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Pragmatic randomised trial of High Or Standard Phosphate Targets in End-stage kidney disease (PHOSPHATE)

Safe People

Organisation name

Cambridge University Hospitals Foundation Trust, Cambridge University

Safe Projects

Project ID

ILD93

Lay summary

Hyperphosphataemia is a condition where you have too much phosphate in your blood. It is highly prevalent in patients with End Stage Kidney Disease (ESKD) and associated with increased mortality risk. Clinical Practice Guidelines suggest lowering elevated phosphate levels towards the normal range. However, trial data demonstrating that treatments that lower serum phosphate will improve patient-centred outcomes are lacking. Treatment with phosphate-lowering medications is associated with significantly increased pill burden, poor quality of life and substantial adverse effects. The PHOSPHATE trial will consist of 3600 adult participants on phosphate-lowering medications from renal units in Australia, New Zealand, Canada and the UK. 2000 participants will be recruited in the UK and will be present in the UKRR dataset. The participants will be randomised to either an intensive phosphate control treatment or to a strategy of liberalised phosphate control. It will include patients age ≥45 years, or Age ≥18 years with diabetes; with ESKD treated with dialysis for at least 3 months; and prescribed at least one phosphate-lowering medication. Phosphate data from the UK Renal Registry (UKRR) is critical to the PHOSPHATE study - access to routinely collected healthcare data will significantly reduce the burden on participants and the local site teams. The study will provide evidence on treatments that control serum phosphate and their patient-centred outcomes, such as survival and how patients feel or function, which will be able to guide policy and drug prescribing. The study results will also be able to inform and make recommendations to Health Organisations/Governments about the clinical care of ESKD patients across the UK.

Latest approval date

16/03/2021

Safe Data

Dataset(s) name