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

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The Guthrie Clinic

Status and phase

Withdrawn
Phase 2

Conditions

Iron Deficiency

Treatments

Drug: Iron sucrose

Study type

Interventional

Funder types

Other

Identifiers

NCT02977611
1611-56

Details and patient eligibility

About

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.

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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.

Trial design

Primary purpose

Treatment

Allocation

N/A

Interventional model

Single Group Assignment

Masking

None (Open label)

0 participants in 1 patient group

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

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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