Acute Kidney InjuryPhase 4ORKIDNCT05158153
Outpatient Recovery From Acute Kidney Injury Requiring Dialysis
A Phase 4 study testing ORKID Bundled Intervention and Furosemide in people with Acute Kidney Injury and Dialysis Hypotension, run by University of California, San Francisco at 1 site in United States.
Trial summary
There are currently no therapies to improve the chances of recovering enough kidney function to come off of dialysis after severe acute kidney injury. It is not known if current routine outpatient dialysis treatments are optimized to maximize the chances of recovery. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Acute Kidney Injury, Dialysis Hypotension
- What is being tested?
- ORKID Bundled Intervention and Furosemide
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1 participants
- Where
- 1 siteUnited States
- Study dates
- 18 Oct 2021to 19 Apr 2022
- Phase
- Phase 4
- 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
- AKI-D (acute kidney injury requiring dialysis), attributed at least in part to acute tubular necrosis by clinical nephrology team
- Age ≥ 18 years
- Pre-hospitalization eGFR ≥ 15 mL/min/1.73m2
- Being discharged to a participating outpatient dialysis unit (within 30 miles of UCSF)
Who cannot join
- Known loop diuretic allergy/intolerance
- Dialysis duration > 3 months
- Pregnant
- Prisoner
- Unable to consent
- Clinical team declines to allow approach for study
Trial locations and contacts
1 site in 1 country.
United States1 site
University of California, San Francisco
San Francisco, California, 94143
About this study
There are currently no therapies to improve the chances of recovering enough kidney function to come off of dialysis after severe acute kidney injury. It is not known if current routine outpatient dialysis treatments are optimized to maximize the chances of recovery. The purpose of this pilot study is to see if we can feasibly and safely provide several changes to the way that dialysis is provided in outpatient dialysis centers which may improve the chances of recovery.
- Conditions
- Acute Kidney Injury, Dialysis Hypotension
- Being tested
- ORKID Bundled Intervention, Furosemide
- Keywords
- Dialysis-requiring Acute Kidney Injury, Renal Recovery
- Medical subject headings
- Acute Kidney Injury
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ORKID Bundled InterventionOther
During the 90-day study period, participants will be prescribed outpatient hemodialysis with cooled dialysate (35-36°C), high sodium dialysate (145 mmol/L), a high ultrafiltration hold threshold (systolic blood pressure > 110 mmHg; ultrafiltration hold threshold will not be applied in participants with baseline systolic blood pressure < 120 mmHg), and high dose diuretics (160 mg oral furosemide twice daily) to be taken every day at home will also be prescribed. Dialysis will be weaned according to an active weaning protocol.
FurosemideDrug
160 mg oral furosemide twice daily to be taken every day at home
| Study group | Role | What they receive |
|---|---|---|
| ORKID Bundled Intervention | Experimental | Not described Receives: Other: ORKID Bundled Intervention; Drug: Furosemide |
What is being measured
The primary outcome is the main question the study is designed to answer.
The Proportion of Patients Who Received the Dialysate Temperature, Dialysate Sodium Concentration, Diuretic Dose, and Ultrafiltration Hold Threshold That Was Ordered at Least Once in the First Two Weeks of Treatment.
Feasibility
Measured: First two weeks of study intervention
Secondary outcomes (8)
The Proportion of Enrolled Patients Completing the 90-day Study Still Continuing Each Intervention.
Tolerability
Measured: Study day 90
Incidence of Adverse Events; Both Serious and Non-serious Adverse Events Will be Monitored Including Electrolyte Abnormalities, Emergent Dialysis Treatments, and Hospitalizations.
Safety
Measured: Study day 90
Time to Renal Recovery
Days after study enrollment before renal recovery, defined as being alive and off dialysis for 14 consecutive days.
Measured: Study day 90
Proportion of Dialysis Sessions Complicated by Intradialytic Hypotension
Defined as nadir systolic blood pressure < 90 mmHg.
Measured: Study day 90
Number of Participants Enrolled Per Month
Recruitment rate
Measured: Total study duration, anticipated 1 year
Ratio of the Number of Participants Who Meet Inclusion Criteria to the Number of Participants Enrolled
Screening-to-recruitment ratio
Measured: Total study duration, anticipated 1 year
Modified Dialysis Symptom Index Score
Measured: Study day 0, 7, 14, 28, and 90
Kidney Disease Quality of Life-36 Score
Measured: Study day 0, 7, 14, 28, and 90
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Dec 2021
- Study start18 Oct 2021
- Primary completion19 Apr 2022
- Study completion19 Apr 2022
Why it stopped: Inadequate recruitment
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.
- Other trials for Acute Kidney InjuryStudies of the same condition, open and under way.
- More trials run by University of California, San FranciscoThe 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 4
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- This is a single-center (multi-clinic), non-randomized pilot study to investigate the feasibility, tolerability, and safety of a bundled intervention (cooled dialysate, high sodium dialysate, high dose diuretics, high ultrafiltration hold threshold, active dialysis weaning) designed to foster recovery from acute kidney injury requiring dialysis.
- Masking
- None (open label)
- Enrolment
- 1 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of California, San Francisco
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Ian McCoy, MD, MS, Principal investigator, University of California, San FraniscoChi-yuan Hsu, MD, MSc, Principal investigator, University of California, San Francisco
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05158153
- Sponsor's protocol ID
- 21-33602
- Acronym
- ORKID
- Status last verified
- Apr 2023
- First submitted
- 19 Nov 2021
- Last updated
- 12 May 2023
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 May 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Outpatient Recovery From Acute Kidney Injury Requiring Dialysis
- ClinicalTrials.gov ID
- NCT05158153
- Acronym / sponsor ID
- ORKID / 21-33602
- Conditions
- Acute Kidney Injury, Dialysis Hypotension
- Keywords
- Dialysis-requiring Acute Kidney Injury, Renal Recovery
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Inadequate recruitment
- Enrolment
- 1 participants (actual)
- Lead sponsor
- University of California, San FranciscoUniversity, hospital or other
- Study start
- 18 Oct 2021 (actual)
- Primary completion
- 19 Apr 2022 (actual)
- Study completion
- 19 Apr 2022 (actual)
- First posted
- 15 Dec 2021 (actual)
- Results
- Posted 12 May 2023
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
There are currently no therapies to improve the chances of recovering enough kidney function to come off of dialysis after severe acute kidney injury. It is not known if current routine outpatient dialysis treatments are optimized to maximize the chances of recovery. The purpose of this pilot study is to see if we can feasibly and safely provide several changes to the way that dialysis is provided in outpatient dialysis centers which may improve the chances of recovery.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- This is a single-center (multi-clinic), non-randomized pilot study to investigate the feasibility, tolerability, and safety of a bundled intervention (cooled dialysate, high sodium dialysate, high dose diuretics, high ultrafiltration hold threshold, active dialysis weaning) designed to foster recovery from acute kidney injury requiring dialysis.
| Arm | Type | Receives |
|---|---|---|
| ORKID Bundled Intervention | Experimental | Other: ORKID Bundled Intervention, Drug: Furosemide |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- AKI-D (acute kidney injury requiring dialysis), attributed at least in part to acute tubular necrosis by clinical nephrology team
- Age ≥ 18 years
- Pre-hospitalization eGFR ≥ 15 mL/min/1.73m2
- Being discharged to a participating outpatient dialysis unit (within 30 miles of UCSF)
Key exclusion criteria (6 listed)
- Known loop diuretic allergy/intolerance
- Dialysis duration > 3 months
- Pregnant
- Prisoner
- Unable to consent
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 |
|---|---|---|
| ORKID Bundled InterventionDuring the 90-day study period, participants will be prescribed outpatient hemodialysis with cooled dialysate (35-36°C), high sodium dialysate (145 mmol/L), a high ultrafiltration hold threshold (systolic blood pressure > 110 mmHg; ultrafiltration hold threshold will not be applied in participants with baseline systolic blood pressure < 120 mmHg), and high dose diuretics (160 mg oral furosemide twice daily) to be taken every day at home will also be prescribed. Dialysis will be weaned according to an active weaning protocol. | Other | ORKID Bundled Intervention |
| Furosemide160 mg oral furosemide twice daily to be taken every day at home | Drug | ORKID Bundled Intervention |
Primary outcome
The Proportion of Patients Who Received the Dialysate Temperature, Dialysate Sodium Concentration, Diuretic Dose, and Ultrafiltration Hold Threshold That Was Ordered at Least Once in the First Two Weeks of Treatment.
Time frame: First two weeks of study intervention
Feasibility
8 secondary outcomes
The Proportion of Enrolled Patients Completing the 90-day Study Still Continuing Each Intervention.
Time frame: Study day 90
Incidence of Adverse Events; Both Serious and Non-serious Adverse Events Will be Monitored Including Electrolyte Abnormalities, Emergent Dialysis Treatments, and Hospitalizations.
Time frame: Study day 90
Time to Renal Recovery
Time frame: Study day 90
Proportion of Dialysis Sessions Complicated by Intradialytic Hypotension
Time frame: Study day 90
Number of Participants Enrolled Per Month
Time frame: Total study duration, anticipated 1 year
Ratio of the Number of Participants Who Meet Inclusion Criteria to the Number of Participants Enrolled
Time frame: Total study duration, anticipated 1 year
Modified Dialysis Symptom Index Score
Time frame: Study day 0, 7, 14, 28, and 90
Kidney Disease Quality of Life-36 Score
Time frame: Study day 0, 7, 14, 28, and 90
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 May 2023.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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Acute Kidney Injury, Hypotension (MeSH: D007022)
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.
Ian McCoy, MD, MS principal investigator
University of California, San Franisco
Chi-yuan Hsu, MD, MSc principal investigator
University of California, San Francisco
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing ORKID Bundled Intervention and Furosemide in people with Acute Kidney Injury and Dialysis Hypotension, run by University of California, San Francisco 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 4 inclusion and 6 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 12 May 2023. 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 12 May 2023). 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?
The Proportion of Patients Who Received the Dialysate Temperature, Dialysate Sodium Concentration, Diuretic Dose, and Ultrafiltration Hold Threshold That Was Ordered at Least Once in the First Two Weeks of Treatment. (time frame: First two weeks of study intervention). 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 May 2023.