Iron Deficiency AnemiaPhase 3IDA-IINCT03817957
Postoperative i.v. Iron Substitution in Patients With Diagnosed Iron Deficiency
A Phase 3 study testing Polyglucoferron, Ferric carboxymaltose and Ferrous Sulfate in people with Iron Deficiency Anemia, run by Prof. Dr. Frank Behrens at 1 site in Germany.
Trial summary
Iron deficiency anaemia (IDA) in postoperative patients with confirmed preoperative iron deficiency (ID) in a population with planned major surgery who need fast replenishment of iron as judged by the treating physician will be treated with i.v. iron using Polyglucoferron, Ferric Carboxymaltose or oral iron Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Iron Deficiency Anemia
- What is being tested?
- Polyglucoferron, Ferric carboxymaltose and Ferrous Sulfate
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 187 participants
- Where
- 1 siteGermany
- Study dates
- 18 Sep 2018to 21 Oct 2024
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Males or female; aged ≥ 18 years
- Patients after major surgery (e.g., orthopaedic/trauma, vascular, visceral, cardiac surgery) with risk of Hb reduction and/or blood loss who develop anaemia defined as haemoglobin of <12 g/dL for female and <13 g/dL for men within 12 to 72 h after start of surgery and with confirmation at Baseline
- Confirmed and documented preoperative iron deficiency defined as S-ferritin <100 ng/mL without anaemia (Hb ≥12 g/dL for female and ≥13 g/dL for male) within 28 days before surgery
- need for fast iron replenishment as judged by the treating physician
- Written informed consent; willing/able to comply with the protocol
Who cannot join
- Pregnancy in female patients or breastfeeding women
- Female patients not willing to use a safe method of contraception (PEARL index <1) for the full study period
- Severe physical inability, e.g., American society of anesthesiologists (ASA) physical status IV or V
- Patients receiving blood transfusion 24 week prior surgery
- Non-iron deficiency anaemia, e.g., known Vitamin B12 or folate deficiency, haemoglobinopathy, or unexplained anaemia
- Anticipated medical need for erythropoiesis-stimulating agents during the main study period
Show all 33Show fewer
- Patients with hemodynamic instability due to any ongoing bleeding. Absence of ongoing bleeding will be confirmed determined either by decision of two independent physicians or by removal of drainage, whichever occurs earlier in routine care)
- Patients with any contraindication to the investigational products, e.g.,
- known sensitivity to iron or an ingredient of the investigational products
- Significant 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
- Chronic kidney disease, defined as Glomerular Filtration Rate (GFR) <30 mL/min
- Active uncontrolled immune-mediated diseases such as rheumatoid arthritis or inflammatory bowel disease
- Primary haematologic disease
- Drug or alcohol abuse according to WHO definition
- Potentially unreliable patients, and those judged by the investigator to be unsuitable for the study
- Current or previous participation in another clinical trial during the last 90 days before screening
- according to Summary of product characteristics (SmPC)
- hypersensitivity to any ingredient in the formulation
- concomitant parenteral iron
- haemochromatosis, and other iron overload syndromes
- according to Summary of product characteristics (SmPC)
- hypersensitivity to the active substance, to Ferric Carboxymaltose or any of its excipients
- known serious hypersensitivity to other parenteral iron products
- anaemia not attributed to iron deficiency
- evidence of iron overload or disturbances in the utilisation of iron
- hypersensitivity to any ingredient in the formulation
- known serious hypersensitivity to other parenteral iron products
- anaemia not attributed to iron deficiency
- evidence of iron overload or disturbances in the utilisation of iron
Trial locations and contacts
1 site in 1 country.
Germany1 site
Department of Anaesthesiology, Intensive Care Medicine and Pain Therapy, University Hospital of Goethe-University
Frankfurt, Hessia, 60590
About this study
Official title: Safety and Efficacy of Postoperative i.v. Iron Substitution With Polyglucoferron Compared to Ferric Carboxymaltose and Oral Iron in Patients With Diagnosed Iron Deficiency Who Develop Anaemia Peri- or Postoperatively (IDA II)
Iron deficiency anaemia (IDA) in postoperative patients with confirmed preoperative iron deficiency (ID) in a population with planned major surgery who need fast replenishment of iron as judged by the treating physician will be treated with i.v. iron using Polyglucoferron, Ferric Carboxymaltose or oral iron
Read the detailed description
In this study, patients with confirmed and documented preoperative non-anaemic iron deficiency (diagnosis up to 28 days before surgery in routine pre-surgery monitoring) who develop anaemia within 12 to 72 hours after start of surgery (with additional confirmation at Baseline) and for whom fast replenishment of iron stores is necessary, will be included and substituted within 24h after Screening Visit/V1. Peri- or postoperative anaemia will be assessed as soon as possible but earliest 12 h after surgery. For short term safety analysis iron in urine will be measured in the first urine after the end of i.v. administration in the first 35 patients who are eligible for analysis in each i.v. treatment group. Only those patients are eligible for whom haematuria and/or proteinuria are excluded using dip stick test. The Ferric Carboxymaltose treatment arm will be closed if a sufficient number of patients is included for safety analysis.The study will then be continued for assessment of co-primary efficacy endpoint: The effectiveness of postoperative i.v. iron substitution with Polyglucoferron compared to conventional oral iron substitution with Ferrous sulfate (treatment 28 - 35 days) to normalize Hb-values or to increase Hb-values by at least 1.5 g/dl until visit 4 will be evaluated as well as patient related outcomes, such as the decreased need for allogenic blood transfusions. In addition, the well-being of the patient will be assumed to improve after treatment using the SF36 questionnaire.
- Conditions
- Iron Deficiency Anemia
- Being tested
- Polyglucoferron, Ferric carboxymaltose, Ferrous Sulfate
- Keywords
- post surgery anemia treatment,
- Medical subject headings
- Anemia, Iron-Deficiency
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PolyglucoferronDrug
Also called Feramyl
intravenous administration
Ferric carboxymaltoseDrug
Also called Ferinject
intravenous administration
Ferrous SulfateDrug
Also called Ferro sanol duodenal
oral administration
| Study group | Role | What they receive |
|---|---|---|
| Polyglucoferron | Experimental | once intravenously, dosing according to Hb-levels and body weight, 500 - 2000 mg Receives: Drug: Polyglucoferron |
| Ferric Carboxymaltose | Active comparator | Once intravenously (a second administration is allowed), dosing according to Hb-levels and body weight (500 - 2000 mg, max. single dose of 1000 mg) Receives: Drug: Ferric carboxymaltose |
| Ferrous sulfate | Active comparator | capsules, orally, dosing 50 mg - 200 mg (50 mg: 1 capsule in total, 200 mg: 4 capsules in total, taken as 2 capsules twice daily), duration of treatment 28 days Receives: Drug: Ferrous Sulfate |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of patients who achieve normalized Hb-levels or increased Hb of at least 1.5 g/dl
Proportion of patients in the Polyglucoferron i.v. arm compared to oral iron substitution with Ferrous sulfate at visit 4 compared to Baseline (BL)
Measured: Baseline to approximately 30 days post-baseline (visit 4)
pre post difference of volumen-corrected urine iron levels
Pre-post difference of volume-corrected urine iron levels measured before and in the first urine after the end of i.v. administration, defined as short term safety surrogate marker after administration of the i.v. treatments, compared between Polyglucoferron and Ferric Carboxymaltose (volume corrected iron urine is defined as the ratio between urine iron and urine creatinine).
Measured: urine sampled prior to administration and approximately 1 to 8 hours post-baseline
Secondary outcomes (40)
Proportion of patients with normalization of Hemoglobin (Hb) at visit 4
measurement of normalization of Hb defined in World Health Organization (WHO) classification
Measured: 30 days after baseline (Visit 4)
Level of Hb until visit 4
determination of levels of Hemoglobin (Hb) (comparison to baseline)
Measured: Baseline to 30 days after baseline (visit 4)
Level of Transferrin Saturation (TSAT) until visit 4
determination of levels of Transferrin Saturation (TSAT) (mean values in comparison to baseline)
Measured: Baseline to 30 days after baseline (visit 4)
Level of serum-iron until visit 4
determination of levels of serum-iron (mean values in comparison to baseline)
Measured: Baseline to 30 days after baseline (visit 4)
Level of serum-transferrin until visit 4
determination of levels of serum-transferrin (mean values in comparison to baseline)
Measured: Baseline to 30 days after baseline (visit 4)
Level of serum-ferritin until visit 4
determination of levels of serum-ferritin (mean values in comparison to baseline)
Measured: Baseline to 30 days after baseline (visit 4)
Value of serum-phosphate levels at visit 4 (i.v. groups only)
measurement of serum-phosphate levels (mean values in comparison to baseline)
Measured: baseline and 30 days after baseline (visit 4)
Overall tolerability and number, incidence, seriousness, severity, relationship of Adverse Events (AE) and serious adverse events (SAE) until 30 days after Investigational medicinal product (IMP) administration
determination of number, incidence, seriousness, severity and causality of adverse events and serious adverse events
Measured: baseline to 30 days after last IMP administration
Level of c-reactive protein on each available visit
Documentation of values of C reactive protein (description of changes in values in comparison to baseline)
Measured: baseline to 30 days after baseline (visit 4)
Values of ALT on each available visit
Documentation of values of ALT (description of changes in values in comparison to baseline)
Measured: baseline to 30 days after baseline (visit 4)
Values of AST on each available visit
Documentation of values of AST (description of changes in values in comparison to baseline)
Measured: baseline to 30 days after baseline (visit 4)
Values of gamma-glutamyltransferase on each available visit
Documentation of values of gamma-glutamyltransferase (description of changes in values in comparison to baseline)
Measured: baseline to 30 days after baseline (visit 4)
Values of urea nitrogen on each available visit
Documentation of values of urea nitrogen (description of changes in values in comparison to baseline)
Measured: baseline to 30 days after baseline (visit 4)
Values of serum creatinine on each available visit
Documentation of values of serum creatinine (description of changes in values in comparison to baseline)
Measured: baseline to 30 days after baseline (visit 4)
Values of white blood cells on each available visit
Documentation of values of white blood cells (description of changes in values in comparison to baseline)
Measured: baseline to 30 days after baseline (visit 4)
Values of thrombocytes on each available visit
Documentation of values of thrombocytes (description of changes in values in comparison to baseline)
Measured: baseline to 30 days after baseline (visit 4)
Changes in systolic blood pressure on each available visit
Documentation of vital signs as systolic blood pressure
Measured: baseline to 30 days after baseline (visit 4)
Changes in body temperature on each available visit
Documentation of body temperature
Measured: baseline to 30 days after baseline (visit 4)
Changes in pulse rate on each available visit
Documentation of pulse rate
Measured: baseline to 30 days after baseline (visit 4)
Changes in diastolic blood pressure on each available visit
Documentation of vital signs as diastolic blood pressure
Measured: baseline to 30 days after baseline (visit 4)
Assessment of general conditions on each available visit
Documentation of clinical assessments of general condition will be made by investigator - changes to preceding visits and in comparison to baseline will be documented
Measured: baseline to 30 days after baseline (visit 4)
clinical assessments of Skin on each available visit
Documentation of clinical assessments of Skin will be made by investigator - changes to preceding visits and in comparison to baseline will be documented
Measured: baseline to 30 days after baseline (visit 4)
clinical assessments of eyes on each available visit
Documentation of clinical assessments of eyes will be made by investigator - changes to preceding visits and in comparison to baseline will be documented
Measured: baseline to 30 days after baseline (visit 4)
clinical assessments of ears on each available visit
Documentation of clinical assessments of ears will be made by investigator - changes to preceding visits and in comparison to baseline will be documented
Measured: baseline to 30 days after baseline (visit 4)
clinical assessments of mouth on each available visit
Documentation of clinical assessments of mouth will be made by investigator - changes to preceding visits and in comparison to baseline will be documented
Measured: baseline to 30 days after baseline (visit 4)
clinical assessments of nose on each available visit
Documentation of clinical assessments of nose will be made by investigator - changes to preceding visits and in comparison to baseline will be documented
Measured: baseline to 30 days after baseline (visit 4)
clinical assessments of throat on each available visit
Documentation of clinical assessments of throat will be made by investigator - changes to preceding visits and in comparison to baseline will be documented
Measured: baseline to 30 days after baseline (visit 4)
clinical assessments of cardiovascular system on each available visit
Documentation of clinical assessments of cardiovascular system will be made by investigator - changes to preceding visits and in comparison to baseline will be documented
Measured: baseline to 30 days after baseline (visit 4)
clinical assessments of respiratory system on each available visit
Documentation of clinical assessments of respiratory system,will be made by investigator - changes to preceding visits and in comparison to baseline will be documented
Measured: baseline to 30 days after baseline (visit 4)
clinical assessments of abdomen on each available visit
Documentation of clinical assessments of abdomen will be made by investigator - changes to preceding visits and in comparison to baseline will be documented
Measured: baseline to 30 days after baseline (visit 4)
clinical assessments of gastrointestinal tract on each available visit
Documentation of clinical assessments of gastrointestinal tract will be made by investigator - changes to preceding visits and in comparison to baseline will be documented
Measured: baseline to 30 days after baseline (visit 4)
clinical assessments of kidneys on each available visit
Documentation of clinical assessments of kidneys will be made by investigator - changes to preceding visits and in comparison to baseline will be documented
Measured: baseline to 30 days after baseline (visit 4)
AEs related to injection/ infusion site reactions (i.v. treatment arms only) and hypersensitivity reactions
Documentation of numbers of adverse events related to injection/infusion site reactions (i.v. treatment arms only) and hypersensitivity reactions
Measured: baseline to 30 days after last IMP administration
Number of deaths from any cause until visit 4
documentation of number of deaths
Measured: baseline to 30 days after baseline (visit 4)
Proportion of units of allogenic red blood cell transfusion from BL until visit 4
Documentation of number of units of allogenic red blood cell transfusion
Measured: Baseline to 30 days after baseline (visit 4)
Proportion of patients with need of allogenic red blood cell transfusion from BL until visit 4
Documentation of the use of allogenic red blood cell transfusion
Measured: Baseline to 30 days after baseline (visit 4)
treatment effect on change in Quality of Life (SF36) at visit 4 compared to BL
documentation of quality of life in the Short Form Health Survey (SF36) with 36 items relying upon patient self-reporting. It contains eight sections: vitality, physical functioning, bodily pain, general health perceptions, physical role functioning, emotional role functioning, social role functioning, mental health. The SF-36 consists of eight scaled scores which are the weighted sums of the questions in their section. Each scale is directly transformed into a 0-100 scale on the assumption that each question carries equal weight. The lower the score the more disability. The higher the score the less disability i.e., a score of zero is equivalent to maximum disability and a score of 100 is equivalent to no disability.
Measured: Baseline to 30 days after baseline (visit 4)
Duration of hospital stay (days) until visit 4
documentation of days in hospital
Measured: Baseline to 30 days after baseline (visit 4)
Level ofl iron in plasma after end of iron administration (for the i.v. groups (safety analysis group) only)
measurement of iron level in plasma
Measured: time points directly after administration of intravenous (i.v.) treatment (approximately 15 minutes post-baseline)
Level of iron in plasma after urine sampling (for the i.v. groups (safety analysis group) only)
measurement of iron level in plasma
Measured: time points after urine sampling (approximately 1 to 8 hours post-baseline)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jan 2019
- Study start18 Sep 2018
- Primary completion4 Dec 2023
- Study completion21 Oct 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Iron Deficiency AnemiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 2:2:1 distribution Polyglucoferron, Ferric Carboxymaltose i.v., or oral iron substitution with Ferrous sulfate. After safety assessment of first 35 patients treated with Polyglucoferron or Ferric Carboxymaltose i.v. respectively, Ferric Carboxymaltose arm will be closed. Remaining patients will be distributed in an 2:1 mode to Polyglucoferron or oral iron
- Masking
- None (open label)
- Enrolment
- 187 participants (actual)
Sponsor and investigators
- Lead sponsor
- Prof. Dr. Frank Behrens
- Sponsor type
- University, hospital or other
- Collaborators
- University Hospital Frankfurt, Department of Anaesthesiology, IRON4U, University Hospital Frankfurt Institute for Biostatistics & Mathematical Modelling
- Responsible party
- Sponsor-investigator, Prof. Dr. Frank Behrens, Fraunhofer Institute for Translational Medicine and Pharmacology ITMP
- Investigators
- Patrick Meybohm, MD, Principal investigator, University Hospital of Goethe-University Frankfurt
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03817957
- Sponsor's protocol ID
- TMP0916_03
- Acronym
- IDA-II
- Status last verified
- Jan 2026
- First submitted
- 19 Nov 2018
- Last updated
- 14 Jan 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Safety and Efficacy of Postoperative i.v. Iron Substitution With Polyglucoferron Compared to Ferric Carboxymaltose and Oral Iron in Patients With Diagnosed Iron Deficiency Who Develop Anaemia Peri- or Postoperatively (IDA II)
- ClinicalTrials.gov ID
- NCT03817957
- Acronym / sponsor ID
- IDA-II / TMP0916_03
- Conditions
- Iron Deficiency Anemia
- Keywords
- post surgery anemia treatment,
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 187 participants (actual)
- Lead sponsor
- Prof. Dr. Frank BehrensUniversity, hospital or other
- Collaborators
- University Hospital Frankfurt, Department of Anaesthesiology, IRON4U, University Hospital Frankfurt Institute for Biostatistics & Mathematical Modelling
- Study start
- 18 Sep 2018 (actual)
- Primary completion
- 4 Dec 2023 (actual)
- Study completion
- 21 Oct 2024 (actual)
- First posted
- 28 Jan 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Iron deficiency anaemia (IDA) in postoperative patients with confirmed preoperative iron deficiency (ID) in a population with planned major surgery who need fast replenishment of iron as judged by the treating physician will be treated with i.v. iron using Polyglucoferron, Ferric Carboxymaltose or oral iron
Detailed description
In this study, patients with confirmed and documented preoperative non-anaemic iron deficiency (diagnosis up to 28 days before surgery in routine pre-surgery monitoring) who develop anaemia within 12 to 72 hours after start of surgery (with additional confirmation at Baseline) and for whom fast replenishment of iron stores is necessary, will be included and substituted within 24h after Screening Visit/V1. Peri- or postoperative anaemia will be assessed as soon as possible but earliest 12 h after surgery. For short term safety analysis iron in urine will be measured in the first urine after the end of i.v. administration in the first 35 patients who are eligible for analysis in each i.v. treatment group. Only those patients are eligible for whom haematuria and/or proteinuria are excluded using dip stick test. The Ferric Carboxymaltose treatment arm will be closed if a sufficient number of patients is included for safety analysis.The study will then be continued for assessment of co-primary efficacy endpoint: The effectiveness of postoperative i.v. iron substitution with Polyglucoferron compared to conventional oral iron substitution with Ferrous sulfate (treatment 28 - 35 days) to normalize Hb-values or to increase Hb-values by at least 1.5 g/dl until visit 4 will be evaluated as well as patient related outcomes, such as the decreased need for allogenic blood transfusions. In addition, the well-being of the patient will be assumed to improve after treatment using the SF36 questionnaire.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
- Model description
- 2:2:1 distribution Polyglucoferron, Ferric Carboxymaltose i.v., or oral iron substitution with Ferrous sulfate. After safety assessment of first 35 patients treated with Polyglucoferron or Ferric Carboxymaltose i.v. respectively, Ferric Carboxymaltose arm will be closed. Remaining patients will be distributed in an 2:1 mode to Polyglucoferron or oral iron
| Arm | Type | Receives |
|---|---|---|
| Polyglucoferron | Experimental | Drug: Polyglucoferrononce intravenously, dosing according to Hb-levels and body weight, 500 - 2000 mg |
| Ferric Carboxymaltose | Active comparator | Drug: Ferric carboxymaltoseOnce intravenously (a second administration is allowed), dosing according to Hb-levels and body weight (500 - 2000 mg, max. single dose of 1000 mg) |
| Ferrous sulfate | Active comparator | Drug: Ferrous Sulfatecapsules, orally, dosing 50 mg - 200 mg (50 mg: 1 capsule in total, 200 mg: 4 capsules in total, taken as 2 capsules twice daily), duration of treatment 28 days |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Males or female; aged ≥ 18 years
- Patients after major surgery (e.g., orthopaedic/trauma, vascular, visceral, cardiac surgery) with risk of Hb reduction and/or blood loss who develop anaemia defined as haemoglobin of <12 g/dL for female and <13 g/dL for men within 12 to 72 h after start of surgery and with confirmation at Baseline
- Confirmed and documented preoperative iron deficiency defined as S-ferritin <100 ng/mL without anaemia (Hb ≥12 g/dL for female and ≥13 g/dL for male) within 28 days before surgery
- need for fast iron replenishment as judged by the treating physician
- Written informed consent; willing/able to comply with the protocol
Key exclusion criteria (33 listed)
- Pregnancy in female patients or breastfeeding women
- Female patients not willing to use a safe method of contraception (PEARL index <1) for the full study period
- Severe physical inability, e.g., American society of anesthesiologists (ASA) physical status IV or V
- Patients receiving blood transfusion 24 week prior surgery
- Non-iron deficiency anaemia, e.g., known Vitamin B12 or folate deficiency, haemoglobinopathy, or unexplained anaemia
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PolyglucoferronAlso: Feramylintravenous administration | Drug | Polyglucoferron |
| Ferric carboxymaltoseAlso: Ferinjectintravenous administration | Drug | Ferric Carboxymaltose |
| Ferrous SulfateAlso: Ferro sanol duodenaloral administration | Drug | Ferrous sulfate |
Primary outcome
Proportion of patients who achieve normalized Hb-levels or increased Hb of at least 1.5 g/dl
Time frame: Baseline to approximately 30 days post-baseline (visit 4)
Proportion of patients in the Polyglucoferron i.v. arm compared to oral iron substitution with Ferrous sulfate at visit 4 compared to Baseline (BL)
pre post difference of volumen-corrected urine iron levels
Time frame: urine sampled prior to administration and approximately 1 to 8 hours post-baseline
Pre-post difference of volume-corrected urine iron levels measured before and in the first urine after the end of i.v. administration, defined as short term safety surrogate marker after administration of the i.v. treatments, compared between Polyglucoferron and Ferric Carboxymaltose (volume corrected iron urine is defined as the ratio between urine iron and urine creatinine).
40 secondary outcomes
Proportion of patients with normalization of Hemoglobin (Hb) at visit 4
Time frame: 30 days after baseline (Visit 4)
Level of Hb until visit 4
Time frame: Baseline to 30 days after baseline (visit 4)
Level of Transferrin Saturation (TSAT) until visit 4
Time frame: Baseline to 30 days after baseline (visit 4)
Level of serum-iron until visit 4
Time frame: Baseline to 30 days after baseline (visit 4)
Level of serum-transferrin until visit 4
Time frame: Baseline to 30 days after baseline (visit 4)
Level of serum-ferritin until visit 4
Time frame: Baseline to 30 days after baseline (visit 4)
Value of serum-phosphate levels at visit 4 (i.v. groups only)
Time frame: baseline and 30 days after baseline (visit 4)
Overall tolerability and number, incidence, seriousness, severity, relationship of Adverse Events (AE) and serious adverse events (SAE) until 30 days after Investigational medicinal product (IMP) administration
Time frame: baseline to 30 days after last IMP administration
Level of c-reactive protein on each available visit
Time frame: baseline to 30 days after baseline (visit 4)
Values of ALT on each available visit
Time frame: baseline to 30 days after baseline (visit 4)
Values of AST on each available visit
Time frame: baseline to 30 days after baseline (visit 4)
Values of gamma-glutamyltransferase on each available visit
Time frame: baseline to 30 days after baseline (visit 4)
Values of urea nitrogen on each available visit
Time frame: baseline to 30 days after baseline (visit 4)
Values of serum creatinine on each available visit
Time frame: baseline to 30 days after baseline (visit 4)
Values of white blood cells on each available visit
Time frame: baseline to 30 days after baseline (visit 4)
Values of thrombocytes on each available visit
Time frame: baseline to 30 days after baseline (visit 4)
Changes in systolic blood pressure on each available visit
Time frame: baseline to 30 days after baseline (visit 4)
Changes in body temperature on each available visit
Time frame: baseline to 30 days after baseline (visit 4)
Changes in pulse rate on each available visit
Time frame: baseline to 30 days after baseline (visit 4)
Changes in diastolic blood pressure on each available visit
Time frame: baseline to 30 days after baseline (visit 4)
Assessment of general conditions on each available visit
Time frame: baseline to 30 days after baseline (visit 4)
clinical assessments of Skin on each available visit
Time frame: baseline to 30 days after baseline (visit 4)
clinical assessments of eyes on each available visit
Time frame: baseline to 30 days after baseline (visit 4)
clinical assessments of ears on each available visit
Time frame: baseline to 30 days after baseline (visit 4)
clinical assessments of mouth on each available visit
Time frame: baseline to 30 days after baseline (visit 4)
clinical assessments of nose on each available visit
Time frame: baseline to 30 days after baseline (visit 4)
clinical assessments of throat on each available visit
Time frame: baseline to 30 days after baseline (visit 4)
clinical assessments of cardiovascular system on each available visit
Time frame: baseline to 30 days after baseline (visit 4)
clinical assessments of respiratory system on each available visit
Time frame: baseline to 30 days after baseline (visit 4)
clinical assessments of abdomen on each available visit
Time frame: baseline to 30 days after baseline (visit 4)
clinical assessments of gastrointestinal tract on each available visit
Time frame: baseline to 30 days after baseline (visit 4)
clinical assessments of kidneys on each available visit
Time frame: baseline to 30 days after baseline (visit 4)
AEs related to injection/ infusion site reactions (i.v. treatment arms only) and hypersensitivity reactions
Time frame: baseline to 30 days after last IMP administration
Number of deaths from any cause until visit 4
Time frame: baseline to 30 days after baseline (visit 4)
Proportion of units of allogenic red blood cell transfusion from BL until visit 4
Time frame: Baseline to 30 days after baseline (visit 4)
Proportion of patients with need of allogenic red blood cell transfusion from BL until visit 4
Time frame: Baseline to 30 days after baseline (visit 4)
treatment effect on change in Quality of Life (SF36) at visit 4 compared to BL
Time frame: Baseline to 30 days after baseline (visit 4)
Duration of hospital stay (days) until visit 4
Time frame: Baseline to 30 days after baseline (visit 4)
Level ofl iron in plasma after end of iron administration (for the i.v. groups (safety analysis group) only)
Time frame: time points directly after administration of intravenous (i.v.) treatment (approximately 15 minutes post-baseline)
Level of iron in plasma after urine sampling (for the i.v. groups (safety analysis group) only)
Time frame: time points after urine sampling (approximately 1 to 8 hours post-baseline)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Jan 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Patrick Meybohm, MD principal investigator
University Hospital of Goethe-University Frankfurt
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Polyglucoferron, Ferric carboxymaltose and Ferrous Sulfate in people with Iron Deficiency Anemia, run by Prof. Dr. Frank Behrens at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 33 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 14 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Proportion of patients who achieve normalized Hb-levels or increased Hb of at least 1.5 g/dl (time frame: Baseline to approximately 30 days post-baseline (visit 4)). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Jan 2026.