HiLo is the first clinical research study that will provide evidence to inform guidelines for phosphate management. When the study is complete, results from HiLo can be integrated into clinical practice to manage the care of kidney patients receiving dialysis.
What is the best blood level of phosphate for people with kidney failure on dialysis?
Lack of Evidence
to Support Current
Our current approach calls for an aggressive treatment of hyperphosphatemia to near normal levels using dietary phosphate binders and restrictive diets. However, the benefits of this approach are unproven and the potential harms of aggressive treatment are unknown.
Because of the lack of data from randomized clinical research studies, dialysis units around the world struggle with a phosphate management strategy that produces the best clinical outcomes and improves quality of life for their patents.
HiLo is a large, pragmatic, cluster-randomized study that will compare the effects of liberalizing the serum phosphate goal (high arm) versus maintaining aggressive phosphate control (low arm) for patients receiving maintenance hemodialysis. HiLo is embedded in the clinical care delivery of U.S. dialysis organizations representing large and regional dialysis providers.
Dietitians will be the primary contact for HiLo study participants and continue to help participants manage phosphate in their diet.
Although facilities will be cluster randomized to the high or low serum phosphate goals, the treating nephrologist will continue to prescribe specific phosphate binding medications and make adjustments based on tolerance and input from the participant.
As with all clinical research, participants may choose to discontinue their participation or be discontinued from HiLo at the discretion of the treating nephrologist.
We owe it to our patients to perform a randomized clinical trial that tests which phosphate treatment target provides the best clinical outcomes for patients receiving hemodialysis.
“The status quo of kidney care is often based on a house of cards of low-quality, small-scale, observational data. HiLo has a chance to gather quality evidence to answer an issue that affects all hemodialysis patients. This study also heralds a new focus on pragmatic trial designs in nephrology with real-world inclusion criteria and generalizable data.”
Daniel Edmonston, MD - HiLo Steering Committee Member, Duke Clinical Research Institute