High Dose IV Iron Plus ESA in Chemotherapy-induced Anemia

Hallym University

Status and phase

Enrolling

Phase 3

Conditions

Anemia

Treatments

Drug: Ferric Derisomaltose Injection

Drug: Darbepoetin Alfa Injection

Study type

Interventional

Funder types

Other

Identifiers

NCT05768997

HIGHEST-CIA

Details and patient eligibility

About

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.

Enrollment

312 estimated patients

Sex

All

Ages

19+ years old

Volunteers

No Healthy Volunteers

Inclusion and exclusion criteria

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
    1. Hemoglobin <10g/dL
    2. 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