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High Dose IV Iron Plus ESA in Chemotherapy-induced Anemia

Primary Purpose

Anemia

Status
Recruiting
Phase
Phase 3
Locations
Korea, Republic of
Study Type
Interventional
Intervention
Ferric Derisomaltose Injection
Darbepoetin Alfa Injection
Sponsored by
Hallym University Medical Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Anemia

Eligibility Criteria

19 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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 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 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

Sites / Locations

  • Hallym University Medical CenterRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

High dose IV iron plus ESA combination arm

ESA monotherapy arm

Arm Description

Outcomes

Primary Outcome Measures

Mean Hb change
Mean change in Hb concentration from baseline to 12 weeks

Secondary Outcome Measures

Hemoglobin response
defined as an increase in Hb level of 2.0g/dL≥ from baseline value during 12-week study period
Time to hemoglobin response
Proportion of patients requiring RBC transfusion 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
Safety analysis
Adverse events including AE of special interst (Anaphylaxis, Infusion reaction, Thromboembolic event)

Full Information

First Posted
October 18, 2022
Last Updated
March 13, 2023
Sponsor
Hallym University Medical Center
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1. Study Identification

Unique Protocol Identification Number
NCT05768997
Brief Title
High Dose IV Iron Plus ESA in Chemotherapy-induced Anemia
Official Title
Prospective, Multicenter, Randomized Phase 3 Trial of High Dose IV Iron in Combination of Erythrocytosis Stimulating Agents in Chemotherapy Induced Anemia With Functional Iron Deficiency
Study Type
Interventional

2. Study Status

Record Verification Date
March 2023
Overall Recruitment Status
Recruiting
Study Start Date
March 1, 2023 (Actual)
Primary Completion Date
December 31, 2025 (Anticipated)
Study Completion Date
December 31, 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Hallym University Medical Center

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Anemia

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
312 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
High dose IV iron plus ESA combination arm
Arm Type
Experimental
Arm Title
ESA monotherapy arm
Arm Type
Active Comparator
Intervention Type
Drug
Intervention Name(s)
Ferric Derisomaltose Injection
Intervention Description
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
Intervention Name(s)
Darbepoetin Alfa Injection
Intervention Description
Darbepoietin alfa (0 weeks, 3 weeks, 6 weeks, 9 weeks): 6.75㎍/kg, subcutaneous or intravenous administration
Primary Outcome Measure Information:
Title
Mean Hb change
Description
Mean change in Hb concentration from baseline to 12 weeks
Time Frame
from baseline to 12 weeks
Secondary Outcome Measure Information:
Title
Hemoglobin response
Description
defined as an increase in Hb level of 2.0g/dL≥ from baseline value during 12-week study period
Time Frame
during 12-week study period
Title
Time to hemoglobin response
Time Frame
during 12-week study period
Title
Proportion of patients requiring RBC transfusion during 12-week study period
Time Frame
during 12-week study period
Title
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
Time Frame
during 12-week study period
Title
Safety analysis
Description
Adverse events including AE of special interst (Anaphylaxis, Infusion reaction, Thromboembolic event)
Time Frame
during 12-week study period

10. Eligibility

Sex
All
Minimum Age & Unit of Time
19 Years
Accepts Healthy Volunteers
No
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 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 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Dae Young Zang, Ph.D.
Phone
+82-31-380-3704
Email
fhdzang@gmail.com
Facility Information:
Facility Name
Hallym University Medical Center
City
Anyang-si
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Dae Young Zang
Phone
+82-31-380-3704
Email
fhdzang@hallym.or.kr

12. IPD Sharing Statement

Plan to Share IPD
No

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High Dose IV Iron Plus ESA in Chemotherapy-induced Anemia

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