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New results from PIVOTAL trial

05 July 2022

The pioneering PIVOTAL trial, one of the largest renal clinical trials undertaken exclusively in the UK, and co-ordinated by Kidney Research UK has delivered a new set of results.   

The PIVOTAL trial investigated the use of intravenous iron to treat anaemia in dialysis patients, focusing on patient safety considerations. The latest results show that a high dose of iron in dialysis patients does not increase the risk of vascular access thrombosis (VAT). 

How does thrombosis affect dialysis patients?

Thrombosis occurs when blood clots. This can result in blockage of the vascular access (VA) through which dialysis is administered, which can cause serious and sometimes life-threatening complications including disruption of dialysis treatment, unscheduled hospital care, surgery to salvage or replace the VA, or the access point becoming irreversibly unusable.  

Pivotal trial patient, Mimi Hoare, and nurse, Elizabeth Clarke
Pivotal trial patient, Mimi Hoare, and nurse, Elizabeth Clarke

Analysing the data

Whilst the findings from the initial trial showed that a high dose of intravenous iron administered to dialysis patients was beneficial in so many ways including reduced risk of hospitalisation for heart failure, cardiovascular events, and death, researchers continued to carefully analyse the data to establish whether other risks occur with a high dose of iron.   

New results

Whilst at least one episode of VAT occurred in 22% of the 2,141 patients taking part in the trial, there was no clear evidence that a lower or higher iron dose was more likely to cause a VAT event. However, the results did shine a useful spotlight on the serious consequences of VAT, showing that:  

  • VAT among dialysis patients can lead to further illness, hospitalisation and healthcare costs.  
  • Patients with diabetic kidney disease, who use diuretics, are female, who smoke and use certain drugs, are at a higher risk of VAT.   

Lead author on the paper, Dr Peter Thomson of the Glasgow Renal and Transplant Unit, highlighted that “this work has provided researchers with new areas to explore around the causes behind vascular access blood clot blockages and has brought the spotlight onto an important area of care for people reliant on regular haemodialysis” 

Kidney Research UK’s executive director of research, Dr Aisling McMahon said: “This update from the PIVOTAL trial is most welcome. The fact that a higher dose of iron has not been shown to increase the risk of vascular access thrombosis is extremely important. We know that anaemia can be a debilitating condition for many dialysis patients and look forward to seeing this evidence being used to optimise treatment safely. We are delighted that the trial continues to provide useful and important information for the kidney community post-funding" 

 To find out more, read the full paper here 

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