The Safety of a High-Dose, Rapid Infusion of Iron Sucrose | NCT02977611

Studies
The Safety of a High-Dose, Rapid Infusion of Iron Sucrose

NCT02977611

Sponsor

The Guthrie Clinic

Status

Withdrawn

Last Update Posted

Oct 18, 2017Actual

Enrollment

0Actual

Phase

Phase 2

Conditions

Iron Deficiency

Interventions

Iron sucrose

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

Oct 2017

Overall Recruitment Status or Expanded Access Status

Withdrawn

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

FDA Clinical Hold

Expanded Access Info

Start Date

Jan 2017Actual

Primary Completion Date

May 2017Actual

Completion Date

May 2017Actual

First Submitted Date

Nov 28, 2016

First Submission Date that Met QC Criteria

Nov 28, 2016

First Posted Date

Nov 30, 2016Estimated

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

Oct 16, 2017

Last Update Posted Date

Oct 18, 2017Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

Iron sucrose infusion is an iron replacement used to treat iron deficiency anemia (not enough iron in the body to make hemoglobin). Iron is a mineral that the body needs to produce hemoglobin, which carries oxygen in the blood. When the body does not get enough iron, it cannot produce enough hemoglobin and you become anemic.

The research study is looking at the side effects of using a higher dose and faster rate of iron sucrose infusion than what is used in standard of care. The purpose of this study is to see if infusion with 500 mg of iron sucrose over a one hour time period can be done safely. If this can be done safely, it may reduce the total number of infusions required and the time for each infusion. This may be less costly and less burdensome to patients.

Detailed Description

Not provided

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 2

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
High Dose, Rapid Infusion Iron Sucrose	Experimental	Patients will receive an infusion of 500 mg of iron sucrose over one hour and will be monitored for four hours.	Drug: Iron sucrose

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Iron sucrose	Drug	Iron sucrose will be infused at dose of 500 mg over a one hour period	High Dose, Rapid Infusion Iron Sucrose

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
incidence of adverse events in the study population attributed to drug administration.		4 hours

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Any patient requiring iron infusion

Exclusion Criteria:

Patients will be excluded from enrollment if they are under the age of 18, unable to give signed consent, are pregnant, have end-stage renal disease, are on hemodialysis (HD), or have a history of clinically significant adverse reactions to iron sucrose.

Accepts Healthy Volunteers

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
Bradley Lash, MD	The Guthrie Clinic	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Robert Packer Hospital		Sayre	Pennsylvania	18840	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
D000090463	Iron Deficiencies

Ancestor Terms

ID	Term
D019189	Iron Metabolism Disorders
D008659	Metabolic Diseases
D009750	Nutritional and Metabolic Diseases

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D000077605	Ferric Oxide, Saccharated

Ancestor Terms

ID	Term
D005290	Ferric Compounds
D058085	Iron Compounds
D007287	Inorganic Chemicals
D005937	Glucaric Acid

Browse Leaves

Not provided

Browse Branches

Not provided