AnemiaPhase 1NCT03013439
Dose-escalation Trial of the Safety, Pharmacokinetics, and Pharmacodynamics of Iron Isomaltoside (Monofer®)
A Phase 1 study testing Iron Isomaltoside in people with Anemia and Deficiency Diseases, run by Pharmacosmos A/S at 1 site in Japan.
Trial summary
The trial is an open-label, 4 cohorts, sequential, dose-escalating, single dose trial. Read more about this study
- Who is it for?
- Ages 20 to 64 years
- Conditions the study is for
- Anemia, Deficiency Diseases, Anemia, Iron Deficiency
- What is being tested?
- Iron Isomaltoside
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- 1 siteJapan
- Study dates
- 6 Jan 2017to 4 Jun 2017
- Phase
- Phase 1
- 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 20 to 64 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Japanese man or woman ≥ 20 years, < 65 years of age
- Hb of ≥ 9.0 g/dL, < 12.0 g/dL for women and < 13.0 g/dL for men
- Serum ferritin < 25 ng/mL
- TIBC ≥ 360 μg/dL
- Body weight ≥ 50 kg
- Willingness to participate and signing the informed consent form
Who cannot join
- Anemia caused by conditions other than iron deficiency
- Cancer
- IV or oral iron treatment, or blood transfusion 4 weeks prior to screening
- Erythropoiesis stimulating agent (ESA) treatment prior to screening
- Imminent expectation of blood transfusion on part of treating physician
- Iron overload or disturbances (e.g. hemochromatosis and hemo-siderosis)
Show all 11Show fewer
- Known hypersensitivity reaction to iv iron preparations
- Decompensated liver cirrhosis or active hepatitis
- Active acute or chronic infections
- Pregnant or nursing women.
- Planned elective surgery during the trial
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Phase I Dose-escalation Trial of the Safety, Pharmacokinetics, and Pharmacodynamics of Iron Isomaltoside (Monofer®) Administered as Single Bolus Injections or Infusions in Japanese Subjects With Iron Deficiency Anemia
The trial is an open-label, 4 cohorts, sequential, dose-escalating, single dose trial.
Read the detailed description
IDA is highly prevalent in subjects with cancer and gastrointestinal diseases such as inflammatory bowel diseases, menstruating or pregnant women, and subjects who have undergone bariatric procedure. IDA can have a substantial medical and quality of life (QoL) burden on the subjects, and treatment of these subjects includes controlling the bleeding and replenishing lost iron.
- Conditions
- Anemia, Deficiency Diseases, Anemia, Iron Deficiency, Hematologic Disease, Iron Metabolism Disorders
- Being tested
- Iron Isomaltoside
- Medical subject headings
- Anemia, Deficiency Diseases, Anemia, Iron-Deficiency, Hematologic Diseases, Iron Metabolism Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Iron IsomaltosideDrug
Also called Monofer
The trial is a dose escalating trial.
| Study group | Role | What they receive |
|---|---|---|
| cohort 1 iron isomaltoside | Experimental | treated with first dose level of iron isomaltoside Receives: Drug: Iron Isomaltoside |
| cohort 2 iron isomaltoside | Experimental | treated with second dose level of iron isomaltoside Receives: Drug: Iron Isomaltoside |
| cohort 3 iron isomaltoside | Experimental | treated with third dose level of iron isomaltoside Receives: Drug: Iron Isomaltoside |
| cohort 4 iron isomaltoside | Experimental | treated with fourth dose level of iron isomaltoside Receives: Drug: Iron Isomaltoside |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of adverse events
Proportion of adverse events will be collected and evaluated for relatedness, severity, seriousness, and expectedness.
Measured: 1 week
Secondary outcomes (8)
Maximum plasma drug concentration [Cmax]
Measured: 1 week
Area Under the Curve [AUC]
Measured: 1 week
Time to reach one-half of the maximum drug concentration [T1/2]
Measured: 1 week
Time to reach maximum drug concentration [Tmax]
Measured: 1week
Change in concentration of hemoglobin (g/dL)
Measured: 1 week
Change in concentration of serum ferritin (ng/mL)
Measured: 1 week
Change in concentration of total iron binding capacity (μg/dL )
Measured: 1 week
Change in concentrations of transferrin saturation (%)
Measured: 1 week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jan 2017 (estimated)
- Study start6 Jan 2017
- Primary completion4 Jun 2017
- Study completion4 Jun 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for 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 1
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 24 participants (actual)
Sponsor and investigators
- Lead sponsor
- Pharmacosmos A/S
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03013439
- Sponsor's protocol ID
- P-Monofer-PK-IDA-01
- Status last verified
- Jan 2017
- First submitted
- 22 Dec 2016
- Last updated
- 12 Dec 2017
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Dec 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase I Dose-escalation Trial of the Safety, Pharmacokinetics, and Pharmacodynamics of Iron Isomaltoside (Monofer®) Administered as Single Bolus Injections or Infusions in Japanese Subjects With Iron Deficiency Anemia
- ClinicalTrials.gov ID
- NCT03013439
- Acronym / sponsor ID
- P-Monofer-PK-IDA-01
- Conditions
- Anemia, Deficiency Diseases, Anemia, Iron Deficiency, Hematologic Disease, Iron Metabolism Disorders
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- Pharmacosmos A/SIndustry (pharma, biotech, devices)
- Study start
- 6 Jan 2017 (actual)
- Primary completion
- 4 Jun 2017 (actual)
- Study completion
- 4 Jun 2017 (actual)
- First posted
- 6 Jan 2017 (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 trial is an open-label, 4 cohorts, sequential, dose-escalating, single dose trial.
Detailed description
IDA is highly prevalent in subjects with cancer and gastrointestinal diseases such as inflammatory bowel diseases, menstruating or pregnant women, and subjects who have undergone bariatric procedure. IDA can have a substantial medical and quality of life (QoL) burden on the subjects, and treatment of these subjects includes controlling the bleeding and replenishing lost iron.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| cohort 1 iron isomaltoside | Experimental | Drug: Iron Isomaltosidetreated with first dose level of iron isomaltoside |
| cohort 2 iron isomaltoside | Experimental | Drug: Iron Isomaltosidetreated with second dose level of iron isomaltoside |
| cohort 3 iron isomaltoside | Experimental | Drug: Iron Isomaltosidetreated with third dose level of iron isomaltoside |
| cohort 4 iron isomaltoside | Experimental | Drug: Iron Isomaltosidetreated with fourth dose level of iron isomaltoside |
Who may qualify
- Ages
- 20 to 64 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- Japanese man or woman ≥ 20 years, < 65 years of age
- Hb of ≥ 9.0 g/dL, < 12.0 g/dL for women and < 13.0 g/dL for men
- Serum ferritin < 25 ng/mL
- TIBC ≥ 360 μg/dL
- Body weight ≥ 50 kg
Key exclusion criteria (11 listed)
- Anemia caused by conditions other than iron deficiency
- Cancer
- IV or oral iron treatment, or blood transfusion 4 weeks prior to screening
- Erythropoiesis stimulating agent (ESA) treatment prior to screening
- Imminent expectation of blood transfusion on part of treating physician
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 IsomaltosideAlso: MonoferThe trial is a dose escalating trial. | Drug | cohort 1 iron isomaltoside, cohort 2 iron isomaltoside, cohort 3 iron isomaltoside, cohort 4 iron isomaltoside |
Primary outcome
Proportion of adverse events
Time frame: 1 week
Proportion of adverse events will be collected and evaluated for relatedness, severity, seriousness, and expectedness.
8 secondary outcomes
Maximum plasma drug concentration [Cmax]
Time frame: 1 week
Area Under the Curve [AUC]
Time frame: 1 week
Time to reach one-half of the maximum drug concentration [T1/2]
Time frame: 1 week
Time to reach maximum drug concentration [Tmax]
Time frame: 1week
Change in concentration of hemoglobin (g/dL)
Time frame: 1 week
Change in concentration of serum ferritin (ng/mL)
Time frame: 1 week
Change in concentration of total iron binding capacity (μg/dL )
Time frame: 1 week
Change in concentrations of transferrin saturation (%)
Time frame: 1 week
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 12 Dec 2017.
- Individual participant dataSharing planned: No
Related trials for Anemia
RecruitingPhase 1/2
The Safety and Efficacy of Daratumumab in Patients With Refractory Aplastic Anemia
Aplastic Anemia, Refractory
Active, not recruitingPhase 1
A Study of YTS109 Cell Injection in Subjects With Relapsed/Refractory Autoimmune Hemolytic Anemia
Autoimmune Hemolytic Anemia, Anti-CD19 STAR T-cell Therapy
Not yet recruitingObservational study
Systematic Intraoperative Cell Salvage in On-Pump Cardiac Surgery Within a Mature Patient Blood Management Programme
Cardiac Surgical Procedures, Blood Transfusion
RecruitingPhase 1/2
Pacritinib, a Kinase Inhibitor of CSF1R, IRAK1, JAK2, and FLT3, in Adults and Pediatric Participants 12 Years of Age or Older With Myelodysplastic Syndromes or Myelodysplastic/Myeloproliferative Neoplasms
Myelodysplastic Syndromes
RecruitingObservational study
Defining the Natural History of Squamous Cell Carcinoma in Fanconi Anemia
Fanconi Anemia, Inherited Bone Marrow Failure Syndrome
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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Iron Isomaltoside in people with Anemia and Deficiency Diseases, run by Pharmacosmos A/S at 1 site in Japan.
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 6 inclusion and 11 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 12 Dec 2017. 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 Japan. 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 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
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 adverse events (time frame: 1 week). 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 12 Dec 2017.