A Study of Intravenous Iron Isomaltoside 1000 (Monofer®) as Mono Therapy (Without Erythropoiesis Stimulating Agents) in Comparison With Oral Iron Sulfate in Subjects With Non-myeloid Malignancies Associated With Chemotherapy Induced Anaemia (CIA)

Phase 3 Completed 350 enrolled Pharmacosmos A/S

RandomizedParallel-groupOpen-labelTreatment

Summary

The purpose of this study is to compare the efficacy and safety of intravenous iron therapy with oral iron therapy in patients with cancer and chemotherapy induced anaemia.

Timeline

Start: 2010-10
Primary completion: 2014-04
Completion: 2014-05

Outcome

Met primary endpoint

paper Iron isomaltoside was noninferior to oral iron in change in hemoglobin concentration from baseline to week 4 PMID 26927900 ↗

Publications

Birgegard G, Henry D, Glaspy J, Chopra R, Thomsen LL, Auerbach M. A Randomized Noninferiority Trial of Intravenous Iron Isomaltoside versus Oral Iron Sulfate in Patients with Nonmyeloid Malignancies and Anemia Receiving Chemotherapy: The PROFOUND Trial. Pharmacotherapy. 2016 Apr;36(4):402-14. doi: 10.1002/phar.1729. Epub 2016 Apr 1.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Iron Isomaltoside	Unknown	500 mg	Intravenous
Subject	Iron Isomaltoside	Unknown	1000 mg	Intravenous
Comparator	Iron Sulfate	Small molecule	100 mg	Oral