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NCT05768997 | RECRUITING | Anemia

High Dose IV Iron Plus ESA in Chemotherapy-induced Anemia
Sponsor:

Hallym University Medical Center

Information provided by (Responsible Party):

Zang, Dae Young

Brief 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.

Condition or disease

Anemia

Intervention/treatment

Ferric Derisomaltose Injection

Darbepoetin Alfa Injection

Phase

PHASE3

Study Type : INTERVENTIONAL
Estimated Enrollment : 312 participants
Masking : NONE
Primary Purpose : TREATMENT
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
Actual Study Start Date : 2023-03-01
Estimated Primary Completion Date : 2025-12-31
Estimated Study Completion Date : 2025-12-31

Information not available for Arms and Intervention/treatment

Ages Eligible for Study: 19 Years
Sexes Eligible for Study: ALL
Accepts Healthy Volunteers:
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
High Dose IV Iron Plus ESA in Chemotherapy-induced Anemia

Location Details

NCT05768997

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Locations

RECRUITING

South Korea,

Hallym University Medical Center

That's it, South Korea,