PIVOTAL – Proactive IV irOn Therapy in haemodialysis patients
‘A complication of being treated for kidney failure using haemodialysis is that patients develop anaemia and iron deficiency. This is a condition that leaves people feeling exhausted and seriously reduces quality of life. Patients are given intravenous iron to treat the condition, but there is limited consistency across the NHS and worldwide, as to how much is administered, because there is no research evidence available’.
A randomised controlled trial which ran from November 2013 to July 2018.
The trial involved 2,141 patients in their first year on haemodialysis and clinicians and research nurses from 50 hospital renal units.
It is the largest renal clinical trial ever undertaken exclusively in the UK.
The trial gathered evidence from two different clinical approaches. Some patients were given high doses of iron to increase the levels of iron in their body (proactive high-dose) whilst another group received lower doses of iron only as per normal routine treatment when their iron levels got too low (reactive low-dose).
After four and a half years, the results were revealed at the 2018 American Society of Nephrology’s Kidney Week conference in San Diego.
- 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:
- a reduction in the dose of erythropoetin (EPO) required - this could be beneficial because high doses of EPO have been associated with an increased risk of cardiovascular events, such as strokes
- fewer blood transfusions - this reduces the risk of developing antibodies which can affect the chance of a successful transplant in the future.
“PIVOTAL has demonstrated the UK renal community can successfully deliver a large, randomised trial. The on-going enthusiasm, commitment and support shown by the participating sites has been a key factor in ensuring the success of this important study. We also need to thank all the patients who have taken part in the trial for many years. Their dedication to and participation in this landmark study will help answer important questions about the treatment of haemodialysis patients with anaemia.” Professor David Wheeler, steering committee member for the trial.
You can read the full impact of the results on the KRUK website, including more patient stories and involvement in the study here https://www.kidneyresearchuk.org/research/case-studies/pivotal and here https://www.kidneyresearchuk.org/news/iron-trial-delivers-significant-results-for-haemodialysis-patients
The study has also been published here https://www.nejm.org/doi/full/10.1056/NEJMoa1810742