End Stage Kidney DiseaseCOMPARENCT04912024
Comparative Outcome Measures of Patients Receiving Acute Renal ThErapy Study
An observational study of End Stage Kidney Disease and End Stage Renal Disease, run by Outset Medical at 2 sites in United States.
Trial summary
Retrospective, multicenter, comparative, post-market study of the Tablo Hemodialysis System in hospitalized participants with End-Stage Renal Disease or Acute Kidney Injury. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- End Stage Kidney Disease, End Stage Renal Disease, Acute Kidney Injury
- What is being tested?
- Intermittent Renal Replacement Therapy using the Tablo Hemodialysis System and Intermittent Renal Replacement Therapy using Conventional Hemodialysis Systems
- Type of treatment
- Medical device
- How many people
- 458 participants
- Where
- 2 sitesUnited States
- Study dates
- 15 May 2021to 15 Jun 2022
- Phase
- Observational
- Are there results?
- None posted in the registry
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
- Adult, Older adult
Study population: Participants with AKI or ESKD who were prescribed acute intermittent Renal Replacement Therapy (RRT).
Who may be able to join
- Participant is 18 years of age.
- Participant weighs ≥ 34kg.
- Participant was hospitalized and had dialysis dependent End-Stage Renal Disease or Acute Kidney Injury and was prescribed acute intermittent renal replacement therapy.
Who cannot join
- Treatments isolated to ultrafiltration only.
- Any documented condition the Physician feels would prevent the participant from successful inclusion in the study.
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Texas Health Harris Methodist Hospital Fort Worth
Fort Worth, Texas, 76104
Adventist Health System
Orlando, Florida, 32803
About this study
Official title: Comparative Outcome Measures of Patients Receiving Acute Renal ThErapy Study (COMPARE)
Retrospective, multicenter, comparative, post-market study of the Tablo Hemodialysis System in hospitalized participants with End-Stage Renal Disease or Acute Kidney Injury.
- Being tested
- Intermittent Renal Replacement Therapy using the Tablo Hemodialysis System, Intermittent Renal Replacement Therapy using Conventional Hemodialysis Systems
- Keywords
- Tablo, Outset Medical, ESRD, AKI
- Medical subject headings
- Kidney Failure, Chronic, Acute Kidney Injury
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Intermittent Renal Replacement Therapy using the Tablo Hemodialysis SystemDevice
Intermittent renal replacement therapy using the Tablo Hemodialysis System in the acute setting for participants with AKI or ESKD
Intermittent Renal Replacement Therapy using Conventional Hemodialysis SystemsDevice
Intermittent renal replacement therapy using Conventional Hemodialysis Systems in the acute setting for participants with AKI or ESKD
| Study group | Role | What they receive |
|---|---|---|
| Tablo Hemodialysis System | Participants who were prescribed acute intermittent renal replacement therapy on the Tablo Hemodialysis System at a dialysate flow rate of 300 mL/min Receives: Device: Intermittent Renal Replacement Therapy using the Tablo Hemodialysis System | |
| Conventional Hemodialysis System | Participants who were prescribed acute intermittent renal replacement therapy on conventional hemodialysis systems (Non-Tablo) with dialysate flow rates of ≥ 500 mL/min Receives: Device: Intermittent Renal Replacement Therapy using Conventional Hemodialysis Systems |
What is being measured
The primary outcome is the main question the study is designed to answer.
BUN Lab Value
Change in Blood Urea Nitrogen
Measured: Change from baseline BUN measurement at 24 hours.
Secondary outcomes (2)
Bicarbonate Lab Value
Change in Bicarbonate
Measured: Change from baseline bicarbonate measurement at 24 hours.
Potassium Lab Value
Change in Potassium
Measured: Change from baseline potassium measurement at 24 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Jun 2021
- Study start15 May 2021
- Primary completion15 Jun 2022
- Study completion15 Jun 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for End Stage Kidney DiseaseStudies of the same condition, open and under way.
- 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
- Observational
- Observational model
- Case-control
- Time perspective
- Retrospective
- Enrolment
- 458 participants (actual)
Sponsor and investigators
- Lead sponsor
- Outset Medical
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04912024
- Sponsor's protocol ID
- 2020-04
- Acronym
- COMPARE
- Status last verified
- Aug 2022
- First submitted
- 26 May 2021
- Last updated
- 12 Aug 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No: Only aggregate data will be shared.
Study at a glance
From the registry record, last updated by the sponsor on 12 Aug 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparative Outcome Measures of Patients Receiving Acute Renal ThErapy Study (COMPARE)
- ClinicalTrials.gov ID
- NCT04912024
- Acronym / sponsor ID
- COMPARE / 2020-04
- Keywords
- Tablo, Outset Medical, ESRD, AKI
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 458 participants (actual)
- Lead sponsor
- Outset MedicalIndustry (pharma, biotech, devices)
- Study start
- 15 May 2021 (actual)
- Primary completion
- 15 Jun 2022 (actual)
- Study completion
- 15 Jun 2022 (actual)
- First posted
- 3 Jun 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Retrospective, multicenter, comparative, post-market study of the Tablo Hemodialysis System in hospitalized participants with End-Stage Renal Disease or Acute Kidney Injury.
Study design
- Observational model
- Case-control
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Tablo Hemodialysis System | – | Device: Intermittent Renal Replacement Therapy using the Tablo Hemodialysis SystemParticipants who were prescribed acute intermittent renal replacement therapy on the Tablo Hemodialysis System at a dialysate flow rate of 300 mL/min |
| Conventional Hemodialysis System | – | Device: Intermittent Renal Replacement Therapy using Conventional Hemodialysis SystemsParticipants who were prescribed acute intermittent renal replacement therapy on conventional hemodialysis systems (Non-Tablo) with dialysate flow rates of ≥ 500 mL/min |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- Participants with AKI or ESKD who were prescribed acute intermittent Renal Replacement Therapy (RRT).
Key inclusion criteria (3 listed)
- Participant is 18 years of age.
- Participant weighs ≥ 34kg.
- Participant was hospitalized and had dialysis dependent End-Stage Renal Disease or Acute Kidney Injury and was prescribed acute intermittent renal replacement therapy.
Key exclusion criteria (2 listed)
- Treatments isolated to ultrafiltration only.
- Any documented condition the Physician feels would prevent the participant from successful inclusion in the study.
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 |
|---|---|---|
| Intermittent Renal Replacement Therapy using the Tablo Hemodialysis SystemIntermittent renal replacement therapy using the Tablo Hemodialysis System in the acute setting for participants with AKI or ESKD | Device | Tablo Hemodialysis System |
| Intermittent Renal Replacement Therapy using Conventional Hemodialysis SystemsIntermittent renal replacement therapy using Conventional Hemodialysis Systems in the acute setting for participants with AKI or ESKD | Device | Conventional Hemodialysis System |
Primary outcome
BUN Lab Value
Time frame: Change from baseline BUN measurement at 24 hours.
Change in Blood Urea Nitrogen
2 secondary outcomes
Bicarbonate Lab Value
Time frame: Change from baseline bicarbonate measurement at 24 hours.
Potassium Lab Value
Time frame: Change from baseline potassium measurement at 24 hours
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Aug 2022.
- Individual participant dataSharing planned: No. Only aggregate data will be shared.
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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.
The record lists no contact. Use the official record to reach the sponsor.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of End Stage Kidney Disease and End Stage Renal Disease, run by Outset Medical at 2 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 2 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 12 Aug 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
BUN Lab Value (time frame: Change from baseline BUN measurement at 24 hours.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 12 Aug 2022.