VEN-DEV-401: Anaemia Control Model (ACM) in end-stage renal disease
Research type
Research Study
Full title
ANEMEX UK Trial: Artificial intelligence for optimal anaemia management in end-stage renal disease: the Anaemia Control Model (ACM) trial
IRAS ID
226888
Contact name
Iain Macdougall
Contact email
Sponsor organisation
Vifor Fresenius Medical Care Renal Pharma Ltd.
Duration of Study in the UK
1 years, 5 months, 1 days
Research summary
Anaemia (decreased red blood cells or haemoglobin in the blood) is common in patients with end-stage kidney disease and is usually treated with medications stimulating red blood cell production (erythropoiesis-stimulating agents [ESA]), iron and/or blood transfusions. Finding the right treatment is important, as both low and high haemoglobin can harm the patients.
Fresenius Medical Care has developed a software, the Anaemia Control Model (ACM) that recommends ESA and intravenous iron doses, based on individual patient information. The ACM has been developed based on real patient data, i.e. real biochemical/clinical data and drug prescriptions from the past. The system has learnt true therapeutic policies and it suggests new data based on past experience.
The aim of the study is to examine whether the ESA and intravenous iron doses recommended by the ACM are as effective as the physicians’ decision would be in normal clinical practice, in keeping the patients’ haemoglobin level within the target range. The physician decides, whether the ACM suggestions become actual prescriptions.
This study consists of a retrospective control period (i.e. a review of the patient’s medical records over the 6 months before study entry) and a prospective period (i.e. data collection for 6 months from the start of the study). During the prospective period, the ACM will recommend ESA and intravenous iron treatment, however the physician will decide in each individual case whether to follow these recommendations. Examinations will follow routine clinical practice. Data on haemoglobin levels as well as the ESA and intravenous iron doses prescribed will be compared between the two periods.
The study will be conducted at the King’s College Hospital, London, UK. It is funded by Vifor Fresenius Medical Care Renal Pharma.
REC name
East Midlands - Leicester South Research Ethics Committee
REC reference
17/EM/0259
Date of REC Opinion
26 Jul 2017
REC opinion
Further Information Favourable Opinion