End-stage Renal DiseaseNCT05225298
SARS-COV-2 Screening in Dialysis Facilities
A study testing Offering SARS-CoV-2 test in people with End-stage Renal Disease and SARS-CoV-2 Acute Respiratory Disease, run by Stanford University at 1 site in United States.
Trial summary
Patients receiving dialysis are one of the highest risk groups for serious illness with SARS-CoV-2 infection. In addition to the inherent risks of travel to and dialysis within indoor facilities, patients receiving dialysis are more likely to be older, non-white, from disadvantaged backgrounds, and have impaired… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- End-stage Renal Disease, SARS-CoV-2 Acute Respiratory Disease, Dialysis; Complications
- What is being tested?
- Offering SARS-CoV-2 test
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 2,389 participants
- Where
- 1 siteUnited States
- Study dates
- 6 Feb 2023to 1 Oct 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
- Facility
- An established US Renal Care in-center hemodialysis facility located in a county with at least two US Renal Care facilities
- Facility governing board (Medical Director, Facility Manager, Social Worker and Charge Nurses) willingness to participate Patient
- Treatment at US Renal Care in-center hemodialysis facility
- Age ≥ 18 years
Who cannot join
- Patient
- Unwillingness to share anonymized clinical (electronic health record) or serum samples drawn during routine dialysis care (i.e., without an additional needlestick). If a patient declines offered testing he/she will still be part of the analyses as long as he/she is willing to share clinical data
- Dementia or cognitive impairment, with inability to comprehend 'opting out' of participation
Trial locations and contacts
1 site in 1 country.
About this study
Official title: SARS-COV-2 Screening in Dialysis Facilities: Building an Optimal Strategy to Protect High Risk Populations
Patients receiving dialysis are one of the highest risk groups for serious illness with SARS-CoV-2 infection. In addition to the inherent risks of travel to and dialysis within indoor facilities, patients receiving dialysis are more likely to be older, non-white, from disadvantaged backgrounds, and have impaired immune responses to viral infections and vaccinations. Universal testing offered at hemodialysis facilities could shield this vulnerable population from exposure, enable early identification and treatment for those affected, and reduce transmission to other patients and family members. In this pragmatic cluster randomized controlled trial as part of NIH RADx-UP Consortium, we will randomize 62 US Renal Care facilities with an estimated 2480 patients to static versus dynamic universal screening testing strategies. Static universal screening will involve offering patients SARS-CoV-2 screening tests every two weeks; the dynamic universal screening strategy will vary the frequency of testing from once every week to once every four weeks, depending on community COVID-19 case rates. We hypothesize that patients dialyzing at facilities randomized to a dynamic testing frequency responsive to community case rates will have higher test acceptability (primary outcome), experience lower rates of COVID-19 death and hospitalization, and report better experience-of-care metrics.
- Being tested
- Offering SARS-CoV-2 test
- Keywords
- Screening, Underserved communities, RADx-UP
- Medical subject headings
- Kidney Failure, Chronic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Offering SARS-CoV-2 testBehavioural
A pragmatic cluster (facility-level) randomized clinical trial, comparing test-based screening performed at a static (every two weeks) frequency versus a dynamic frequency (ranging from once a week to once every four weeks) anchored to county COVID-19 case rates
| Study group | Role | What they receive |
|---|---|---|
| Static frequency | Active comparator | Test based screening for SARS-CoV-2 every two weeks Receives: Behavioral: Offering SARS-CoV-2 test |
| Dynamic frequency | Active comparator | Test based screening for SARS-CoV-2 ranging from once a week to once every four weeks anchored to county COVID-19 case rates Receives: Behavioral: Offering SARS-CoV-2 test |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number and Percentage of Total SARS-CoV-2 Tests Accepted Out of Total Tests Offered
Measured: 3 months
Secondary outcomes (3)
Deaths
Measured: 4 months
Hospitalizations
Measured: 4 months
Change in Facility Scores on In-Center Hemodialysis Consumer Assessment of Healthcare Providers and Systems (ICH CAHPS) Survey
this survey is administered annually at each dialysis facility dialysis facility (based on Centers for Medicare Services regulation)
Measured: 4 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Feb 2022
- Study start6 Feb 2023
- Primary completion1 Aug 2023
- Study completion1 Oct 2023
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 (2)Papers the sponsor has linked to this study.
- Other trials for End-stage Renal DiseaseStudies of the same condition, open and under way.
- More trials run by Stanford 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
- Screening
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 2,389 participants (actual)
Sponsor and investigators
- Lead sponsor
- Stanford University
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute on Minority Health and Health Disparities (NIMHD), National Institute of Allergy and Infectious Diseases (NIAID)
- Responsible party
- Principal investigator, Shuchi Anand, Stanford University
- Investigators
- Shuchi Anand, MD, Principal investigator, Stanford UniversityJulie Parsonnet, MD, Principal investigator, Stanford UniversityGlenn Chertow, MD, Principal investigator, Stanford UniversityGeoff Block, MD, Study director, US Renal Care
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05225298
- Sponsor's protocol ID
- 64616
- Other IDs
- U01AI169477
- Status last verified
- Oct 2024
- First submitted
- 24 Jan 2022
- Last updated
- 30 Oct 2024
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Anonymized data will be shared with NIH Radx-UP data repository.
Publications
Montez-Rath M, Varkila M, Yu X, Brillhart S, Morgan C, Leppink A, Block MS, Mehta S, Hunsader P, Fountaine A, Subramanian N, Dittrich M, Owens DK, Chertow GM, Parsonnet J, Anand S, Block GA. Acceptance of SARS-CoV-2 Surveillance Testing Among Patients Receiving Dialysis: A Cluster Randomized Trial. JAMA Netw Open. 2024 Sep 3;7(9):e2434159. doi: 10.1001/jamanetworkopen.2024.34159.
PubMed 39298171Anand S, Montez-Rath M, Varkila M, Yu X, Block M, Brillhart S, Leppink A, Hunsader P, Owens DK, Chertow GM, Parsonnet J, Block GA. Feasibility and Acceptability of SARS-CoV-2 Screening among Patients Receiving Hemodialysis: A Pilot Study. Clin J Am Soc Nephrol. 2023 Jul 1;18(7):930-932. doi: 10.2215/CJN.0000000000000137. Epub 2023 Apr 24. No abstract available.
PubMed 36976655
Study at a glance
From the registry record, last updated by the sponsor on 30 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- SARS-COV-2 Screening in Dialysis Facilities: Building an Optimal Strategy to Protect High Risk Populations
- ClinicalTrials.gov ID
- NCT05225298
- Acronym / sponsor ID
- 64616
- Keywords
- Screening, Underserved communities, RADx-UP
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 2,389 participants (actual)
- Lead sponsor
- Stanford UniversityUniversity, hospital or other
- Collaborators
- National Institute on Minority Health and Health Disparities (NIMHD), National Institute of Allergy and Infectious Diseases (NIAID)
- Study start
- 6 Feb 2023 (actual)
- Primary completion
- 1 Aug 2023 (actual)
- Study completion
- 1 Oct 2023 (actual)
- First posted
- 4 Feb 2022 (actual)
- Results
- Posted 30 Oct 2024
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Patients receiving dialysis are one of the highest risk groups for serious illness with SARS-CoV-2 infection. In addition to the inherent risks of travel to and dialysis within indoor facilities, patients receiving dialysis are more likely to be older, non-white, from disadvantaged backgrounds, and have impaired immune responses to viral infections and vaccinations. Universal testing offered at hemodialysis facilities could shield this vulnerable population from exposure, enable early identification and treatment for those affected, and reduce transmission to other patients and family members. In this pragmatic cluster randomized controlled trial as part of NIH RADx-UP Consortium, we will randomize 62 US Renal Care facilities with an estimated 2480 patients to static versus dynamic universal screening testing strategies. Static universal screening will involve offering patients SARS-CoV-2 screening tests every two weeks; the dynamic universal screening strategy will vary the frequency of testing from once every week to once every four weeks, depending on community COVID-19 case rates. We hypothesize that patients dialyzing at facilities randomized to a dynamic testing frequency responsive to community case rates will have higher test acceptability (primary outcome), experience lower rates of COVID-19 death and hospitalization, and report better experience-of-care metrics.
Study design
- Primary purpose
- Screening
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Static frequency | Active comparator | Behavioral: Offering SARS-CoV-2 testTest based screening for SARS-CoV-2 every two weeks |
| Dynamic frequency | Active comparator | Behavioral: Offering SARS-CoV-2 testTest based screening for SARS-CoV-2 ranging from once a week to once every four weeks anchored to county COVID-19 case rates |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Facility
Key exclusion criteria (3 listed)
- Patient
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 |
|---|---|---|
| Offering SARS-CoV-2 testA pragmatic cluster (facility-level) randomized clinical trial, comparing test-based screening performed at a static (every two weeks) frequency versus a dynamic frequency (ranging from once a week to once every four weeks) anchored to county COVID-19 case rates | Behavioural | Dynamic frequency, Static frequency |
Primary outcome
Number and Percentage of Total SARS-CoV-2 Tests Accepted Out of Total Tests Offered
Time frame: 3 months
3 secondary outcomes
Deaths
Time frame: 4 months
Hospitalizations
Time frame: 4 months
Change in Facility Scores on In-Center Hemodialysis Consumer Assessment of Healthcare Providers and Systems (ICH CAHPS) Survey
Time frame: 4 months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Oct 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 39298171Montez-Rath M, Varkila M, Yu X, Brillhart S, Morgan C, Leppink A, Block MS, Mehta S, Hunsader P, Fountaine A, Subramanian N, Dittrich M, Owens DK, Chertow GM, Parsonnet J, Anand S, Block GA. Acceptance of SARS-CoV-2 Surveillance Testing Among Patients Receiving Dialysis: A Cluster Randomized Trial. JAMA Netw Open. 2024 Sep 3;7(9):e2434159. doi: 10.1001/jamanetworkopen.2024.34159.
- Derived from this study: PubMed 36976655Anand S, Montez-Rath M, Varkila M, Yu X, Block M, Brillhart S, Leppink A, Hunsader P, Owens DK, Chertow GM, Parsonnet J, Block GA. Feasibility and Acceptability of SARS-CoV-2 Screening among Patients Receiving Hemodialysis: A Pilot Study. Clin J Am Soc Nephrol. 2023 Jul 1;18(7):930-932. doi: 10.2215/CJN.0000000000000137. Epub 2023 Apr 24. No abstract available.
- Individual participant dataSharing planned: Yes. Anonymized data will be shared with NIH Radx-UP data repository.
Related trials for End-stage Renal Disease
Not yet recruitingObservational study
Microbiota Changes Related to Outcomes in Kidney Transplantation
End-stage Renal Disease (ESRD), Kidney Transplantation
Recruiting
Laser Acupuncture for Fatigue in Hemodialysis Patients
ESRD (End Stage Renal Disease), Dialysis
Active, not recruitingObservational study
Acetoacetate and Acetate Metabolism in Patients With Chronic Kidney Failure.(RENO-TEP)
Kidney Failure, Chronic
Active, not recruitingObservational study
Central Blood Pressure and Pulse Wave Velocity in Kidney Transplant Recipients
End Stage Renal Disease
RecruitingObservational study
Sensor-based Congestion ALert for Events in Peritoneal Dialysis (SCALE-PD)
Kidney Disease, Peritoneal Dialysis (PD)
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.
Shuchi Anand, MD principal investigator
Stanford University
Julie Parsonnet, MD principal investigator
Stanford University
Glenn Chertow, MD principal investigator
Stanford University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Offering SARS-CoV-2 test in people with End-stage Renal Disease and SARS-CoV-2 Acute Respiratory Disease, run by Stanford University at 1 site 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 5 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: finished, as of the sponsor's last update on 30 Oct 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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 30 Oct 2024). 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?
Number and Percentage of Total SARS-CoV-2 Tests Accepted Out of Total Tests Offered (time frame: 3 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 NCT05225298, which also lists 2 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 30 Oct 2024.