Iron Isomaltoside/Ferric Derisomaltose vs Iron Sucrose for the Treatment of Iron Deficiency Anemia (IDA)

NCT02940886 | Completed Phase 3 Results DMC

• 1 other identifier: P-Monofer-IDA-03
• Study Type: interventional
• Target: 1,512
• Locations: 1 country
• Sites: 114

Brief Summary

Evaluate safety and efficacy of iron isomaltoside/ferric derisomaltose (Monofer®/Monoferric®) compared with iron sucrose (Venofer®), in subjects diagnosed with IDA.

Conditions

Iron Deficiency Anaemia; Iron Deficiency Anemia

Keywords

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

Outcome Measures

Primary Outcomes (2)

• Change in Hemoglobin (Hb) From Baseline to Week 8

  Efficacy Evaluate the effect on the hemoglobin (Hb) level following treatment with iron isomaltoside/ferric derisomaltose vs iron sucrose in subjects with iron deficiency anaemia (IDA) . Response was defined as change from baseline in hemoglobin (Hb) to week 8, i.e. ability to increase Hb in subjects with IDA, when oral iron preparations were ineffective or could not be used or in whom the screening Hb measurement in Investigators' opinion were sufficiently low to require rapid repletion of iron stores.

  Baseline to week 8

• Incidence of Protocol-defined Serious or Severe Hypersensitivity Reactions

  Safety For this endpoint, the number of participants with serious or severe hypersensitivity reactions were evaluated. The hypersensitivity reactions that were included in the analysis were those that started on or after the first dose of randomised treatment (i.e. treatment emergent). The terms used to define hypersensitivity were those specified by the Standardised MedDRA Queries (SMQ) for hypersensitivity, plus four additional terms: loss of consciousness, seizure, syncope, unresponsiveness. The potential hypersensitivity AEs were adjudicated in a blinded fashion by an independent Clinical Endpoint Adjudication Committee (CEAC). Results show only those participants that had adjudicated and confirmed serious or severe hypersensitivity reactions.

  Baseline to week 8

Secondary Outcomes (18)

• Composite Cardiovascular Adverse Events (AEs)

  Baseline, week 1, 2, and 8

• Time to First Composite Cardiovascular Safety AE

  Baseline, week 1, 2, 4, and 8

• S-phosphate <2 mg/dL at Any Time From Baseline to Week 1, 2, 4, and 8

  Baseline, week 1, 2, 4, and 8

• Hb Concentration Increase of ≥2 g/dL From Baseline to Week 1, 2, 4, and 8

  Baseline, week 1, 2, 4, and 8

• Time to Change in Hb Concentration ≥2 g/dL

  Baseline, week 1, 2, 4, and 8

Study Arms (2)

Iron isomaltoside/ferric derisomaltose

EXPERIMENTAL

Administered IV

Drug: Iron isomaltoside/ferric derisomaltose

Iron sucrose

ACTIVE COMPARATOR

Administered IV

Drug: Iron sucrose

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 set to 1000 mg. The dose was diluted in 100 mL 0.9 % sodium chloride (100 mL bags) and administered as a single IV infusion over approximately 20 minutes.

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

Iron isomaltoside/ferric derisomaltose

Iron sucrose DRUG

Iron sucrose (Venofer®; 20 mg elemental iron/mL) was the comparator in this trial. Iron sucrose was administered as 200 mg undiluted IV injections over approximately 2-5 minutes and repeated according to standard practice or physician choice up to a maximum of five times within the first two weeks starting at baseline. A cumulative dose of 1000 mg was recommended.

Also known as: Venofer®

Iron sucrose

Eligibility Criteria

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

You may qualify if:

• Men or women ≥ 18 years
• Subjects having IDA caused by different etiologies
• Subjects with intolerance to oral iron therapy or a need for rapid repletion of iron stores:
• Haemoglobin (Hb) ≤ 11 g/dL
• Transferrin Saturation (TSAT) \< 20 %
• S-ferritin \< 100 ng/mL
• Willingness to participate and signing the informed consent form

You may not qualify if:

• Anemia predominantly caused by factors other than IDA
• Hemochromatosis or other iron storage disorders
• Previous serious hypersensitivity reactions to any IV iron compound
• Erythropoiesis stimulating agent (ESA) treatment
• Prior to screening or during the trial period; has or will be treated with a red blood cell transfusion, radiotherapy, and/or chemotherapy
• Will require a surgical procedure that necessitated general anesthesia prior to screening or during the trial period
• Alanine aminotransferase and/or aspartate aminotransferase \> 3 times upper limit of normal
• Required dialysis for treatment of chronic kidney disease (CKD)
• Alcohol or drug abuse within the past 6 months
• Pregnant or nursing women

Sponsors & Collaborators

• Pharmacosmos A/S: lead

Study Sites (114)

Pharmacosmos Investigational Site

Birmingham, Alabama, 35205, United States

Location

Pharmacosmos Investigational Site

Dothan, Alabama, 36305, United States

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Pharmacosmos Investigational Site

Guntersville, Alabama, 35976, United States

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Pharmacosmos Investigational Site

Phoenix, Arizona, 85018, United States

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Pharmacosmos Investigational Site

Little Rock, Arkansas, 72204, United States

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Pharmacosmos Investigational Site

Little Rock, Arkansas, 72205, United States

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Pharmacosmos Investigational Site

Foothill Ranch, California, 92610, United States

Location

Pharmacosmos Investigational Site 1

La Mesa, California, 91942, United States

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Pharmacosmos Investigational Site 2

La Mesa, California, 91942, United States

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Pharmacosmos Investigational Site

Long Beach, California, 90806, United States

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Pharmacosmos Investigational Site

National City, California, 91950, United States

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Pharmacosmos Investigational Site 1

Northridge, California, 91324, United States

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Pharmacosmos Investigational Site 2

Northridge, California, 91324, United States

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Pharmacosmos Investigational Site

Oceanside, California, 92056, United States

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Quartz Hill, California, 93536, United States

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Rialto, California, 92377, United States

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Riverside, California, 92501, United States

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San Diego, California, 92103, United States

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San Diego, California, 92117, United States

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San Marcos, California, 92078, United States

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Whittier, California, 90603, United States

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Plainville, Connecticut, 06062, United States

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Pharmacosmos Investigational Site

Aventura, Florida, 33180, United States

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Pharmacosmos Investigational Site

Boynton Beach, Florida, 33426, United States

Location

Pharmacosmos Investigational Site 1

Doral, Florida, 33166, United States

Location

Pharmacosmos Investigational Site 2

Doral, Florida, 33166, United States

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Pharmacosmos Investigational Site

Doral, Florida, 33172, United States

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Pharmacosmos Investigational Site

Fort Lauderdale, Florida, 33308, United States

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Hialeah, Florida, 33012, United States

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Pharmacosmos Investigational Site

Hialeah, Florida, 33015, United States

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Pharmacosmos Investigational Site

Hialeah, Florida, 33016, United States

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Hollywood, Florida, 33024, United States

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Jacksonville, Florida, 32204, United States

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Kissimmee, Florida, 34741, United States

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Lake City, Florida, 32024, United States

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Lake Worth, Florida, 33461, United States

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Pharmacosmos Investigational Site

Lake Worth, Florida, 33467, United States

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Pharmacosmos Investigational Site

Miami, Florida, 33015, United States

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Pharmacosmos Investigational Site

Miami, Florida, 33126, United States

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Pharmacosmos Investigational Site

Miami, Florida, 33130, United States

Location

Pharmacosmos Investigational Site

Miami, Florida, 33135, United States

Location

Pharmacosmos Investigational Site 1

Miami, Florida, 33144, United States

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Pharmacosmos Investigational Site 2

Miami, Florida, 33144, United States

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Pharmacosmos Investigational Site

Miami, Florida, 33147, United States

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Pharmacosmos Investigational Site

Miami, Florida, 33155, United States

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Pharmacosmos Investigational Site

Miami, Florida, 33165, United States

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Pharmacosmos Investigational Site

Miami, Florida, 33173, United States

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Pharmacosmos Investigational Site

Miami, Florida, 33174, United States

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Pharmacosmos Investigational Site

Miami, Florida, 33185, United States

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Pharmacosmos Investigational Site 1

Miami Lakes, Florida, 33014, United States

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Pharmacosmos Investigational Site 2

Miami Lakes, Florida, 33014, United States

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Pharmacosmos Investigational Site

Miami Lakes, Florida, 33014, United States

Location

Pharmacosmos Investigational Site 1

Naples, Florida, 34102, United States

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Pharmacosmos Investigational Site 2

Naples, Florida, 34102, United States

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Pharmacosmos Investigational Site

Palmetto Bay, Florida, 33157, United States

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Pharmacosmos Investigational Site

Plantation, Florida, 33324, United States

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West Palm Beach, Florida, 33409, United States

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Pharmacosmos Investigational Site

Champaign, Illinois, 61820, United States

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Joliet, Illinois, 60435, United States

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Palos Heights, Illinois, 60463, United States

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Terre Haute, Indiana, 47802, United States

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Wichita, Kansas, 67214, United States

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Owensboro, Kentucky, 42303, United States

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Baton Rouge, Louisiana, 70809, United States

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Pharmacosmos Investigational Site

Marrero, Louisiana, 70072, United States

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Pharmacosmos Investigational Site

Metairie, Louisiana, 70006, United States

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Pharmacosmos Investigational Site

New Orleans, Louisiana, 70125, United States

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Pharmacosmos Investigational Site

Shreveport, Louisiana, 71103, United States

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Pharmacosmos Investigational Site

Bethesda, Maryland, 20817, United States

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Pharmacosmos Investigational Site

Hagerstown, Maryland, 21740, United States

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Pharmacosmos Investigational Site

Towson, Maryland, 21204, United States

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Pharmacosmos Investigational Site

Fall River, Massachusetts, 02720, United States

Location

Pharmacosmos Investigational Site

Grand Rapids, Michigan, 49525, United States

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Pharmacosmos Investigational Site

Saginaw, Michigan, 48604, United States

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Pharmacosmos Investigational Site

Troy, Michigan, 48085, United States

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Pharmacosmos Investigational Site

Florissant, Missouri, 63031, United States

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Pharmacosmos Investigational Site

Omaha, Nebraska, 68134, United States

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Pharmacosmos Investigational Site

Las Vegas, Nevada, 89109, United States

Location

Pharmacosmos Investigational Site

Neptune City, New Jersey, 07753, United States

Location

Pharmacosmos Investigational Site

Plainsboro, New Jersey, 08536, United States

Location

Unknown Facility

Brooklyn, New York, 11235, United States

Location

Pharmacosmos Investigational Site 1

East Setauket, New York, 11733, United States

Location

Pharmacosmos Investigational Site 2

East Setauket, New York, 11733, United States

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Pharmacosmos Investigational Site

New York, New York, 10016, United States

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Pharmacosmos Investigational Site

Wilmington, North Carolina, 28401, United States

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Pharmacosmos Investigational Site

Wilmington, North Carolina, 28403, United States

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Pharmacosmos Investigational Site

Beavercreek, Ohio, 45431, United States

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Pharmacosmos Investigational Site

Canton, Ohio, 44718, United States

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Pharmacosmos Investigational Site

Centerville, Ohio, 45459, United States

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Pharmacosmos Investigational Site

Cincinnati, Ohio, 45206, United States

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Pharmacosmos Investigational Site

Columbus, Ohio, 43231, United States

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Pharmacosmos Investigational Site

Norman, Oklahoma, 73069, United States

Location

Pharmacosmos Investigational Site

Tulsa, Oklahoma, 74136, United States

Location

Pharmacosmos Investigational Site

Jenkintown, Pennsylvania, 19046, United States

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Pharmacosmos Investigational Site

Columbia, South Carolina, 29209, United States

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Pharmacosmos Investigational Site

Myrtle Beach, South Carolina, 29572, United States

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Pharmacosmos Investigational Site

Chattanooga, Tennessee, 37404, United States

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Pharmacosmos Investigational Site

Franklin, Tennessee, 37067, United States

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Pharmacosmos Investigational Site

Knoxville, Tennessee, 37923, United States

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Pharmacosmos Investigational Site

Memphis, Tennessee, 38104, United States

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Pharmacosmos Investigational Site

Austin, Texas, 78704, United States

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Pharmacosmos Investigational Site

Baytown, Texas, 77521, United States

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Pharmacosmos Investigational Site

Beaumont, Texas, 77702, United States

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Pharmacosmos Investigational Site

Corsicana, Texas, 75110, United States

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Pharmacosmos Investigational Site

DeSoto, Texas, 75115, United States

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Pharmacosmos Investigational Site

Houston, Texas, 77030, United States

Location

Pharmacosmos Investigational Site

Houston, Texas, 77079, United States

Location

Pharmacosmos Investigational Site

Houston, Texas, 77099, United States

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Pharmacosmos Investigational Site

McAllen, Texas, 78503, United States

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Pharmacosmos Investigational Site

San Antonio, Texas, 78215, United States

Location

Pharmacosmos Investigational Site

San Antonio, Texas, 78217, United States

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Pharmacosmos Investigational Site

Ogden, Utah, 84405, United States

Location

Pharmacosmos Investigational Site

Chesapeake, Virginia, 23320, United States

Location

Pharmacosmos Investigational Site

Tacoma, Washington, 98405, United States

Location

Related Publications (2)

• Auerbach M, Henry D, Derman RJ, Achebe MM, Thomsen LL, Glaspy J. A prospective, multi-center, randomized comparison of iron isomaltoside 1000 versus iron sucrose in patients with iron deficiency anemia; the FERWON-IDA trial. Am J Hematol. 2019 Sep;94(9):1007-1014. doi: 10.1002/ajh.25564. Epub 2019 Jul 13.

  PMID: 31243803 RESULT

• Auerbach M and Lykke LL. A single infusion of iron isomaltoside 1000 allows a more rapid hemoglobin increment than multiple doses of iron sucrose with a similar safety profile in patients with iron deficiency anemia. Blood 2018 132:2334; doi: https://doi.org/10.1182/blood-2018-99-110199

  RESULT

MeSH Terms

Conditions

Anemia, Iron-Deficiency

Interventions

iron isomaltoside 1000; ferric derisomaltose; Ferric Oxide, Saccharated

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)

Ferric Compounds; Iron Compounds; Inorganic Chemicals; Glucaric Acid; Sugar Acids; Acids, Acyclic; Carboxylic Acids; Organic Chemicals; Hydroxy Acids; Carbohydrates

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: September 27, 2016
• First Posted: October 21, 2016
• Study Start: November 8, 2016
• Primary Completion: March 28, 2018
• Study Completion: March 28, 2018
• Last Updated: October 6, 2020
• Results First Posted: March 10, 2020

Record last verified: 2020-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (114)