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

NCT02977611 — Phase 2, Withdrawn, The Guthrie Clinic

ClinicalTrials Daily · Areas · Conditions · Drugs · Sponsors ·

The Safety of a High-Dose, Rapid Infusion of Iron Sucrose in a Non-Dialysis Dependent Population

Registry	NCT02977611
Status	Withdrawn - FDA Clinical Hold
Phase	Phase 2
Study type	Interventional; na, single group, masking: none, treatment
Sponsor	The Guthrie Clinic (Other)
Conditions	Iron Deficiency
Interventions	Iron sucrose (Drug)
Dates	start 2017-01-01, primary completion 2017-05-01, completion 2017-05-01, first posted 2016-11-30, last updated 2017-10-18
Locations	1 site in United States

-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.

Expand all sections · Collapse all

+Arms and interventions

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

Iron sucrose (Drug), also known as Venofer: Iron sucrose will be infused at dose of 500 mg over a one hour period

+Outcome measures

Primary outcomes

incidence of adverse events in the study population attributed to drug administration. [4 hours]

+Eligibility

Sex: All, ages: 18 Years to any

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.

+Locations (1)

Facility	City	Country	Status
Robert Packer Hospital	Sayre, Pennsylvania	United States

+Investigators

Bradley Lash, MD, Principal investigator, The Guthrie Clinic