Evaluate safety and efficacy of intravenous (IV) iron isomaltoside/ferric derisomaltose re-dosing, in subjects who were previously treated with iron isomaltoside/ferric derisomaltose.
Among the various formulations of parenteral iron that are currently available, iron isomaltoside/ferric derisomaltose may allow flexibility in terms of high and rapid dosing. Up to now, most clinical trials with intravenous (IV) iron treatment were of 4-12 weeks in duration; longer trials are warranted to follow-up on long-term safety. The aim of the trial was to evaluate the safety and efficacy of IV iron isomaltoside/ferric derisomaltose re-dosing in subjects who were previously treated with iron isomaltoside/ferric derisomaltose in lead-in trials. This was a 6-months extension trial lasting 26 weeks. Eligible subjects attended 5 visits: screening, baseline (subjects treated with a single IV dose of 1000 mg iron isomaltoside/ferric derisomaltose), and follow-up visits at week 2, 13, and 26 weeks after the IV dose, for safety and efficacy assessments.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
103
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 from the site's supply and administered over approximately 20 minutes using IV infusion.
Pharmacosmos Investigational Site
Chula Vista, California, United States
Number of Subjects With Adverse Drug Reactions (ADR)
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.
Time frame: Baseline to week 26
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 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 Adjudication Committee (CEAC). Results show only those participants that had adjudicated and confirmed serious or severe hypersensitivity reactions.
Time frame: Baseline to week 26
Composite Cardiovascular Adverse Events (AEs)
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 Results show only those participants that had adjudicated and confirmed treatment-emergent composite cardiovascular AEs.
Time frame: Baseline to week 26
Time to First Composite Cardiovascular Safety AE
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Pharmacosmos Investigational Site 1
La Mesa, California, United States
Pharmacosmos Investigational Site 2
La Mesa, California, United States
Pharmacosmos Investigational Site
Northridge, California, United States
Pharmacosmos Investigational Site
Porterville, California, United States
Pharmacosmos Investigational Site
Doral, Florida, United States
Pharmacosmos Investigational Site
Hialeah, Florida, United States
Pharmacosmos Investigational Site
Miami, Florida, United States
Pharmacosmos Investigational Site
Miami, Florida, United States
Pharmacosmos Investigational Site
Miami, Florida, United States
...and 12 more locations
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 composite cardiovascular AE. For subjects not reporting a composite cardiovascular AE, the time was censored at the date of the last attended visit.
Time frame: Baseline, week 2, 13, and 26
S-phosphate <2 mg/dL at Any Time From 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.
Time frame: Baseline to week 26
Change in Hb From Baseline to Week 2, 13, and 26
Efficacy. Change in Hb from baseline to week 2, 13, and 26.
Time frame: Baseline, week 2, 13, and 26
Change in S-ferritin From Baseline to Week 2, 13, and 26
Efficacy. Change in s-ferritin from baseline to week 2, 13, and 26.
Time frame: Baseline, week 2, 13, and 26
Change in Transferrin Saturation (TSAT) From Baseline to 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.
Time frame: Baseline, week 2, 13, and 26
Change in S-iron From Baseline to Week 2, 13, and 26
Efficacy. Change in s-iron from baseline to week 2, 13, and 26.
Time frame: Baseline, week 2, 13, and 26