AnemiaPhase 3NCT05768997
High Dose IV Iron Plus ESA in Chemotherapy-induced Anemia
A Phase 3 study testing Ferric Derisomaltose Injection and Darbepoetin Alfa Injection in people with Anemia, run by Hallym University Medical Center at 1 site in South Korea.
Trial summary
This study is a multicenter, prospective, randomized phase 3 clinical study comparing the efficacy and safety of the combination treatment of ESA and high-dose IV iron (darbepoietin alfa + ferric derisomaltose/iron isomaltoside) with ESA monotherapy (darbepoietin alfa alone) in CIA patients with functional iron… Read more about this study
- Who is it for?
- Ages 19 years and older
- Conditions the study is for
- Anemia
- What is being tested?
- Ferric Derisomaltose Injection and Darbepoetin Alfa Injection
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 312 participants
- Where
- 1 siteSouth Korea
- Study dates
- 1 Mar 2023to 31 Dec 2025
- 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 19 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patient who has signed a written consent
- Age ≥ 19 ③ Histologically diagnosed advanced/metastatic solid cancer
- Patients who have received myelosuppressive chemotherapy for palliative purposes within 1 month of participating in the study and plan to proceed with chemotherapy while participating in this study
- Anemia with functional iron deficiency
- Hemoglobin <10g/dL
- functional iron deficiency: transferrin saturation <50% AND serum ferritin 30-800ng/mL ⑤ ECOG performance status 0-2 ⑥ life expectancy ≥ 24weeks
Who cannot join
- Absolute iron deficiency (serum ferritin <30 ng/mL AND transferrin saturation <20%) or no iron deficiency (serum ferritin ≥800 ng/mL OR transferrin saturation ≥50%)
- If there is another cause of anemia other than chemotherapy-induced anemia (eg, vitamin B12 or folic acid deficiency, hemolytic anemia, myelodysplastic syndrome, etc.)
- Ongoing bleeding at the time of study registration
- Patients who require rapid blood transfusion at the time of study registration (eg, rapidly progressing anemia)
- Presence of bone marrow tumor invasion
- Receiving erythropoiesis stimulating agents within 3 weeks of study registration or have a history of oral or intravenous iron administration or blood transfusion within 2 weeks of study registration
- History of venous thromboembolism within 6 months or taking anticoagulants at the time of study registration
- Past or family history of hemochromatosis ⑨ History of hypersensitivity to iron treatment or erythropoiesis stimulating agents ⑩ Uncontrolled acute or chronic infection ⑪ Renal dysfunction (serum creatinine ≥2.0 mg/dL, or glomerular filtration rate <30 mL/min/1.73 m2) or liver dysfuction (AST or ALT 3 times or more the upper limit of normal) ⑫ Pregnant or lactating women
Trial locations and contacts
1 site in 1 country.
South Korea1 site, 1 recruiting
- Recruiting
Hallym University Medical Center
Anyang-si
Dae Young Zang, +82-31-380-3704, fhdzang@hallym.or.kr
About this study
Official title: Prospective, Multicenter, Randomized Phase 3 Trial of High Dose IV Iron in Combination of Erythrocytosis Stimulating Agents in Chemotherapy Induced Anemia With Functional Iron Deficiency
This study is a multicenter, prospective, randomized phase 3 clinical study comparing the efficacy and safety of the combination treatment of ESA and high-dose IV iron (darbepoietin alfa + ferric derisomaltose/iron isomaltoside) with ESA monotherapy (darbepoietin alfa alone) in CIA patients with functional iron deficiency.
- Conditions
- Anemia
- Being tested
- Ferric Derisomaltose Injection, Darbepoetin Alfa Injection
- Medical subject headings
- Anemia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ferric Derisomaltose InjectionDrug
Ferric derisomaltose/iron isomaltoside (as iron) (0 weeks): 20mg/kg, diluted in 250ml of 0.9% physiological saline and injected intravenously over 30-60 minutes
Darbepoetin Alfa InjectionDrug
Darbepoietin alfa (0 weeks, 3 weeks, 6 weeks, 9 weeks): 6.75㎍/kg, subcutaneous or intravenous administration
| Study group | Role | What they receive |
|---|---|---|
| High dose IV iron plus ESA combination arm | Experimental | Not described Receives: Drug: Ferric Derisomaltose Injection; Drug: Darbepoetin Alfa Injection |
| ESA monotherapy arm | Active comparator | Not described Receives: Drug: Darbepoetin Alfa Injection |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mean Hb change
Mean change in Hb concentration from baseline to 12 weeks
Measured: from baseline to 12 weeks
Secondary outcomes (5)
Hemoglobin response
defined as an increase in Hb level of 2.0g/dL≥ from baseline value during 12-week study period
Measured: during 12-week study period
Time to hemoglobin response
Measured: during 12-week study period
Proportion of patients requiring RBC transfusion during 12-week study period
Measured: during 12-week study period
Quality of life assessment by Functional Assessment of Cancer Therapy-Anemia (FACT-An)/health-related quality of life instrument with 8 items (HINT-8)/EQ-5D-5L
Measured: during 12-week study period
Safety analysis
Adverse events including AE of special interst (Anaphylaxis, Infusion reaction, Thromboembolic event)
Measured: during 12-week study period
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Mar 2023
- Study start1 Mar 2023
- Primary completion31 Dec 2025 (estimated)
- Study completion31 Dec 2025 (estimated)
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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 312 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hallym University Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Zang, Dae Young, Hallym University Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05768997
- Sponsor's protocol ID
- HIGHEST-CIA
- Status last verified
- Mar 2023
- First submitted
- 18 Oct 2022
- Last updated
- 15 Mar 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective, Multicenter, Randomized Phase 3 Trial of High Dose IV Iron in Combination of Erythrocytosis Stimulating Agents in Chemotherapy Induced Anemia With Functional Iron Deficiency
- ClinicalTrials.gov ID
- NCT05768997
- Acronym / sponsor ID
- HIGHEST-CIA
- Conditions
- Anemia
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 312 participants (estimated)
- Lead sponsor
- Hallym University Medical CenterUniversity, hospital or other
- Study start
- 1 Mar 2023 (actual)
- Primary completion
- 31 Dec 2025 (estimated)
- Study completion
- 31 Dec 2025 (estimated)
- First posted
- 15 Mar 2023 (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.
This study is a multicenter, prospective, randomized phase 3 clinical study comparing the efficacy and safety of the combination treatment of ESA and high-dose IV iron (darbepoietin alfa + ferric derisomaltose/iron isomaltoside) with ESA monotherapy (darbepoietin alfa alone) in CIA patients with functional iron deficiency.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| High dose IV iron plus ESA combination arm | Experimental | Drug: Ferric Derisomaltose Injection, Drug: Darbepoetin Alfa Injection |
| ESA monotherapy arm | Active comparator | Drug: Darbepoetin Alfa Injection |
Who may qualify
- Ages
- 19 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Patient who has signed a written consent
Key exclusion criteria (8 listed)
- Absolute iron deficiency (serum ferritin <30 ng/mL AND transferrin saturation <20%) or no iron deficiency (serum ferritin ≥800 ng/mL OR transferrin saturation ≥50%)
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 InjectionFerric derisomaltose/iron isomaltoside (as iron) (0 weeks): 20mg/kg, diluted in 250ml of 0.9% physiological saline and injected intravenously over 30-60 minutes | Drug | High dose IV iron plus ESA combination arm |
| Darbepoetin Alfa InjectionDarbepoietin alfa (0 weeks, 3 weeks, 6 weeks, 9 weeks): 6.75㎍/kg, subcutaneous or intravenous administration | Drug | ESA monotherapy arm, High dose IV iron plus ESA combination arm |
Primary outcome
Mean Hb change
Time frame: from baseline to 12 weeks
Mean change in Hb concentration from baseline to 12 weeks
5 secondary outcomes
Hemoglobin response
Time frame: during 12-week study period
Time to hemoglobin response
Time frame: during 12-week study period
Proportion of patients requiring RBC transfusion during 12-week study period
Time frame: during 12-week study period
Quality of life assessment by Functional Assessment of Cancer Therapy-Anemia (FACT-An)/health-related quality of life instrument with 8 items (HINT-8)/EQ-5D-5L
Time frame: during 12-week study period
Safety analysis
Time frame: during 12-week study period
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Mar 2023.
- 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.
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 Ferric Derisomaltose Injection and Darbepoetin Alfa Injection in people with Anemia, run by Hallym University Medical Center at 1 site in South Korea.
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 8 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: status not confirmed, as of the sponsor's last update on 15 Mar 2023. 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 South Korea. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Dae Young Zang, Ph.D. (+82-31-380-3704, fhdzang@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Mean Hb change (time frame: from baseline to 12 weeks). 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 15 Mar 2023.