Status:
TERMINATED
HiLo: Pragmatic Trial of Higher vs Lower Serum Phosphate Targets in Patients Undergoing Hemodialysis
Lead Sponsor:
Duke University
Collaborating Sponsors:
Northwestern University
University of Pennsylvania
Conditions:
All-cause Mortality
Hospitalization
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
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 mainta...
Detailed Description
Pragmatic Trial Demonstration Goals The HiLo Trial is one of the pragmatic trial demonstration projects of the NIH Health Care Systems (HCS) Research Collaboratory. These demonstration projects are i...
Eligibility Criteria
Inclusion
- Adults over 18 years of age
- Undergoing 3 times weekly in-center hemodialysis and have been receiving dialysis treatment for at least 3 months
- Able to provide written informed consent
Exclusion
- Pregnancy
- In-center Nocturnal
- Calciphylaxis
Key Trial Info
Start Date :
March 11 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 17 2023
Estimated Enrollment :
793 Patients enrolled
Trial Details
Trial ID
NCT04095039
Start Date
March 11 2020
End Date
November 17 2023
Last Update
April 24 2025
Active Locations (84)
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1
DaVita Ensley
Birmingham, Alabama, United States, 35218
2
DaVita Phoenix Dialysis
Phoenix, Arizona, United States, 85004
3
DaVita Ouachita Valley
Camden, Arkansas, United States, 71701
4
DaVita South Arkansas
El Dorado, Arkansas, United States, 71730