Mi-iron - Moderately Increased Iron - is Reducing Iron Overload Necessary?

Summary

Haemochromatosis is a preventable genetic iron overload disorder. Untreated, it can shorten life due mainly to liver cirrhosis and cancer. It can be prevented by blood donation to maintain normal iron levels. It is unclear, however, whether treatment is necessary when individuals have moderate elevation of iron in the body. This research project will study the effects of treatment in this group by assessing a number of scans, questionnaires and blood tests in treated and untreated individuals.

Conditions

• Hereditary Haemochromatosis

Interventions

PROCEDURE

Erythrocytapheresis

To achieve a blinded randomised trial, apheresis treatment will be used. Those in arm 1 will have erythrocytapheresis reducing iron levels and those in arm 2 will have plasmapheresis and their iron levels will not be reduced. An apheresis machine will be used to remove red blood cells only from the erythrocytapheresis group. Subjects will have third weekly treatments until SF levels are reduced to \~100 ug/L in accordance with current guidelines.

PROCEDURE

Plasmapheresis

An apheresis machine will be used to remove blood plasma only from the plasmapheresis group. Those in arm 2 will have the approximate number of episodes of apheresis that would be required to reduce their SF to normal had they been randomised to the true treatment arm. Those in the sham arm will be offered to have venesection at their choice of venue or to have their SF normalised by erythrocytapheresis after the initial blinded part of the study. This will be done because it will not be known for some time if there is benefit from normalisation of SF and therefore leaving people with elevated SF that may be harmful.

Sponsors & Collaborators

• Austin Health

  collaborator OTHER_GOV

• Royal Brisbane and Women's Hospital

  collaborator OTHER_GOV

• Fremantle Hospital and Health Service

  collaborator OTHER

• Melbourne Health

  collaborator OTHER

• The University of Queensland

  collaborator OTHER

• Murdoch Childrens Research Institute

  lead OTHER

Principal Investigators

• Martin B Delatycki · Austin Health/Murdoch Childrens Research Institute

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Model

SINGLE_GROUP

Eligibility

Min Age

18 Years

Max Age

70 Years

Sex

ALL

Healthy Volunteers

Yes

Timeline & Regulatory

Start

2012-06-30

Primary Completion

2016-07-31

Completion

2016-07-31

Countries

• Australia

Study Locations