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IV Iron for Anemia in Ovarian Cancer
NCT06248749Phase 3
Key facts
- Status
- Not yet recruiting
- Start
- Feb 2024
- Primary completion
- Dec 2028
- Countries
- 1
- Sponsor
- University of Saskatchewan
- Modality
- Inorganic Nanoparticles, Small Molecules
- Conditions
- iron deficiency anemia (IDA)
01
Overview
Phase 3, randomised, open-label trial of iron sucrose, sodium ferric gluconate and ferric derisomaltose in iron deficiency anemia (IDA) (2 arms), sponsored by University of Saskatchewan. Primary endpoints: Maintenance of Hgb > 100 g/L up to 3 years, Safety of IV iron up to 3 years and 4 more. Planned start Feb 2024; status: not yet recruiting.
02
Design
2 arms- Study design
- RandomizedOpen-label
Iron Infusion Arm
IV Iron (Sucrose, Gluconate, or Isomaltoside)
No Iron Infusion
No Iron Infusion (Standard of Care)
03
Who it enrols
Female patients aged 18+ with histologically confirmed ovarian cancer (FIGO stage IC-IV) and iron deficiency anemia (Hgb < 100 g/L and/or TSAT < 20%), eligible for active cancer treatment.
04
Endpoints
Primary
Maintenance of Hgb > 100 g/L
Safety of IV iron
Efficiency of IV iron
Time to response
Delay In Chemotherapy
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