CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 56 enrolled
Drug / intervention
Saline +1 moredrug
Likely dose
Ferinject or CosmoFer 1000 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/NCT01447628
NCT01447628Phase 2Completed

What is the Effect of Intravenous Iron Supplementation on Cardiopulmonary Haemodynamics, Exercise Capacity and Quality of Life in Patients With IPAH and Iron Deficiency?

Imperial College London·interventional·Posted Oct 6, 2011·Updated Mar 7, 2022

In Brief

A Phase 2 clinical trial evaluating Saline and Ferinject or CosmoFer for Pulmonary Arterial Hypertension and Iron Deficiency. Completed, enrolled 56 participants across 5 sites in 3 countries.

Detailed 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

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesChina, Germany, United Kingdom

Timeline

Phase 2CompletedFinished
2011201220132014201520162017201820192020202120222023202420252026
First PostedOct 6, 2011
Enrollment StartMar 29, 2011
Primary CompletionDec 22, 2017
TodayJul 2, 2026
Enrollment to primary: 6.7 yearsPosted 14.7 years ago

Interventions

Salinedrug

intravenous, no active drug

Ferinject or CosmoFerdrug

Intravenous, 1000 mg iron