Iron Deficiency AnemiaPhase 4AGE-ANEMIANCT04913649
Intravenous Iron to Treat Postoperative Anemia in Older Cardiac Surgery Patients
A Phase 4 study testing Ferric Derisomaltose 100 MG/ML and Sodium chloride in people with Iron Deficiency Anemia, run by dr. P. Noordzij at 2 sites in Netherlands.
Trial summary
Postoperative anemia is common in cardiac surgery with cardiopulmonary bypass. Iron deficiency delays the recovery from postoperative anemia and may negatively affect the postoperative trajectory of cardiac surgery patients. Read more about this study
- Who is it for?
- Ages 70 years and older
- Conditions the study is for
- Iron Deficiency Anemia
- What is being tested?
- Ferric Derisomaltose 100 MG/ML and Sodium chloride
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 310 participants
- Where
- 2 sitesNetherlands
- Study dates
- 23 Sep 2021to Dec 2026
- Phase
- Phase 4
- Are there results?
- Not yet: the study is under way
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 70 years and older
- All sexes
- No healthy volunteers
- Older adult
Who may be able to join
- Mentally competent with age ≥ 70 years
- Elective AVR or CABG surgery
- Expected uncomplicated postoperative trajectory, defined as:
- No inotropic agents or ventilation at time of final inclusion (POD 1)
- Expected discharge to general ward at POD 1
- Moderate postoperative IDA, defined as:
Show all 9Show fewer
- Hb between 85 and 110 g/L and
- Ferritin <100 µg/L or
- Iron saturation (TSAT) < 20%
Who cannot join
- Medical history of iron overload/haemochromatosis
- Medical history of liver cirrhosis or ALT/AST value in blood serum triple of normal value (female patients: ALT >120, AST >105 U/L. Male patients: ALT>150, AST>135 U/L)
- Severe renal failure (eGFR<15ml/min/1.73m2)
- Recent treatment with IVI (<12 weeks prior)
- Serious or severe allergic reaction to IVI in medical history
- Severe asthma or eczema in medical history (atopic constitution)
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Netherlands2 sites, 2 recruiting
- Recruiting
Amphia Hospital
Breda
Thijs Rettig
- Recruiting
St Antonius Hospital
Nieuwegein
Peter Noordzij
Rosa Smoor
About this study
Official title: Intravenous Iron to Treat Postoperative Anemia in Older Cardiac Surgery Patients: a Randomized Controlled Trial'
Postoperative anemia is common in cardiac surgery with cardiopulmonary bypass. Iron deficiency delays the recovery from postoperative anemia and may negatively affect the postoperative trajectory of cardiac surgery patients. The objective of the study is to determine the effect of treatment of postoperative iron deficiency anemia with intravenous iron on disability 90 days after surgery. This will be evaluated in a randomized placebo-controlled double blind two-center trial in which 310 elective cardiac surgery patients will be included.
Read the detailed description
Rationale: Postoperative anemia is common in cardiac surgery with cardiopulmonary bypass. Iron deficiency delays the recovery from postoperative anemia and may negatively affect the postoperative trajectory of cardiac surgery patients.
Objective: To determine the effect of treatment of postoperative iron deficiency anemia (IDA) with intravenous iron (IVI) on disability 90 days after surgery.
Study design: Randomized placebo-controlled double blind two-center trial
Study population: 310 elderly patients (≥70 years) with moderate postoperative IDA on postoperative day (POD) 1 (hemoglobin (Hb) 85 - 110 g/L, ferritin concentration < 100 µg/L or iron saturation <20%) after uncomplicated elective cardiac surgery (aortic valve repair (AVR) and coronary artery bypass graft (CABG) surgery).
Intervention: Postoperative treatment with a single dose IVI (ferric derisomaltose, Monofer®, N = 155) compared to postoperative treatment with sodium chloride (NaCL) 0.9% (placebo, N = 155).
Main study endpoints: Primary endpoint is disability as measured by the 12- item World Health Organization Disability Assessment score 2.0 (WHODAS-12 at POD 90 after elective cardiac surgery. Secondary endpoints are change in patient reported outcome measures (PROMs) related to dyspnea (assessed with the Rose Dyspnea Score (RDS)) and to health-related quality of life (HRQL) (assessed with The Older Persons and Informal Caregivers-Short Form (TOPICS-SF) questionnaire) at POD 90, the number of postoperative red blood cell (RBC) transfusions, change in reticulocyte hemoglobin content (pg) from randomization to hospital discharge, Hb levels at discharge, hospital complications and days alive and out of hospital at 90 days. Lastly, the difference in functional outcomes (e.g. steep ramp or 6-minute walk test) and Hb value at POD 90 will be assessed as an exploratory endpoint.
- Conditions
- Iron Deficiency Anemia
- Being tested
- Ferric Derisomaltose 100 MG/ML, Sodium chloride
- Keywords
- Cardiac surgery, Postoperative anemia, Intravenous iron, Postoperative disability
- 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.
Ferric Derisomaltose 100 MG/MLDrug
Also called Monofer
Postoperative treatment with a single dose IVI (ferric derisomaltose), with a dose of 20mg/kg in approximately 60 minutes.
Sodium chlorideDrug
Also called Placebo
Postoperative treatment with a single dose NaCl 0.9% in approximately 60 minutes.
| Study group | Role | What they receive |
|---|---|---|
| Intravenous iron (ferric derisomaltose) | Experimental | The intervention consists of a single dose of ferric derisomaltose (Monofer®) 100 mg/mL solution for infusion (Monofer® is a registered product with a marketing authorization in the Netherlands (RVG number: 103070). Manufacturer: Pharmacosmos A/S, Denmark. Dutch marketing authorization holder: Cablon Medical B.V). The method of administration and dosage of the investigational medication are standard treatment. The ferric derisomaltose dose will calculated for each patient depending on body weight (20mg/kg) and diluted in 250 ml NaCl 0.9%. Treatment takes approximately 60 minutes. Vital signs of the patient will be monitored during administration of the investigational medication and for 30 minutes afterwards Receives: Drug: Ferric Derisomaltose 100 MG/ML |
| Placebo | Placebo comparator | Single dose of sodium chloride 0.9% (250ml). Treatment takes approximately 60 minutes. Vital signs of the patient will be monitored during administration of the investigational medication and for 30 minutes afterwards Receives: Drug: Sodium chloride |
What is being measured
The primary outcome is the main question the study is designed to answer.
Disability
Disability measured by the 12- item World Health Organization Disability Assessment score 2.0 (WHODAS-12). Based on the answers a disability score can be calculated. 0% is no disability and 100% is fully disabled.
Measured: 90 days after elective cardiac surgery
Secondary outcomes (7)
Change in patient reported outcome measures (PROMs) related to dyspnea
PROMS related to dyspnea are assessed with the Rose Dyspnea Scale (RDS). Rose Dyspnea Scale scores range from 0 to 4 with higher scores indicating more dyspnea with common activities.
Measured: 90 days after elective cardiac surgery
Change in patient reported outcome measures (PROMs) related to health related quality of life (HRQL)
HRQL is assessed with The Older Persons and Informal Caregivers-Short Form (TOPICS-SF) questionnaire. The TOPIC-SF is comprised of 22 items in 7 domains of health and well-being. Scores in the different domains ranges from 0 to 5, higher scores indicating diminished quality of life.
Measured: 90 days after elective cardiac surgery
Red blood cell transfusions
Number of red blood cell transfusions during hospital stay
Measured: +/- 7 days after elective cardiac surgery
Change in reticulocyte hemoglobin content
Change in reticulocyte hemoglobin content from randomization to hospital discharge
Measured: +/- 7 days after elective cardiac surgery
Change in Hb level
Change in Hb level from randomization to hospital discharge
Measured: +/- 7 days after elective cardiac surgery
Postoperative complications
Postoperative complications during hospital stay
Measured: +/- 7 days after elective cardiac surgery
Days alive and out of hospital
Days alive and out of hospital
Measured: 90 days after elective cardiac surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Jun 2021
- Study start23 Sep 2021
- Primary completionNov 2026 (estimated)
- Study completionDec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Two center randomized controlled trial. Patients will either receive IVI (Monofer) or placebo. Via a computer generated randomization patients will be randomly assigned (1:1) to either a single dose of intravenous ferric derisomaltose (Monofer) 100 mg/mL solution for infusion (intervention group) or intravenous NaCl 0.9% (placebo group) (randomisation with block size 4). Stratification takes surgical intervention (AVR or CABG) and hospital location into account.
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 310 participants (estimated)
Sponsor and investigators
- Lead sponsor
- dr. P. Noordzij
- Sponsor type
- University, hospital or other
- Collaborators
- Pharmacosmos A/S
- Responsible party
- Sponsor-investigator, dr. P. Noordzij, St. Antonius Hospital
- Investigators
- Peter Noordzij, MD, PhD, Principal investigator, St. Antonius Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04913649
- Sponsor's protocol ID
- NL77442.100.21
- Acronym
- AGE-ANEMIA
- Status last verified
- Apr 2026
- First submitted
- 28 May 2021
- Last updated
- 27 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Smoor RM, Rettig TCD, Vernooij LM, Groenewegen EM, van Dongen HPA, Noordzij PG. The effect of postoperative intravenous iron in anaemic, older cardiac surgery patients on disability-free survival (AGE ANEMIA study): study protocol for a multi-centre, double-blind, randomized, placebo-controlled trial. Trials. 2023 Oct 26;24(1):693. doi: 10.1186/s13063-023-07725-y.
PubMed 37885026
Study at a glance
From the registry record, last updated by the sponsor on 27 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Intravenous Iron to Treat Postoperative Anemia in Older Cardiac Surgery Patients: a Randomized Controlled Trial'
- ClinicalTrials.gov ID
- NCT04913649
- Acronym / sponsor ID
- AGE-ANEMIA / NL77442.100.21
- Conditions
- Iron Deficiency Anemia
- Keywords
- Cardiac surgery, Postoperative anemia, Intravenous iron, Postoperative disability
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 310 participants (estimated)
- Lead sponsor
- dr. P. NoordzijUniversity, hospital or other
- Collaborators
- Pharmacosmos A/S
- Study start
- 23 Sep 2021 (actual)
- Primary completion
- Nov 2026 (estimated)
- Study completion
- Dec 2026 (estimated)
- First posted
- 4 Jun 2021 (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.
Postoperative anemia is common in cardiac surgery with cardiopulmonary bypass. Iron deficiency delays the recovery from postoperative anemia and may negatively affect the postoperative trajectory of cardiac surgery patients. The objective of the study is to determine the effect of treatment of postoperative iron deficiency anemia with intravenous iron on disability 90 days after surgery. This will be evaluated in a randomized placebo-controlled double blind two-center trial in which 310 elective cardiac surgery patients will be included.
Detailed description
Rationale: Postoperative anemia is common in cardiac surgery with cardiopulmonary bypass. Iron deficiency delays the recovery from postoperative anemia and may negatively affect the postoperative trajectory of cardiac surgery patients.
Objective: To determine the effect of treatment of postoperative iron deficiency anemia (IDA) with intravenous iron (IVI) on disability 90 days after surgery.
Study design: Randomized placebo-controlled double blind two-center trial
Study population: 310 elderly patients (≥70 years) with moderate postoperative IDA on postoperative day (POD) 1 (hemoglobin (Hb) 85 - 110 g/L, ferritin concentration < 100 µg/L or iron saturation <20%) after uncomplicated elective cardiac surgery (aortic valve repair (AVR) and coronary artery bypass graft (CABG) surgery).
Intervention: Postoperative treatment with a single dose IVI (ferric derisomaltose, Monofer®, N = 155) compared to postoperative treatment with sodium chloride (NaCL) 0.9% (placebo, N = 155).
Main study endpoints: Primary endpoint is disability as measured by the 12- item World Health Organization Disability Assessment score 2.0 (WHODAS-12 at POD 90 after elective cardiac surgery. Secondary endpoints are change in patient reported outcome measures (PROMs) related to dyspnea (assessed with the Rose Dyspnea Score (RDS)) and to health-related quality of life (HRQL) (assessed with The Older Persons and Informal Caregivers-Short Form (TOPICS-SF) questionnaire) at POD 90, the number of postoperative red blood cell (RBC) transfusions, change in reticulocyte hemoglobin content (pg) from randomization to hospital discharge, Hb levels at discharge, hospital complications and days alive and out of hospital at 90 days. Lastly, the difference in functional outcomes (e.g. steep ramp or 6-minute walk test) and Hb value at POD 90 will be assessed as an exploratory endpoint.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
- Model description
- Two center randomized controlled trial. Patients will either receive IVI (Monofer) or placebo. Via a computer generated randomization patients will be randomly assigned (1:1) to either a single dose of intravenous ferric derisomaltose (Monofer) 100 mg/mL solution for infusion (intervention group) or intravenous NaCl 0.9% (placebo group) (randomisation with block size 4). Stratification takes surgical intervention (AVR or CABG) and hospital location into account.
| Arm | Type | Receives |
|---|---|---|
| Intravenous iron (ferric derisomaltose) | Experimental | Drug: Ferric Derisomaltose 100 MG/MLThe intervention consists of a single dose of ferric derisomaltose (Monofer®) 100 mg/mL solution for infusion (Monofer® is a registered product with a marketing authorization in the Netherlands (RVG number: 103070). Manufacturer: Pharmacosmos A/S, Denmark. Dutch marketing authorization holder: Cablon Medical B.V). The method of administration and dosage of the investigational medication are standard treatment. The ferric derisomaltose dose will calculated for each patient depending on body weight (20mg/kg) and diluted in 250 ml NaCl 0.9%. Treatment takes approximately 60 minutes. Vital signs of the patient will be monitored during administration of the investigational medication and for 30 minutes afterwards |
| Placebo | Placebo comparator | Drug: Sodium chlorideSingle dose of sodium chloride 0.9% (250ml). Treatment takes approximately 60 minutes. Vital signs of the patient will be monitored during administration of the investigational medication and for 30 minutes afterwards |
Who may qualify
- Ages
- 70 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (9 listed)
- Mentally competent with age ≥ 70 years
- Elective AVR or CABG surgery
- Expected uncomplicated postoperative trajectory, defined as:
- No inotropic agents or ventilation at time of final inclusion (POD 1)
- Expected discharge to general ward at POD 1
Key exclusion criteria (6 listed)
- Medical history of iron overload/haemochromatosis
- Medical history of liver cirrhosis or ALT/AST value in blood serum triple of normal value (female patients: ALT >120, AST >105 U/L. Male patients: ALT>150, AST>135 U/L)
- Severe renal failure (eGFR<15ml/min/1.73m2)
- Recent treatment with IVI (<12 weeks prior)
- Serious or severe allergic reaction to IVI in medical history
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 |
|---|---|---|
| Ferric Derisomaltose 100 MG/MLAlso: MonoferPostoperative treatment with a single dose IVI (ferric derisomaltose), with a dose of 20mg/kg in approximately 60 minutes. | Drug | Intravenous iron (ferric derisomaltose) |
| Sodium chlorideAlso: PlaceboPostoperative treatment with a single dose NaCl 0.9% in approximately 60 minutes. | Drug | Placebo |
Primary outcome
Disability
Time frame: 90 days after elective cardiac surgery
Disability measured by the 12- item World Health Organization Disability Assessment score 2.0 (WHODAS-12). Based on the answers a disability score can be calculated. 0% is no disability and 100% is fully disabled.
7 secondary outcomes
Change in patient reported outcome measures (PROMs) related to dyspnea
Time frame: 90 days after elective cardiac surgery
Change in patient reported outcome measures (PROMs) related to health related quality of life (HRQL)
Time frame: 90 days after elective cardiac surgery
Red blood cell transfusions
Time frame: +/- 7 days after elective cardiac surgery
Change in reticulocyte hemoglobin content
Time frame: +/- 7 days after elective cardiac surgery
Change in Hb level
Time frame: +/- 7 days after elective cardiac surgery
Postoperative complications
Time frame: +/- 7 days after elective cardiac surgery
Days alive and out of hospital
Time frame: 90 days after elective cardiac surgery
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Apr 2026.
- Derived from this study: PubMed 37885026Smoor RM, Rettig TCD, Vernooij LM, Groenewegen EM, van Dongen HPA, Noordzij PG. The effect of postoperative intravenous iron in anaemic, older cardiac surgery patients on disability-free survival (AGE ANEMIA study): study protocol for a multi-centre, double-blind, randomized, placebo-controlled trial. Trials. 2023 Oct 26;24(1):693. doi: 10.1186/s13063-023-07725-y.
- 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.
Peter Noordzij, MD, PhD principal investigator
St. Antonius Hospital
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Ferric Derisomaltose 100 MG/ML and Sodium chloride in people with Iron Deficiency Anemia, run by dr. P. Noordzij at 2 sites in Netherlands.
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 9 inclusion and 6 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: looking for participants now, as of the sponsor's last update on 27 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Netherlands. 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. Some participants in this study may receive a placebo. 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Peter Noordzij, MD, PhD (883203000 ext. + 31 (0), p.noordzij@antoniusziekenhuis.nl), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Disability (time frame: 90 days after elective cardiac surgery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04913649, which also lists 1 linked publication.
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 27 Apr 2026.