60
Participants
Start Date
April 3, 2025
Primary Completion Date
December 31, 2026
Study Completion Date
June 30, 2027
Monoferric Injectable Product
Ferric derisomaltose will be prepared by an unblinded research pharmacist/delegated staff as per standard of care procedures. Specifically, 10 mL (containing 1000 mg ferric derisomaltose) will be diluted in 100 mL of sterile 0.9% sodium chloride solution and drawn up into blinded syringes and tubing. The 1000 mg doses of ferric derisomaltose will be administered by a bedside nurse over 60 minutes via an infusion pump through a dedicated IV.
0.9% sodium chloride solution
Patients in the control group will receive placebo, which will be 100 mL of sterile 0.9% sodium chloride solution and drawn up into blinded syringes and tubing according to good manufacturing practice (GMP).
NOT_YET_RECRUITING
Kingston Health Sciences Centre, Kingston
RECRUITING
Sunnybrook Health Sciences Centre, Toronto
RECRUITING
Toronto General Hospital - University Health Network, Toronto
Kingston Health Sciences Centre
OTHER
Sunnybrook Health Sciences Centre
OTHER
Heart and Stroke Foundation of Canada
OTHER
University Health Network, Toronto
OTHER