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PIVOTAL

PIVOTAL (Proactive IV irOn Therapy in haemodiALsis patients)

People with kidney failure do not make enough erythropoietin (EPO), a hormone that triggers the bone marrow to produce red blood cells. Haemodialysis patients are also deficient in iron as it is lost during dialysis and patients are unable to absorb enough in their diet. Iron makes up the haemoglobin in the red blood cells which transports oxygen around the body.

Therefore, one of the complications for haemodialysis patients is that they develop anaemia. This leaves people feeling exhausted, lethargic and can reduce their quality of life.

Patients already have EPO injections and intravenous iron to treat the condition, but there is no consistency across the NHS as to how much is given due to a lack of research evidence.

The PIVOTAL trial:This is the largest clinical trial that has been conducted in renal units in the UK. It is funded through Kidney Research UK and Vifor Fresenius Medical Care Renal Pharma Ltd. Kidney Research UK co-ordinates the whole trial.

Aim of the trial:To provide evidence about how much intravenous iron can be given to patients on dialysis to treat anaemia effectively and safely.

The PIVOTAL trial will test two different approaches. Some patients will be given high doses of iron to increase the levels of iron in their body, but not so much as to be considered unsafe whilst another group will receive lower doses of iron only as per normal routine treatment when their iron levels start getting too low. The trial will gather evidence as to the safety and potential benefits of giving more iron.

Patients will be treated for at least two years once they are in the trial. It will be overseen by a safety committee of experts who will check that no patient is placed at risk.

The outcome of the trial will be evidence to identify the best method so that we can continue to treat all patients safely and improve their quality of life on dialysis. This new evidence can then be used to influence decision makers in the NHS to change the approach across the UK and may also influence healthcare globally.

Who’s involved? Around 2,080 patients from more than 50 renal units across the UK, who are in their first 12 months of receiving dialysis, will be recruited. The chief investigator is Professor Iain Macdougall of King’s College Hospital, London, who is a world-renowned clinical expert on renal anaemia care. The trial manager is Claire White, also based at King’s. The local investigator for Guy’s patients is Dr Paramit Chowdhury and the study nurse is Emmanuel Mangahis.

The Robertson Centre for Biostatistics and Glasgow Clinical Trials Unit, University of Glasgow, collect all the data. There is a steering committee of experts, as well as an Advisory Board with representation from all of the major stakeholders in the kidney community.

For more information in the PIVOTAL trial, please contact Claire White, Clinical Trial Manager at clairewhite4@nhs.net

Patient and carer support group:Patients have played a key role in the development of PIVOTAL and a Patient and Carer Support Group has been established to raise awareness of research in their local areas. Members of the group also provide support and understanding for patients and research nurses as well as gathering feedback, to help inform the research, improve practice and care, and potentially help boost recruitment to the trial. If you are interested in being part of the Patient and carer support group, contact patients@kidneyresearchuk.org

By: Dr Paramit Chowdhury, Consultant Kidney Doctor