One iron shot vs. many: which fixes Post-Surgery anemia faster?

NCT ID NCT07772453

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Recruiting now
This trial is taking on new participants right now.
Not yet recruiting This study
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
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Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

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Status unknown
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First seen Aug 19, 2026 · Last updated Aug 20, 2026 · Updated 1 time

Summary

This trial tests whether a single dose of ferric carboxymaltose can treat iron-deficiency anemia after stomach cancer surgery as effectively as multiple doses of iron sucrose. About 160 adults who had curative stomach cancer surgery and developed anemia will be randomly assigned to one of the two treatments. The main goal is to see how many patients have a meaningful rise in hemoglobin by three weeks after treatment, with safety and recovery also tracked.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
Ferric carboxymaltose (single-dose IV) compared to iron sucrose (multiple IV infusions)
What this could lead to
If ferric carboxymaltose works better, it could simplify anemia treatment after gastric cancer surgery, requiring just one infusion instead of several.
What could go wrong
This is a phase 4 trial with 160 participants, so results may not apply to everyone. Both drugs can cause side effects like low phosphorus or allergic reactions.

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Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 4

Runs after approval, following long-term safety and how well the treatment works in everyday use.

Participants

About 160 people

The number the study aims to enrol. It can still change while the study runs.

Expected to start

Aug 2026

An estimate. Start dates often move.

Expected to finish

Mar 2028

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 to 75 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: * Age 18 to 75 years, sex male or female, and body weight ≥ 50 kg. * Histopathologically confirmed gastric cancer (TNM stage I-III according to the AJCC 8th edition) and have undergone curative (R0) resection. * Postoperative anemia defined as a hemoglobin (Hb) level \< 100 g/L within 24 hours after surgery (i.e., on postoperative day 1), meeting the diagnostic criteria for postoperative anemia in gastric cancer patients. * Evidence of iron deficiency, as indicated by: * serum ferritin \< 30 μg/L, or * serum ferritin \< 100 μg/L and transferrin saturation (TSAT) \< 20%, confirming iron-deficiency anemia. * Eastern Cooperative Oncology Group (ECOG) performance status score of 0-2. * Adequate hepatic, renal, and coagulation function, defined as: * ALT and AST ≤ 2.5 × upper limit of normal (ULN), * serum creatinine ≤ 1.5 × ULN, * prothrombin time international normalized ratio (INR) ≤ 1.5. * Estimated life expectancy ≥ 3 months. * Voluntary written informed consent and ability to comply with the trial treatment and follow-up procedures. Exclusion Criteria: Non-iron-deficiency anemia (e.g., hemolytic anemia, thalassemia, megaloblastic anemia, aplastic anemia, tumor-related non-iron-deficiency anemia, etc.) or disorders of hemoglobin synthesis. * Known hypersensitivity to ferric carboxymaltose, iron sucrose injection, or any of their excipients. * Evidence of iron overload (serum ferritin \> 1000 μg/L) or a history of hemochromatosis. * Severe hepatic or renal impairment, defined as: * ALT/AST \> 2.5 × upper limit of normal (ULN), * serum creatinine \> 1.5 × ULN, * or coagulopathy (INR \> 1.5); * or active bleeding (e.g., major postoperative anastomotic hemorrhage, intra-abdominal bleeding, etc.). * Receipt of oral iron, intravenous iron, or erythropoiesis-stimulating agents (ESAs) / erythropoietin (EPO) within the past 3 months prior to screening. * Concurrent other malignancies, severe cardiovascular disease (e.g., heart failure, history of myocardial infarction, severe arrhythmias), uncontrolled infectious disease (e.g., sepsis), or immunodeficiency disorders. * Pregnant or breastfeeding women, or women who plan to become pregnant during the trial period. * Inability to comply with the treatment and follow-up procedures (e.g., due to cognitive impairment, psychiatric disorders), or any other condition that, in the investigator's judgment, would render the participant unsuitable for inclusion in the study.

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Conditions

The condition(s) this trial relates to.

As listed by the trial registrant

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