High Dose IV Iron Plus ESA in Chemotherapy-induced Anemia

NCT05768997 | Unknown Phase 3

• 1 other identifier: HIGHEST-CIA
• Study Type: interventional
• Target: 312
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (1)

• Mean Hb change

  Mean change in Hb concentration from baseline to 12 weeks

  from baseline to 12 weeks

Secondary Outcomes (5)

• Hemoglobin response

  during 12-week study period

• 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

• 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

• Safety analysis

  during 12-week study period

Study Arms (2)

High dose IV iron plus ESA combination arm

EXPERIMENTAL

Drug: Ferric Derisomaltose Injection; Drug: Darbepoetin Alfa Injection

ESA monotherapy arm

ACTIVE COMPARATOR

Drug: Darbepoetin Alfa Injection

Interventions

Ferric Derisomaltose Injection 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

High dose IV iron plus ESA combination arm

Darbepoetin Alfa Injection DRUG

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

ESA monotherapy arm; High dose IV iron plus ESA combination arm

Eligibility Criteria

• Age: 19 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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
• Hemoglobin \<10g/dL
• functional iron deficiency: transferrin saturation \<50% AND serum ferritin 30-800ng/mL ⑤ ECOG performance status 0-2 ⑥ life expectancy ≥ 24weeks

You may not qualify if:

• 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

Sponsors & Collaborators

• Hallym University Medical Center: lead

Study Sites (1)

Hallym University Medical Center

Anyang-si, South Korea

RECRUITING

MeSH Terms

Conditions

Anemia

Interventions

ferric derisomaltose; Darbepoetin alfa

Condition Hierarchy (Ancestors)

Hematologic Diseases; Hemic and Lymphatic Diseases

Intervention Hierarchy (Ancestors)

Erythropoietin; Colony-Stimulating Factors; Glycoproteins; Glycoconjugates; Carbohydrates; Proteins; Amino Acids, Peptides, and Proteins

Central Study Contacts

Dae Young Zang, Ph.D.

CONTACT

+82-31-380-3704; fhdzang@gmail.com

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: October 18, 2022
• First Posted: March 15, 2023
• Study Start: March 1, 2023
• Primary Completion: December 31, 2025
• Study Completion: December 31, 2025
• Last Updated: March 15, 2023

Record last verified: 2023-03

Data Sharing

• IPD Sharing: Will not share

Locations

KR (1)