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Intravenous Iron in Non-anemic Iron Deficient Colorectal Cancer Patients
NCT05220800Phase 2
Key facts
- Status
- Not yet recruiting
- Start
- Mar 2022
- Primary completion
- Mar 2024
- Countries
- 1
- Sponsor
- Zealand University Hospital
- Modality
- Inorganic Nanoparticles, Small Molecules
- Drugs
- ferric derisomaltose
- Conditions
- iron deficiency anemia (IDA)
01
Overview
Phase 2, randomised, double-blind trial in iron deficiency anemia (IDA) comparing Iron(III)isomaltoside 1000 with Placebo (2 arms). Primary endpoints: Change in oxygen uptake at the anaerobic threshold, Change in neutrophile to lymphocyte ratio and 1 more. Planned start Mar 2022; status: not yet recruiting.
02
Design
2 arms- Study design
- RandomizedDouble-blind
Iron(III)isomaltoside 1000
Weight-dependent single dose of Monofer
Placebo
Isotonic saline infusion
03
Endpoints
Primary
Change in oxygen uptake at the anaerobic threshold
Change in neutrophile to lymphocyte ratio
Changes in T-cell function - mRNA expression analysis
Secondary
Quality of Recovery 15
Complications
Days alive and out of hospital - 30
1 year cancer free survival
5 year cancer free survival
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