Incidence of Hypophosphatemia After Treatment With Iron Isomaltoside/Ferric Derisomaltose vs Ferric Carboxymaltose in Subjects With Iron Deficiency Anaemia

NCT03238911 | Completed Phase 3 Results FDA Drug

• 1 other identifier: P-Monofer-IDA-04
• Study Type: interventional
• Target: 123
• Locations: 1 country
• Sites: 16

Brief Summary

The trial was designed to evaluate the incidence of unintended hypophosphatemia (low level of phosphate in the blood) in subjects with iron deficiency anaemia (IDA).

Conditions

Iron Deficiency Anaemia; Iron Deficiency Anemia

Keywords

Iron Deficiency Anaemia; Iron Deficiency Anemia; IDA; Intravenous iron replacement therapy; Iron deficiency; Iron isomaltoside; Ferric derisomaltose; Monofer; Monoferric; Monover; Monofar; Monoferro; Hypophosphatemia; Ferric carboxymaltose

Outcome Measures

Primary Outcomes (1)

• Incidence of Hypophosphatemia (S-phosphate Level <2 mg/dL)

  Safety The incidence of hypophosphatemia (defined as s-phosphate \<2 mg/dL) at any time from baseline up to day 35.

  Baseline to day 35

Secondary Outcomes (16)

• Time With Hypophosphatemia ( S-phosphate Level <2.0 mg/dL)

  Baseline to day 35

• Proportion of Subjects With Hypophosphatemia on Day 35 ( S-phosphate Level <2.0 mg/dL)

  Baseline to day 35

• Absolute [∆] Changes in S-phosphate From Baseline to Day 1, 7, 8, 14, 21, and 35

  Baseline, days 1, 7, 8, 14, 21, and 35

• Relative [%] Changes in S-phosphate From Baseline to Day 1, 7, 8, 14, 21, and 35

  Baseline, days 1, 7, 8, 14, 21, and 35

• Change From Baseline in Fractional Phosphate Urinary Excretion

  Baseline, days 1, 7, 8, 14, 21, and 35

Study Arms (2)

Iron isomaltoside/ferric derisomaltose

EXPERIMENTAL

Administered IV

Drug: Iron isomaltoside/ferric derisomaltose

Ferric carboxymaltose

ACTIVE COMPARATOR

Administered IV

Drug: Ferric carboxymaltose

Interventions

Iron isomaltoside/ferric derisomaltose DRUG

Iron isomaltoside/ferric derisomaltose (Monofer®/Monoferric®; 100 mg/mL) was the test product in this trial. The dose of iron isomaltoside/ferric derisomaltose for the individual subject was a single IV infusion of 1000 mg (10 mL containing 1000 mg iron isomaltoside/ferric derisomaltose diluted in 100 mL 0.9 % sodium chloride), given over approximately 20 minutes (50 mg iron/min) at baseline (cumulative dose: 1000 mg).

Also known as: Monofer®, Monoferric®, Monover®, Monofar®, Monoferro®

Iron isomaltoside/ferric derisomaltose

Ferric carboxymaltose DRUG

Ferric carboxymaltose (Injectafer®; 50 mg/mL) was the comparator in this trial. Ferric carboxymaltose was administered as 750 mg, infused over at least 15 minutes at baseline and on day 7 (cumulative dose: 1500 mg).

Also known as: Injectafer®, Ferinject®

Ferric carboxymaltose

Eligibility Criteria

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

You may qualify if:

• Subjects diagnosed with IDA, caused by different aetiologies
• Haemoglobin (Hb) ≤ 11 g/dL
• Body weight \> 50 kg
• Serum ferritin (S-ferritin) \< 100 ng/mL
• Estimated glomerular filtration rate (eGFR) ≥ 65 mL/min/1.73 m2
• Serum phosphate (S-phosphate) \> 2.5 mg/dL
• Intolerance or unresponsiveness to oral iron
• Willingness to participate and signing the Informed Consent Form (ICF)

You may not qualify if:

• Acute bleeding \> 500 mL within 72 hours
• Anaemia predominantly caused by factors other than IDA
• Hemochromatosis or other iron storage disorders
• Previous serious hypersensitivity reactions to any IV iron compounds
• Treatment with IV iron within the last 30 days prior to screening
• Treatment with erythropoietin or erythropoietin-stimulation agents
• Red blood cell transfusion, radiotherapy, and/or chemotherapy
• Received an investigational drug within the last 30 days prior to screening
• Planned surgical procedure within the trial period
• Hepatic enzymes \> 3 times upper limit of normal
• Surgery under anaesthetic within the last 30 days prior to screening
• Any non-viral infection within the last 30 days prior to screening
• Alcohol or drug abuse within the past 6 months
• Vitamin D deficiency
• Untreated hyperparathyroidism

Sponsors & Collaborators

• Pharmacosmos A/S: lead

Study Sites (16)

Pharmacosmos Investigational Site

Los Angeles, California, 90036, United States

Location

Pharmacosmos Investigational Site

Sacramento, California, 95831, United States

Location

Pharmacosmos Investigational Site

Santa Ana, California, 92704, United States

Location

Pharmacosmos Investigational Site

Clearwater, Florida, 33759, United States

Location

Pharmacosmos Investigational Site

Miami, Florida, 33125, United States

Location

Pharmacosmos Investigational Site 1

Miami, Florida, 33126, United States

Location

Pharmacosmos Investigational Site 2

Miami, Florida, 33126, United States

Location

Pharmacosmos Investigational Site

Miami, Florida, 33143, United States

Location

Pharmacosmos Investigational Site

Miami, Florida, 33144, United States

Location

Pharmacosmos Investigational Site

Indianapolis, Indiana, 46202, United States

Location

Pharmacosmos Investigational Site

Wichita, Kansas, 67206, United States

Location

Pharmacosmos Investigational Site

Metairie, Louisiana, 70001, United States

Location

Pharmacosmos Investigational Site

Lancaster, Pennsylvania, 17605, United States

Location

Pharmacosmos Investigational Site

Houston, Texas, 77024, United States

Location

Pharmacosmos Investigational Site

Orem, Utah, 84058, United States

Location

Pharmacosmos Investigational Site

Leesburg, Virginia, 20176, United States

Location

Related Publications (2)

• Wolf M, Rubin J, Achebe M, Econs M, Peacock M, Imel E, Thomsen L, Carpenter T, Weber T, Zoller H. Effects of iron isomaltoside versus ferric carboxymaltose on hormonal control of phosphate homeostasis: The PHOSPHARE-IDA04/05 randomized controlled trials. Journal of the Endocrine Society, Volume 3, Issue Supplement_1, April-May 2019, OR13-3, https://doi.org/10.1210/js.2019-OR13-3

  RESULT

• Wolf M, Rubin J, Achebe M, Econs MJ, Peacock M, Imel EA, Thomsen LL, Carpenter TO, Weber T, Brandenburg V, Zoller H. Effects of Iron Isomaltoside vs Ferric Carboxymaltose on Hypophosphatemia in Iron-Deficiency Anemia: Two Randomized Clinical Trials. JAMA. 2020 Feb 4;323(5):432-443. doi: 10.1001/jama.2019.22450.

  PMID: 32016310 DERIVED

MeSH Terms

Conditions

Anemia, Iron-Deficiency; Iron Deficiencies; Hypophosphatemia

Interventions

iron isomaltoside 1000; ferric derisomaltose; ferric carboxymaltose

Condition Hierarchy (Ancestors)

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

Results Point of Contact

• Title: Clinical trial disclosure desk
• Organization: Pharmacosmos A/S

trial@pharmacosmos.com

+45 5948 5935

Study Officials

• Pharmacosmos A/S Clinical and Non-clinical Research

  Pharmacosmos A/S

  STUDY DIRECTOR

Publication Agreements

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

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 6, 2017
• First Posted: August 3, 2017
• Study Start: October 24, 2017
• Primary Completion: June 19, 2018
• Study Completion: June 19, 2018
• Last Updated: February 25, 2020
• Results First Posted: February 25, 2020

Record last verified: 2020-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (16)