CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 103 enrolled
Drug / intervention
Iron isomaltoside/ferric derisomaltosedrug
Likely dose
Iron isomaltoside/ferric derisomaltose 100 mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT02962648
NCT02962648Phase 3Completed
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An Open-label, Multicentre, Extension Trial to Assess the Safety of Re-dosing of Intravenous Iron Isomaltoside/Ferric Derisomaltose (Monofer®/Monoferric®)

Pharmacosmos A/S·interventional·Posted Nov 11, 2016·Updated Mar 10, 2020

In Brief

A Phase 3 clinical trial evaluating Iron isomaltoside/ferric derisomaltose for Iron Deficiency Anemia and Iron Deficiency Anaemia. Completed, enrolled 103 participants across 22 sites.

Detailed Summary

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

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsIron Deficiency Anemia, Iron Deficiency Anaemia
CountriesUnited States
Collaborators--

Timeline

Phase 3CompletedFinished
2017201820192020202120222023202420252026
First PostedNov 11, 2016
Enrollment StartJan 9, 2017
Primary CompletionJun 12, 2018
TodayJul 2, 2026
Enrollment to primary: 1.4 yearsPosted 9.6 years ago

Interventions

Iron isomaltoside/ferric derisomaltosedrug

Iron isomaltoside/ferric derisomaltose (Monofer®/Monoferric®; 100 mg/mL) was the test product in this trial. The dose of iron isomaltoside/ferric derisomaltose for the individual subject was set to 1000 mg. The dose was diluted in 100 mL 0.9 % sodium chloride from the site's supply and administered over approximately 20 minutes using IV infusion.