A Randomized Study to Compare the Dosing Schedule of INFe... | NCT03286205

Studies
A Randomized Study to Compare the Dosing Schedule of INFeD in Anemic Patients.

NCT03286205

Sponsor

Sutter Gould Medical Foundation

Status

Withdrawn

Last Update Posted

Jun 5, 2019Actual

Enrollment

0Actual

Phase

Phase 4

Conditions

Anemia, Iron Deficiency

Interventions

IV iron

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jun 2019

Overall Recruitment Status or Expanded Access Status

Withdrawn

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

IP unavailable at site.

Expanded Access Info

Start Date

Apr 14, 2015Actual

Primary Completion Date

Aug 31, 2018Actual

Completion Date

Aug 31, 2018Actual

First Submitted Date

Sep 14, 2017

First Submission Date that Met QC Criteria

Sep 14, 2017

First Posted Date

Sep 18, 2017Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jun 3, 2019

Last Update Posted Date

Jun 5, 2019Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

David Adkins, Principal Investigator, Sutter Gould Medical FoundationPrincipal Investigator

Lead Sponsor

Sutter Gould Medical FoundationOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Yes

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

FDAAA801 Violation

Not provided

Description Module

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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 4

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

0Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Weekly Dosage	Active Comparator	weekly dose of 100mg	Drug: IV iron
3 week dosage	Active Comparator	every 3 week dosage.	Drug: IV iron

Interventions

Name	Type	Description	Arm Group Labels	Other Names
IV iron	Drug	IV iron infusion based on weekly or every 3 week dosage.	3 week dosage Weekly Dosage

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
superior dosing regimen exists for INfed	shown by a 2gm/dl increase in HgB	3 years
High Dose Effect	INfed can be given at high dose without an increase in AE and/or SAEs frequency	3 years

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

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 \

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
David Adkins, MD	Principal Investigator	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Sutter Gould Medical Foundation		Modesto	California	95355	United States

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D018798	Anemia, Iron-Deficiency

Ancestor Terms

ID	Term
D000747	Anemia, Hypochromic
D000740	Anemia
D006402	Hematologic Diseases
D006425	Hemic and Lymphatic Diseases

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
C066317	ferryl iron

Ancestor Terms

Not provided

Browse Leaves

Not provided

Browse Branches

Not provided