drugset / Trial / NCT01447628

IV Iron Replacement for Iron Deficiency in Idiopathic Pulmonary Arterial Hypertension (IPAH) Patients

NCT01447628

RandomizedCrossoverQuadruple-blindTreatment

Summary

This study will establish whether intravenous iron replacement has clinical benefit in idiopathic pulmonary arterial hypertension. A 24-week double-blind, randomised, placebo-controlled, crossover study will investigate whether a single dose of 1g of Ferinject® or CosmoFer improves cardiopulmonary haemodynamics, exercise capacity and quality of life and is well-tolerated. IV iron formulation used in Europe - Ferinject IV iron formulation used in China - CosmoFer

Timeline

Start
2011-03-29
Primary completion
2017-12-22
Completion
2017-12-22

Drugs

EvaluationDrugModalityDoseRoute
Comparator Ferric carboxymaltose Other / unclassified 15 mg/kg Intravenous
Comparator Ferric carboxymaltose Other / unclassified 1000 mg Intravenous
Comparator Iron dextran Unknown 20 mg/kg Intravenous