Iron Deficiency AnaemiaPhase 3NCT02940886

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

A Phase 3 study testing Iron isomaltoside/ferric derisomaltose and Iron sucrose in people with Iron Deficiency Anaemia and Iron Deficiency Anemia, run by Pharmacosmos A/S at 114 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

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

Who is it for?: Ages 18 years and older
Conditions the study is for: Iron Deficiency Anaemia, Iron Deficiency Anemia
What is being tested?: Iron isomaltoside/ferric derisomaltose and Iron sucrose
Type of treatment: Injection or infusion
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 1,512 participants
Where: 114 sitesUnited States
Study dates: 8 Nov 2016to 28 Mar 2018
Phase: Phase 3
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

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

Who cannot join

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

Show all 10Show fewer

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

Trial locations and contacts

114 sites in 1 country.

City, postcode or hospital

114 sites in 1 country

United States114 sites

Pharmacosmos Investigational Site
Austin, Texas, 78704
Pharmacosmos Investigational Site
Aventura, Florida, 33180
Pharmacosmos Investigational Site
Baton Rouge, Louisiana, 70809
Pharmacosmos Investigational Site
Baytown, Texas, 77521
Pharmacosmos Investigational Site
Beaumont, Texas, 77702
Pharmacosmos Investigational Site
Beavercreek, Ohio, 45431
Pharmacosmos Investigational Site
Bethesda, Maryland, 20817
Pharmacosmos Investigational Site
Birmingham, Alabama, 35205
Pharmacosmos Investigational Site
Boynton Beach, Florida, 33426
Study site
Brooklyn, New York, 11235
Pharmacosmos Investigational Site
Canton, Ohio, 44718
Pharmacosmos Investigational Site
Centerville, Ohio, 45459
Pharmacosmos Investigational Site
Champaign, Illinois, 61820
Pharmacosmos Investigational Site
Chattanooga, Tennessee, 37404
Pharmacosmos Investigational Site
Chesapeake, Virginia, 23320
Pharmacosmos Investigational Site
Cincinnati, Ohio, 45206
Pharmacosmos Investigational Site
Columbia, South Carolina, 29209
Pharmacosmos Investigational Site
Columbus, Ohio, 43231
Pharmacosmos Investigational Site
Corsicana, Texas, 75110
Pharmacosmos Investigational Site
DeSoto, Texas, 75115
Pharmacosmos Investigational Site 1
Doral, Florida, 33166
Pharmacosmos Investigational Site 2
Doral, Florida, 33166
Pharmacosmos Investigational Site
Doral, Florida, 33172
Pharmacosmos Investigational Site
Dothan, Alabama, 36305
Pharmacosmos Investigational Site 1
East Setauket, New York, 11733
Pharmacosmos Investigational Site 2
East Setauket, New York, 11733
Pharmacosmos Investigational Site
Fall River, Massachusetts, 02720
Pharmacosmos Investigational Site
Florissant, Missouri, 63031
Pharmacosmos Investigational Site
Foothill Ranch, California, 92610
Pharmacosmos Investigational Site
Fort Lauderdale, Florida, 33308
Pharmacosmos Investigational Site
Franklin, Tennessee, 37067
Pharmacosmos Investigational Site
Grand Rapids, Michigan, 49525
Pharmacosmos Investigational Site
Guntersville, Alabama, 35976
Pharmacosmos Investigational Site
Hagerstown, Maryland, 21740
Pharmacosmos Investigational Site
Hialeah, Florida, 33012
Pharmacosmos Investigational Site
Hialeah, Florida, 33015
Pharmacosmos Investigational Site
Hialeah, Florida, 33016
Pharmacosmos Investigational Site
Hollywood, Florida, 33024
Pharmacosmos Investigational Site
Houston, Texas, 77030
Pharmacosmos Investigational Site
Houston, Texas, 77079
Pharmacosmos Investigational Site
Houston, Texas, 77099
Pharmacosmos Investigational Site
Jacksonville, Florida, 32204
Pharmacosmos Investigational Site
Jenkintown, Pennsylvania, 19046
Pharmacosmos Investigational Site
Joliet, Illinois, 60435
Pharmacosmos Investigational Site
Kissimmee, Florida, 34741
Pharmacosmos Investigational Site
Knoxville, Tennessee, 37923
Pharmacosmos Investigational Site 1
La Mesa, California, 91942
Pharmacosmos Investigational Site 2
La Mesa, California, 91942
Pharmacosmos Investigational Site
Lake City, Florida, 32024
Pharmacosmos Investigational Site
Lake Worth, Florida, 33461
Pharmacosmos Investigational Site
Lake Worth, Florida, 33467
Pharmacosmos Investigational Site
Las Vegas, Nevada, 89109
Pharmacosmos Investigational Site
Little Rock, Arkansas, 72204
Pharmacosmos Investigational Site
Little Rock, Arkansas, 72205
Pharmacosmos Investigational Site
Long Beach, California, 90806
Pharmacosmos Investigational Site
Marrero, Louisiana, 70072
Pharmacosmos Investigational Site
McAllen, Texas, 78503
Pharmacosmos Investigational Site
Memphis, Tennessee, 38104
Pharmacosmos Investigational Site
Metairie, Louisiana, 70006
Pharmacosmos Investigational Site
Miami, Florida, 33015
Pharmacosmos Investigational Site
Miami, Florida, 33126
Pharmacosmos Investigational Site
Miami, Florida, 33130
Pharmacosmos Investigational Site
Miami, Florida, 33135
Pharmacosmos Investigational Site 1
Miami, Florida, 33144
Pharmacosmos Investigational Site 2
Miami, Florida, 33144
Pharmacosmos Investigational Site
Miami, Florida, 33147
Pharmacosmos Investigational Site
Miami, Florida, 33155
Pharmacosmos Investigational Site
Miami, Florida, 33165
Pharmacosmos Investigational Site
Miami, Florida, 33173
Pharmacosmos Investigational Site
Miami, Florida, 33174
Pharmacosmos Investigational Site
Miami, Florida, 33185
Pharmacosmos Investigational Site 1
Miami Lakes, Florida, 33014
Pharmacosmos Investigational Site 2
Miami Lakes, Florida, 33014
Pharmacosmos Investigational Site
Miami Lakes, Florida, 33014
Pharmacosmos Investigational Site
Myrtle Beach, South Carolina, 29572
Pharmacosmos Investigational Site 1
Naples, Florida, 34102
Pharmacosmos Investigational Site 2
Naples, Florida, 34102
Pharmacosmos Investigational Site
National City, California, 91950
Pharmacosmos Investigational Site
Neptune City, New Jersey, 07753
Pharmacosmos Investigational Site
New Orleans, Louisiana, 70125
Pharmacosmos Investigational Site
New York, New York, 10016
Pharmacosmos Investigational Site
Norman, Oklahoma, 73069
Pharmacosmos Investigational Site 1
Northridge, California, 91324
Pharmacosmos Investigational Site 2
Northridge, California, 91324
Pharmacosmos Investigational Site
Oceanside, California, 92056
Pharmacosmos Investigational Site
Ogden, Utah, 84405
Pharmacosmos Investigational Site
Omaha, Nebraska, 68134
Pharmacosmos Investigational Site
Owensboro, Kentucky, 42303
Pharmacosmos Investigational Site
Palmetto Bay, Florida, 33157
Pharmacosmos Investigational Site
Palos Heights, Illinois, 60463
Pharmacosmos Investigational Site
Phoenix, Arizona, 85018
Pharmacosmos Investigational Site
Plainsboro, New Jersey, 08536
Pharmacosmos Investigational Site
Plainville, Connecticut, 06062
Pharmacosmos Investigational Site
Plantation, Florida, 33324
Pharmacosmos Investigational Site
Quartz Hill, California, 93536
Pharmacosmos Investigational Site
Rialto, California, 92377
Pharmacosmos Investigational Site
Riverside, California, 92501
Pharmacosmos Investigational Site
Saginaw, Michigan, 48604
Pharmacosmos Investigational Site
San Antonio, Texas, 78215
Pharmacosmos Investigational Site
San Antonio, Texas, 78217
Pharmacosmos Investigational Site
San Diego, California, 92103
Pharmacosmos Investigational Site
San Diego, California, 92117
Pharmacosmos Investigational Site
San Marcos, California, 92078
Pharmacosmos Investigational Site
Shreveport, Louisiana, 71103
Pharmacosmos Investigational Site
Tacoma, Washington, 98405
Pharmacosmos Investigational Site
Terre Haute, Indiana, 47802
Pharmacosmos Investigational Site
Towson, Maryland, 21204
Pharmacosmos Investigational Site
Troy, Michigan, 48085
Pharmacosmos Investigational Site
Tulsa, Oklahoma, 74136
Pharmacosmos Investigational Site
West Palm Beach, Florida, 33409
Pharmacosmos Investigational Site
Whittier, California, 90603
Pharmacosmos Investigational Site
Wichita, Kansas, 67214
Pharmacosmos Investigational Site
Wilmington, North Carolina, 28401
Pharmacosmos Investigational Site
Wilmington, North Carolina, 28403

Other trials in United States

About this study

Official title: A Phase III, Randomised, Open-label, Comparative Safety and Efficacy Trial of Intravenous Iron Isomaltoside/Ferric Derisomaltose (Monofer®/Monoferric®) and Iron Sucrose in Subjects With Iron Deficiency Anemia (FERWON-IDA)

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

Read the detailed description

IDA is highly prevalent condition in subjects with cancer and gastrointestinal diseases such as inflammatory bowel diseases, menstruating or pregnant women, and subjects who have undergone bariatric procedure or surgery. IDA can have a substantial medical and quality of life (QoL) burden. Treatment of subjects diagnosed with IDA includes controlling the bleeding and replenishing lost iron.

This study was designed to evaluate the safety and efficacy of iron isomaltoside/ferric derisomaltose compared with iron sucrose in subjects diagnosed with IDA. In a subfraction of 35 subjects treated with iron isomaltoside/ferric derisomaltose, ECG and iron will be frequently measured.

The study subjects received either a single intravenous (IV) dose of iron isomaltoside/ferric derisomaltose (1000 mg at baseline) or iron sucrose (200 mg IV injections at baseline 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). The study subjects were monitored for up to 8 weeks from baseline.

Conditions: Iron Deficiency Anaemia, Iron Deficiency Anemia
Being tested: Iron isomaltoside/ferric derisomaltose, Iron sucrose
Keywords: Iron Deficiency Anaemia, Iron Deficiency Anemia, IDA, Intravenous iron replacement therapy, Iron isomaltoside, Ferric derisomaltose, Monofer, Monoferric, Monover, Monofar, Monoferro
Medical subject headings: Anemia, Iron-Deficiency

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Iron isomaltoside/ferric derisomaltoseDrug
Also called Monofer®, Monoferric®, Monover®, Monofar®, Monoferro®
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.
Iron sucroseDrug
Also called Venofer®
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.

Study groups in NCT02940886
Study group	Role	What they receive
Iron isomaltoside/ferric derisomaltose	Experimental	Administered IV Receives: Drug: Iron isomaltoside/ferric derisomaltose
Iron sucrose	Active comparator	Administered IV Receives: Drug: Iron sucrose

What is being measured

The primary outcome is the main question the study is designed to answer.

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.
Measured: 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.
Measured: Baseline to week 8

Secondary outcomes (18)

Composite Cardiovascular Adverse Events (AEs)
Safety
Results show the composite cardiovascular adverse events (AEs), that started on or after the first dose of randomised treatment (i.e. treatment emergent) up to week 8.
The reported potential cardiovascular AEs were adjudicated in a blinded fashion by an independent Clinical Endpoint Adjudication Committee (CEAC).
The potential cardiovascular AEs included the following:
- Death due to any cause
- Non-fatal myocardial infarction
- Non-fatal stroke
- Unstable angina requiring hospitalisation
- Congestive heart failure requiring hospitalisation or medical intervention
- Arrhythmias
- Hypertension
- Hypotension
Results show only those participants that had adjudicated and confirmed treatment-emergent composite cardiovascular AEs.
Measured: Baseline, week 1, 2, and 8
Time to First Composite Cardiovascular Safety AE
Safety
Time to first composite cardiovascular AE was defined as the actual time in days from first dose of treatment until the date of the composite cardiovascular AE. For subjects not reporting a composite cardiovascular AE, the time was censored at the date of the last attended visit. Only the adjudicated and confirmed composite cardiovascular safety AEs, as judged by the CEAC, were considered for this endpoint.
Time to first composite cardiovascular AE was defined as the actual time in days from first dose of treatment until the date of the composite cardiovascular AE. For subjects not reporting a composite cardiovascular AE, the time was censored at the date of the last attended visit.
Measured: Baseline, week 1, 2, 4, and 8
S-phosphate <2 mg/dL at Any Time From Baseline to Week 1, 2, 4, and 8
Safety
Results show the number of subjects who had s-phosphate <2 mg/dL at any time from baseline to week 1, 2, 4, or 8.
Measured: Baseline, week 1, 2, 4, and 8
Hb Concentration Increase of ≥2 g/dL From Baseline to Week 1, 2, 4, and 8
Efficacy
Results show responders to the treatment. A subject was considered a Hb responder to a certain week if an increase in Hb of at least 2 g/dL from baseline to the week in question was observed (week 1, 2, 4, and 8).
Measured: Baseline, week 1, 2, 4, and 8
Time to Change in Hb Concentration ≥2 g/dL
Efficacy
Time to change in Hb concentration ≥2 g/dL. Subjects who achieved Hb concentration increase of ≥2 g/dL (from baseline to week 1, 2, 4, or 8).
For responders, time to Hb response was defined as the scheduled time from baseline until the visit where the first Hb response was measured.
Measured: Baseline, week 1, 2, 4, and 8
Hb Concentration of >12 g/dL at Any Time From Week 1 to Week 8
Efficacy
Hb concentration of >12 g/dL at any time from week 1 to week 8.
Results show the number of participants who achieved Hb concentration of >12 g/dL at any time from week 1 to week 8.
Measured: Week 1 to week 8
Hb Concentration Increase of ≥2 g/dL at Any Time From Week 1 to Week 8
Efficacy
Results show the number of participants who achieved Hb concentration increase of ≥2 g/dL at any time from week 1 to week 8.
Measured: Week 1 to week 8
S-Ferritin Concentration of ≥100 ng/mL and Transferrin Saturation (TSAT) of 20-50% at Any Time From Week 1 to Week 8
Efficacy
Proportion of subjects reaching the composite endpoint of s-ferritin concentration ≥100 ng/mL and TSAT of 20-50% at any time from week 1 to 8.
Measured: Week 1 to week 8
Change in Hb Concentration From Baseline to Week 1, 2, and 4
Efficacy
Change in Hb concentration from baseline to week 1, 2, and 4.
Measured: Baseline, week 1, 2, and 4
Change in S-ferritin Concentration From Baseline to Weeks 1, 2, 4, and 8
Efficacy
Change in s-ferritin concentration from baseline to weeks 1, 2, 4, and 8.
Measured: Baseline, week 1, 2, 4, and 8
Change in Transferrin Saturation (TSAT) From Baseline to Week 1, 2, 4, and 8
Efficacy
Changes in transferrin saturation (TSAT) from baseline to week 1, 2, 4, and 8.
TSAT is the value of serum iron divided by the total iron-binding capacity and the unit is %, which referrers to % of iron-binding sites of transferrin being occupied by iron.
Measured: Baseline, week 1, 2, 4, and 8
Change in Concentrations of Serum Iron (S-iron) From Baseline to Week 1, 2, 4, and 8
Efficacy
Changes in the concentrations of serum iron (s-iron) from baseline to week 1, 2, 4, and 8.
Measured: Baseline, week 1, 2, 4, and 8
Change in Fatigue Symptoms From Baseline to Week 1, 2, and 8
Efficacy
Change in fatigue symptoms from baseline to week 1, 2, and 8 was measured by the Functional Assessment of Chronic Illness Therapy (FACIT) Fatigue Scale.
The Functional Assessment of Chronic Illness Therapy (FACIT) Fatigue Scale consisted of 13 items ranging from 0 (not at all) to 4 (very much), except items #7 and #8 which are reversed scored. The total score range is 0-52.
A score of less than 30 indicated severe fatigue, and the higher the score, the better outcome/quality of life (QoL). If more than 50% of the items for a subject at a given visit were missing, the total score was not calculated.
Total score was calculated as shown below:
Total score= Sum of individual scores x 13 / Number of items answered
Measured: Baseline, week 1, 2, and 8
Intervals in Screening for Diabetic Retinopathy (ISDR) Questionnaire, Cost of Public Transport/Taxi And Parking
Pharmacoeconomics
The Intervals in Screening for Diabetic Retinopathy (ISDR) questionnaire at the baseline visit assessed the resources used by subjects to receive treatment. Resources used on other trial activities were not included. ISDR responses were summarised using descriptive statistics.
The data for this endpoint show the responses at baseline for both treatment groups.
The frequency of drug administration between the 2 treatment groups is different, however, (i.e. up to a factor 5 in the iron sucrose treatment group).
Measured: Baseline
Intervals in Screening for Diabetic Retinopathy (ISDR) Questionnaire, Return Journey by Car
Pharmacoeconomics
The Intervals in Screening for Diabetic Retinopathy (ISDR) questionnaire at the baseline visit assessed the resources used by subjects to receive treatment. Resources used on other trial activities were not included. ISDR responses were summarised using descriptive statistics.
The data for this endpoint show the responses at baseline for both treatment groups.
The frequency of drug administration between the 2 treatment groups is different, however, (i.e. up to a factor 5 in the iron sucrose treatment group).
Measured: Baseline
Intervals in Screening for Diabetic Retinopathy (ISDR) Questionnaire, Time Spent on Visit/Helping on Visit
Pharmacoeconomics
The Intervals in Screening for Diabetic Retinopathy (ISDR) questionnaire at the baseline visit assessed the resources used by subjects to receive treatment. Resources used on other trial activities were not included. ISDR responses were summarised using descriptive statistics.
The data for this endpoint show the responses at baseline for both treatment groups.
The frequency of drug administration between the 2 treatment groups is different, however, (i.e. up to a factor 5 in the iron sucrose treatment group).
Measured: Baseline
Intervals in Screening for Diabetic Retinopathy (ISDR) Questionnaire, Participants/Others Who Took Time Off Work to Attend Visits
Pharmacoeconomics
The Intervals in Screening for Diabetic Retinopathy (ISDR) questionnaire at the baseline visit assessed the resources used by subjects to receive treatment. Resources used on other trial activities were not included. ISDR responses were summarised using descriptive statistics.
The data for this endpoint show the responses at baseline for both treatment groups.
The frequency of drug administration between the 2 treatment groups is different, however, (i.e. up to a factor 5 in the iron sucrose treatment group).
Measured: Baseline
Health Care Resource Use Questionnaire
Pharmacoeconomics
Resources used by the health care staff (per administration), measured by the health care resource use questionnaire. The questionnaire assessed the time used by the health care staff during administration of the investigational product and the administration time (including the observational time). The health care participants included in the evaluation were: investigator, pharmacist, physician, study coordinator, study nurse.
The data for this endpoint show the responses at baseline for both treatment groups.
The frequency of drug administration between the treatment groups is different (i.e. up to a factor 5 more frequent in the iron sucrose treatment group).
Measured: Baseline

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

8 Nov 201628 Mar 2018

First posted21 Oct 2016 (estimated)
Study start8 Nov 2016
Primary completion28 Mar 2018
Study completion28 Mar 2018

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (2)Papers the sponsor has linked to this study.
Other trials for Iron Deficiency AnaemiaStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 3
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Enrolment: 1,512 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02940886
Sponsor's protocol ID: P-Monofer-IDA-03
Status last verified: Jan 2020
First submitted: 27 Sep 2016
Last updated: 6 Oct 2020
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes
Individual data sharing: No

Publications

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.
PubMed 31243803
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

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Heart Failure With Reduced Ejection Fraction, Iron Deficiency
RecruitingPhase 4
The Effects of Ferric Derisomaltose in Patients With Acute Heart Failure and Iron Deficiency on Exercise Capacity and Quality of Life
Heart Failure With Preserved Ejection Fraction, Iron Deficiencies
Recruiting
The Effects of Iron Treatment on Vaccine Immunogenicity in Kenyan Infants With Iron Deficiency
Iron Deficiencies
RecruitingPhase 4
The Effects of Low-Dose Versus High-Dose Intravenous IRON Therapy With Ferric DerisomaltOSE in Patients With Chronic Heart Failure and Iron Deficiency
Heart Failure, Iron Deficiency
Enrolling by invitationObservational study
Long-term Impacts of Psychosocial Stimulation and Iron Supplementation
Iron Deficiency Anemia, Parenting Intervention

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Study at a glance

From the registry record, last updated by the sponsor on 6 Oct 2020. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Phase III, Randomised, Open-label, Comparative Safety and Efficacy Trial of Intravenous Iron Isomaltoside/Ferric Derisomaltose (Monofer®/Monoferric®) and Iron Sucrose in Subjects With Iron Deficiency Anemia (FERWON-IDA)
ClinicalTrials.gov ID: NCT02940886
Acronym / sponsor ID: P-Monofer-IDA-03
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
Phase: Phase 3
Study type: Interventional
Recruitment status: Completed
Enrolment: 1,512 participants (actual)
Lead sponsor: Pharmacosmos A/SIndustry (pharma, biotech, devices)
Study start: 8 Nov 2016 (actual)
Primary completion: 28 Mar 2018 (actual)
Study completion: 28 Mar 2018 (actual)
First posted: 21 Oct 2016 (estimated)
Results: Posted 10 Mar 2020

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

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

Detailed description

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 2

Arm	Type	Receives
Iron isomaltoside/ferric derisomaltose	Experimental	Drug: Iron isomaltoside/ferric derisomaltoseAdministered IV
Iron sucrose	Active comparator	Drug: Iron sucroseAdministered IV

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (7 listed)

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 %

Key exclusion criteria (10 listed)

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

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Iron isomaltoside/ferric derisomaltoseAlso: Monofer®, Monoferric®, Monover®, Monofar®, Monoferro®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.	Drug	Iron isomaltoside/ferric derisomaltose
Iron sucroseAlso: Venofer®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.	Drug	Iron sucrose

Primary outcome

Change in Hemoglobin (Hb) From Baseline to Week 8
Time frame: 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.
Incidence of Protocol-defined Serious or Severe Hypersensitivity Reactions
Time frame: Baseline to week 8
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.

18 secondary outcomes

Composite Cardiovascular Adverse Events (AEs)
Time frame: Baseline, week 1, 2, and 8
Time to First Composite Cardiovascular Safety AE
Time frame: Baseline, week 1, 2, 4, and 8
S-phosphate <2 mg/dL at Any Time From Baseline to Week 1, 2, 4, and 8
Time frame: Baseline, week 1, 2, 4, and 8
Hb Concentration Increase of ≥2 g/dL From Baseline to Week 1, 2, 4, and 8
Time frame: Baseline, week 1, 2, 4, and 8
Time to Change in Hb Concentration ≥2 g/dL
Time frame: Baseline, week 1, 2, 4, and 8
Hb Concentration of >12 g/dL at Any Time From Week 1 to Week 8
Time frame: Week 1 to week 8
Hb Concentration Increase of ≥2 g/dL at Any Time From Week 1 to Week 8
Time frame: Week 1 to week 8
S-Ferritin Concentration of ≥100 ng/mL and Transferrin Saturation (TSAT) of 20-50% at Any Time From Week 1 to Week 8
Time frame: Week 1 to week 8
Change in Hb Concentration From Baseline to Week 1, 2, and 4
Time frame: Baseline, week 1, 2, and 4
Change in S-ferritin Concentration From Baseline to Weeks 1, 2, 4, and 8
Time frame: Baseline, week 1, 2, 4, and 8
Change in Transferrin Saturation (TSAT) From Baseline to Week 1, 2, 4, and 8
Time frame: Baseline, week 1, 2, 4, and 8
Change in Concentrations of Serum Iron (S-iron) From Baseline to Week 1, 2, 4, and 8
Time frame: Baseline, week 1, 2, 4, and 8
Change in Fatigue Symptoms From Baseline to Week 1, 2, and 8
Time frame: Baseline, week 1, 2, and 8
Intervals in Screening for Diabetic Retinopathy (ISDR) Questionnaire, Cost of Public Transport/Taxi And Parking
Time frame: Baseline
Intervals in Screening for Diabetic Retinopathy (ISDR) Questionnaire, Return Journey by Car
Time frame: Baseline
Intervals in Screening for Diabetic Retinopathy (ISDR) Questionnaire, Time Spent on Visit/Helping on Visit
Time frame: Baseline
Intervals in Screening for Diabetic Retinopathy (ISDR) Questionnaire, Participants/Others Who Took Time Off Work to Attend Visits
Time frame: Baseline
Health Care Resource Use Questionnaire
Time frame: Baseline

Results and safety

Results posted to the registry on 10 Mar 2020, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Iron Isomaltoside/Ferric Derisomaltose	1,009	907
Iron Sucrose	503	449

Primary outcome: Change in Hemoglobin (Hb) From Baseline to Week 8

Time frame: Baseline to week 8. Least squares mean (95% Confidence Interval). Unit: g/dL

Measure	Iron Isomaltoside/Ferric Derisomaltose n = 1009	Iron Sucrose n = 503
Value	2.49 (2.41 to 2.56)	2.49 (2.38 to 2.59)

Iron Isomaltoside/Ferric Derisomaltose vs Iron Sucrose: Mean Difference (Final Values): 0.00 (95% CI -0.13 to 0.13)

Population analysed: Intention to treat (ITT). All randomised subjects.

Primary outcome: Incidence of Protocol-defined Serious or Severe Hypersensitivity Reactions

Time frame: Baseline to week 8. Count of participants. Unit: Participants

Measure	Iron Isomaltoside/Ferric Derisomaltose n = 989	Iron Sucrose n = 494
Value	3	2

Iron Isomaltoside/Ferric Derisomaltose: 95% two-sided CI (iron isomaltoside): 0.3 (95% CI 0.06 to 0.88)
Iron Isomaltoside/Ferric Derisomaltose vs Iron Sucrose: Risk Difference (RD): -0.10 (95% CI -0.91 to 0.71)
Iron Isomaltoside/Ferric Derisomaltose vs Iron Sucrose: Risk Difference (RD): 0.10 (95% CI -0.57 to 0.48)

Population analysed: Safety analysis set. All randomised subjects who received at least one dose of the investigational product.

18 secondary outcomes are reported in the full results.

Adverse events

Time frame: From the time a subjects had signed the informed consent form (CRF) and until they had completed the study, all adverse events (AEs) or serious adverse events (SAEs) were reported in the CRF. The actual study duration was 8 weeks (or shorted if the trial was discontinued). Overall, eligible subjects participated in the trial for approximately 10-15 weeks (including a 14-day screening period and if necessary a run-in period).. Other adverse events reported at 3% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Iron Isomaltoside/Ferric Derisomaltose	21 of 989 (2.1%)	31 of 989 (3.1%)	1 of 989
Iron Sucrose	13 of 494 (2.6%)	16 of 494 (3.2%)	0 of 494

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 6 Oct 2020.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Results publication: PubMed 31243803Auerbach 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.
Results publicationAuerbach 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
Individual participant dataSharing planned: No

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Pharmacosmos A/S Clinical and Non-clinical Research study director

Pharmacosmos A/S

114 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 7 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 6 Oct 2020. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 114 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 10 Mar 2020). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change in Hemoglobin (Hb) From Baseline to Week 8 (time frame: Baseline to week 8). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02940886, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Oct 2020.