Anemia
Conditions
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.
Interventions
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
Darbepoietin alfa (0 weeks, 3 weeks, 6 weeks, 9 weeks): 6.75㎍/kg, subcutaneous or intravenous administration
Sponsors
Hallym University Medical Center
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
19 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Mean Hb change | from baseline to 12 weeks | Mean change in Hb concentration from baseline to 12 weeks |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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 |
| 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 | Adverse events including AE of special interst (Anaphylaxis, Infusion reaction, Thromboembolic event) |
Countries
South Korea
Contacts
Primary ContactDae Young Zang, Ph.D.
Outcome results
None listed