An Extension Trial to Assess the Safety of Re-dosing of Iron Isomaltoside/Ferric Derisomaltose (Monofer®/Monoferric®)
NCT ID: NCT02962648
Last Updated: 2020-03-10
Study Results
Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.
View full resultsBasic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
PHASE3
103 participants
INTERVENTIONAL
2017-01-09
2018-06-12
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Time to Relapse of Iron Deficiency Anemia After Standard Treatment With a New Intravenous Iron (Monofer®)
NCT01900197
A Study of Intravenous Iron Isomaltoside 1000 (Monofer®) Administered by Infusions to Iron-deficient Blood Donors
NCT01895231
A Study Comparing the Iron Substitution With the Medicinal Products Ferinject or Monofer
NCT02905539
A Randomized, Double-blind, Comparative Study of Intravenous Iron Isomaltoside 1000 (Monofer®) Against Placebo
NCT02172001
Incidence of Hypophosphatemia After Treatment With Iron Isomaltoside/Ferric Derisomaltose vs Ferric Carboxymaltose in Subjects With Iron Deficiency Anaemia
NCT03238911
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
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.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Iron isomaltoside/ferric derisomaltose
Administered IV
Iron isomaltoside/ferric derisomaltose
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.
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Iron isomaltoside/ferric derisomaltose
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.
Other Intervention Names
Discover alternative or legacy names that may be used to describe the listed interventions across different sources.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
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
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
18 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Pharmacosmos A/S
INDUSTRY
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Pharmacosmos A/S Clinical and Non-clinical Research
Role: STUDY_DIRECTOR
Pharmacosmos A/S
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Pharmacosmos Investigational Site
Chula Vista, California, United States
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
Pharmacosmos Investigational Site
Miami Lakes, Florida, United States
Pharmacosmos Investigational Site
West Palm Beach, Florida, United States
Pharmacosmos Investigational Site
Baton Rouge, Louisiana, United States
Pharmacosmos Investigational Site
Metairie, Louisiana, United States
Pharmacosmos Investigational Site
New Orleans, Louisiana, United States
Pharmacosmos Investigational Site
Shreveport, Louisiana, United States
Pharmacosmos Investigational Site
Plainsboro, New Jersey, United States
Pharmacosmos Investigational Site
Albuquerque, New Mexico, United States
Pharmacosmos Investigational Site
Chattanooga, Tennessee, United States
Pharmacosmos Investigational Site
Houston, Texas, United States
Pharmacosmos Investigational Site 1
San Antonio, Texas, United States
Pharmacosmos Investigational Site 2
San Antonio, Texas, United States
Countries
Review the countries where the study has at least one active or historical site.
Provided Documents
Download supplemental materials such as informed consent forms, study protocols, or participant manuals.
Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
P-Monofer-IDA/CKD-EXT-01
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.