High Dose IV Iron Plus ESA in Chemotherapy-induced Anemia

Last updated: March 13, 2023
Sponsor: Hallym University Medical Center
Overall Status: Active - Recruiting

Phase

3

Condition

Anemia

Treatment

N/A

Clinical Study ID

NCT05768997
HIGHEST-CIA
  • Ages > 19
  • All Genders

Study 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 deficiency.

Eligibility Criteria

Inclusion

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 palliativepurposes within 1 month of participating in the study and plan to proceedwith chemotherapy while participating in this study
  • Anemia with functional iron deficiency
  1. Hemoglobin <10g/dL
  2. functional iron deficiency: transferrin saturation <50% AND serumferritin 30-800ng/mL ⑤ ECOG performance status 0-2 ⑥ life expectancy ≥ 24weeks

Exclusion

Exclusion Criteria:

  • Absolute iron deficiency (serum ferritin <30 ng/mL AND transferrin saturation <20%) orno 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 studyregistration (eg, rapidly progressing anemia)
  • Presence of bone marrow tumor invasion
  • Receiving erythropoiesis stimulating agents within 3 weeks ofstudy registration or have a history of oral or intravenousiron administration or blood transfusion within 2 weeks ofstudy registration
  • History of venous thromboembolism within 6 months ortaking anticoagulants at the time of study registration
  • Past or family history of hemochromatosis ⑨ Historyof hypersensitivity to iron treatment orerythropoiesis stimulating agents ⑩ Uncontrolledacute or chronic infection ⑪ Renal dysfunction (serum creatinine ≥2.0 mg/dL, or glomerularfiltration rate <30 mL/min/1.73 m2) or liverdysfuction (AST or ALT 3 times or more the upperlimit of normal) ⑫ Pregnant or lactating women

Study Design

Total Participants: 312
Study Start date:
March 01, 2023
Estimated Completion Date:
December 31, 2025

Connect with a study center

  • Hallym University Medical Center

    Anyang-si,
    Korea, Republic of

    Active - Recruiting

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