An Extension Trial to Assess the Safety of Re-dosing of Iron Isomaltoside/Ferric Derisomaltose (Monofer®/Monoferric®)

Completed · Phase 3

Conditions studied: Iron Deficiency Anemia, Iron Deficiency Anaemia

In brief

Evaluate safety and efficacy of intravenous (IV) iron isomaltoside/ferric derisomaltose re-dosing, in subjects who were previously treated with iron isomaltoside/ferric derisomaltose.

Key facts

Study ID

NCT02962648

Run by

Pharmacosmos A/S

People needed

103

Starts

2017-01-09

Expected to finish

2018-06-12

Last updated by the study team

2020-03-10

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Completed one of the lead-in trials
• Randomised and dosed with iron isomaltoside/ferric derisomaltose in one of the lead-in trials.
• Haemoglobin (Hb) of ≤ 11 g/dL
• Screening serum ferritin (s-ferritin) ≤ 100 ng/mL, or ≤ 300 ng/mL if transferrin saturation (TSAT) ≤ 30 %
• Willingness to participate and signing the informed consent form (ICF)

You may not qualify if…

• Intravenous (IV) iron treatment between the lead-in trial and screening
• During 30-day period prior to screening or during the trial period; has or will be treated with a red blood cell transfusion, radiotherapy, and/or chemotherapy
• Received an investigational drug within 30 days of screening
• Decompensated liver cirrhosis or active hepatitis
• Pregnant or nursing women.
• Any other laboratory abnormality, medical condition, or psychiatric disorders which, in the opinion of the Investigator, will put the subject's disease management at risk or may result in the subject being unable to comply with the trial requirements

Where it is running

• Pharmacosmos Investigational Site — Chula Vista, California, United States
• Pharmacosmos Investigational Site 1 — La Mesa, California, United States
• Pharmacosmos Investigational Site 2 — La Mesa, California, United States
• Pharmacosmos Investigational Site — Northridge, California, United States
• Pharmacosmos Investigational Site — Porterville, California, United States
• Pharmacosmos Investigational Site — Doral, Florida, United States
• Pharmacosmos Investigational Site — Hialeah, Florida, United States
• Pharmacosmos Investigational Site — Miami, Florida, United States
• Pharmacosmos Investigational Site — Miami, Florida, United States
• Pharmacosmos Investigational Site — Miami, Florida, United States
• Pharmacosmos Investigational Site — Miami Lakes, Florida, United States
• Pharmacosmos Investigational Site — West Palm Beach, Florida, United States
• Pharmacosmos Investigational Site — Baton Rouge, Louisiana, United States
• Pharmacosmos Investigational Site — Metairie, Louisiana, United States
• Pharmacosmos Investigational Site — New Orleans, Louisiana, United States
• Pharmacosmos Investigational Site — Shreveport, Louisiana, United States
• Pharmacosmos Investigational Site — Plainsboro, New Jersey, United States
• Pharmacosmos Investigational Site — Albuquerque, New Mexico, United States
• Pharmacosmos Investigational Site — Chattanooga, Tennessee, United States
• Pharmacosmos Investigational Site — Houston, Texas, United States
• Pharmacosmos Investigational Site 1 — San Antonio, Texas, United States
• Pharmacosmos Investigational Site 2 — San Antonio, Texas, United States

Full record on ClinicalTrials.gov

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