drugset / Trial / NCT01447628
IV Iron Replacement for Iron Deficiency in Idiopathic Pulmonary Arterial Hypertension (IPAH) Patients
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
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| 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 |