PIVOTAL trial delivers significant results for haemodialysis patients

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 on haemodialysis, were revealed at the 2018 ASN Kidney Week conference in San Diego during the high- impact clinical trials session. The results were also published online in the New England Journal of Medicine.

The trial compared proactive, high-dose and reactive low-dose intravenous iron regimens for patients in their first year on haemodialysis.

Main findings:

The trial demonstrated no evidence of harm with the proactive high-dose strategy – with no increased risk of death, heart failure or infection..

There were also 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

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 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 largest renal clinical trial ever undertaken exclusively in the UK.

Further information here.