Clinical trial NCT02962648: An Extension Trial to Assess the Safety of Re-dosing of Iron Isomaltoside/Ferric Derisomaltose (Monofer®/Monoferric®)
Official title: An Open-label, Multicentre, Extension Trial to Assess the Safety of Re-dosing of Intravenous Iron Isomaltoside/Ferric Derisomaltose (Monofer®/Monoferric®)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Iron Deficiency Anemia
Iron Deficiency Anaemia
Keywords: Iron Deficiency Anemia
Iron Deficiency Anaemia
IDA
Intravenous iron replacement therapy
Chronic Kidney Disease
CKD
Iron isomaltoside
Ferric derisomaltose
Monofer
Monoferric
Monover
Monofar
Monoferro
Lead sponsor: Pharmacosmos A/S
Sponsor class: INDUSTRY
First posted: 2016-11-11
Enrollment: 103
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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

Detailed description: 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.

Eligibility criteria: Inclusion Criteria:

1. Completed one of the lead-in trials
2. Randomised and dosed with iron isomaltoside/ferric derisomaltose in one of the lead-in trials.
3. Haemoglobin (Hb) of ≤ 11 g/dL
4. Screening serum ferritin (s-ferritin) ≤ 100 ng/mL, or ≤ 300 ng/mL if transferrin saturation (TSAT) ≤ 30 %
5. Willingness to participate and signing the informed consent form (ICF)

Exclusion Criteria:

1. Intravenous (IV) iron treatment between the lead-in trial and screening
2. During 30-day period prior to screening or during the trial period; has or will be treated with a red blood cell transfusion, radiotherapy, and/or chemotherapy
3. Received an investigational drug within 30 days of screening
4. Decompensated liver cirrhosis or active hepatitis
5. Pregnant or nursing women.
6. Any other laboratory abnormality, medical condition, or psychiatric disorders which, in the opinion of the Investigator, will put the subject's disease management at risk or may result in the subject being unable to comply with the trial requirements

Primary outcomes:
measure: Number of Subjects With Adverse Drug Reactions (ADR)
timeFrame: Baseline to week 26
Secondary outcomes:
measure: Incidence of Protocol-defined Serious or Severe Hypersensitivity Reactions
timeFrame: Baseline to week 26
measure: Composite Cardiovascular Adverse Events (AEs)
timeFrame: Baseline to week 26
measure: Time to First Composite Cardiovascular Safety AE
timeFrame: Baseline, week 2, 13, and 26
measure: S-phosphate <2 mg/dL at Any Time From Baseline to Week 26
timeFrame: Baseline to week 26
measure: Change in Hb From Baseline to Week 2, 13, and 26
timeFrame: Baseline, week 2, 13, and 26
measure: Change in S-ferritin From Baseline to Week 2, 13, and 26
timeFrame: Baseline, week 2, 13, and 26
measure: Change in Transferrin Saturation (TSAT) From Baseline to Week 2, 13, and 26
timeFrame: Baseline, week 2, 13, and 26
measure: Change in S-iron From Baseline to Week 2, 13, and 26
timeFrame: Baseline, week 2, 13, and 26
Other outcomes:
Locations:
city: Chula Vista
country: United States
facility: Pharmacosmos Investigational Site
state: California
city: La Mesa
country: United States
facility: Pharmacosmos Investigational Site 1
state: California
city: La Mesa
country: United States
facility: Pharmacosmos Investigational Site 2
state: California
city: Northridge
country: United States
facility: Pharmacosmos Investigational Site
state: California
city: Porterville
country: United States
facility: Pharmacosmos Investigational Site
state: California
city: Doral
country: United States
facility: Pharmacosmos Investigational Site
state: Florida
city: Hialeah
country: United States
facility: Pharmacosmos Investigational Site
state: Florida
city: Miami Lakes
country: United States
facility: Pharmacosmos Investigational Site
state: Florida
city: Miami
country: United States
facility: Pharmacosmos Investigational Site
state: Florida
city: Miami
country: United States
facility: Pharmacosmos Investigational Site
state: Florida
city: Miami
country: United States
facility: Pharmacosmos Investigational Site
state: Florida
city: West Palm Beach
country: United States
facility: Pharmacosmos Investigational Site
state: Florida
city: Baton Rouge
country: United States
facility: Pharmacosmos Investigational Site
state: Louisiana
city: Metairie
country: United States
facility: Pharmacosmos Investigational Site
state: Louisiana
city: New Orleans
country: United States
facility: Pharmacosmos Investigational Site
state: Louisiana
city: Shreveport
country: United States
facility: Pharmacosmos Investigational Site
state: Louisiana
city: Plainsboro
country: United States
facility: Pharmacosmos Investigational Site
state: New Jersey
city: Albuquerque
country: United States
facility: Pharmacosmos Investigational Site
state: New Mexico
city: Chattanooga
country: United States
facility: Pharmacosmos Investigational Site
state: Tennessee
city: Houston
country: United States
facility: Pharmacosmos Investigational Site
state: Texas
city: San Antonio
country: United States
facility: Pharmacosmos Investigational Site 1
state: Texas
city: San Antonio
country: United States
facility: Pharmacosmos Investigational Site 2
state: Texas
Study officials:
affiliation: Pharmacosmos A/S
name: Pharmacosmos A/S Clinical and Non-clinical Research
role: STUDY_DIRECTOR
References: