Anemia, Iron-DeficiencyPhase 4HOMe_aFers_1NCT02905539
A Study Comparing the Iron Substitution With the Medicinal Products Ferinject or Monofer
A Phase 4 study testing Iron Isomaltoside 1000 and Ferric Carboxymaltose in people with Anemia, Iron-Deficiency, run by Universität des Saarlandes at 1 site in Germany.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Anemia, Iron-Deficiency
- What is being tested?
- Iron Isomaltoside 1000 and Ferric Carboxymaltose
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 26 participants
- Where
- 1 siteGermany
- Study dates
- Jul 2016to Jun 2020
- Phase
- Phase 4
- 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
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- written informed consent,
- female,
- gynecological blood losses,
- age ≥ 18 years,
- iron deficiency anemia,
- Hemoglobin < 12,0 g/dl,
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- 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
Who cannot join
- known hypersensitivity to MonoFer® or FERINJECT®,
- severe, known hypersensitivity to other intravenous iron preparations,
- Plasma Phosphate < 2.5 mg/dl at screening,
- Hemochromatosis,
- Untreated hyperparathyroidism,
- Renal replacement therapy/kidney transplantation,
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- 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,
- pregnancy,
- women of childbearing potential without an effective method of contraception,
- lactating women,
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Randomized, Double-blind Comparative Study Comparing Ferric Carboxymaltose (Ferinject) and Iron Isomaltoside 1000 (Monofer) for Iron Substitution in Iron-deficiency Anemia
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.
Read the detailed description
Recent studies suggested that intravenous iron preparations for anemia treatment may have adverse effects on phosphorus regulation, as they may induce an increase in the phosphaturic hormone Fibroblast Growth Factor-23 (FGF-23) and a subsequent fall in plasma phosphorus levels.
So far it is unknown if these effects are class- or substance-specific.
This study will address the question whether among female participants with iron deficiency anemia the application of ferric-(III)-derisomaltose and ferric carboxymaltose will cause episodes of hypophosphatemia to same extend. The investigators will additionally compare the effects of the two iron preparations on other parameters of calcium-phosphate metabolism, and decipher potential consequences of hypophosphatemia by analysing cardiac function, immunological parameters and quality of life.
In order to investigate these outcomes, 60 women with iron deficient anemia will be randomised to receive either ferric-(III)-derisomaltose or ferric carboxymaltose.
The monocentric study will be conducted at Saarland University Medical Center. For each participating woman, the study comprises five visits to the study center during a period of five weeks.
- Conditions
- Anemia, Iron-Deficiency
- Being tested
- Iron Isomaltoside 1000, Ferric Carboxymaltose
- Keywords
- Iron, anemia, phosphorus, FGF-23
- Medical subject headings
- Anemia, Iron-Deficiency, Anemia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Iron Isomaltoside 1000Drug
Also called Monofer
Ferric CarboxymaltoseDrug
Also called Ferinject
| Study group | Role | What they receive |
|---|---|---|
| Iron Isomaltoside 1000 | Experimental | Subjects receive Iron Isomaltoside 1000 solution intravenously. Dosage: A unique dose of 20 mg per kilogram bodyweight, but total dose is not more than 1000 mg. Receives: Drug: Iron Isomaltoside 1000 |
| Ferric Carboxymaltose | Active comparator | Subjects receive Ferric Carboxymaltose solution intravenously. Dosage: A unique dose of 20 mg per kilogram bodyweight, but total dose is not more than 1000 mg. Receives: Drug: Ferric Carboxymaltose |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of hypophosphatemia
The incidence of hypophosphatemia is defined as a drop of serum phosphate below 2.0 mg/dl.
Measured: From baseline to day 35
Secondary outcomes (22)
Changes of plasma phosphate concentrations.
Measured: From baseline to day 35
Changes of fractional Phosphate urinary excretion.
Measured: From baseline to day 35
Changes of Plasma Vitamin D (active, inactive).
Measured: From baseline to day 35
Changes of fibroblast growth factor 23 (intact and c-terminal).
Measured: From baseline to day 35
Changes of parathyroid Hormone.
Measured: From baseline to day 35
Changes of Plasma calcium.
Measured: From baseline to day 35
Changes of Plasma alkaline Phosphatase.
Measured: From baseline to day 35
Changes of Plasma soluble Klotho.
Measured: From baseline to day 35
Changes of Plasma Hepcidin-25.
Measured: From baseline to day 35
Changes of Serum N-Terminal Propeptide of Type I Collagen (PINP).
Measured: From baseline to day 35
Changes of Pyridinoline (PYD) in the urine
Measured: From baseline to day 35
Changes of Quality of life.
German Version of the Short Form (36) Health Survey by Matthias Morfeld, Inge Kirchberger, Monika Bullinger.
Measured: From baseline to day 35
Incidence of (supra)ventricular cardiac arrhythmias in the ambulatory Electrocardiography.
Measured: Before and 7 days after administration of iron compound
Changes of QT-time in the 12-lead Electrocardiography.
Measured: From baseline to day 35
Changes of QT-Dispersion in the 12-lead Electrocardiography.
Measured: From baseline to day 35
Changes of Left Ventricular Mass Index
Echocardiographic measurement
Measured: From baseline to day 7
Count of monocyte subpopulations.
Count of classical , intermediate and nonclassical monocytes using flow cytometry.
Measured: Right before the singular infusion of the iron compound is started and right after infusion of the iron compound is completed.
Measurement of phagocytic capacity of monocytes.
Exposition of Monocytes to Fluoresbrite Yellow Green (YG) Carboxylate Microspheres and subsequent flow cytometric count of Fluorescein isothiocyanate-positive Monocytes.
Measured: Right before the singular infusion of the iron compound is started and right after the infusion of iron compound is completed.
Changes of fatigue
The German Version of the Multidimensional Fatigue Inventory. (Smets E. M. A., Garssen B., Bonke B. and Haes de J. C. J. M. (1995). The Multidimensional Fatigue Inventory (MFI); Psychometric qualities of an instrument to assess fatigue. Journal of Psychosomatic Research, 39, 315-325.)
Measured: From baseline to day 35
Changes of Left Atrial Volume Index
Echocardiographic measurement
Measured: From Baseline to day 7
Changes of Systolic Ejection Fraction
Echocardiographic measurement
Measured: From Baseline to day 7
Changes of Diastolic Left Ventricular Function
Echocardiographic measurement
Measured: From Baseline to day 7
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Sep 2016 (estimated)
- Study startJul 2016
- Primary completionJun 2020
- Study completionJun 2020
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 Anemia, Iron-DeficiencyStudies 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
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 26 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universität des Saarlandes
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Gunnar Heine, MD, Principal investigator, Universität des SaarlandesDanilo Fliser, MD, Study director, Universität des Saarlandes
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02905539
- Sponsor's protocol ID
- P-0101
- Other IDs
- 2015-004808-36, U1111-1176-4563, DRKS00010766, 2015
- Acronym
- HOMe_aFers_1
- Status last verified
- Apr 2019
- First submitted
- 8 Sep 2016
- Last updated
- 30 Nov 2020
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
Emrich IE, Lizzi F, Siegel JD, Seiler-Mussler S, Ukena C, Kaddu-Mulindwa D, D'Amelio R, Wagenpfeil S, Brandenburg VM, Bohm M, Fliser D, Heine GH. Hypophosphatemia after high-dose iron repletion with ferric carboxymaltose and ferric derisomaltose-the randomized controlled HOMe aFers study. BMC Med. 2020 Jul 13;18(1):178. doi: 10.1186/s12916-020-01643-5.
PubMed 32654663
Study at a glance
From the registry record, last updated by the sponsor on 30 Nov 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Double-blind Comparative Study Comparing Ferric Carboxymaltose (Ferinject) and Iron Isomaltoside 1000 (Monofer) for Iron Substitution in Iron-deficiency Anemia
- ClinicalTrials.gov ID
- NCT02905539
- Acronym / sponsor ID
- HOMe_aFers_1 / P-0101
- Conditions
- Anemia, Iron-Deficiency
- Keywords
- Iron, anemia, phosphorus, FGF-23
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 26 participants (actual)
- Lead sponsor
- Universität des SaarlandesUniversity, hospital or other
- Study start
- Jul 2016
- Primary completion
- Jun 2020 (actual)
- Study completion
- Jun 2020 (actual)
- First posted
- 19 Sep 2016 (estimated)
- 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.
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.
Detailed description
Recent studies suggested that intravenous iron preparations for anemia treatment may have adverse effects on phosphorus regulation, as they may induce an increase in the phosphaturic hormone Fibroblast Growth Factor-23 (FGF-23) and a subsequent fall in plasma phosphorus levels.
So far it is unknown if these effects are class- or substance-specific.
This study will address the question whether among female participants with iron deficiency anemia the application of ferric-(III)-derisomaltose and ferric carboxymaltose will cause episodes of hypophosphatemia to same extend. The investigators will additionally compare the effects of the two iron preparations on other parameters of calcium-phosphate metabolism, and decipher potential consequences of hypophosphatemia by analysing cardiac function, immunological parameters and quality of life.
In order to investigate these outcomes, 60 women with iron deficient anemia will be randomised to receive either ferric-(III)-derisomaltose or ferric carboxymaltose.
The monocentric study will be conducted at Saarland University Medical Center. For each participating woman, the study comprises five visits to the study center during a period of five weeks.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Iron Isomaltoside 1000 | Experimental | Drug: Iron Isomaltoside 1000Subjects receive Iron Isomaltoside 1000 solution intravenously. Dosage: A unique dose of 20 mg per kilogram bodyweight, but total dose is not more than 1000 mg. |
| Ferric Carboxymaltose | Active comparator | Drug: Ferric CarboxymaltoseSubjects receive Ferric Carboxymaltose solution intravenously. Dosage: A unique dose of 20 mg per kilogram bodyweight, but total dose is not more than 1000 mg. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- written informed consent,
- female,
- gynecological blood losses,
- age ≥ 18 years,
- iron deficiency anemia,
Key exclusion criteria (21 listed)
- known hypersensitivity to MonoFer® or FERINJECT®,
- severe, known hypersensitivity to other intravenous iron preparations,
- Plasma Phosphate < 2.5 mg/dl at screening,
- Hemochromatosis,
- Untreated hyperparathyroidism,
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 |
|---|---|---|
| Iron Isomaltoside 1000Also: Monofer | Drug | Iron Isomaltoside 1000 |
| Ferric CarboxymaltoseAlso: Ferinject | Drug | Ferric Carboxymaltose |
Primary outcome
Incidence of hypophosphatemia
Time frame: From baseline to day 35
The incidence of hypophosphatemia is defined as a drop of serum phosphate below 2.0 mg/dl.
22 secondary outcomes
Changes of plasma phosphate concentrations.
Time frame: From baseline to day 35
Changes of fractional Phosphate urinary excretion.
Time frame: From baseline to day 35
Changes of Plasma Vitamin D (active, inactive).
Time frame: From baseline to day 35
Changes of fibroblast growth factor 23 (intact and c-terminal).
Time frame: From baseline to day 35
Changes of parathyroid Hormone.
Time frame: From baseline to day 35
Changes of Plasma calcium.
Time frame: From baseline to day 35
Changes of Plasma alkaline Phosphatase.
Time frame: From baseline to day 35
Changes of Plasma soluble Klotho.
Time frame: From baseline to day 35
Changes of Plasma Hepcidin-25.
Time frame: From baseline to day 35
Changes of Serum N-Terminal Propeptide of Type I Collagen (PINP).
Time frame: From baseline to day 35
Changes of Pyridinoline (PYD) in the urine
Time frame: From baseline to day 35
Changes of Quality of life.
Time frame: From baseline to day 35
Incidence of (supra)ventricular cardiac arrhythmias in the ambulatory Electrocardiography.
Time frame: Before and 7 days after administration of iron compound
Changes of QT-time in the 12-lead Electrocardiography.
Time frame: From baseline to day 35
Changes of QT-Dispersion in the 12-lead Electrocardiography.
Time frame: From baseline to day 35
Changes of Left Ventricular Mass Index
Time frame: From baseline to day 7
Count of monocyte subpopulations.
Time frame: Right before the singular infusion of the iron compound is started and right after infusion of the iron compound is completed.
Measurement of phagocytic capacity of monocytes.
Time frame: Right before the singular infusion of the iron compound is started and right after the infusion of iron compound is completed.
Changes of fatigue
Time frame: From baseline to day 35
Changes of Left Atrial Volume Index
Time frame: From Baseline to day 7
Changes of Systolic Ejection Fraction
Time frame: From Baseline to day 7
Changes of Diastolic Left Ventricular Function
Time frame: From Baseline to day 7
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 30 Nov 2020.
- Derived from this study: PubMed 32654663Emrich IE, Lizzi F, Siegel JD, Seiler-Mussler S, Ukena C, Kaddu-Mulindwa D, D'Amelio R, Wagenpfeil S, Brandenburg VM, Bohm M, Fliser D, Heine GH. Hypophosphatemia after high-dose iron repletion with ferric carboxymaltose and ferric derisomaltose-the randomized controlled HOMe aFers study. BMC Med. 2020 Jul 13;18(1):178. doi: 10.1186/s12916-020-01643-5.
- 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.
Gunnar Heine, MD principal investigator
Universität des Saarlandes
Danilo Fliser, MD study director
Universität des Saarlandes
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Iron Isomaltoside 1000 and Ferric Carboxymaltose in people with Anemia, Iron-Deficiency, run by Universität des Saarlandes 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 9 inclusion and 21 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 30 Nov 2020. 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 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?
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?
Incidence of hypophosphatemia (time frame: From baseline to day 35). 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 NCT02905539, 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 30 Nov 2020.