High Dose IV Iron Plus ESA in Chemotherapy-induced Anemia

Study Overview
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Brief Summary
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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.

Official Title
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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

Conditions
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Anemia

Intervention / Treatment
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* Drug: Ferric Derisomaltose Injection
* Drug: Darbepoetin Alfa Injection


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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 Exclusion Criteria: 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

Ages Eligible for Study
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Minimum Age: 19 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: High dose IV iron plus ESA combination arm<br> | Drug: Ferric Derisomaltose Injection<br>* 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<br>Drug: Darbepoetin Alfa Injection<br>* Darbepoietin alfa (0 weeks, 3 weeks, 6 weeks, 9 weeks): 6.75㎍/kg, subcutaneous or intravenous administration<br>|
| Active Comparator: ESA monotherapy arm<br> | Drug: Darbepoetin Alfa Injection<br>* Darbepoietin alfa (0 weeks, 3 weeks, 6 weeks, 9 weeks): 6.75㎍/kg, subcutaneous or intravenous administration<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mean Hb change | Mean change in Hb concentration from baseline to 12 weeks | from baseline to 12 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Hemoglobin response | defined as an increase in Hb level of 2.0g/dL≥ from baseline value during 12-week study period | during 12-week study period | 
| Time to hemoglobin response |  | during 12-week study period | 
| Proportion of patients requiring RBC transfusion during 12-week study period |  | 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 |  | during 12-week study period | 
| Safety analysis | Adverse events including AE of special interst (Anaphylaxis, Infusion reaction, Thromboembolic event) | during 12-week study period |