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Abstract: INFO35

HiLo: A Pragmatic Trial of Phosphate Management in ESRD

Session Information

  • Informational Posters
    October 25, 2018 | Location: Exhibit Hall, San Diego Convention Center
    Abstract Time: 10:00 AM - 12:00 PM


  • No subcategory defined


  • Wolf, Myles, Duke University, Durham, North Carolina, United States
  • Dember, Laura M., University of Pennsylvania School of Medicine, Philadelphia, Pennsylvania, United States
  • Beddhu, Srinivasan, University of Utah School of Medicine, Sandy, Utah, United States
  • Block, Geoffrey A., Colorado Kidney Care, Denver, Colorado, United States
  • Brunelli, Steven M., DaVita Clinical Research, Needham, Massachusetts, United States
  • Weiner, Daniel E., Tufts Medical Center, Boston, Massachusetts, United States
  • Isakova, Tamara, Feinberg School of Medicine, Northwestern University, Chicago, Illinois, United States

Group or Team Name

  • HiLo Steering Committee

Background: The prevalence of end-stage renal disease (ESRD) continues to increase. Although clinical outcomes among patients receiving dialysis have improved modestly in recent years, annual rates of hospitalizations and mortality remain unacceptably high, and quality of life is poor. Poor outcomes are driven primarily by increased risk of cardiovascular disease (CVD), but interventions proven to improve outcomes in the general population by targeting traditional CVD risk factors have mostly failed in patients with ESRD. In response, the nephrology community has embraced targeting of kidney-specific risk factors, including hyperphosphatemia. Current clinical practice guidelines advocate treatment of hyperphosphatemia to near normal levels using dietary phosphate binders and restrictive diets. The benefits of this approach, however, are unproven, the optimal serum phosphate target remains unknown and potential harms of aggressive treatment have not been determined. The HiLo trial aims to address these clinically important gaps in a pragmatic, cluster-randomized trial that will compare the effects of liberalizing serum phosphate targets (“Hi”) versus maintaining aggressive phosphate control (“Lo”) in patients receiving treatment with maintenance hemodialysis.
Hypotheses: Compared to current standard approach of targeting serum phosphate to <5.5 mg/dl, targeting 6–7 mg/dl will yield non-inferior rates of all-cause hospitalization (primary outcome), and reduce risk of all-cause mortality (secondary outcome) among patients with ESRD undergoing hemodialysis.
Methods: HiLo will be embedded in the clinical care of a large, mid-size, and regional dialysis organizations in the US. The planned sample of ~4400 patients at 120-150 hemodialysis facilities will enable detection of a non-inferiority band of 5% with 80% power for the primary outcome. Pragmatic aspects of HiLo include using an electronic consent; collaboration with facility dietitians to implement the interventions; extracting clinical trial data from electronic health records; central bioinformatic-based monitoring of the fidelity of the interventions; and use of a novel primary endpoint in an ESRD trial.
Support: NIH-NIDDK UG3DK118748
Target start date: July 1, 2019
Data Coordinating Center: Duke Clinical Research Institute


  • NIH-NIDDK UG3DK118748