Last updated: March 13, 2023
Sponsor: Hallym University Medical Center
Overall Status: Active - Recruiting
Phase
3
Condition
Anemia
Treatment
N/AClinical Study ID
NCT05768997
HIGHEST-CIA
Ages > 19 All Genders
Study Summary
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
- Hemoglobin <10g/dL
- 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 ofActive - Recruiting

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