The purpose of this study is to determine to what extend a treatment with the iron compounds
Iron Isomaltoside 1000 or Ferric Carboxymaltose is leading to hypophosphatemia and to study
the potential clinical impact of hypophosphatemia.
Drug: Iron Isomaltoside 1000
Drug: Ferric Carboxymaltose
We will connect you to the doctor responsible for this trial and help you get more information.
Locations near you
Unfortunately, there are no recruiting locations near you. Please check the list with all locations below.
Full eligibility criteria for NCT02905539
Ages eligible for Study
18 Years and older
Genders eligible for Study
Accepts Healthy Volunteers
written informed consent,
gynecological blood losses,
age ≥ 18 years,
iron deficiency anemia,
Hemoglobin < 12,0 g/dl,
Serum-Ferritin ≤ 100 ng/ml or Serum-Ferritin ≤ 300 ng/ml and Transferrin-saturation ≤ 30 %,
Intolerance to or inefficacy of an oral iron supplement
estimated Glomerular Filtration Rate > 15 ml/min/1.73 m²
known hypersensitivity to MonoFer® or FERINJECT®,
severe, known hypersensitivity to other intravenous iron preparations,
Plasma Phosphate < 2.5 mg/dl at screening,
Renal replacement therapy/kidney transplantation,
Active malignant disease, disease-free survival for less than 5 years,
Intravenous iron administration within the last 30 days,
Treatment with erythropoietin or erythropoietin-stimulating agents, transfusion of red blood cells, radiotherapy or chemotherapy within the last 60 days,
Surgery under anesthetic within the last 10 days,
Alanine transaminase (ALT) or aspartate transaminase (AST) > 1.5 fold above levels in healthy individuals,
Acute febrile infections within the last 7 days,
Chronic inflammatory diseases requiring a systemic antiinflammatory treatment,
self-reported severe asthma or eczema,
presence of relative contraindications (any allergy, any immunologic or inflammatory disease, history of atopic allergies), for which a treatment with the medicinal investigational products is not deemed indicated by the investigator,
women of childbearing potential without an effective method of contraception,
Present alcohol or drug dependency,
Patients with a history of a psychological illness or seizures,
Non-compliance or administration of any investigational drug within 30 days preceding the study start.
All locations for NCT02905539
Universitätsklinikum des Saarlandes
Homburg, Saarland, Germany, 66421
View full eligibility
Tris trial is registered with FDA with number: NCT02905539. The sponsor of the trial is Saarland University and it is looking for 60 volunteers for the current phase.
Official trial title: A Randomized, Double-blind Comparative Study Comparing Ferric Carboxymaltose (Ferinject) and Iron Isomaltoside 1000 (Monofer) for Iron Substitution in Iron-deficiency Anemia
1What's a trial
4Get in touch
What's a trial
Not sure you're well informed about clinical trials? Learn more about their benefits, risks and other important details.
Enter your details like condition, age, gender and other preferences and we will show you a list of all relevant clinical trials.
Review the summary of the selected clinical trial and all the locations near you in order to see if it's of interest to you.
Get in touch
You've found an interesting trial? We'll need a bit more information about you so we can connect you to the doctor in charge.
Thank you for applying!
We'll contact you soon with more information.
Consult your doctor?
Some people want to consult their doctor before considering participation in a clinical trial. This is absolutely normal as your doctor should know your medical history and should be able to advise you. If you want you can easily share the information for this trial with your doctor by clicking on the button below.