13/02/18

PIVOTAL Trial Update

Many of you are involved in the PIVOTAL trial which has recruited 2142 patients at 50 renal units across the UK. By investigating two different regimens for administering intravenous iron to incident haemodialysis patients – (1) a “proactive” high-dose regimen, and (2) a “reactive” low-dose regimen, the PIVOTAL trial will provide informative data to help address the clinical equipoise regarding the possible benefits or harm of using more liberal amounts of intravenous iron.

The trial, led by Professor Iain Macdougall at King’s College Hospital and supported by Kidney Research UK, has now been running for over 4 years, and there is much excitement as we are now in the “last lap”, with the expectation that we will reach our required number of 944 primary endpoints sometime mid-2018. Currently we have around 300 confirmed adjudicated endpoints, with over 500 potential endpoints in the system.

An abstract, which includes the baseline data, has been submitted to UKKW; for those who are attending the conference in Harrogate, we are planning that there will be an opportunity to meet you to discuss some of the study issues that you may be experiencing.

Professor Iain Macdougall says;

“I am hugely grateful to everyone who is involved with the study and we have been overwhelmed with everyone’s on-going enthusiasm. There is a lot of hard work to be done before we reach the finishing line; however, I am hopeful that later this year we will have accrued the required number of endpoints.  There continues to be huge interest internationally in PIVOTAL and, although it will be sometime before we will know the outcome of the study, I think we can be confident that the results will be of interest to all healthcare  professionals looking after dialysis patients worldwide.”