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Iron Supplement

Ferric Derisomaltose for Gynecologic Cancers

Phase 3

Waitlist Available

Research Sponsored by AHS Cancer Control Alberta

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Major surgery is defined as an operation of a duration of 1 hour or greater, with an Aletti complexity score of at least 1

The expected time from recruitment to surgery is 28-90 days

Must not have

Cervical cancer with a clinical stage of 2A or greater

Known chronic liver disease or active hepatitis

Timeline

Screening 3 weeks

Treatment Varies

Follow Up baseline to 0-3 days prior to surgery and at 23-33 days postoperative

Awards & highlights

Pivotal Trial

Summary

This trial will help determine if preoperative ferric derisomaltose/iron isomaltoside can reduce transfusion rates and improve outcomes in patients undergoing surgery for gynecologic malignancy.

Who is the study for?

This trial is for adults over 18 with iron-deficiency anemia who are scheduled for elective major gynecologic oncology surgery within the next 28-90 days. They must have low hemoglobin and transferrin saturation levels, not be pregnant, and agree to use contraception. Exclusions include other causes of anemia, hypersensitivity to the drug being tested, certain infections or liver diseases, recent iron therapy or erythropoietin use, pregnancy/lactation, psychiatric/social issues affecting compliance.

What is being tested?

The trial tests if ferric derisomaltose can correct pre-operative iron-deficiency anemia better than a placebo in patients undergoing surgery for gynecologic malignancy. It's randomized and double-blinded; participants won't know if they're getting the actual drug or a dummy treatment.

What are the potential side effects?

Potential side effects of ferric derisomaltose may include allergic reactions due to hypersensitivity to the medication or its components. The exact side effects will be monitored throughout the study.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I have undergone a major surgery lasting more than an hour.

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My surgery is scheduled between 28 to 90 days from now.

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I am 18 years old or older.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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My cervical cancer is at stage 2A or more advanced.

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I have a long-term liver condition or active hepatitis.

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I am on immunosuppressive therapy for an organ transplant or will be on dialysis.

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I have had a fever over 38C or am currently on antibiotics not for prevention.

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I have a history of too much iron in my blood or it runs in my family.

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I am not a candidate for planned surgery.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ baseline to 0-3 days prior to surgery and at 23-33 days postoperative

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~baseline to 0-3 days prior to surgery and at 23-33 days postoperative

This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline to 0-3 days prior to surgery and at 23-33 days postoperative for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Mean preoperative haemoglobin concentration

Secondary study objectives

Assessment of the requirement of postoperative blood transfusion

Clinical surgical complications

Clinical surgical site infection

+9 more

Awards & Highlights

Pivotal Trial

The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

Trial Design

2Treatment groups

Experimental Treatment

Placebo Group

Group I: Iron Therapy ArmExperimental Treatment1 Intervention

500 or 1000mg of IV Ferric Derisomaltose in 100mL normal saline will be administered intravenously over 1 hour. Participants with bodyweight \<50kg will receive 500mg, participants with bodyweight \>50kg will receive 1000mg to ensure no patient exceeds the manufacturer's recommended dose of 20mg/kg bodyweight.

Group II: Placebo ArmPlacebo Group1 Intervention

100mL of normal saline will be administered intravenously over 1 hour between 21 and 90 days preceding surgical intervention.

0 / 9Eligibility criteria met