness known to interact with iron status.
Patients unwilling to consent to required blood draws.
Patients who are viewed as unable to complete treatment, based on PI recommendation.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
David Adkins, MD
Organizational Affiliation
Principal Investigator
Official's Role
Principal Investigator
Facility Information:
Facility Name
Sutter Gould Medical Foundation
City
Modesto
State/Province
California
ZIP/Postal Code
95355
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
A Randomized Study to Compare the Dosing Schedule of INFeD in Anemic Patients.
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