High Dose IV Iron Plus ESA in Chemotherapy-induced Anemia

Phase 3

Recruiting

• Conditions: Anemia
• Interventions: Drug: Darbepoetin Alfa Injection; Drug: Ferric Derisomaltose Injection

• Registration Number: NCT05768997
• Lead Sponsor: Hallym University Medical Center

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2022-10-18
• Status Verified: 2023-03
• Study Start: 2023-03-01
• Study First Submitted QC: 2023-03-13
• Last Update Submitted: 2023-03-13
• Study First Posted: 2023-03-15
• Last Update Posted: 2023-03-15
• Primary Completion: 2025-12-31
• Study Completion: 2025-12-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 312

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
ESA monotherapy arm	Darbepoetin Alfa Injection	-
High dose IV iron plus ESA combination arm	Darbepoetin Alfa Injection	-
High dose IV iron plus ESA combination arm	Ferric Derisomaltose Injection	-

Primary Outcome Measures

Name	Time	Method
Mean Hb change	from baseline to 12 weeks	Mean change in Hb concentration from baseline to 12 weeks

Secondary Outcome Measures

Name	Time	Method
Time to hemoglobin response	during 12-week study period
Proportion of patients requiring RBC transfusion during 12-week study period	during 12-week study period
Safety analysis	during 12-week study period	Adverse events including AE of special interst (Anaphylaxis, Infusion reaction, Thromboembolic event)
Quality of life assessment by Functional Assessment of Cancer Therapy-Anemia (FACT-An)/health-related quality of life instrument with 8 items (HINT-8)/EQ-5D-5L	during 12-week study period
Hemoglobin response	during 12-week study period	defined as an increase in Hb level of 2.0g/dL≥ from baseline value during 12-week study period

Trial Locations

Locations (1)

Hallym University Medical Center; 🇰🇷 Anyang-si, Korea, Republic of