Ferric Derisomaltose/Iron Isomaltoside and Outcomes in the Recovery of Gynecologic Oncology ERAS (FORGE)
Primary Purpose
Gynecologic Cancer, Anemia, Iron Deficiency, Surgery
Status
Not yet recruiting
Phase
Phase 3
Locations
Study Type
Interventional
Intervention
Ferric Derisomaltose Injection
Normal saline
Sponsored by
About this trial
This is an interventional treatment trial for Gynecologic Cancer focused on measuring Ferric derisomaltose, iron isomaltoside, intravenous iron
Eligibility Criteria
Inclusion Criteria:
- At least 18 years of age and signed written informed consent
Patients undergoing elective major surgery on the gynecologic oncology service with the following criteria will be considered for inclusion:
- The indication for the operation may be for suspected or proven gynecologic malignancy.
- Major surgery is defined as an operation of a duration of 1 hour or greater, with an Aletti complexity score of at least 1[19].
- The expected time from recruitment to surgery is at least 28 days.
- Screening haemoglobin less than 120g/L and transferrin saturation (TSAT) <20%
- Randomization and administration of study infusion a minimum of 21 days and maximum 90 days before planned operation.
- Negative pregnancy test for women of childbearing potential (within last 7 days), and agree to use effective form of contraception until 6 weeks post treatment (if applicable)
- Laboratory data used for determination of eligibility at the baseline visit must not be older than 4 weeks.
Exclusion Criteria:
- Known history of acquired iron overload, or family history of haemochromatosis or thalassemia, or TSAT >50%
- Known alternative cause for anemia (e.g. B12 or folate deficiency, or haemoglobinopathy)
- Known hypersensitivity to FDI or its excipients
- Temperature >38 C or patient on non-prophylactic antibiotics
- Known chronic liver disease or active hepatitis
- Received erythropoietin or IV iron therapy in previous 12 weeks
- If LFT's are ordered, either clinically indicated or for chemotherapy, and screening alanine transaminase (ALT) or aspartate transaminase (AST) is above three times the upper limit of normal (ULN) range
- Immunosuppressive therapy (for solid organ transplant), or renal dialysis (current, or planned within next 12 months)
- Unfit for elective surgery
- Pregnancy or lactation
- Unable to fully comprehend and/or perform study procedures
- Cervical cancer with a clinical stage of 2A or greater.
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
Ferric derisomaltose
Placebo
Arm Description
1000mg of intravenous Ferric derisomaltose/Iron isomaltoside in 100mL of normal saline will be administered 21-90 days prior to planned surgery for gynecologic malignancy as a single dose.
100mL of normal saline will be administered 21-90 days prior to planned surgery for gynecologic malignancy as a single dose.
Outcomes
Primary Outcome Measures
Preoperative hemoglobin level
Hemoglobin measured, in g/L, following intervention prior to planned gynecologic surgery.
Secondary Outcome Measures
Full Information
NCT ID
NCT05467319
First Posted
July 18, 2022
Last Updated
July 19, 2022
Sponsor
Alberta Health Services, Calgary
Collaborators
Pharmacosmos A/S
1. Study Identification
Unique Protocol Identification Number
NCT05467319
Brief Title
Ferric Derisomaltose/Iron Isomaltoside and Outcomes in the Recovery of Gynecologic Oncology ERAS
Acronym
FORGE
Official Title
Feasibility and Efficacy of Intravenous Ferric Derisomaltose to Correct Pre-operative Iron-deficiency Anemia in Patients Undergoing Gynecologic Oncology Surgery: a Pilot Randomized Double Blinded Parallel Group Placebo-controlled Study
Study Type
Interventional
2. Study Status
Record Verification Date
July 2022
Overall Recruitment Status
Not yet recruiting
Study Start Date
September 30, 2022 (Anticipated)
Primary Completion Date
September 2023 (Anticipated)
Study Completion Date
December 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Alberta Health Services, Calgary
Collaborators
Pharmacosmos A/S
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
Iron deficiency has been reported in up to 35% of patients with a gynecologic malignancy. These patients often require surgical intervention to determine the stage and to treat their illness. Blood transfusions occur in approximately 14% of these surgeries and carry immediate and long-term risks, including surgical site infection, cancer recurrence, and increased surgical length of stay. Intravenous iron formulations have the potential to rapidly correct anemia in patients with gynecologic malignancy and potentially decrease blood transfusion and complications following surgery. This prospective, randomized, placebo-controlled, double blind study aims to assess the effectiveness of preoperative ferric derisomaltose/iron isomaltoside compared to placebo in correcting preoperative hemoglobin in patients undergoing surgery for gynecologic malignancy. The primary outcome is to assess the effectiveness of this formulation on pre-operative hemoglobin, and the feasibility of a larger, outcomes based, study in the future. Exploratory outcomes are to assess the effect of preoperative intravenous iron on surgical length of stay, complications, and patient-reported quality of life.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Gynecologic Cancer, Anemia, Iron Deficiency, Surgery
Keywords
Ferric derisomaltose, iron isomaltoside, intravenous iron
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Model Description
Parallel groups, randomized placebo-controlled, double blind
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Masking Description
Intravenous treatment will be prepared by an unblinded provider and placed in opaque bags/tubing to blind the patient, administrator of the medication, and subsequent outcome assessors and care providers.
Allocation
Randomized
Enrollment
82 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Ferric derisomaltose
Arm Type
Experimental
Arm Description
1000mg of intravenous Ferric derisomaltose/Iron isomaltoside in 100mL of normal saline will be administered 21-90 days prior to planned surgery for gynecologic malignancy as a single dose.
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
100mL of normal saline will be administered 21-90 days prior to planned surgery for gynecologic malignancy as a single dose.
Intervention Type
Drug
Intervention Name(s)
Ferric Derisomaltose Injection
Other Intervention Name(s)
iron isomaltoside, Monoferric, Monofer
Intervention Description
1000mg of ferric derisomaltose in 100mL of normal saline by intravenous infusion
Intervention Type
Drug
Intervention Name(s)
Normal saline
Intervention Description
100 mL of 0.9% normal saline (w/v) by intravenous infusion
Primary Outcome Measure Information:
Title
Preoperative hemoglobin level
Description
Hemoglobin measured, in g/L, following intervention prior to planned gynecologic surgery.
Time Frame
0 to 3 days prior to planned surgical intervention
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
At least 18 years of age and signed written informed consent
Patients undergoing elective major surgery on the gynecologic oncology service with the following criteria will be considered for inclusion:
The indication for the operation may be for suspected or proven gynecologic malignancy.
Major surgery is defined as an operation of a duration of 1 hour or greater, with an Aletti complexity score of at least 1[19].
The expected time from recruitment to surgery is at least 28 days.
Screening haemoglobin less than 120g/L and transferrin saturation (TSAT) <20%
Randomization and administration of study infusion a minimum of 21 days and maximum 90 days before planned operation.
Negative pregnancy test for women of childbearing potential (within last 7 days), and agree to use effective form of contraception until 6 weeks post treatment (if applicable)
Laboratory data used for determination of eligibility at the baseline visit must not be older than 4 weeks.
Exclusion Criteria:
Known history of acquired iron overload, or family history of haemochromatosis or thalassemia, or TSAT >50%
Known alternative cause for anemia (e.g. B12 or folate deficiency, or haemoglobinopathy)
Known hypersensitivity to FDI or its excipients
Temperature >38 C or patient on non-prophylactic antibiotics
Known chronic liver disease or active hepatitis
Received erythropoietin or IV iron therapy in previous 12 weeks
If LFT's are ordered, either clinically indicated or for chemotherapy, and screening alanine transaminase (ALT) or aspartate transaminase (AST) is above three times the upper limit of normal (ULN) range
Immunosuppressive therapy (for solid organ transplant), or renal dialysis (current, or planned within next 12 months)
Unfit for elective surgery
Pregnancy or lactation
Unable to fully comprehend and/or perform study procedures
Cervical cancer with a clinical stage of 2A or greater.
12. IPD Sharing Statement
Plan to Share IPD
Undecided
Learn more about this trial
Ferric Derisomaltose/Iron Isomaltoside and Outcomes in the Recovery of Gynecologic Oncology ERAS
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