Phase 3 N=1,512 Randomized Treatment

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

Iron Deficiency Anaemia · Iron Deficiency Anemia

Bottom Line

View on ClinicalTrials.gov: NCT02940886 ↗

Enrolled (actual)

1,512

Serious AEs

2.3%

Results posted

Mar 2020

Primary outcome: Primary: Change in Hemoglobin (Hb) From Baseline to Week 8 — 2.49; 2.49 g/dL

Study Design & Population

Study type: Interventional
Phase: Phase 3
Interventions: Iron isomaltoside/ferric derisomaltose (Drug); Iron sucrose (Drug)
Age: Adult, Older Adult · 18+ yrs
Sex: All
Sponsor: Pharmacosmos A/S
Primary completion: Mar 2018

Outcome Measures

Outcome	Result	p-value
PRIMARY Change in Hemoglobin (Hb) From Baseline to Week 8	2.49; 2.49	—
PRIMARY Incidence of Protocol-defined Serious or Severe Hypersensitivity Reactions	3; 2	—
SECONDARY Composite Cardiovascular Adverse Events (AEs)	8; 6	0.5695
SECONDARY Time to First Composite Cardiovascular Safety AE	NA; NA	0.3913
SECONDARY S-phosphate <2 mg/dL at Any Time From Baseline to Week 1, 2, 4, and 8	38; 11	—
SECONDARY Hb Concentration Increase of ≥2 g/dL From Baseline to Week 1, 2, 4, and 8	51; 12; 297; 94; 514; 250	0.0077 sig
SECONDARY Time to Change in Hb Concentration ≥2 g/dL	28; 28	0.0880
SECONDARY Hb Concentration of >12 g/dL at Any Time From Week 1 to Week 8	484; 225	0.2420
SECONDARY Hb Concentration Increase of ≥2 g/dL at Any Time From Week 1 to Week 8	687; 340	0.8746
SECONDARY S-Ferritin Concentration of ≥100 ng/mL and Transferrin Saturation (TSAT) of 20-50% at Any Time From Week 1 to Week 8	680; 164	<0.0001 sig
SECONDARY Change in Hb Concentration From Baseline to Week 1, 2, and 4	0.70; 0.47; 1.49; 1.25; 2.15; 2.13	<0.0001 sig
SECONDARY Change in S-ferritin Concentration From Baseline to Weeks 1, 2, 4, and 8	373.5; 105.7; 211.8; 169.9; 98.0; 109.2	<0.0001 sig
SECONDARY Change in Transferrin Saturation (TSAT) From Baseline to Week 1, 2, 4, and 8	16.68; 5.84; 12.33; 10.58; 11.63; 11.08	<0.0001 sig
SECONDARY Change in Concentrations of Serum Iron (S-iron) From Baseline to Week 1, 2, 4, and 8	63.2; 22.4; 38.8; 37.0; 31.2; 35.1	<0.0001 sig
SECONDARY Change in Fatigue Symptoms From Baseline to Week 1, 2, and 8	7.98; 7.38; 10.74; 11.89; 14.08; 15.36	0.0422 sig
SECONDARY Intervals in Screening for Diabetic Retinopathy (ISDR) Questionnaire, Cost of Public Transport/Taxi And Parking	5.0; 5.0; 0.0; 0.0	—
SECONDARY Intervals in Screening for Diabetic Retinopathy (ISDR) Questionnaire, Return Journey by Car	15.0; 15.0	—
SECONDARY Intervals in Screening for Diabetic Retinopathy (ISDR) Questionnaire, Time Spent on Visit/Helping on Visit	2.0; 2.0; 2.0; 2.0	—
SECONDARY Intervals in Screening for Diabetic Retinopathy (ISDR) Questionnaire, Participants/Others Who Took Time Off Work to Attend Visits	529; 258; 233; 113; 211; 111	—
SECONDARY Health Care Resource Use Questionnaire	1.08; 1.00; 3.38; 3.00	—

Summary

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

Eligibility Criteria

Inclusion criteria includes:

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) 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

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Data sourced from ClinicalTrials.gov (NCT02940886). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.