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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

About this trial

This is an interventional treatment trial for Gynecologic Cancer focused on measuring Ferric derisomaltose, iron isomaltoside, intravenous iron

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)FemaleAccepts Healthy Volunteers

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:
1. The indication for the operation may be for suspected or proven gynecologic malignancy.
2. 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].
3. 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

Studies a U.S. FDA-regulated Device Product

Product Manufactured in and Exported from the U.S.

Data Monitoring Committee

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

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

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Ferric Derisomaltose/Iron Isomaltoside and Outcomes in the Recovery of Gynecologic Oncology ERAS

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