PIVOTAL results pave the way for improved haemodialysis treatment
The results of the four-and-a-half year PIVOTAL clinical trial to determine how much intravenous iron could safely be given to kidney patients have been published in the New England Journal of Medicine (N Engl J Med 2019; 380:447-458).
The trial compared proactive, high-dose and reactive low-dose intravenous iron regimens for patients in their first year on haemodialysis.
The trial demonstrated that among these patients, who had recently started dialysis, high-dose intravenous iron administered proactively was better than a low-dose course administered reactively.
There was a significantly reduced risk of death, hospitalisation for heart failure, and other major non-fatal cardiovascular events and no increased infections.
There were also additional benefits in the higher dose group:
- reduced erythropoetin (EPO) dose requirements
this could be beneficial as high doses of EPO have been associated with an increased risk of cardiovascular events, such as strokes
- fewer blood transfusions
this is positive news as it reduces the risk of developing antibodies which can affect the chance of a successful transplant in the future
“PIVOTAL shows that patients treated with higher iron doses (who also received less EPO) experienced fewer cardiovascular events and no increase in serious adverse events when compared to those receiving lower doses,” said Professor David Wheeler, Steering Committee member. “The PIVOTAL trial provides reassurance that this is a good approach.”
The trial data is expected to influence future clinical practice in the management of anaemia in patients on haemodialysis.
Facilitated by Kidney Research UK, PIVOTAL was a randomised controlled trial led by Professor Iain MacDougall at King’s College Hospital, London, in partnership with Glasgow University Clinical Trials Unit. The trial involved the collaboration of clinicians and research nurses from 50 renal units and 2,141 kidney patients, making it the one of the largest renal clinical trials ever undertaken exclusively in the UK.
Further information here.