All-cause MortalityNCT04095039
HiLo: Pragmatic Trial of Higher vs Lower Serum Phosphate Targets in Patients Undergoing Hemodialysis
A study testing Hemodialysis in people with All-cause Mortality and Hospitalization, run by Duke University at 84 sites in United States.
Trial 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 maintained by two dialysis organizations that care for a substantial proportion of the US dialysis population. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- All-cause Mortality, Hospitalization
- What is being tested?
- Hemodialysis
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 793 participants
- Where
- 84 sitesUnited States
- Study dates
- 11 Mar 2020to 17 Nov 2023
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- Pregnancy
- In-center Nocturnal
- Calciphylaxis
Trial locations and contacts
84 sites in 1 country.
84 sites in 1 country
United States84 sites
American Fork Dialysis
American Fork, Utah, 84003
DaVita Arden Hills
Arden Hills, Minnesota, 55112
DaVita Ensley
Birmingham, Alabama, 35218
DaVita Bloomington
Bloomington, Minnesota, 55420
DaVita Bountiful Dialysis
Bountiful, Utah, 84010
Burlington Dialysis
Burlington, North Carolina, 27215
North Burlington Dialysis
Burlington, North Carolina, 27217-2928
DaVita Burnsville
Burnsville, Minnesota, 55337
DaVita Northeast Cambridge
Cambridge, Massachusetts, 02138
DaVita Ouachita Valley
Camden, Arkansas, 71701
DaVita Cass Lake
Cass Lake, Minnesota, 56633
DaVita Stony Island
Chicago, Illinois, 60617
DaVita Coon Rapids
Coon Rapids, Minnesota, 55433
DaVita Cottage Grove
Cottage Grove, Minnesota, 55016
DaVita Moorehead
Dilworth, Minnesota, 56529
Durham Dialysis
Durham, North Carolina, 27701
Bull City Dialysis
Durham, North Carolina, 27705
Durham West Dialysis
Durham, North Carolina, 27705
Southpoint Dialysis
Durham, North Carolina, 27713
DaVita Eden Prairie
Eden Prairie, Minnesota, 55344
DaVita South Arkansas
El Dorado, Arkansas, 71730
DaVita Midwest Fairborn
Fairborn, Ohio, 45324
DaVita Fargo
Fargo, North Dakota, 58104
DaVita Faribault
Faribault, Minnesota, 55021
DaVita Fayetteville
Fayetteville, Arkansas, 72703
DaVita Federal Way Dialysis
Federal Way, Washington, 98003
DaVita East River Road
Fridley, Minnesota, 55421
DaVita Glencoe
Glencoe, Minnesota, 55336
DaVita Goldsboro South Dialysis
Goldsboro, North Carolina, 27534
DaVita Hamden
Hamden, Connecticut, 06518
DaVita Historical Hastings
Hastings, Minnesota, 55033
Vance County Dialysis
Henderson, North Carolina, 27536
DaVita Highland Park
Highland Park, Michigan, 48203
DaVita West Joliet
Joliet, Illinois, 60435
DaVita Celebration Dialysis
Kissimmee, Florida, 34747
DaVita Troup County Dialysis
La Grange, Georgia, 30240
DaVita Lakeville
Lakeville, Minnesota, 55044
DaVita Centennial
Las Vegas, Nevada, 89149
DaVita Farmington Bay Dialysis
Layton, Utah, 84041
DaVita El Dorado Dialysis
Long Beach, California, 90806
Kerr Lake
Louisburg, North Carolina, 27549
DaVita Maple Grove
Maple Grove, Minnesota, 55369
DaVita Blount Dialysis
Maryville, Tennessee, 37804
DaVita McKeesport West
McKeesport, Pennsylvania, 15132-3953
DaVita Wellington Circle
Medford, Massachusetts, 02155
DaVita Mena
Mena, Arkansas, 71953
DaVita Middlesex
Middletown, Connecticut, 06457
DaVita Minneapolis Uptown
Minneapolis, Minnesota, 55409
DaVita Minnetonka
Minnetonka, Minnesota, 55345
DaVita Moore
Moore, Oklahoma, 73160
DaVita New Britain
New Britain, Connecticut, 06052-2016
DaVita New Ulm
New Ulm, Minnesota, 56073
DaVita Northfield
Northfield, Minnesota, 55057
DaVita Omaha West Dialysis
Omaha, Nebraska, 68154
DaVita Pahrump
Pahrump, Nevada, 89048
Payson Dialysis
Payson, Utah, 84651
DaVita Phoenix Dialysis
Phoenix, Arizona, 85004
Provo Dialysis
Provo, Utah, 84604
DaVita Radnor
Radnor, Pennsylvania, 19406
DaVita Redwood Falls
Redwood Falls, Minnesota, 56283
DaVita Reidsville Dialysis
Reidsville, North Carolina, 27320
DaVita Richfield
Richfield, Minnesota, 55423
DaVita Rochester
Rochester, Minnesota, 55904
DaVita Roxboro Dialysis
Roxboro, North Carolina, 27573
DaVita St. Louis Park
Saint Louis Park, Minnesota, 55426
DaVita St. Paul
Saint Paul, Minnesota, 55103
DaVita Sun Ray
Saint Paul, Minnesota, 55106
DaVita University Riverside
Saint Paul, Minnesota, 55114
DaVita Kolff
Salt Lake City, Utah, 84108
DaVita San Diego South
San Diego, California, 27560
DaVita Sandy Dialysis
Sandy City, Utah, 84070
DaVita Scott County
Savage, Minnesota, 55378
DaVita Southern Pines Dialysis
Southern Pines, North Carolina, 28387
DaVita Springdale
Springdale, Arkansas, 71953
DaVita Tahlequah
Tahlequah, Oklahoma, 74464
Sandy Dialysis
Taylorsville, Utah, 84129
DaVita Bronx
The Bronx, New York, 10461
DaVita Thomaston Dialysis
Thomaston, Georgia, 30286
DaVita Torrington
Torrington, Connecticut, 06790-6268
Renal Center of Waterton
Tyler, Texas, 75703
DaVita Vincennes Dialysis
Vincennes, Indiana, 47591
DaVita West St. Paul
West Saint Paul, Minnesota, 55118
DaVita Orchard Park Dialysis
West Seneca, New York, 14127
DaVita Wyoming
Wyoming, Minnesota, 55092
About this study
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.
Read more
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:
- Feasibility of obtaining informed consent using electronic devices (e-consent)
- Use of a single IRB of record for hundreds of dialysis facilities
- Successful implementation of a trial-driven treatment algorithm by dietitians at the participating dialysis units
- Harmonization of data from a large for-profit dialysis provider and an academically-owned small dialysis provider
- Effective monitoring of trial implementation using a centralized approach
Read the 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 intended to be large clinical trials that are conducted within the clinical care environment and evaluate interventions implemented by care providers and relying as much as possible on data obtained as part of routine clinical care. HiLo has the following demonstration project goals:
- To implement an electronic consent process;
- To use a single IRB of record to oversee hundreds of dialysis facilities;
- To implement a trial-driven treatment algorithm by dietitians at the participating dialysis units
- To harmonize across 2 different dialysis providers data elements obtained though clinical care;
- To monitor safety without using individual adverse event reporting.
HiLo will individually randomize participants using facility-level stratification to achieve balance across the two arms. Stratification will be 1:1 within each facility.
Participants will be followed for up to 27 (enter at enrollment end) - 45 (enter at enrollment start) months.
Two phosphate titration protocols will be used that have the same "look and feel" as those used in practice in an effort to sustain a mean time-averaged difference in serum phosphate between the two arms of ≥1 mg/dl:
- Low serum phosphate target that is consistent with current standard of care: The goal is to titrate and maintain serum phosphate to <5.5 mg/dl.
- Higher serum phosphate target that is the intervention strategy: The goal is to titrate and maintain serum phosphate to ≥6.5 mg/dl by setting a serum phosphate threshold >7.0 mg/dl when binders will be initiated, as has been done previously.
A mean serum phosphate of 4.8-5.2 is anticipated in the low arm and 6.5-6.8 in the high arm, as observed in two pilot clinical trials.Since serum phosphate is 4-7 mg/dl in most patients with ESRD, ≥1 mg/dl difference equates with a ≥33% difference within the modifiable range of time-averaged phosphate exposure. Specific binder choices will be relegated to the discretion of local providers based on local practice.
Planned Enrollment and randomization Enrollment of the first subject - 03/13/2020 (Actual) 25% of planned enrollment recruited - 06/30/2022 (Anticipated) 50% of planned enrollment recruited - 10/30/2022 (Anticipated) 75% of planned enrollment recruited - 03/31/2023 (Anticipated) 100% of planned enrollment recruited - 09/30/2023 (Anticipated) 6.4. Completion of primary endpoint data analyses - 11/30/2024 (Anticipated) 6.5. Reporting of results in ClinicalTrials.gov - 1/31/2025 (Anticipated)
- Conditions
- All-cause Mortality, Hospitalization
- Being tested
- Hemodialysis
- Keywords
- All-cause Mortality, All-cause hospitalization, Phosphate management, Hemodialysis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HemodialysisProcedure or surgery
Patients in both arms will undergo hemodialysis to remove phosphate from the blood; however, patients in the Hi Arm will only be titrated down to no lower than 6.5mg/dl
| Study group | Role | What they receive |
|---|---|---|
| Hi Arm | Experimental | Patients to allow blood serum phosphate levels to rise to 6.5 mg/dl or above Receives: Procedure: Hemodialysis |
| Lo Arm | No intervention | Patients to titrate blood serum phosphate levels to the standard <5.5mg/dl |
What is being measured
The primary outcome is the main question the study is designed to answer.
Hierarchical Composite Mortality and All Cause Hospitalization
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
Measured: up to 27 (enter at enrollment end) - 45 (enter at enrollment start) months
Secondary outcomes (4)
Time to All-cause-mortality
Time to all-cause-mortality from baseline for both cluster-randomized and individually randomized cohorts.
Measured: up to 27 (enter at enrollment end) - 45 (enter at enrollment start) months
Hospitalization Days
Total days hospitalized (Data reflects participants with valid, non-missing hospitalization start and end dates.)
Measured: up to 27 (enter at enrollment end) - 45 (enter at enrollment start) months
Serum Albumin
serum albumin as markers of diet and nutrition.
Measured: Baseline (days -30 - 0)
Protein Catabolic Rate (PCR)
protein catabolic rate (PCR) as markers of diet and nutrition (g/kg/day).
Measured: Baseline (days -30 - 0)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Sep 2019
- Study start11 Mar 2020
- Primary completion17 Nov 2023
- Study completion17 Nov 2023
Why it stopped: Futility of enrollment and futility of separation between study arms
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for All-cause MortalityStudies of the same condition, open and under way.
- More trials run by Duke UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 793 participants (actual)
Sponsor and investigators
- Lead sponsor
- Duke University
- Sponsor type
- University, hospital or other
- Collaborators
- Northwestern University, University of Pennsylvania, Davita Clinical Research, National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK), American Association of Kidney Patients
- Responsible party
- Sponsor
- Investigators
- Myles Wolf, MD, MMSc, Principal investigator, Duke Nephrology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04095039
- Sponsor's protocol ID
- Pro00100325
- Other IDs
- 5UH3DK118748-05
- Status last verified
- Jul 2023
- First submitted
- 10 Sep 2019
- Last updated
- 24 Apr 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Will share data in accordance with the NIH data sharing guidelines
Publications
Edmonston D, Isakova T, Dember LM, Waymyers S, Andersen D, Chan KE, Chakraborty H, Wolf M. Higher versus Lower Phosphate Targets for Patients Undergoing In-Center Hemodialysis: A Randomized Controlled Trial. J Am Soc Nephrol. 2025 Dec 1;36(12):2445-2455. doi: 10.1681/ASN.0000000765. Epub 2025 Jul 10.
PubMed 40638247Fajol A, Faul C. The Pathologic Actions of Phosphate in CKD. Kidney360. 2025 Apr 17;6(6):1040-1049. doi: 10.34067/KID.0000000820.
PubMed 40241437Edmonston DL, Isakova T, Dember LM, Brunelli S, Young A, Brosch R, Beddhu S, Chakraborty H, Wolf M. Design and Rationale of HiLo: A Pragmatic, Randomized Trial of Phosphate Management for Patients Receiving Maintenance Hemodialysis. Am J Kidney Dis. 2021 Jun;77(6):920-930.e1. doi: 10.1053/j.ajkd.2020.10.008. Epub 2020 Dec 3.
PubMed 33279558
Study at a glance
From the registry record, last updated by the sponsor on 24 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- HiLo: Pragmatic Trial of Higher vs Lower Serum Phosphate Targets in Patients Undergoing Hemodialysis
- ClinicalTrials.gov ID
- NCT04095039
- Acronym / sponsor ID
- Pro00100325
- Conditions
- All-cause Mortality, Hospitalization
- Keywords
- All-cause Mortality, All-cause hospitalization, Phosphate management, Hemodialysis
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Futility of enrollment and futility of separation between study arms
- Enrolment
- 793 participants (actual)
- Lead sponsor
- Duke UniversityUniversity, hospital or other
- Collaborators
- Northwestern University, University of Pennsylvania, Davita Clinical Research, National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK), American Association of Kidney Patients
- Study start
- 11 Mar 2020 (actual)
- Primary completion
- 17 Nov 2023 (actual)
- Study completion
- 17 Nov 2023 (actual)
- First posted
- 19 Sep 2019 (actual)
- Results
- Posted 8 Jan 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- Feasibility of obtaining informed consent using electronic devices (e-consent)
- Use of a single IRB of record for hundreds of dialysis facilities
- Successful implementation of a trial-driven treatment algorithm by dietitians at the participating dialysis units
- Harmonization of data from a large for-profit dialysis provider and an academically-owned small dialysis provider
- Effective monitoring of trial implementation using a centralized approach
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 intended to be large clinical trials that are conducted within the clinical care environment and evaluate interventions implemented by care providers and relying as much as possible on data obtained as part of routine clinical care. HiLo has the following demonstration project goals:
- To implement an electronic consent process;
- To use a single IRB of record to oversee hundreds of dialysis facilities;
- To implement a trial-driven treatment algorithm by dietitians at the participating dialysis units
- To harmonize across 2 different dialysis providers data elements obtained though clinical care;
- To monitor safety without using individual adverse event reporting.
HiLo will individually randomize participants using facility-level stratification to achieve balance across the two arms. Stratification will be 1:1 within each facility.
Participants will be followed for up to 27 (enter at enrollment end) - 45 (enter at enrollment start) months.
Two phosphate titration protocols will be used that have the same "look and feel" as those used in practice in an effort to sustain a mean time-averaged difference in serum phosphate between the two arms of ≥1 mg/dl:
- Low serum phosphate target that is consistent with current standard of care: The goal is to titrate and maintain serum phosphate to <5.5 mg/dl.
- Higher serum phosphate target that is the intervention strategy: The goal is to titrate and maintain serum phosphate to ≥6.5 mg/dl by setting a serum phosphate threshold >7.0 mg/dl when binders will be initiated, as has been done previously.
A mean serum phosphate of 4.8-5.2 is anticipated in the low arm and 6.5-6.8 in the high arm, as observed in two pilot clinical trials.Since serum phosphate is 4-7 mg/dl in most patients with ESRD, ≥1 mg/dl difference equates with a ≥33% difference within the modifiable range of time-averaged phosphate exposure. Specific binder choices will be relegated to the discretion of local providers based on local practice.
Planned Enrollment and randomization Enrollment of the first subject - 03/13/2020 (Actual) 25% of planned enrollment recruited - 06/30/2022 (Anticipated) 50% of planned enrollment recruited - 10/30/2022 (Anticipated) 75% of planned enrollment recruited - 03/31/2023 (Anticipated) 100% of planned enrollment recruited - 09/30/2023 (Anticipated) 6.4. Completion of primary endpoint data analyses - 11/30/2024 (Anticipated) 6.5. Reporting of results in ClinicalTrials.gov - 1/31/2025 (Anticipated)
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Hi Arm | Experimental | Procedure: HemodialysisPatients to allow blood serum phosphate levels to rise to 6.5 mg/dl or above |
| Lo Arm | No intervention | –Patients to titrate blood serum phosphate levels to the standard <5.5mg/dl |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (3 listed)
- Pregnancy
- In-center Nocturnal
- Calciphylaxis
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| HemodialysisPatients in both arms will undergo hemodialysis to remove phosphate from the blood; however, patients in the Hi Arm will only be titrated down to no lower than 6.5mg/dl | Procedure or surgery | Hi Arm |
Primary outcome
Hierarchical Composite Mortality and All Cause Hospitalization
Time frame: 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
4 secondary outcomes
Time to All-cause-mortality
Time frame: up to 27 (enter at enrollment end) - 45 (enter at enrollment start) months
Hospitalization Days
Time frame: up to 27 (enter at enrollment end) - 45 (enter at enrollment start) months
Serum Albumin
Time frame: Baseline (days -30 - 0)
Protein Catabolic Rate (PCR)
Time frame: Baseline (days -30 - 0)
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Apr 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 40638247Edmonston D, Isakova T, Dember LM, Waymyers S, Andersen D, Chan KE, Chakraborty H, Wolf M. Higher versus Lower Phosphate Targets for Patients Undergoing In-Center Hemodialysis: A Randomized Controlled Trial. J Am Soc Nephrol. 2025 Dec 1;36(12):2445-2455. doi: 10.1681/ASN.0000000765. Epub 2025 Jul 10.
- Derived from this study: PubMed 40241437Fajol A, Faul C. The Pathologic Actions of Phosphate in CKD. Kidney360. 2025 Apr 17;6(6):1040-1049. doi: 10.34067/KID.0000000820.
- Derived from this study: PubMed 33279558Edmonston DL, Isakova T, Dember LM, Brunelli S, Young A, Brosch R, Beddhu S, Chakraborty H, Wolf M. Design and Rationale of HiLo: A Pragmatic, Randomized Trial of Phosphate Management for Patients Receiving Maintenance Hemodialysis. Am J Kidney Dis. 2021 Jun;77(6):920-930.e1. doi: 10.1053/j.ajkd.2020.10.008. Epub 2020 Dec 3.
- Individual participant dataSharing planned: Yes. Will share data in accordance with the NIH data sharing guidelines
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Myles Wolf, MD, MMSc principal investigator
Duke Nephrology
84 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Hemodialysis in people with All-cause Mortality and Hospitalization, run by Duke University at 84 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 24 Apr 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 84 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 8 Jan 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Hierarchical Composite Mortality and All Cause Hospitalization (time frame: up to 27 (enter at enrollment end) - 45 (enter at enrollment start) months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04095039, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Apr 2025.