High Dose IV Iron Plus ESA in Chemotherapy-induced Anemia

NCT ID: NCT05768997

Last Updated: 2023-03-15

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: PHASE3
• Total Enrollment: 312 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-03-01
• Study Completion Date: 2025-12-31

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.

Conditions

Anemia

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

High dose IV iron plus ESA combination arm

Group Type: EXPERIMENTAL

Ferric Derisomaltose Injection

Intervention Type: DRUG

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

Darbepoetin Alfa Injection

Intervention Type: DRUG

Darbepoietin alfa (0 weeks, 3 weeks, 6 weeks, 9 weeks): 6.75㎍/kg, subcutaneous or intravenous administration

ESA monotherapy arm

Group Type: ACTIVE_COMPARATOR

Darbepoetin Alfa Injection

Intervention Type: DRUG

Darbepoietin alfa (0 weeks, 3 weeks, 6 weeks, 9 weeks): 6.75㎍/kg, subcutaneous or intravenous administration

Interventions

Ferric Derisomaltose Injection

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

Intervention Type: DRUG

Darbepoetin Alfa Injection

Darbepoietin alfa (0 weeks, 3 weeks, 6 weeks, 9 weeks): 6.75㎍/kg, subcutaneous or intravenous administration

Intervention Type: DRUG

Eligibility 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

• Minimum Eligible Age: 19 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Hallym University Medical Center

OTHER

Sponsor Role: lead

Responsible Party

Zang, Dae Young

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Hallym University Medical Center

Anyang-si, , South Korea

Site Status: RECRUITING

Countries

South Korea

Central Contacts

Dae Young Zang, Ph.D.

Role: CONTACT

fhdzang@gmail.com

+82-31-380-3704

Facility Contacts

Dae Young Zang

Role: primary

fhdzang@hallym.or.kr

+82-31-380-3704

Other Identifiers

HIGHEST-CIA

Identifier Type: -

Identifier Source: org_study_id