Acute Kidney InjuryRAD-AKINCT03305549
Recovery After Dialysis-Requiring Acute Kidney Injury
A study testing Conservative dialysis strategy and TIW dialysis strategy in people with Acute Kidney Injury, run by University of California, San Francisco at 1 site in United States.
Trial summary
The Recovery After Dialysis-Requiring Acute Kidney Injury (RAD-AKI) Pilot Study is a 2-arm randomized clinical trial of hospitalized patients with dialysis-requiring acute kidney injury (RAD-AKI), comparing conventional thrice-weekly intermittent hemodialysis dialysis (control) to a "conservative dialysis strategy" in… Read more about this study
- Who is it for?
- Ages 18 to 100 years
- Conditions the study is for
- Acute Kidney Injury
- What is being tested?
- Conservative dialysis strategy and TIW dialysis strategy
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 16 participants
- Where
- 1 siteUnited States
- Study dates
- 29 Sep 2017to 13 Nov 2019
- Phase
- Interventional
- 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 to 100 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adult inpatients with AKI-D due to acute tubular necrosis who have already initiated renal replacement therapy
- If initiated on CRRT, patients will be eligible only if they have already tolerated 1 intermittent hemodialysis (IHD) session at the research site.
- If transferred from an outside hospital, eligible patients must have tolerated 1 IHD session at the research site prior to enrollment.
- Not requiring vasopressor support
- Not intubated and not having a supplemental oxygen requirement of >5 L/min via nasal cannula
- Treating MDs (nephrology and primary team attendings) and patient (or legally authorized representative) consent to enrollment
Who cannot join
- Diagnosis of end-stage renal disease (ESRD) or chronic dialysis prior to hospitalization
- Baseline estimated glomerular filtration rate (eGFR) <15 mL/min/1.73m2
- Liver transplant unit patients
- Patients who underwent kidney transplantation during index hospitalization
- Cause of AKI-D is complete nephrectomy
- Current pregnancy
Trial locations and contacts
1 site in 1 country.
United States1 site
UCSF Medical Center Moffitt-Long Hospital
San Francisco, California, 94143
About this study
Official title: Recovery After Dialysis-Requiring Acute Kidney Injury Pilot Study
The Recovery After Dialysis-Requiring Acute Kidney Injury (RAD-AKI) Pilot Study is a 2-arm randomized clinical trial of hospitalized patients with dialysis-requiring acute kidney injury (RAD-AKI), comparing conventional thrice-weekly intermittent hemodialysis dialysis (control) to a "conservative dialysis strategy" in which hemodialysis is not continued unless specific metabolic or clinical indications for RRT are present. The overall hypothesis is that the current practice of thrice-weekly acute intermittent hemodialysis for AKI-D masks evidence of renal recovery and may actually delay or preclude recovery. The primary objective of this pilot study is to assess the safety and feasibility of the proposed intervention and study design.
Read the detailed description
The recent landmark Artificial Kidney Initiation in Kidney Injury (AKIKI) trial showed that a delayed strategy for RRT initiation among patients with incident stage 3 AKI - in which RRT was delayed unless specific metabolic or clinical indications for RRT were present - was safe and averted the need for RRT in nearly half of the critically ill participants, in comparison to an early RRT initiation strategy. The hypothesis for this study is: for prevalent patients with established AKI-D, a conservative dialysis strategy - in which hemodialysis is not continued unless specific metabolic or clinical indications for RRT are present - will shorten time to RRT-independence and improve the likelihood of renal recovery.
The RAD-AKI Pilot Study is a 2-arm randomized clinical trial of hospitalized patients with dialysis-requiring acute kidney injury (RAD-AKI) that will compare conventional thrice-weekly intermittent hemodialysis dialysis (control) to a "conservative dialysis strategy." The primary objective of this pilot study is to assess the safety and feasibility of the proposed intervention and study design.
- Conditions
- Acute Kidney Injury
- Being tested
- Conservative dialysis strategy, TIW dialysis strategy
- 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.
Conservative dialysis strategyOther
Participants will receive RRT only when meeting 1 of the following indications (patterned after the AKIKI trial's delayed RRT initiation arm):
- Blood urea nitrogen >112 mg/dL (40 mmol/L)
- Serum potassium concentration >6 mmol/L
- Serum potassium concentration >5.5 mmol/L despite medical treatment (e.g., bicarbonate, glucose-insulin infusion, albuterol, diuretics, sodium polystyrene sulfonate)
- Arterial blood gas pH <7.15 in a context of pure metabolic acidosis (PaCO2 <35 mmHg) or in a context of mixed acidosis with PaCO2 50 mmHg despite medical treatment to reverse respiratory acidosis (e.g., naloxone), or in the absence of an available arterial blood gas, serum bicarbonate <12 mmol/L
- Acute pulmonary edema due to fluid overload, responsible for hypoxemia requiring oxygen flow rate >5 L/min to maintain SpO2 >95% or requiring FiO2 >50% in patients already on invasive or non-invasive mechanical ventilation and despite diuretic therapy
TIW dialysis strategyOther
Thrice-weekly acute intermittent hemodialysis schedule.
| Study group | Role | What they receive |
|---|---|---|
| TIW Dialysis Strategy | Active comparator | Conventional thrice-weekly acute intermittent hemodialysis treatment schedule. Receives: Other: TIW dialysis strategy |
| Conservative Dialysis Strategy | Experimental | Conservative acute intermittent hemodialysis strategy, in which hemodialysis is not continued unless specific metabolic or clinical indications for RRT are present. Receives: Other: Conservative dialysis strategy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Protocol adherence [feasibility measure]
Number of times a participant in the "conservative dialysis" arm receives dialysis despite not meeting one of the pre-specified indications for dialysis, number of times a participant in the "TIW dialysis" arm is dialyzed off-schedule
Measured: Through completion of active study participation (anticipated <2 weeks for each participant)
Number of participants with adverse events in each arm [safety measure]
Both serious and non-serious adverse events will be monitored, including arrhythmias due to metabolic disturbances, death, emergent dialysis needs, and transfer to ICU or intubation after enrollment
Measured: Through completion of active study participation (anticipated <2 weeks for each participant)
Secondary outcomes (4)
Patient-reported symptoms
Survey will assess dyspnea, light-headedness, intradialytic cramping, pain and impaired mobility due to edema
Measured: Through completion of active study participation (anticipated <2 weeks for each participant)
Hospital length of stay
Length of inpatient admission, starting after study enrollment
Measured: Through completion of active study participation (anticipated <2 weeks for each participant)
Recovery status at 30, 60, and 90 days after dialysis initiation
Assessment of recovery status via phone call or e-mail contact
Measured: From enrollment to 90 days after dialysis initiation for each patient
Screen-to-enroll ratio [feasibility measure]
Ratio of number of participants who meet eligibility criteria to number of participants who actually enroll into the study
Measured: Through study completion (anticipated 2 years total)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Oct 2017
- Study start29 Sep 2017
- Primary completion13 Nov 2019
- Study completion13 Nov 2019
Why it stopped: Study stopped because sufficient pilot data collected to proceed to next clinical trial.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Pilot 2-arm parallel-comparison randomized clinical trial comparing TIW dialysis (control) to a "conservative dialysis strategy."
- Masking
- None (open label)
- Enrolment
- 16 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of California, San Francisco
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Chi-yuan Hsu, MD, MSc, Principal investigator, University of California, San FranciscoKathleen Liu, MD, PhD, Principal investigator, University of California, San Francisco
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03305549
- Sponsor's protocol ID
- F32DK115030
- Other IDs
- F32DK115030
- Acronym
- RAD-AKI
- Status last verified
- Mar 2025
- First submitted
- 29 Sep 2017
- Last updated
- 19 Mar 2025
- Results posted
- No
- Data monitoring committee
- Yes
- 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 19 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Recovery After Dialysis-Requiring Acute Kidney Injury Pilot Study
- ClinicalTrials.gov ID
- NCT03305549
- Acronym / sponsor ID
- RAD-AKI / F32DK115030
- Conditions
- Acute Kidney Injury
- Keywords
- Dialysis-requiring Acute Kidney Injury, Renal Recovery
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Study stopped because sufficient pilot data collected to proceed to next clinical trial.
- Enrolment
- 16 participants (actual)
- Lead sponsor
- University of California, San FranciscoUniversity, hospital or other
- Collaborators
- National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
- Study start
- 29 Sep 2017 (actual)
- Primary completion
- 13 Nov 2019 (actual)
- Study completion
- 13 Nov 2019 (actual)
- First posted
- 10 Oct 2017 (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.
The Recovery After Dialysis-Requiring Acute Kidney Injury (RAD-AKI) Pilot Study is a 2-arm randomized clinical trial of hospitalized patients with dialysis-requiring acute kidney injury (RAD-AKI), comparing conventional thrice-weekly intermittent hemodialysis dialysis (control) to a "conservative dialysis strategy" in which hemodialysis is not continued unless specific metabolic or clinical indications for RRT are present. The overall hypothesis is that the current practice of thrice-weekly acute intermittent hemodialysis for AKI-D masks evidence of renal recovery and may actually delay or preclude recovery. The primary objective of this pilot study is to assess the safety and feasibility of the proposed intervention and study design.
Detailed description
The recent landmark Artificial Kidney Initiation in Kidney Injury (AKIKI) trial showed that a delayed strategy for RRT initiation among patients with incident stage 3 AKI - in which RRT was delayed unless specific metabolic or clinical indications for RRT were present - was safe and averted the need for RRT in nearly half of the critically ill participants, in comparison to an early RRT initiation strategy. The hypothesis for this study is: for prevalent patients with established AKI-D, a conservative dialysis strategy - in which hemodialysis is not continued unless specific metabolic or clinical indications for RRT are present - will shorten time to RRT-independence and improve the likelihood of renal recovery.
The RAD-AKI Pilot Study is a 2-arm randomized clinical trial of hospitalized patients with dialysis-requiring acute kidney injury (RAD-AKI) that will compare conventional thrice-weekly intermittent hemodialysis dialysis (control) to a "conservative dialysis strategy." The primary objective of this pilot study is to assess the safety and feasibility of the proposed intervention and study design.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Pilot 2-arm parallel-comparison randomized clinical trial comparing TIW dialysis (control) to a "conservative dialysis strategy."
| Arm | Type | Receives |
|---|---|---|
| TIW Dialysis Strategy | Active comparator | Other: TIW dialysis strategyConventional thrice-weekly acute intermittent hemodialysis treatment schedule. |
| Conservative Dialysis Strategy | Experimental | Other: Conservative dialysis strategyConservative acute intermittent hemodialysis strategy, in which hemodialysis is not continued unless specific metabolic or clinical indications for RRT are present. |
Who may qualify
- Ages
- 18 to 100 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Adult inpatients with AKI-D due to acute tubular necrosis who have already initiated renal replacement therapy
- If initiated on CRRT, patients will be eligible only if they have already tolerated 1 intermittent hemodialysis (IHD) session at the research site.
- If transferred from an outside hospital, eligible patients must have tolerated 1 IHD session at the research site prior to enrollment.
- Not requiring vasopressor support
- Not intubated and not having a supplemental oxygen requirement of >5 L/min via nasal cannula
Key exclusion criteria (6 listed)
- Diagnosis of end-stage renal disease (ESRD) or chronic dialysis prior to hospitalization
- Baseline estimated glomerular filtration rate (eGFR) <15 mL/min/1.73m2
- Liver transplant unit patients
- Patients who underwent kidney transplantation during index hospitalization
- Cause of AKI-D is complete nephrectomy
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 |
|---|---|---|
| Conservative dialysis strategyParticipants will receive RRT only when meeting 1 of the following indications (patterned after the AKIKI trial's delayed RRT initiation arm): * Blood urea nitrogen >112 mg/dL (40 mmol/L) * Serum potassium concentration >6 mmol/L * Serum potassium concentration >5.5 mmol/L despite medical treatment (e.g., bicarbonate, glucose-insulin infusion, albuterol, diuretics, sodium polystyrene sulfonate) * Arterial blood gas pH <7.15 in a context of pure metabolic acidosis (PaCO2 <35 mmHg) or in a context of mixed acidosis with PaCO2 50 mmHg despite medical treatment to reverse respiratory acidosis (e.g., naloxone), or in the absence of an available arterial blood gas, serum bicarbonate <12 mmol/L * Acute pulmonary edema due to fluid overload, responsible for hypoxemia requiring oxygen flow rate >5 L/min to maintain SpO2 >95% or requiring FiO2 >50% in patients already on invasive or non-invasive mechanical ventilation and despite diuretic therapy | Other | Conservative Dialysis Strategy |
| TIW dialysis strategyThrice-weekly acute intermittent hemodialysis schedule. | Other | TIW Dialysis Strategy |
Primary outcome
Protocol adherence [feasibility measure]
Time frame: Through completion of active study participation (anticipated <2 weeks for each participant)
Number of times a participant in the "conservative dialysis" arm receives dialysis despite not meeting one of the pre-specified indications for dialysis, number of times a participant in the "TIW dialysis" arm is dialyzed off-schedule
Number of participants with adverse events in each arm [safety measure]
Time frame: Through completion of active study participation (anticipated <2 weeks for each participant)
Both serious and non-serious adverse events will be monitored, including arrhythmias due to metabolic disturbances, death, emergent dialysis needs, and transfer to ICU or intubation after enrollment
4 secondary outcomes
Patient-reported symptoms
Time frame: Through completion of active study participation (anticipated <2 weeks for each participant)
Hospital length of stay
Time frame: Through completion of active study participation (anticipated <2 weeks for each participant)
Recovery status at 30, 60, and 90 days after dialysis initiation
Time frame: From enrollment to 90 days after dialysis initiation for each patient
Screen-to-enroll ratio [feasibility measure]
Time frame: Through study completion (anticipated 2 years total)
Results and safety
The study was stopped early (reason given: Study stopped because sufficient pilot data collected to proceed to next clinical trial.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Mar 2025.
- 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. This study is not recruiting at the moment.
Chi-yuan Hsu, MD, MSc principal investigator
University of California, San Francisco
Kathleen Liu, MD, PhD 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 Conservative dialysis strategy and TIW dialysis strategy in people with 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 6 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 19 Mar 2025. 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?
The study was stopped early (reason given: Study stopped because sufficient pilot data collected to proceed to next clinical trial.). Results are not available in the source record.
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?
Protocol adherence [feasibility measure] (time frame: Through completion of active study participation (anticipated <2 weeks for each participant)). The study lists 2 primary outcomes in all. 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 19 Mar 2025.