18 and older, any sex, with All-cause Mortality or Hospitalization. Patients with the condition only — healthy volunteers not accepted.
Results — posted to ClinicalTrials.gov
Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.
Hierarchical Composite Mortality and All Cause HospitalizationPrimary· up to 27 (enter at enrollment end) - 45 (enter at enrollment start) months
Hierarchical composite of time to all-cause mortality and all-cause hospitalization rate (total counts per person-years of follow-up) for the individually randomized cohort
All-cause mortality
Group
Value
95% CI
Lo Arm
2
Hi Arm
5
All-cause Hospitalizations
Group
Value
95% CI
Lo Arm
98
Hi Arm
128
Time to All-cause-mortalitySecondary· up to 27 (enter at enrollment end) - 45 (enter at enrollment start) months
Time to all-cause-mortality from baseline for both cluster-randomized and individually randomized cohorts.
Group
Value
95% CI
Lo Arm
1.2
± 0.72
Hi Arm
1.4
± 0.80
Hospitalization DaysSecondary· up to 27 (enter at enrollment end) - 45 (enter at enrollment start) months
Total days hospitalized (Data reflects participants with valid, non-missing hospitalization start and end dates.)
Group
Value
95% CI
Lo Arm
27.9
± 29.4
Hi Arm
35.4
± 46.1
Serum AlbuminSecondary· Baseline (days -30 - 0)
serum albumin as markers of diet and nutrition.
Group
Value
95% CI
Lo Arm
4.1
± 0.35
Hi Arm
4.1
± 0.35
Protein Catabolic Rate (PCR)Secondary· Baseline (days -30 - 0)
protein catabolic rate (PCR) as markers of diet and nutrition (g/kg/day).
Group
Value
95% CI
Hi Arm
1.0
± 0.29
Lo Arm
1.1
± 0.32
Sponsor's own description
HiLo will be a pragmatic, open-label, multicenter, clinical trial with individual level randomization of \~4400 patients with ESRD undergoing in-center maintenance hemodialysis at 120-150 units maintained by two dialysis organizations that care for a substantial proportion of the US dialysis population. The 1st objective of HiLo is to test the following primary and secondary hypotheses of HiLo:
Primary hypothesis: Compared to the current standard approach of targeting serum phosphate levels of \<5.5 mg/dl, less stringent control of serum phosphate to target levels of ≥6.5 mg/dl will yield a reduction in the hierarchical composite outcome of time to all-cause mortality and all-cause hospitalization among patients with ESRD undergoing hemodialysis.
Secondary hypothesis: The main secondary hypotheses are that less stringent control of serum phosphate will reduce risk of all-cause mortality as well as the risk of all-cause hospitalization (individually) compared to the current standard approach of strict phosphate control (superiority analysis). In addition, the trial will test the secondary hypotheses that less stringent control of serum phosphate will result in increased serum albumin and protein catabolic rate (PCR), as markers of diet and nutrition.
The 2nd objective of HiLo is to conduct a second-generation pragmatic clinical trial in dialysis. In partnership with two dialysis provider organizations, demonstrate the following for a trial embedded in clinical care delivery:
1. Feasibility of obtaining informed consent using electronic devices (e-consent)
2. Use of a single IRB of record for hundreds of dialysis facilities
3. Successful implementation of a trial-driven treatment algorithm by dietitians at the participating dialysis units
4. Harmonization of data from a large for-profit dialysis provider and an academically-owned small dialysis provider
5. Effective monitoring of trial implementation using a centralized approach
Publications & conference data
8 peer-reviewed publications reference this trial (live from Europe PMC):
NCT07054827 — Effect of Intradialytic Resistance Versus Aerobic Exercise on Cardiovascular System in Patients on Regular Hemodialysis
· NA
· not yet recruiting
NCT06129617 — Intermittent ADVOS vs. Hemodialysis in Non-intensive Care Patients With Liver Dysfunction
· NA
· recruiting
NCT06141798 — Twice vs Thrice Weekly Incident Hemodialysis in Elderly Patients
· NA
· recruiting
NCT04705701 — Comparing Post Cardiac Surgery Outcomes in ESRD Patient's With Early Dialysis Versus Standard Care
· NA
· withdrawn
NCT04527328 — A Study to Assess the Tolerability and Efficacy of AKST1210 in Patients on Hemodialysis With Cognitive Impairment
· NA
· completed
Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Duke University
Last refreshed: 24 April 2025
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT04095039.