Clinical trial NCT02940886: Iron Isomaltoside/Ferric Derisomaltose vs Iron Sucrose for the Treatment of Iron Deficiency Anemia (IDA)
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)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
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
Lead sponsor: Pharmacosmos A/S
Sponsor class: INDUSTRY
First posted: 2016-10-21
Enrollment: 1512
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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

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.

Eligibility criteria: Inclusion criteria includes:

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

Exclusion Criteria includes :

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

Primary outcomes:
measure: Change in Hemoglobin (Hb) From Baseline to Week 8
timeFrame: Baseline to week 8
measure: Incidence of Protocol-defined Serious or Severe Hypersensitivity Reactions
timeFrame: Baseline to week 8
Secondary outcomes:
measure: Composite Cardiovascular Adverse Events (AEs)
timeFrame: Baseline, week 1, 2, and 8
measure: Time to First Composite Cardiovascular Safety AE
timeFrame: Baseline, week 1, 2, 4, and 8
measure: S-phosphate <2 mg/dL at Any Time From Baseline to Week 1, 2, 4, and 8
timeFrame: Baseline, week 1, 2, 4, and 8
measure: Hb Concentration Increase of ≥2 g/dL From Baseline to Week 1, 2, 4, and 8
timeFrame: Baseline, week 1, 2, 4, and 8
measure: Time to Change in Hb Concentration ≥2 g/dL
timeFrame: Baseline, week 1, 2, 4, and 8
measure: Hb Concentration of >12 g/dL at Any Time From Week 1 to Week 8
timeFrame: Week 1 to week 8
measure: Hb Concentration Increase of ≥2 g/dL at Any Time From Week 1 to Week 8
timeFrame: Week 1 to week 8
measure: S-Ferritin Concentration of ≥100 ng/mL and Transferrin Saturation (TSAT) of 20-50% at Any Time From Week 1 to Week 8
timeFrame: Week 1 to week 8
measure: Change in Hb Concentration From Baseline to Week 1, 2, and 4
timeFrame: Baseline, week 1, 2, and 4
measure: Change in S-ferritin Concentration From Baseline to Weeks 1, 2, 4, and 8
timeFrame: Baseline, week 1, 2, 4, and 8
measure: Change in Transferrin Saturation (TSAT) From Baseline to Week 1, 2, 4, and 8
timeFrame: Baseline, week 1, 2, 4, and 8
measure: Change in Concentrations of Serum Iron (S-iron) From Baseline to Week 1, 2, 4, and 8
timeFrame: Baseline, week 1, 2, 4, and 8
measure: Change in Fatigue Symptoms From Baseline to Week 1, 2, and 8
timeFrame: Baseline, week 1, 2, and 8
measure: Intervals in Screening for Diabetic Retinopathy (ISDR) Questionnaire, Cost of Public Transport/Taxi And Parking
timeFrame: Baseline
measure: Intervals in Screening for Diabetic Retinopathy (ISDR) Questionnaire, Return Journey by Car
timeFrame: Baseline
measure: Intervals in Screening for Diabetic Retinopathy (ISDR) Questionnaire, Time Spent on Visit/Helping on Visit
timeFrame: Baseline
measure: Intervals in Screening for Diabetic Retinopathy (ISDR) Questionnaire, Participants/Others Who Took Time Off Work to Attend Visits
timeFrame: Baseline
measure: Health Care Resource Use Questionnaire
timeFrame: Baseline
Other outcomes:
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state: Texas
city: McAllen
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state: Texas
city: San Antonio
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state: Texas
city: San Antonio
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state: Texas
city: Ogden
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state: Utah
city: Chesapeake
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state: Virginia
city: Tacoma
country: United States
facility: Pharmacosmos Investigational Site
state: Washington
Study officials:
affiliation: Pharmacosmos A/S
name: Pharmacosmos A/S Clinical and Non-clinical Research
role: STUDY_DIRECTOR
References:
citation: 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.
citation: 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