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

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

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.

Study Overview

• Status: Withdrawn
• Conditions: Iron Deficiency
• Intervention / Treatment: Drug: Iron sucrose

• Study Type: Interventional
• Phase: Phase 2

Contacts and Locations

Study Locations

• United States
  • Pennsylvania
    • Sayre, Pennsylvania, United States, 18840
      • Robert Packer Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: NA
• Interventional Model: SINGLE_GROUP
• Masking: NONE

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: High Dose, Rapid Infusion Iron Sucrose; Patients will receive an infusion of 500 mg of iron sucrose over one hour and will be monitored for four hours.	Drug: Iron sucrose; Iron sucrose will be infused at dose of 500 mg over a one hour period; Other Names: Venofer

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

• Sponsor: The Guthrie Clinic
• Investigators: Principal Investigator: Bradley Lash, MD, The Guthrie Clinic

Study record dates

Study Major Dates

• Study Start (ACTUAL): January 1, 2017
• Primary Completion (ACTUAL): May 1, 2017
• Study Completion (ACTUAL): May 1, 2017

Study Registration Dates

• First Submitted: November 28, 2016
• First Submitted That Met QC Criteria: November 28, 2016
• First Posted (ESTIMATE): November 30, 2016

Study Record Updates

• Last Update Posted (ACTUAL): October 18, 2017
• Last Update Submitted That Met QC Criteria: October 16, 2017
• Last Verified: October 1, 2017

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Metabolic Diseases; Hematologic Diseases; Anemia, Hypochromic; Anemia; Iron Metabolism Disorders; Anemia, Iron-Deficiency; Hematinics; Ferric Oxide, Saccharated
• Other Study ID Numbers: 1611-56

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO