The HiLo study team has activated its first wave of study sites and started enrollment. The first 5 participants were enrolled by DaVita Southpoint Dialysis in Durham, North Carolina, in the first week after site activation.
HiLo, an NIH Collaboratory Demonstration Project, is a cluster randomized trial comparing the effects of pursuing high vs low serum phosphate targets in patients undergoing hemodialysis. The study will provide the first clinical trial evidence to inform guidelines for whether to liberalize the recommended serum phosphate target or to maintain aggressive phosphate control for patients receiving maintenance hemodialysis for end-stage renal disease.
Activation of HiLo sites and enrollment of participants align with National Kidney Month, an opportunity for communities across the country to raise awareness about kidney disease. The study website offers information for study participants, kidney professionals, and the broader kidney research and advocacy community.
As with all clinical research activities, the impact of the COVID-19 public health emergency on the HiLo study is being assessed daily. The health and safety of all study participants and team members is the study team’s top priority.