This is a research study testing the effectiveness of an investigational drug called BGE-117, for unexplained anaemia.
Anaemia is a decrease in red blood cells of haemoglobin (an oxygen carrying protein inside the red blood cells) in the blood. There are many causes of anaemia such as severe blood loss, kidney disease, cancer, and vitamin or nutritional deficiencies. These anaemias are treated by treating their underlying cause. However, in the case of unexplained anaemia, an underlying cause cannot be found after appropriate testing. Older people (> 65 years old) are more likely to have unexplained anaemia, accounting for about 1/3 of anaemia cases in that population. There is no approved treatment for unexplained anaemia.
It is important to try to treat anaemia because it is associated with many potential problems, such as tiredness, weakness, shortness of breath, and fatigue. In older people, this weakness can be associated with a greater chance of falling, which may indirectly increase the risk of fractures (broken bones), such as hip fractures. I addition with less oxygen in the blood, anaemia can cause extra strain on the heart. For people with lunch problems (like emphysema or chronic obstructive pulmonary disease (COPD)), this can make it even harder for them to breathe.
This study will involve about 160 participants at 19 different centres in Australia.
The study involves taking an investigational drug or a placebo, daily for 12 weeks. It is hoped the investigational drug will improve the anaemia. The study will take place over 22 weeks. You will have 16 visits to the study clinic located in the Royal Adelaide Hospital, with each visit lasting approximately 1-2 hours.
If you are aged 65 or older, feeling fatigued or weak, you may have symptoms of unexplained anaemia.
If you would like to learn more about this research study and whether you are suitable to participate, please click “NEXT” to continue onto the questionnaire.
One of our Clinical Trial Coordinators will be in touch after you have submitted the form to discuss your eligibility for this trial.
If you would like further information prior to completion of this form, please visit our website or call us on 7074 4404 for more information.