PIVOTAL Clinical Trial Reaches a Major Milestone
The PIVOTAL study team are delighted to report that this large event-driven randomised controlled trial has now reached the required number of primary endpoints to complete the study. PIVOTAL, which has been running for over 4½ years, having commenced in November 2013, is facilitated and funded by Kidney Research UK through an unrestricted grant of just under £3.5 million from Vifor Fresenius Medical Care Renal Pharma Ltd. It has recruited 2141 patients across 50 sites in the UK, making it the largest renal trial ever conducted exclusively in the UK.
The median length of patient follow-up is over 2½ years, with a maximum follow-up of well over 4 years. Over 500 deaths have been reported in the study, which is one of the target endpoints, and there have been well over 6000 SAEs. This wealth of data will allow the study investigators to provide meaningful conclusions on the optimum dose of intravenous iron to administer to haemodialysis patients.
Professor Iain Macdougall, the Chief Investigator at King’s College Hospital, said
“Everyone working on the study should be immensely proud of what they have achieved in reaching this impressive milestone. Study sites are now working hard to return all the required data to the Endpoint Adjudication Committee, with the aim of being able to release the results of the trial towards the end of the year.
We also need to acknowledge and thank the many patients who have remained in the trial for many years, and whose dedication to and participation in this landmark study will help us answer important questions about the treatment of haemodialysis patients with anaemia.”