drugset / Trial / NCT02213653

Randomized Study Evaluating Agents Stimulants Erythropoiesis (ASE) Associated With Ferric Carboxymaltose (Ferinject ®) in Concomitant or Sequential Patients Treated for Cancer and With Anemia Associated With Functional Iron Deficiency

NCT02213653

RandomizedParallel-groupOpen-labelTreatment

Summary

Anemia in patients with cancer is a common problem associated with an impaired quality of life. Treatment with erythropoiesis stimulating agents (ESA) allows an increase in hemoglobin levels in 40-70% of patients and decreased transfusion requirements. Absolute or functional iron deficiency is also common with about 30% of cancer patients with all histologies combined iron deficiency and anemia. Several studies have shown the benefits of the combination of intravenous iron to erythropoiesis-stimulating agents in improving hemoglobin. However, none of them, to the investigators knowledge, has not been specifically performed on a population of patients with functional iron deficiency. In addition, in clinical practice, this association is not carried out in particular because there is no dosage or consensus sequence for the administration of iron associated with ESAs.

Timeline

Start
2013-04
Primary completion
2014-11
Completion
2014-11

Drugs

EvaluationDrugModalityDoseRoute
Subject Ferric carboxymaltose Other / unclassified 500 mg Intravenous
Subject Ferric carboxymaltose Other / unclassified 1000 mg Intravenous
Subject epoietin zeta Unknown 450 iu/kg Subcutaneous