Incidence of Hypophosphatemia After Treatment With Iron Isomaltoside/Ferric Derisomaltose or Ferric Carboxymaltose in Subjects With Iron Deficiency Anaemia
NCT ID: NCT03237065
Last Updated: 2020-02-25
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
122 participants
INTERVENTIONAL
2017-10-30
2018-05-29
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.
Incidence of Hypophosphatemia After Treatment With Iron Isomaltoside/Ferric Derisomaltose vs Ferric Carboxymaltose in Subjects With Iron Deficiency Anaemia
NCT03238911
Intravenous Iron Isomaltoside Versus Oral Iron Supplementation for Treatment of Iron Deficiency in Pregnancy.
NCT03188445
Multi-center Trial of Ferric Derisomaltose in Children 0 to <18 Years of Age With Iron Deficiency Anemia
NCT05179226
A Study Comparing the Iron Substitution With the Medicinal Products Ferinject or Monofer
NCT02905539
Efficacy and Safety of Intravenous Ferric Carboxymaltose (FCM) in Patients With Iron Deficiency Anemia (IDA)
NCT00982007
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
The subjects received either a single intravenous (IV) dose of iron isomaltoside/ferric derisomaltose (1000 mg at baseline) or two IV doses of ferric carboxymaltose (one dose 750 mg at baseline and a second dose 750 mg on day 7; cumulative dose: 1500 mg). The study subjects were monitored for up to 35 days from baseline.
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.
RANDOMIZED
PARALLEL
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 a single IV infusion of 1000 mg (10 mL containing 1000 mg iron isomaltoside/ferric derisomaltose diluted in 100 mL 0.9 % sodium chloride), given over approximately 20 minutes (50 mg iron/min) at baseline (cumulative dose: 1000 mg).
Ferric carboxymaltose
Administered IV
Ferric carboxymaltose
Ferric carboxymaltose (Injectafer®; 50 mg/mL) was the comparator in this trial. The dose of ferric carboxymaltose for the individual subject was 750 mg, infused over at least 15 minutes at baseline and on day 7 (cumulative dose: 1500 mg).
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 a single IV infusion of 1000 mg (10 mL containing 1000 mg iron isomaltoside/ferric derisomaltose diluted in 100 mL 0.9 % sodium chloride), given over approximately 20 minutes (50 mg iron/min) at baseline (cumulative dose: 1000 mg).
Ferric carboxymaltose
Ferric carboxymaltose (Injectafer®; 50 mg/mL) was the comparator in this trial. The dose of ferric carboxymaltose for the individual subject was 750 mg, infused over at least 15 minutes at baseline and on day 7 (cumulative dose: 1500 mg).
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
* Haemoglobin (Hb) ≤ 11 g/dL
* Body weight \> 50 kg
* Serum ferritin (S-ferritin) \< 100 ng/mL
* Estimated Glomerular Filtration Rate (eGFR) ≥ 65 mL/min/1.73 m2
* Serum phosphate (S-phosphate) \> 2.5 mg/dL
* Intolerance or unresponsiveness to oral iron
* Willingness to participate and signing the Informed Consent Form (ICF)
Exclusion Criteria
* Anaemia predominantly caused by factors other than IDA
* Hemochromatosis or other iron storage disorders
* Previous serious hypersensitivity reactions to any IV iron compounds
* Treatment with IV iron within the last 30 days prior to screening
* Treatment with erythropoietin or erythropoietin-stimulation agents
* Red blood cell transfusion, radiotherapy, and/or chemotherapy
* Received an investigational drug within the last 30 days prior to screening
* Planned surgical procedure within the trial period
* Hepatic enzymes \> 3 times upper limit of normal
* Surgery under anaesthetic within the last 30 days prior to screening
* Any non-viral infection within the last 30 days prior to screening
* Alcohol or drug abuse within the past 6 months
* Vitamin D deficiency
* Untreated hyperparathyroidism
* Kidney transplantation
* Active malignant disease, disease-free for less than 5 years
* History of a psychological illness or seizures
* Pregnant or nursing women.
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
Muscle Shoals, Alabama, United States
Pharmacosmos Investigational Site
Doral, 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
Orlando, Florida, United States
Pharmacosmos Investigational Site
Idaho Falls, Idaho, United States
Pharmacosmos Investigational Site
Oak Brook, Illinois, United States
Pharmacosmos investigational Site
Flint, Michigan, United States
Pharmacosmos Investigational Site
St Louis, Missouri, United States
Pharmacosmos Investigational Site
Las Vegas, Nevada, United States
Pharmacosmos Investigational Site
Albuquerque, New Mexico, United States
Pharmacosmos Investigational Site
Morehead City, North Carolina, United States
Pharmacosmos Investigational Site
Raleigh, North Carolina, United States
Pharmacosmos Investigational Site
Winston-Salem, North Carolina, United States
Countries
Review the countries where the study has at least one active or historical site.
References
Explore related publications, articles, or registry entries linked to this study.
Wolf M, Rubin J, Achebe M, Econs M, Peacock M, Imel E, Thomsen L, Carpenter T, Weber T, Zoller H. Effects of iron isomaltoside versus ferric carboxymaltose on hormonal control of phosphate homeostasis: The PHOSPHARE-IDA04/05 randomized controlled trials. Journal of the Endocrine Society, Volume 3, Issue Supplement_1, April-May 2019, OR13-3, https://doi.org/10.1210/js.2019-OR13-3
Wolf M, Rubin J, Achebe M, Econs MJ, Peacock M, Imel EA, Thomsen LL, Carpenter TO, Weber T, Brandenburg V, Zoller H. Effects of Iron Isomaltoside vs Ferric Carboxymaltose on Hypophosphatemia in Iron-Deficiency Anemia: Two Randomized Clinical Trials. JAMA. 2020 Feb 4;323(5):432-443. doi: 10.1001/jama.2019.22450.
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-05
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.