NCT02962648: FERWON-EXT

An Extension Trial to Assess the Safety of Re-dosing of Iron Isomaltoside/Ferric Derisomaltose (Monofer®/Monoferric®)

Completed Phase 3 Results posted Last updated 10 March 2020

What this trial tests

Phase 3 trial testing Iron isomaltoside/ferric derisomaltose in Iron Deficiency Anemia in 103 participants. Completed in 12 June 2018.

Timeline

9 January 2017

Primary endpoint
12 June 2018

12 June 2018

Quick facts

Lead sponsor	Pharmacosmos A/S
Phase	Phase 3
Status	Completed
Study type	INTERVENTIONAL
Allocation	na
Design	single group
Masking	none
Primary purpose	treatment
Enrollment	103
Start date	9 January 2017
Primary completion	12 June 2018
Estimated completion	12 June 2018
Sites	22 locations across United States

Drugs / interventions tested

• Iron isomaltoside/ferric derisomaltose — full drug profile →

Conditions studied

• Iron Deficiency Anemia — all drugs for Iron Deficiency Anemia →
• Iron Deficiency Anaemia — all drugs for Iron Deficiency Anaemia →

Sponsor

Pharmacosmos A/S — full company profile →

Who can join

18 and older, any sex, with Iron Deficiency Anemia or Iron Deficiency Anaemia. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Number of Subjects With Adverse Drug Reactions (ADR) Primary · Baseline to week 26

Safety Evaluate the number of subjects with adverse drug reactions (ADRs), defined as AEs that were assessed by the investigator as related or possible related to the investigational product.

Group	Value	95% CI
Iron Isomaltoside/Ferric Derisomaltose	5

Incidence of Protocol-defined Serious or Severe Hypersensitivity Reactions Secondary · Baseline to week 26

Safety. For this endpoint, the number of participants with serious or severe hypersensitivity reactions were evaluated. The hypersensitivity terms that were included in the analysis were those that started or after the first dose of 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 Adjudi

Group	Value	95% CI
Iron Isomaltoside/Ferric Derisomaltose	0

Composite Cardiovascular Adverse Events (AEs) Secondary · Baseline to week 26

Safety Results show the composite cardiovascular AEs, that started on or after the first dose of treatment (i.e. treatment emergent) up to month 6. 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 R

Group	Value	95% CI
Iron Isomaltoside/Ferric Derisomaltose	6

Time to First Composite Cardiovascular Safety AE Secondary · Baseline, week 2, 13, and 26

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 Clinical Endpoint Adjudication Committee (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 compo

Group	Value	95% CI
Iron Isomaltoside/Ferric Derisomaltose	NA	NA – NA

S-phosphate <2 mg/dL at Any Time From Baseline to Week 26 Secondary · Baseline to week 26

Safety Results show the number of trial participants and their status of s-phosphate \<2 mg/dL, at any time from baseline to week 26.

Group	Value	95% CI
Iron Isomaltoside/Ferric Derisomaltose	8
Iron Isomaltoside/Ferric Derisomaltose	94

Change in Hb From Baseline to Week 2, 13, and 26 Secondary · Baseline, week 2, 13, and 26

Efficacy. Change in Hb from baseline to week 2, 13, and 26.

Week 2

Group	Value	95% CI
Iron Isomaltoside/Ferric Derisomaltose	1.23	± 1.40

Week 13

Group	Value	95% CI
Iron Isomaltoside/Ferric Derisomaltose	1.73	± 1.83

Week 26

Group	Value	95% CI
Iron Isomaltoside/Ferric Derisomaltose	1.34	± 1.93

Change in S-ferritin From Baseline to Week 2, 13, and 26 Secondary · Baseline, week 2, 13, and 26

Efficacy. Change in s-ferritin from baseline to week 2, 13, and 26.

Week 2

Group	Value	95% CI
Iron Isomaltoside/Ferric Derisomaltose	255.6	± 177.9

Week 13

Group	Value	95% CI
Iron Isomaltoside/Ferric Derisomaltose	87.9	± 123.6

Week 26

Group	Value	95% CI
Iron Isomaltoside/Ferric Derisomaltose	93.9	± 180.4

Change in Transferrin Saturation (TSAT) From Baseline to Week 2, 13, and 26 Secondary · Baseline, week 2, 13, and 26

Efficacy Change in transferrin saturation (TSAT) from baseline to week 2, 13, and 26. 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.

Week 2

Group	Value	95% CI
Iron Isomaltoside/Ferric Derisomaltose	8.16	± 11.87

Week 13

Group	Value	95% CI
Iron Isomaltoside/Ferric Derisomaltose	4.42	± 10.81

Week 26

Group	Value	95% CI
Iron Isomaltoside/Ferric Derisomaltose	1.78	± 10.63

Change in S-iron From Baseline to Week 2, 13, and 26 Secondary · Baseline, week 2, 13, and 26

Efficacy. Change in s-iron from baseline to week 2, 13, and 26.

Week 2

Group	Value	95% CI
Iron Isomaltoside/Ferric Derisomaltose	21.1	± 50.5

Week 13

Group	Value	95% CI
Iron Isomaltoside/Ferric Derisomaltose	10.7	± 45.4

Week 26

Group	Value	95% CI
Iron Isomaltoside/Ferric Derisomaltose	4.0	± 44.1

Adverse events — posted to ClinicalTrials.gov

Time frame: From the time subjects signed the informed consent form (CRF) until they completed the trial, all adverse events (AEs) or serious adverse events (SAEs) were recorded in the CRF. The actual study duration was 6 months (or shorted if the trial was discontinued). Overall, eligible subjects participated in the trial for approximately 6.5 months (including a 14-day screening period).. Reporting threshold: 2%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.

Iron Isomaltoside/Ferric Derisomaltose

Serious: 13/102 (13%)

Deaths: 1/193

Serious adverse events (12 terms)

Reaction	System	Iron Isomaltoside/Ferric D…
Chronic kidney disease	Renal and urinary disorders	—
Appendicitis	Infections and infestations	—
Cellulitis	Infections and infestations	—
Endometritis	Infections and infestations	—
Cardiac failure congestive	Cardiac disorders	—
Chest pain	General disorders	—
Fall	Injury, poisoning and procedural complications	—
Hypocalcaemia	Metabolism and nutrition disorders	—
Neck pain	Musculoskeletal and connective tissue disorders	—
Menorrhagia	Reproductive system and breast disorders	—
Pulmonary embolism	Respiratory, thoracic and mediastinal disorders	—
Hypertensive crisis	Vascular disorders	—

Other adverse events (7 terms — click to expand)

Reaction	System	Iron Isomaltoside/Ferric D…
Fatigue	General disorders	—
Abdominal pain	Gastrointestinal disorders	—
Urinary tract infection	Infections and infestations	—
Dizziness	Nervous system disorders	—
Headache	Nervous system disorders	—
Hypertension	Vascular disorders	—
Anaemia	Blood and lymphatic system disorders	—

Most-reported serious reactions: Chronic kidney disease, Appendicitis, Cellulitis, Endometritis, Cardiac failure congestive, Chest pain, Fall, Hypocalcaemia.

Data from ClinicalTrials.gov NCT02962648 adverse events section.

Sponsor's own description

Evaluate safety and efficacy of intravenous (IV) iron isomaltoside/ferric derisomaltose re-dosing, in subjects who were previously treated with iron isomaltoside/ferric derisomaltose.

Publications & conference data

No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.