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Monoferric for Anemia

Phase 4

Waitlist Available

Led By Richard D. Urman, MD

Research Sponsored by Brigham and Women's Hospital

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 3-4 weeks after infusion

Awards & highlights

Study Summary

This trial will help researchers understand if it's feasible to give patients a one-time dose of iron before surgery to improve outcomes, and what processes and infrastructure are needed to make it happen.

Eligible Conditions

Anemia
Surgery

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 3-4 weeks after infusion

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~3-4 weeks after infusion

This trial's timeline: 3 weeks for screening, Varies for treatment, and 3-4 weeks after infusion for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Serum hemoglobin concentration

Secondary outcome measures

Requirement for perioperative blood transfusion

Trial Design

1Treatment groups

Experimental Treatment

Group I: Intravenous Iron Infusion ArmExperimental Treatment1 Intervention

If the patient is found to have iron deficiency anemia, the patient will receive IV iron preoperatively. Patients that agree to be enrolled in the study will be scheduled for the IV iron dose approximately 3-4 weeks prior to surgery. A single IV dose of 1000 mg of Monoferric will be administered. This will be administered at the Brigham and Women's Hospital infusion center and coordinated with the Hematology team.

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Who is running the clinical trial?

Brigham and Women's HospitalLead Sponsor

1,610 Previous Clinical Trials

11,470,327 Total Patients Enrolled

2 Trials studying Anemia

2,100 Patients Enrolled for Anemia

Pharmacosmos A/SIndustry Sponsor

44 Previous Clinical Trials

9,670 Total Patients Enrolled

22 Trials studying Anemia

6,487 Patients Enrolled for Anemia

Richard D. Urman, MDPrincipal InvestigatorBrigham and Women's Hospital

1 Previous Clinical Trials

30 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Has Monoferric attained the necessary FDA authorization?

"Monoferric has been approved by the relevant authorities, and thus scored a 3 on our internal evaluation system."

Answered by AI

Are there still openings available for participants to join this research trial?

"Unfortunately, this clinical trial is not presently enrolling patients. Despite originally being posted on November 1st 2022, the study was last updated 8th October 2022. Nevertheless, there are 469 other research efforts that currently seek volunteers."

Answered by AI

Recent research and studies

European Journal of Pharmaceutics and BiopharmaceuticsJournal

A Comparative Study of the Physicochemical Properties of Iron Isomaltoside 1000 (monofer®), a New Intravenous Iron Preparation and Its Clinical Implications

Jahn, Markus R., Hans B. Andreasen, Sören Fütterer, Thomas Nawroth, Volker Schünemann, Ute Kolb, Wolfgang Hofmeister, et al.. 2011. “A Comparative Study of the Physicochemical Properties of Iron Isomaltoside 1000 (monofer®), a New Intravenous Iron Preparation and Its Clinical Implications”. European Journal of Pharmaceutics and Biopharmaceutics. Elsevier BV. doi:10.1016/j.ejpb.2011.03.016.

Journal of NephrologyJournal

Iron Isomaltoside 1000: A New Intravenous Iron for Treating Iron Deficiency in Chronic Kidney Disease

Wikström, Björn, Sunil Bhandari, Peter Barany, Philip A. Kalra, Søren Ladefoged, Jan Wilske, and Lars L. Thomsen. 2011. “Iron Isomaltoside 1000: A New Intravenous Iron for Treating Iron Deficiency in Chronic Kidney Disease”. Journal of Nephrology. SAGE Publications. doi:10.5301/jn.2011.6248.

American Journal of HematologyJournal

A Prospective, Multi‐center, Randomized Comparison of Iron Isomaltoside 1000 Versus Iron Sucrose in Patients with Iron Deficiency Anemia; the FERWON‐IDA Trial

Auerbach, Michael, David Henry, Richard J. Derman, Maureen M. Achebe, Lars L. Thomsen, and John Glaspy. 2019. “A Prospective, Multi‐center, Randomized Comparison of Iron Isomaltoside 1000 Versus Iron Sucrose in Patients with Iron Deficiency Anemia; the FERWON‐IDA Trial”. American Journal of Hematology. Wiley. doi:10.1002/ajh.25564.

clinicaltrials.govStudy