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

NCT01447628 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 56

Last updated 2022-03-07

Study results available
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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

Conditions

Interventions

DRUG

Saline

intravenous, no active drug

DRUG

Ferinject or CosmoFer

Intravenous, 1000 mg iron

Sponsors & Collaborators

  • Fu Wai Hospital, Beijing, China

    collaborator OTHER

  • Imperial College London

    lead OTHER

Principal Investigators

  • Luke Howard, DPhil, FRCP · Imperial College London

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
CROSSOVER

Eligibility

Min Age
16 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

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

Countries

  • China
  • Germany
  • United Kingdom

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01447628 on ClinicalTrials.gov