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

Pharmacosmos

Status and phase: Completed; Phase 3

Conditions: Iron Deficiency Anemia; Iron Deficiency Anaemia

Treatments: Drug: Iron sucrose; Drug: Iron isomaltoside/ferric derisomaltose

Study type: Interventional

Funder types: Industry

Identifiers

NCT02940886

P-Monofer-IDA-03

Details and patient eligibility

About

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

Full 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.

Enrollment: 1,512 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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1,512 participants in 2 patient groups

Iron isomaltoside/ferric derisomaltose

Experimental group

Description:

Administered IV

Treatment:

Drug: Iron isomaltoside/ferric derisomaltose

Iron sucrose

Active Comparator group

Description:

Administered IV

Treatment:

Drug: Iron sucrose