Intravaneous Iron(1000 mg Low Molecular Weight Iron Dextran Over 60 Minutes) for Pregnant Women

NCT02038023 | Completed Phase 2 Results

• 2 other identifiers: Intravaneous Iron in PregnancyInfed
• Study Type: interventional
• Target: 74
• Locations: 1 country
• Sites: 1

Brief Summary

To determine the percentage of women who achieve anemia correction after a single dose of 1000mg of low molecular weight iron dextran(infed).

Conditions

Pregnancy

Keywords

Iv iron in pregnant women; second and third trimester

Outcome Measures

Primary Outcomes (1)

• Percentage of Women Who Achieve Anemia Correction After a Single Dose of 1000mg of Low Molecular Weight Iron Dextran(INfeD).

  4 weeks after infusion or post-partum

Secondary Outcomes (3)

• Serum Ferritin

  4 weeks post infusion or post-partum

• Percent Transferrin Saturation

  4 weeks post infusion or post-partum

• Safety as Measured by Number of Adverse Events

  4 weeks after infusion and 4 weeks post-partum

Study Arms (1)

IV iron

OTHER

Intravaneous iron(1000 mg low molecular weight iron dextran over 60 minutes) for moderate to severe iron deficient anemia of pregnancy in women intolerant of or unresponsive to oral iron.

Drug: Intravaneous iron(low molecular weight iron dextran)

Interventions

Intravaneous iron(low molecular weight iron dextran) DRUG

1000 mg of Iron dextran administered over one hour

Also known as: Iron Dextran(InFed)

IV iron

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• pregnant women intolerable to oral iron. hbg \<10.9 g/dl during second or third trimester.

You may not qualify if:

• known sensitivity to IV iron. hemoglobinopathies. hemolytic anemia. women who have received or will receive blood transfusions. women with significant vaginal bleeding(\>200 cc blood loss)prior to delivery. women with documented history of allergy to more than one class of drug clinically significant anemia requiring therapy in the opinion of the obstetrician, in the first trimester.

Sponsors & Collaborators

• Auerbach Hematology Oncology Associates P C: lead
• Pharmacosmos A/S: collaborator

Study Sites (1)

Auerbach Hematology Oncology Assoc

Baltimore, Maryland, 21237, United States

Location

Related Publications (1)

• Auerbach M, James SE, Nicoletti M, Lenowitz S, London N, Bahrain HF, Derman R, Smith S. Results of the First American Prospective Study of Intravenous Iron in Oral Iron-Intolerant Iron-Deficient Gravidas. Am J Med. 2017 Dec;130(12):1402-1407. doi: 10.1016/j.amjmed.2017.06.025. Epub 2017 Jul 21.

  PMID: 28739199 RESULT

MeSH Terms

Conditions

Neoplasm Metastasis

Condition Hierarchy (Ancestors)

Neoplastic Processes; Neoplasms; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Results Point of Contact

• Title: Dr Michael AUERBACH
• Organization: AUERBACH HEMATOLOGY ONCOLOGY ASSOC

MAUERBACHMD@ABHEMONC.COM

410-780-4050

Study Officials

• Michael Auerbach, MD

  Auerbach Hematology Oncology

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 9, 2014
• First Posted: January 16, 2014
• Study Start: July 1, 2013
• Primary Completion: July 1, 2015
• Study Completion: August 1, 2015
• Last Updated: June 28, 2018
• Results First Posted: June 28, 2018

Record last verified: 2018-01

Locations

US (1)