AKIORKID-2NCT07106151
Outpatient Recovery From Acute Kidney Injury Requiring Dialysis - 2
A study testing Transmission of additional AKI-D recovery information and No additional AKI-D recovery information in people with AKI and AKI - Acute Kidney Injury, run by University of California, San Francisco at 1 site in United States.
Trial summary
Providing additional information to patients with acute kidney injury who continue dialysis after hospital discharge and to the accepting kidney doctor (nephrologist) who manages their dialysis may be feasible and beneficial. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- AKI, AKI - Acute Kidney Injury, Dialysis Patients
- What is being tested?
- Transmission of additional AKI-D recovery information and No additional AKI-D recovery information
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteUnited States
- Study dates
- 23 Feb 2026to Jan 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 (not ESKD, as determined by the clinical inpatient nephrology team)
- Age ≥ 18 years
- Planned for continued dialysis outside the acute hospital setting (at outpatient dialysis unit/SNF/LTACH, not planned transfer to another short-stay acute care hospital).
Who cannot join
- Pregnant
- Prisoner
- Unable to consent and no surrogate decision maker available
- Clinical team declines to allow approach for study
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
University of California, San Francisco
San Francisco, California, 94143
About this study
Providing additional information to patients with acute kidney injury who continue dialysis after hospital discharge and to the accepting kidney doctor (nephrologist) who manages their dialysis may be feasible and beneficial. This study will pilot measuring the patient's residual kidney function at the time of discharge and communicating that result to the accepting nephrologist and the patient, along with information on recommended recovery monitoring frequency and criteria for consideration of a twice-weekly hemodialysis schedule.
- Conditions
- AKI, AKI - Acute Kidney Injury, Dialysis Patients
- Being tested
- Transmission of additional AKI-D recovery information, No additional AKI-D recovery information
- 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.
Transmission of additional AKI-D recovery informationBehavioural
Measuring residual kidney function at the time of hospital discharge by timed urine collection (6-24 hours in duration), transmitting the results (urine volume, urea clearance, and creatinine clearance) to the accepting nephrologist and to the patient, along with information on recommended recovery monitoring frequency and criteria for consideration of a twice-weekly hemodialysis schedule.
No additional AKI-D recovery informationOther
The same timed urine collection will be collected at the time of hospital discharge as in the intervention arm, but in the control arm the results will not be transmitted to the accepting nephrologist or to the patient and no information on recommended recovery monitoring frequency and criteria for consideration of a twice-weekly hemodialysis schedule will be transmitted. Instead, the research team will call the accepting nephrologist to alert them that this is an AKI-D patient that is being followed by the research team for recovery for up to 60 days.
| Study group | Role | What they receive |
|---|---|---|
| Additional AKI-D recovery information | Experimental | Not described Receives: Behavioral: Transmission of additional AKI-D recovery information |
| No additional AKI-D recovery information | Active comparator | Not described Receives: Other: No additional AKI-D recovery information |
What is being measured
The primary outcome is the main question the study is designed to answer.
Feasibility: The proportion of patients who complete the timed urine collection within seven days before discharge and are able to have the results successfully transmitted to the accepting nephrologist and patient.
Measured: Baseline
Secondary outcomes (7)
Recruitment rate: Number of patients enrolled per month
Measured: Total study duration, anticipated 2 years
Screening-to-recruitment ratio: Number of patients who meet inclusion criteria divided by the number of patients enrolled.
Measured: Total study duration, anticipated 2 years
Number of post-discharge urine collections completed
Measured: Study day 60
Proportion prescribed a <3x/wk hemodialysis schedule at any time within 60 days of hospital discharge
Measured: Study day 60
Proportion who recover from needing dialysis
Measured: Study day 60
Proportion who trial a <3x/wk hemodialysis schedule but subsequently need to be increased to >= 3x/wk during the 60-day follow-up.
Measured: Study day 60
Incidence of adverse events
Measured: Study day 60
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Aug 2025
- Study start23 Feb 2026
- Primary completionJan 2028 (estimated)
- Study completionJan 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AKIStudies 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 N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of California, San Francisco
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Ian E McCoy, MD, MS, Principal investigator, University of California, San Francisco
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07106151
- Sponsor's protocol ID
- 25-44531
- Other IDs
- 5K23DK128605
- Acronym
- ORKID-2
- Status last verified
- Feb 2026
- First submitted
- 22 Jul 2025
- Last updated
- 27 Feb 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Outpatient Recovery From Acute Kidney Injury Requiring Dialysis - 2
- ClinicalTrials.gov ID
- NCT07106151
- Acronym / sponsor ID
- ORKID-2 / 25-44531
- Conditions
- AKI, AKI - Acute Kidney Injury, Dialysis Patients
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- University of California, San FranciscoUniversity, hospital or other
- Collaborators
- National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
- Study start
- 23 Feb 2026 (actual)
- Primary completion
- Jan 2028 (estimated)
- Study completion
- Jan 2028 (estimated)
- First posted
- 6 Aug 2025 (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.
Providing additional information to patients with acute kidney injury who continue dialysis after hospital discharge and to the accepting kidney doctor (nephrologist) who manages their dialysis may be feasible and beneficial. This study will pilot measuring the patient's residual kidney function at the time of discharge and communicating that result to the accepting nephrologist and the patient, along with information on recommended recovery monitoring frequency and criteria for consideration of a twice-weekly hemodialysis schedule.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Additional AKI-D recovery information | Experimental | Behavioral: Transmission of additional AKI-D recovery information |
| No additional AKI-D recovery information | Active comparator | Other: No additional AKI-D recovery information |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- AKI-D (not ESKD, as determined by the clinical inpatient nephrology team)
- Age ≥ 18 years
- Planned for continued dialysis outside the acute hospital setting (at outpatient dialysis unit/SNF/LTACH, not planned transfer to another short-stay acute care hospital).
Key exclusion criteria (4 listed)
- Pregnant
- Prisoner
- Unable to consent and no surrogate decision maker available
- Clinical team declines to allow approach for 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 |
|---|---|---|
| Transmission of additional AKI-D recovery informationMeasuring residual kidney function at the time of hospital discharge by timed urine collection (6-24 hours in duration), transmitting the results (urine volume, urea clearance, and creatinine clearance) to the accepting nephrologist and to the patient, along with information on recommended recovery monitoring frequency and criteria for consideration of a twice-weekly hemodialysis schedule. | Behavioural | Additional AKI-D recovery information |
| No additional AKI-D recovery informationThe same timed urine collection will be collected at the time of hospital discharge as in the intervention arm, but in the control arm the results will not be transmitted to the accepting nephrologist or to the patient and no information on recommended recovery monitoring frequency and criteria for consideration of a twice-weekly hemodialysis schedule will be transmitted. Instead, the research team will call the accepting nephrologist to alert them that this is an AKI-D patient that is being followed by the research team for recovery for up to 60 days. | Other | No additional AKI-D recovery information |
Primary outcome
Feasibility: The proportion of patients who complete the timed urine collection within seven days before discharge and are able to have the results successfully transmitted to the accepting nephrologist and patient.
Time frame: Baseline
7 secondary outcomes
Recruitment rate: Number of patients enrolled per month
Time frame: Total study duration, anticipated 2 years
Screening-to-recruitment ratio: Number of patients who meet inclusion criteria divided by the number of patients enrolled.
Time frame: Total study duration, anticipated 2 years
Number of post-discharge urine collections completed
Time frame: Study day 60
Proportion prescribed a <3x/wk hemodialysis schedule at any time within 60 days of hospital discharge
Time frame: Study day 60
Proportion who recover from needing dialysis
Time frame: Study day 60
Proportion who trial a <3x/wk hemodialysis schedule but subsequently need to be increased to >= 3x/wk during the 60-day follow-up.
Time frame: Study day 60
Incidence of adverse events
Time frame: Study day 60
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Feb 2026.
- Individual participant dataSharing planned: No
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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.
Ian E McCoy, MD, MS 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 study testing Transmission of additional AKI-D recovery information and No additional AKI-D recovery information in people with AKI and AKI - Acute Kidney Injury, 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 3 inclusion and 4 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: looking for participants now, as of the sponsor's last update on 27 Feb 2026. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Ian E McCoy, MD, MS (415-353-2507, ian.mccoy@ucsf.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Feasibility: The proportion of patients who complete the timed urine collection within seven days before discharge and are able to have the results successfully transmitted to the accepting nephrologist and patient. (time frame: Baseline). 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 27 Feb 2026.