Polyglucoferron Compared to i.v. Ferric Carboxymaltose and Oral Iron Substitution in Preoperative… (NCT04087993) | Clinical Trial Compass
WithdrawnPhase 3
Polyglucoferron Compared to i.v. Ferric Carboxymaltose and Oral Iron Substitution in Preoperative Treatment of Iron Deficiency Anaemia in Patients
Stopped: difficult recruitment - redesign in discussion
Germany0Started 2020-05-15
Plain-language summary
Patients with IDA and for whom fast replenishment of iron stores is necessary, e.g. if its not appropriated to postpone surgery, will be identified within 28 to 42 days before surgery. Patients will be randomised to receive either Polyglucoferron intravenously (i.v.), Ferric Carboxymaltose i.v. or oral iron substitution with Ferrous sulfate.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Exclusion criteria
. known sensitivity to iron or an ingredient of the investigational products
. History of systemic allergic reactions
. Haemachromatosis, thalassemia or TSAT \>50% as indicator of iron overload
. Acute or chronic intoxication
. Infection (patient on non-prophylactic antibiotics)
. Chronic liver disease and/or screening Alanine Aminotransferase (ALT) or Aspartate Aminotransferase (AST) above three times the upper limit of the normal range
. according to summary of product characteristics (SmPC)
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1This trial was withdrawn before enrolling anyone — does that mean there are safety or feasibility concerns with Polyglucoferron that I should know about before considering it as a treatment option?
2Since this was a Phase 3 trial comparing Polyglucoferron to intravenous ferric carboxymaltose and oral iron, can you explain how those three approaches differ and which one you would currently recommend for my situation given that this study never completed?
3The trial was focused on patients with iron deficiency anemia before surgery — given my own situation, would preoperative iron treatment be relevant for me, and if so, which available treatment has the strongest evidence right now?
4One of the things this trial was measuring was iron showing up in urine, which can signal how the body is processing or losing the iron supplement — is that something worth monitoring in my case, and what does it mean if iron is appearing in urine?
5Because this trial was withdrawn and never produced results, are there other completed studies or standard-of-care guidelines my care team is using to decide between intravenous and oral iron therapy for people in my position?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Normalisation or Increase of hemaglobin(Hb)-level
Timeframe: baseline (BL) to day before surgery (visit 4)