Iron Deficiency AnemiaPhase 3FERWON-EXTNCT02962648
An Extension Trial to Assess the Safety of Re-dosing of Iron Isomaltoside/Ferric Derisomaltose (Monofer®/Monoferric®)
A Phase 3 study testing Iron isomaltoside/ferric derisomaltose in people with Iron Deficiency Anemia and Iron Deficiency Anaemia, run by Pharmacosmos A/S at 22 sites in United States.
Trial summary
Evaluate safety and efficacy of intravenous (IV) iron isomaltoside/ferric derisomaltose re-dosing, in subjects who were previously treated with iron isomaltoside/ferric derisomaltose. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Iron Deficiency Anemia, Iron Deficiency Anaemia
- What is being tested?
- Iron isomaltoside/ferric derisomaltose
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 103 participants
- Where
- 22 sitesUnited States
- Study dates
- 9 Jan 2017to 12 Jun 2018
- Phase
- Phase 3
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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
- Completed one of the lead-in trials
- Randomised and dosed with iron isomaltoside/ferric derisomaltose in one of the lead-in trials.
- Haemoglobin (Hb) of ≤ 11 g/dL
- Screening serum ferritin (s-ferritin) ≤ 100 ng/mL, or ≤ 300 ng/mL if transferrin saturation (TSAT) ≤ 30 %
- Willingness to participate and signing the informed consent form (ICF)
Who cannot join
- Intravenous (IV) iron treatment between the lead-in trial and screening
- During 30-day period prior to screening or during the trial period; has or will be treated with a red blood cell transfusion, radiotherapy, and/or chemotherapy
- Received an investigational drug within 30 days of screening
- Decompensated liver cirrhosis or active hepatitis
- Pregnant or nursing women.
- Any other laboratory abnormality, medical condition, or psychiatric disorders which, in the opinion of the Investigator, will put the subject's disease management at risk or may result in the subject being unable to comply with the trial requirements
Trial locations and contacts
22 sites in 1 country.
22 sites in 1 country
United States22 sites
Pharmacosmos Investigational Site
Albuquerque, New Mexico, 87109
Pharmacosmos Investigational Site
Baton Rouge, Louisiana, 70808
Pharmacosmos Investigational Site
Chattanooga, Tennessee, 37404
Pharmacosmos Investigational Site
Chula Vista, California, 91910
Pharmacosmos Investigational Site
Doral, Florida, 33172
Pharmacosmos Investigational Site
Hialeah, Florida, 33012
Pharmacosmos Investigational Site
Houston, Texas, 77030
Pharmacosmos Investigational Site 1
La Mesa, California, 91942
Pharmacosmos Investigational Site 2
La Mesa, California, 91942
Pharmacosmos Investigational Site
Metairie, Louisiana, 70006
Pharmacosmos Investigational Site
Miami, Florida, 33135
Pharmacosmos Investigational Site
Miami, Florida, 33147
Pharmacosmos Investigational Site
Miami, Florida, 33165
Pharmacosmos Investigational Site
Miami Lakes, Florida, 33014
Pharmacosmos Investigational Site
New Orleans, Louisiana, 70125
Pharmacosmos Investigational Site
Northridge, California, 91324
Pharmacosmos Investigational Site
Plainsboro, New Jersey, 08536
Pharmacosmos Investigational Site
Porterville, California, 93257
Pharmacosmos Investigational Site 1
San Antonio, Texas, 78215
Pharmacosmos Investigational Site 2
San Antonio, Texas, 78215
Pharmacosmos Investigational Site
Shreveport, Louisiana, 71101
Pharmacosmos Investigational Site
West Palm Beach, Florida, 33409
About this study
Official title: An Open-label, Multicentre, Extension Trial to Assess the Safety of Re-dosing of Intravenous Iron Isomaltoside/Ferric Derisomaltose (Monofer®/Monoferric®)
Evaluate safety and efficacy of intravenous (IV) iron isomaltoside/ferric derisomaltose re-dosing, in subjects who were previously treated with iron isomaltoside/ferric derisomaltose.
Read the detailed description
Among the various formulations of parenteral iron that are currently available, iron isomaltoside/ferric derisomaltose may allow flexibility in terms of high and rapid dosing. Up to now, most clinical trials with intravenous (IV) iron treatment were of 4-12 weeks in duration; longer trials are warranted to follow-up on long-term safety.
The aim of the trial was to evaluate the safety and efficacy of IV iron isomaltoside/ferric derisomaltose re-dosing in subjects who were previously treated with iron isomaltoside/ferric derisomaltose in lead-in trials.
This was a 6-months extension trial lasting 26 weeks. Eligible subjects attended 5 visits: screening, baseline (subjects treated with a single IV dose of 1000 mg iron isomaltoside/ferric derisomaltose), and follow-up visits at week 2, 13, and 26 weeks after the IV dose, for safety and efficacy assessments.
- Conditions
- Iron Deficiency Anemia, Iron Deficiency Anaemia
- Being tested
- Iron isomaltoside/ferric derisomaltose
- Keywords
- Iron Deficiency Anemia, Iron Deficiency Anaemia, IDA, Intravenous iron replacement therapy, Chronic Kidney Disease, CKD, Iron isomaltoside, Ferric derisomaltose, Monofer, Monoferric, Monover, Monofar, Monoferro
- Medical subject headings
- Anemia, Iron-Deficiency, Renal Insufficiency, Chronic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Iron isomaltoside/ferric derisomaltoseDrug
Also called Monofer®, Monoferric®, Monover®, Monofar®, Monoferro®
Iron isomaltoside/ferric derisomaltose (Monofer®/Monoferric®; 100 mg/mL) was the test product in this trial.
The dose of iron isomaltoside/ferric derisomaltose for the individual subject was set to 1000 mg. The dose was diluted in 100 mL 0.9 % sodium chloride from the site's supply and administered over approximately 20 minutes using IV infusion.
| Study group | Role | What they receive |
|---|---|---|
| Iron isomaltoside/ferric derisomaltose | Experimental | Administered IV Receives: Drug: Iron isomaltoside/ferric derisomaltose |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Subjects With Adverse Drug Reactions (ADR)
Safety
Evaluate the number of subjects with adverse drug reactions (ADRs), defined as AEs that were assessed by the investigator as related or possible related to the investigational product.
Measured: Baseline to week 26
Secondary outcomes (8)
Incidence of Protocol-defined Serious or Severe Hypersensitivity Reactions
Safety.
For this endpoint, the number of participants with serious or severe hypersensitivity reactions were evaluated. The hypersensitivity terms that were included in the analysis were those that started or after the first dose of treatment (i.e. treatment emergent). The terms used to define hypersensitivity were those specified by the Standardised MedDRA Queries (SMQ) for hypersensitivity, plus four additional terms: Loss of consciousness; Seizure; Syncope; Unresponsiveness.
The potential hypersensitivity AEs were adjudicated in a blinded fashion by an independent Clinical Endpoint Adjudication Committee (CEAC).
Results show only those participants that had adjudicated and confirmed serious or severe hypersensitivity reactions.
Measured: Baseline to week 26
Composite Cardiovascular Adverse Events (AEs)
Safety
Results show the composite cardiovascular AEs, that started on or after the first dose of treatment (i.e. treatment emergent) up to month 6.
The reported potential cardiovascular AEs were adjudicated in a blinded fashion by an independent Clinical Endpoint Adjudication Committee (CEAC).
The potential cardiovascular AEs included the following:
- Death due to any cause
- Non-fatal myocardial infarction
- Non-fatal stroke
- Unstable angina requiring hospitalisation
- Congestive heart failure requiring hospitalisation or medical intervention
- Arrhythmias
- Hypertension
- Hypotension
Results show only those participants that had adjudicated and confirmed treatment-emergent composite cardiovascular AEs.
Measured: Baseline to week 26
Time to First Composite Cardiovascular Safety AE
Safety
Time to first composite cardiovascular AE was defined as the actual time in days from first dose of treatment until the date of the composite cardiovascular AE. For subjects not reporting a composite cardiovascular AE, the time was censored at the date of the last attended visit. Only the adjudicated and confirmed composite cardiovascular safety AEs, as judged by the Clinical Endpoint Adjudication Committee (CEAC), were considered for this endpoint.
Time to first composite cardiovascular AE was defined as the actual time in days from first dose of treatment until the date of the composite cardiovascular AE. For subjects not reporting a composite cardiovascular AE, the time was censored at the date of the last attended visit.
Measured: Baseline, week 2, 13, and 26
S-phosphate <2 mg/dL at Any Time From Baseline to Week 26
Safety
Results show the number of trial participants and their status of s-phosphate <2 mg/dL, at any time from baseline to week 26.
Measured: Baseline to week 26
Change in Hb From Baseline to Week 2, 13, and 26
Efficacy.
Change in Hb from baseline to week 2, 13, and 26.
Measured: Baseline, week 2, 13, and 26
Change in S-ferritin From Baseline to Week 2, 13, and 26
Efficacy.
Change in s-ferritin from baseline to week 2, 13, and 26.
Measured: Baseline, week 2, 13, and 26
Change in Transferrin Saturation (TSAT) From Baseline to Week 2, 13, and 26
Efficacy
Change in transferrin saturation (TSAT) from baseline to week 2, 13, and 26.
TSAT is the value of serum iron divided by the total iron-binding capacity and the unit is %, which referrers to % of iron-binding sites of transferrin being occupied by iron.
Measured: Baseline, week 2, 13, and 26
Change in S-iron From Baseline to Week 2, 13, and 26
Efficacy.
Change in s-iron from baseline to week 2, 13, and 26.
Measured: Baseline, week 2, 13, and 26
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Nov 2016 (estimated)
- Study start9 Jan 2017
- Primary completion12 Jun 2018
- Study completion12 Jun 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 103 participants (actual)
Sponsor and investigators
- Lead sponsor
- Pharmacosmos A/S
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Pharmacosmos A/S Clinical and Non-clinical Research, Study director, Pharmacosmos A/S
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02962648
- Sponsor's protocol ID
- P-Monofer-IDA/CKD-EXT-01
- Acronym
- FERWON-EXT
- Status last verified
- Jan 2020
- First submitted
- 9 Nov 2016
- Last updated
- 10 Mar 2020
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Mar 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open-label, Multicentre, Extension Trial to Assess the Safety of Re-dosing of Intravenous Iron Isomaltoside/Ferric Derisomaltose (Monofer®/Monoferric®)
- ClinicalTrials.gov ID
- NCT02962648
- Acronym / sponsor ID
- FERWON-EXT / P-Monofer-IDA/CKD-EXT-01
- Conditions
- Iron Deficiency Anemia, Iron Deficiency Anaemia
- Keywords
- Iron Deficiency Anemia, Iron Deficiency Anaemia, IDA, Intravenous iron replacement therapy, Chronic Kidney Disease, CKD, Iron isomaltoside, Ferric derisomaltose
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 103 participants (actual)
- Lead sponsor
- Pharmacosmos A/SIndustry (pharma, biotech, devices)
- Study start
- 9 Jan 2017 (actual)
- Primary completion
- 12 Jun 2018 (actual)
- Study completion
- 12 Jun 2018 (actual)
- First posted
- 11 Nov 2016 (estimated)
- Results
- Posted 10 Mar 2020
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Evaluate safety and efficacy of intravenous (IV) iron isomaltoside/ferric derisomaltose re-dosing, in subjects who were previously treated with iron isomaltoside/ferric derisomaltose.
Detailed description
Among the various formulations of parenteral iron that are currently available, iron isomaltoside/ferric derisomaltose may allow flexibility in terms of high and rapid dosing. Up to now, most clinical trials with intravenous (IV) iron treatment were of 4-12 weeks in duration; longer trials are warranted to follow-up on long-term safety.
The aim of the trial was to evaluate the safety and efficacy of IV iron isomaltoside/ferric derisomaltose re-dosing in subjects who were previously treated with iron isomaltoside/ferric derisomaltose in lead-in trials.
This was a 6-months extension trial lasting 26 weeks. Eligible subjects attended 5 visits: screening, baseline (subjects treated with a single IV dose of 1000 mg iron isomaltoside/ferric derisomaltose), and follow-up visits at week 2, 13, and 26 weeks after the IV dose, for safety and efficacy assessments.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Iron isomaltoside/ferric derisomaltose | Experimental | Drug: Iron isomaltoside/ferric derisomaltoseAdministered IV |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Completed one of the lead-in trials
- Randomised and dosed with iron isomaltoside/ferric derisomaltose in one of the lead-in trials.
- Haemoglobin (Hb) of ≤ 11 g/dL
- Screening serum ferritin (s-ferritin) ≤ 100 ng/mL, or ≤ 300 ng/mL if transferrin saturation (TSAT) ≤ 30 %
- Willingness to participate and signing the informed consent form (ICF)
Key exclusion criteria (6 listed)
- Intravenous (IV) iron treatment between the lead-in trial and screening
- During 30-day period prior to screening or during the trial period; has or will be treated with a red blood cell transfusion, radiotherapy, and/or chemotherapy
- Received an investigational drug within 30 days of screening
- Decompensated liver cirrhosis or active hepatitis
- Pregnant or nursing women.
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/ferric derisomaltoseAlso: Monofer®, Monoferric®, Monover®, Monofar®, Monoferro®Iron isomaltoside/ferric derisomaltose (Monofer®/Monoferric®; 100 mg/mL) was the test product in this trial. The dose of iron isomaltoside/ferric derisomaltose for the individual subject was set to 1000 mg. The dose was diluted in 100 mL 0.9 % sodium chloride from the site's supply and administered over approximately 20 minutes using IV infusion. | Drug | Iron isomaltoside/ferric derisomaltose |
Primary outcome
Number of Subjects With Adverse Drug Reactions (ADR)
Time frame: Baseline to week 26
Safety Evaluate the number of subjects with adverse drug reactions (ADRs), defined as AEs that were assessed by the investigator as related or possible related to the investigational product.
8 secondary outcomes
Incidence of Protocol-defined Serious or Severe Hypersensitivity Reactions
Time frame: Baseline to week 26
Composite Cardiovascular Adverse Events (AEs)
Time frame: Baseline to week 26
Time to First Composite Cardiovascular Safety AE
Time frame: Baseline, week 2, 13, and 26
S-phosphate <2 mg/dL at Any Time From Baseline to Week 26
Time frame: Baseline to week 26
Change in Hb From Baseline to Week 2, 13, and 26
Time frame: Baseline, week 2, 13, and 26
Change in S-ferritin From Baseline to Week 2, 13, and 26
Time frame: Baseline, week 2, 13, and 26
Change in Transferrin Saturation (TSAT) From Baseline to Week 2, 13, and 26
Time frame: Baseline, week 2, 13, and 26
Change in S-iron From Baseline to Week 2, 13, and 26
Time frame: Baseline, week 2, 13, and 26
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Mar 2020.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- 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.
Pharmacosmos A/S Clinical and Non-clinical Research study director
Pharmacosmos A/S
22 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Iron isomaltoside/ferric derisomaltose in people with Iron Deficiency Anemia and Iron Deficiency Anaemia, run by Pharmacosmos A/S at 22 sites in United States.
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 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: finished, as of the sponsor's last update on 10 Mar 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 22 sites in United States. 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?
Yes. Results are posted in the registry (first posted 10 Mar 2020). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Number of Subjects With Adverse Drug Reactions (ADR) (time frame: Baseline to week 26). 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 10 Mar 2020.