Hypophosphatemia With Ferric Carboxymaltose Vs. Iron Dextran in Iron Deficiency Secondary to Heavy Uterine Bleeding

NCT01307007 | Completed Phase 2 Results

• 1 other identifier: 1VIT08023
• Study Type: interventional
• Target: 69
• Locations: 0 countries
• Sites: N/A

Brief Summary

The primary objective of this study is to assess the safety of an investigational intravenous iron (ferric carboxymaltose \[FCM\]) or an equal dose of iron dextran and explore the mechanism of hypophosphatemia following administration of FCM or that of an equal dose of iron dextran when treating women with iron deficiency anemia due to heavy uterine bleeding (HUB).

Conditions

Iron Deficiency Anemia

Outcome Measures

Primary Outcomes (1)

• Changes in Blood Markers

  Changes in blood markers of phosphate

  Day 35

Study Arms (2)

Ferric Carboxymaltose (FCM)

EXPERIMENTAL

15 mg/kg up to a maximum of 1000 mg intravenous diluted in 250 cc normal saline solution administered over 15 minutes on Day 0

Drug: Ferric Carboxymaltose (FCM)

Iron Dextran Injection

ACTIVE COMPARATOR

Test dose of 25 mg administered over 5 minutes, if no reaction occurs then the remainder of the dose (15 mg/kg or 1000 mg including the test dose) will be administered as per investigator. The infusion must be given only when resuscitative techniques for the treatment of anaphylactic reactions are readily available.

Drug: Iron Dextran Injection

Interventions

Ferric Carboxymaltose (FCM) DRUG

15 mg/kg up to a maximum of 1000 mg intravenous diluted in 250 cc normal saline solution administered over 15 minutes on Day 0

Also known as: Injectafer

Ferric Carboxymaltose (FCM)

Iron Dextran Injection DRUG

Test dose of 25 mg administered over 5 minutes, if no reaction occurs then the remainder of the dose (15 mg/kg or 1000 mg including the test dose) will be administered as per investigator. The infusion must be given only when resuscitative techniques for the treatment of anaphylactic reactions are readily available.

Also known as: Dexferrum and INFeD

Iron Dextran Injection

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Female subjects \> or = to 18 years of age
• History of Heavy Uterine Bleeding within the past 6 months
• Screening visit central laboratory Hgb \< 12 g/dL
• Screening Visit ferritin \< or = to 100 ng/mL or \< or = to 300 when transferrin saturation (TSAT) is \< or = to 30%
• Demonstrate the ability to understand the requirements of the study, willingness to abide by study restrictions and to return for the required assessments

You may not qualify if:

• Known hypersensitivity reaction to any component of ferric carboxymaltose or iron dextran
• Previously randomized in a clinical study of ferric carboxymaltose
• Requires dialysis for treatment of chronic kidney disease
• Chronic kidney disease, marked by estimated glomerular filtration rate \< 60 ml/min/1.73m squared
• Previous kidney transplant
• History of primary hypophosphatemic disorder
• Hypophosphatemia \< 2.6 mg/dl
• No evidence of iron deficiency
• During the 10 day period prior to screening has been treated with intravenous iron
• During the 30 day period prior to screening or during the study period has or will be treated with erythropoiesis stimulating agents (ESA) in a regimen that is off label
• During the 30 day period prior to screening or during the study period has or will be treated with a red blood cell transfusion, radiotherapy and/or chemotherapy
• During the 30 day period prior to screening or during the study period has or will require a surgical procedure that necessitates general anesthesia
• Any non-viral infection
• Aspartate aminotransferase (AST) or Alanine Aminotransferase (ALT) at screening, as determined by central labs, greater than 1.5 times the upper limit of normal
• Known positive hepatitis with evidence of active disease

Sponsors & Collaborators

• American Regent, Inc.: lead

Related Publications (1)

• Wolf M, Koch TA, Bregman DB. Effects of iron deficiency anemia and its treatment on fibroblast growth factor 23 and phosphate homeostasis in women. J Bone Miner Res. 2013 Aug;28(8):1793-803. doi: 10.1002/jbmr.1923.

  PMID: 23505057 RESULT

Related Links

• FGF23; IRON; PHOSPHATE; PTH; VITAMIN D

MeSH Terms

Conditions

Anemia, Iron-Deficiency

Interventions

ferric carboxymaltose; Iron-Dextran Complex

Condition Hierarchy (Ancestors)

Anemia, Hypochromic; Anemia; Hematologic Diseases; Hemic and Lymphatic Diseases; Iron Deficiencies; Iron Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

Coordination Complexes; Organic Chemicals; Dextrans; Glucans; Polysaccharides; Carbohydrates

Results Point of Contact

• Title: Sumita Chowdhury, MD, MPH, FACC, MBA
• Organization: Luitpold Pharmaceuticals, Inc.

SChowdhury@lpicrd.com

610-650-4200

Study Officials

• Mark Falone, MD

  American Regent, Inc.

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: GT60
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 4, 2010
• First Posted: March 2, 2011
• Study Start: September 1, 2010
• Primary Completion: May 1, 2011
• Study Completion: August 1, 2013
• Last Updated: February 19, 2018
• Results First Posted: June 27, 2017

Record last verified: 2018-01

Data Sharing

• IPD Sharing: Will not share