Iron Deficiency AnemiaPhase 3IDA-INCT04087993
Polyglucoferron Compared to i.v. Ferric Carboxymaltose and Oral Iron Substitution in Preoperative Treatment of Iron Deficiency Anaemia in Patients
A Phase 3 study testing Polyglucoferron, Ferric carboxymaltose and Ferrous Sulfate in people with Iron Deficiency Anemia, run by Dr. Frank Behrens at 1 site in Germany.
Trial 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. 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
- 0 participants
- Where
- 1 siteGermany
- Study dates
- 15 May 2020to 31 Dec 2020
- 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
- Male or female; aged ≥ 18 years
- Planned to undergo non-cardiac surgery (e.g., orthopaedic, vascular, visceral surgery) within 28 to 42 days, which requires a fast replenishment of the patients' iron stores (e.g.if it is not appropriate to postpone surgery) as judged by the treating physician
- Iron deficiency defined as s-ferritin <100 ng/mL and s-transferrin saturation <20%
- Relevant anaemia defined as haemoglobin of <12 g/dL for female and <13 g/dL for men
- Written informed consent; willing and 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 anaemia with Hb < 8 g/dL
- Any ingoing bleeding as judged by the treating physician
- Patients receiving blood transfusion 24 weeks prior screening
- Severe physical inability, e.g., American Society of Anesthesiologists (ASA) physical status IV or V
Show all 36Show fewer
- Haematuria and proteinuria of unknown or known origin
- 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 study period
- Patients with any contraindication to the investigational products, e.g.,
- 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
- Chronic kidney disease, defined as Glomerular Filtration Rate (GFR) <30 mL/min
- Serum Creatinine > 150 μmol/L
- 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 SmPC
- hypersensitivity to the active substance, to Ferinject 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
- Exclusion criteria related to Polyglucoferron f) 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: Randomised, Open Lable, Active Controlled Clinical Trial to Demonstrate Safety and Efficacy of an i.v. Administration of Polyglucoferron Compared to i.v. Ferric Carboxymaltose and Oral Iron Substitution in Preoperative Treatment of Iron Deficiency Anaemia in Patients With Elective Non-cardiac Surgery (IDA I)
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.
Read the detailed description
Randomised, active-controlled, open-labelled, parallel group, multicentre study to demonstrate superiority of Polyglucoferron i.v. compared to oral iron substitution for the treatment of iron deficient anaemic patients who need fast replenishment of iron stores as judged by the treating physician, e.g. if it is not appropriate to postpone surgery, before elective non-cardiac surgery and superiority of Polyglucoferron i.v. vs Ferric Carboxymaltose in short term safety monitoring.
- Conditions
- Iron Deficiency Anemia
- Being tested
- Polyglucoferron, Ferric carboxymaltose, Ferrous Sulfate
- Keywords
- pre surgery iron 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.
Normalisation or Increase of hemaglobin(Hb)-level
Proportion of patients achieving normalized Hb-levels (according to World Health Organization (WHO) definition) or an increase of at least 1.5 g/dl Hb at day before surgery (visit 4) compared to baseline (BL) in the Polyglucoferron treatment arm compared to oral iron substitution with Ferrous sulfate
Measured: baseline (BL) to day before surgery (visit 4)
Detection of urine iron
Detection of urine iron 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
Measured: approx. 8 hours
Secondary outcomes (38)
Units of allogenic red blood cell transfusion
Proportion of units of allogenic red blood cell transfusion from BL until visit 5
Measured: baseline to visit 5 approx. 70 day
Hb values
Mean change in Hb at visit 4 compared to BL
Measured: baseline to visit 4 approx. 35 day
Hb values
Mean change in Hb at visit 5 compared to BL
Measured: baseline to visit 5 approx. 70 day
Transferrin Saturation (TSAT) values
Mean change in TSAT at visit 5 compared to BL
Measured: baseline to visit 5 approx. 70 day
Transferrin Saturation (TSAT) values
Mean change in TSAT at visit 4 compared to BL
Measured: baseline to visit 4 approx. 35 day
iron values
Mean change in serum iron at visit 4 compared to BL
Measured: baseline to visit 4 approx. 35 day
iron values
Mean change in serum iron at visit 5 compared to BL
Measured: baseline to visit 5 approx. 70 day
ferritin values
Mean change in serum ferritin at visit 5 compared to BL
Measured: baseline to visit 5 approx. 70 day
ferritin values
Mean change in serum ferritin at visit 4 compared to BL
Measured: baseline to visit 4 approx. 35 day
transferrin values
Mean change in serum ferritin at visit 4 compared to BL
Measured: baseline to visit 4 approx. 35 day
transferrin values
Mean change in serum ferritin at visit 5 compared to BL
Measured: baseline to visit 5 approx. 70 day
number of adverse events (AE)/serious adverse events (SAE)
Tolerability measured by overall number of AEs/SAEs until 28 days after surgery
Measured: baseline to 28 days after surgery, approx. 56 days
incidence of adverse events (AE)/serious adverse events (SAE)
Tolerability by incidence of AEs/SAEs until 28 days after surgery
Measured: baseline to 28 days after surgery, approx. 56 days
Seriousness of adverse events (AE)/serious adverse events (SAE)
Overall tolerability by seriousness of AEs/SAEs until 28 days after surgery
Measured: baseline to 28 days after surgery, approx. 56 days
Relationship of adverse events (AE)/serious adverse events (SAE)
Overall tolerability by relationship of AEs/SAEs until 28 days after surgery
Measured: baseline to 28 days after surgery, approx. 56 days
Severity of adverse events (AE)/serious adverse events (SAE)
Overall tolerability by severity of AEs/SAEs until 28 days after surgery
Measured: baseline to 28 days after surgery, approx. 56 days
Changes in Laboratory parameters
Changes White blood count on each visit
Measured: throughout study conduction, max 77 days
Changes in Laboratory parameters
Changes in thrombocytes on each visit
Measured: throughout study conduction, max 77 days
Changes in Laboratory parameters
Changes in serum creatinine on each visit
Measured: throughout study conduction, max 77 days
Changes in Laboratory parameters
Changes in AST on each visit
Measured: throughout study conduction, max 77 days
Changes in Laboratory parameters
Changes in ALT on each visit
Measured: throughout study conduction, max 77 days
Changes in Laboratory parameters
Changes in gamma GT on each visit
Measured: throughout study conduction, max 77 days
Changes in Laboratory parameters
Changes in phosphate on each visit
Measured: throughout study conduction, max 77 days
Changes in vital signs
Changes in vital signs on each visit
Measured: throughout study conduction, max 77 days
Changes in blood pressure
Changes in blood pressure on each visit
Measured: throughout study conduction, max 77 days
Changes in heart rate
Changes in heart rate on each visit
Measured: throughout study conduction, max 77 days
Changes in physical exam
Changes in physical exam on each visit
Measured: throughout study conduction, max 77 days
adverse events related to administration
AEs related to injection/infusion site reactions (i.v. group only)
Measured: at baseline
adverse events related to administration
AEs related to injection/infusion site reactions (i.v. group only)
Measured: 7 days after baseline, at Visit 3
hypersensitivity reactions
documentation of anaphylatic or anaphylactoid reactions (i.v. group only)
Measured: at baseline
hypersensitivity reactions
documentation of anaphylatic or anaphylactoid reactions (i.v. group only)
Measured: at study visit 3
Mortality
All-cause mortality within 28 days after surgery
Measured: within 28 days after surgery, approx. 56 days
Quality of Life (SF36)
Assessment of Quality of Life by SF36 questionnaire at visits 4 compared to BL
Measured: base line to visit 4 approx 35 days
Quality of Life (SF36)
Assessment of Quality of Life by SF36 questionnaire at visits 5 compared to BL
Measured: baseline to visit 5 approx 70 days
Duration of hospital stay
Duration of hospital stay (days) until 28 days after surgery
Measured: 28 days
Number of patients with normalized Hb-values
Number of patients with normalized Hb-values after iron substitution (n, %) at visits 4 and 5
Measured: baseline to visit 4 approx 35 days
Number of patients with normalized Hb-values
Number of patients with normalized Hb-values after iron substitution (n, %) at and 5
Measured: baseline to visit 5 approx 70 days
Analysis of total iron levels
Analysis of total iron levels in plasma at BL after end of iron administration (for the i.v. groups (safety analysis group) only)
Measured: approx 4 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Sep 2019
- Study start15 May 2020 (estimated)
- Primary completion31 Dec 2020 (estimated)
- Study completion31 Dec 2020 (estimated)
Why it stopped: difficult recruitment - redesign in discussion
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.
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- 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, Dr. Frank Behrens, Fraunhofer Institute for Translational Medicine and Pharmacology ITMP
- Investigators
- Kai Zacharowski, Prof. MD, Principal investigator, University Hospital of Goethe-University Frankfurt
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04087993
- Sponsor's protocol ID
- TMP0916_02
- Acronym
- IDA-I
- Status last verified
- Aug 2024
- First submitted
- 29 Aug 2019
- Last updated
- 28 Aug 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomised, Open Lable, Active Controlled Clinical Trial to Demonstrate Safety and Efficacy of an i.v. Administration of Polyglucoferron Compared to i.v. Ferric Carboxymaltose and Oral Iron Substitution in Preoperative Treatment of Iron Deficiency Anaemia in Patients With Elective Non-cardiac Surgery (IDA I)
- ClinicalTrials.gov ID
- NCT04087993
- Acronym / sponsor ID
- IDA-I / TMP0916_02
- Conditions
- Iron Deficiency Anemia
- Keywords
- pre surgery iron treatment
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: difficult recruitment - redesign in discussion
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Dr. Frank BehrensUniversity, hospital or other
- Collaborators
- University Hospital Frankfurt, Department of Anaesthesiology, IRON4U, University Hospital Frankfurt Institute for Biostatistics & Mathematical Modelling
- Study start
- 15 May 2020 (estimated)
- Primary completion
- 31 Dec 2020 (estimated)
- Study completion
- 31 Dec 2020 (estimated)
- First posted
- 12 Sep 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.
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.
Detailed description
Randomised, active-controlled, open-labelled, parallel group, multicentre study to demonstrate superiority of Polyglucoferron i.v. compared to oral iron substitution for the treatment of iron deficient anaemic patients who need fast replenishment of iron stores as judged by the treating physician, e.g. if it is not appropriate to postpone surgery, before elective non-cardiac surgery and superiority of Polyglucoferron i.v. vs Ferric Carboxymaltose in short term safety monitoring.
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.
| 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)
- Male or female; aged ≥ 18 years
- Planned to undergo non-cardiac surgery (e.g., orthopaedic, vascular, visceral surgery) within 28 to 42 days, which requires a fast replenishment of the patients' iron stores (e.g.if it is not appropriate to postpone surgery) as judged by the treating physician
- Iron deficiency defined as s-ferritin <100 ng/mL and s-transferrin saturation <20%
- Relevant anaemia defined as haemoglobin of <12 g/dL for female and <13 g/dL for men
- Written informed consent; willing and able to comply with the protocol
Key exclusion criteria (36 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 anaemia with Hb < 8 g/dL
- Any ingoing bleeding as judged by the treating physician
- Patients receiving blood transfusion 24 weeks prior screening
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
Normalisation or Increase of hemaglobin(Hb)-level
Time frame: baseline (BL) to day before surgery (visit 4)
Proportion of patients achieving normalized Hb-levels (according to World Health Organization (WHO) definition) or an increase of at least 1.5 g/dl Hb at day before surgery (visit 4) compared to baseline (BL) in the Polyglucoferron treatment arm compared to oral iron substitution with Ferrous sulfate
Detection of urine iron
Time frame: approx. 8 hours
Detection of urine iron 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
38 secondary outcomes
Units of allogenic red blood cell transfusion
Time frame: baseline to visit 5 approx. 70 day
Hb values
Time frame: baseline to visit 4 approx. 35 day
Hb values
Time frame: baseline to visit 5 approx. 70 day
Transferrin Saturation (TSAT) values
Time frame: baseline to visit 5 approx. 70 day
Transferrin Saturation (TSAT) values
Time frame: baseline to visit 4 approx. 35 day
iron values
Time frame: baseline to visit 4 approx. 35 day
iron values
Time frame: baseline to visit 5 approx. 70 day
ferritin values
Time frame: baseline to visit 5 approx. 70 day
ferritin values
Time frame: baseline to visit 4 approx. 35 day
transferrin values
Time frame: baseline to visit 4 approx. 35 day
transferrin values
Time frame: baseline to visit 5 approx. 70 day
number of adverse events (AE)/serious adverse events (SAE)
Time frame: baseline to 28 days after surgery, approx. 56 days
incidence of adverse events (AE)/serious adverse events (SAE)
Time frame: baseline to 28 days after surgery, approx. 56 days
Seriousness of adverse events (AE)/serious adverse events (SAE)
Time frame: baseline to 28 days after surgery, approx. 56 days
Relationship of adverse events (AE)/serious adverse events (SAE)
Time frame: baseline to 28 days after surgery, approx. 56 days
Severity of adverse events (AE)/serious adverse events (SAE)
Time frame: baseline to 28 days after surgery, approx. 56 days
Changes in Laboratory parameters
Time frame: throughout study conduction, max 77 days
Changes in Laboratory parameters
Time frame: throughout study conduction, max 77 days
Changes in Laboratory parameters
Time frame: throughout study conduction, max 77 days
Changes in Laboratory parameters
Time frame: throughout study conduction, max 77 days
Changes in Laboratory parameters
Time frame: throughout study conduction, max 77 days
Changes in Laboratory parameters
Time frame: throughout study conduction, max 77 days
Changes in Laboratory parameters
Time frame: throughout study conduction, max 77 days
Changes in vital signs
Time frame: throughout study conduction, max 77 days
Changes in blood pressure
Time frame: throughout study conduction, max 77 days
Changes in heart rate
Time frame: throughout study conduction, max 77 days
Changes in physical exam
Time frame: throughout study conduction, max 77 days
adverse events related to administration
Time frame: at baseline
adverse events related to administration
Time frame: 7 days after baseline, at Visit 3
hypersensitivity reactions
Time frame: at baseline
hypersensitivity reactions
Time frame: at study visit 3
Mortality
Time frame: within 28 days after surgery, approx. 56 days
Quality of Life (SF36)
Time frame: base line to visit 4 approx 35 days
Quality of Life (SF36)
Time frame: baseline to visit 5 approx 70 days
Duration of hospital stay
Time frame: 28 days
Number of patients with normalized Hb-values
Time frame: baseline to visit 4 approx 35 days
Number of patients with normalized Hb-values
Time frame: baseline to visit 5 approx 70 days
Analysis of total iron levels
Time frame: approx 4 hours
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Aug 2024.
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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.
Kai Zacharowski, Prof. 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 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 36 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: withdrawn, as of the sponsor's last update on 28 Aug 2024. 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 was withdrawn before enrolling participants, so there are no results.
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?
Normalisation or Increase of hemaglobin(Hb)-level (time frame: baseline (BL) to day before surgery (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 28 Aug 2024.