Acute Kidney InjuryPhase 2/3NEPH-ROSISNCT06000748
NEPH-ROSIS (NEPHrology in CirRhOSIS) Pilot Trial: A Trial to Treat Acute Kidney Injury Among Hospitalized Cirrhosis Patients
A Phase 2/3 study testing MAP-Target Algorithm in people with Acute Kidney Injury and Cirrhosis, run by University of California, San Francisco at 1 site in United States.
Trial summary
The goal of this pilot, randomized, single-blind clinical trial is to estimate the effect size of a high and low mean arterial pressure (MAP)-target algorithm among cirrhosis patients hospitalized with acute kidney injury. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Acute Kidney Injury, Cirrhosis, Portal Hypertension
- What is being tested?
- MAP-Target Algorithm
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 14 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Feb 2024to 31 Jul 2024
- Phase
- Phase 2/3
- 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
- Hospitalized patients with decompensated cirrhosis, defined as a Child-Pugh Score ≥ 7
- Acute Kidney Injury: a ≥50% increase in sCr from an outpatient baseline sCr measured 7 to 365 days prior to admission
Who cannot join
- Patients without a baseline (7 - 365 days prior to AKI development) sCr measurement;
- Patients who are already on kidney replacement therapy (KRT) at the time of enrollment;
- Patients with an oxygen requirement greater than 6L via nasal cannula;
- Patients with a serum creatinine level exceeding 5 mg/dL.
Trial locations and contacts
1 site in 1 country.
United States1 site
University of California San Francisco
San Francisco, California, 94143
About this study
The goal of this pilot, randomized, single-blind clinical trial is to estimate the effect size of a high and low mean arterial pressure (MAP)-target algorithm among cirrhosis patients hospitalized with acute kidney injury. The main aims to answer are: • Does an algorithm that has low (<80 mmHg) and high (≥80) MAP-targets lead to significant differences in mean arterial pressure? • Are there any serious adverse events (e.g., ischemia) in a high blood pressure algorithm as compared to a low blood pressure algorithm? • Are there any differences in the incidence of AKI reversal in the high v. low MAP-target groups? Participants will be: 1) Randomized to a clinical algorithm that will either target a low (<80 mmHg) or high (≥80 mmHg) MAP. 2) Depending on their group, investigators will titrate commonly used medications to a specific MAP target. Researchers will compare the high and low MAP-target groups to see if these algorithms lead to significant changes in MAP, if they have any impact on AKI reversal, and if there are any adverse events in the high MAP-target group.
- Conditions
- Acute Kidney Injury, Cirrhosis, Portal Hypertension, Hepatorenal Syndrome, Acute Tubule Necrosis, Prerenal Failure
- Being tested
- MAP-Target Algorithm
- Keywords
- PRAGMATIC, FEASIBILITY
- Medical subject headings
- Acute Kidney Injury, Fibrosis, Hypertension, Portal, Hepatorenal Syndrome, Kidney Cortex Necrosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MAP-Target AlgorithmDrug
This is a clinical treatment algorithm that will determine the escalation and deescalation of vasoconstrictor utilization based on a target MAP, either high (≥80 mmHg) in the treatment group and low (< 80 mmHg) in the comparator group.
| Study group | Role | What they receive |
|---|---|---|
| Low MAP-Target | Active comparator | This group will be randomized to a treatment algorithm that utilizes a low MAP-target (<80 mmHg) to determine if titration of vasoconstrictors is needed. Receives: Drug: MAP-Target Algorithm |
| High MAP-Target | Active comparator | This group will be randomized to a treatment algorithm that utilizes a high MAP-target (≥80 mmHg) to determine if titration of vasoconstrictors is needed. Receives: Drug: MAP-Target Algorithm |
What is being measured
The primary outcome is the main question the study is designed to answer.
Differences in Mean Arterial Pressure.
Measured: Baseline and End of Study or Day 14.
Secondary outcomes (1)
Acute Kidney Injury Reversal, Which Was Defined as a Decrease in sCr to Within 0.3 mg/dL of Baseline.
The investigators will determine if a high, as compared to a low, MAP-target algorithm leads to significantly different incidences of acute kidney injury reversal. This will be defined as a decrease in serum creatinine (sCr) to within 0.3 mg/dL of the baseline sCr.
Measured: 14 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Aug 2023
- Study start1 Feb 2024
- Primary completion31 Jul 2024
- Study completion31 Jul 2024
Why it stopped: Investigator Left Institution
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 2/3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- This is a single-blind, randomized control, parallel-group, pragmatic trial.
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 14 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of California, San Francisco
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Giuseppe Cullaro, MD, MAS, Principal investigator, University of California, San Francisco
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06000748
- Sponsor's protocol ID
- 23-39806
- Acronym
- NEPH-ROSIS
- Status last verified
- Aug 2026
- First submitted
- 14 Aug 2023
- Last updated
- 24 Sep 2026
- 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 24 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- NEPH-ROSIS (NEPHrology in CirRhOSIS) Pilot Trial: A Trial to Treat Acute Kidney Injury Among Hospitalized Cirrhosis Patients
- ClinicalTrials.gov ID
- NCT06000748
- Acronym / sponsor ID
- NEPH-ROSIS / 23-39806
- Conditions
- Acute Kidney Injury, Cirrhosis, Portal Hypertension, Hepatorenal Syndrome, Acute Tubule Necrosis, Prerenal Failure
- Keywords
- PRAGMATIC, FEASIBILITY
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Investigator Left Institution
- Enrolment
- 14 participants (actual)
- Lead sponsor
- University of California, San FranciscoUniversity, hospital or other
- Study start
- 1 Feb 2024 (actual)
- Primary completion
- 31 Jul 2024 (actual)
- Study completion
- 31 Jul 2024 (actual)
- First posted
- 21 Aug 2023 (actual)
- Results
- Posted 24 Sep 2026
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The goal of this pilot, randomized, single-blind clinical trial is to estimate the effect size of a high and low mean arterial pressure (MAP)-target algorithm among cirrhosis patients hospitalized with acute kidney injury. The main aims to answer are: • Does an algorithm that has low (<80 mmHg) and high (≥80) MAP-targets lead to significant differences in mean arterial pressure? • Are there any serious adverse events (e.g., ischemia) in a high blood pressure algorithm as compared to a low blood pressure algorithm? • Are there any differences in the incidence of AKI reversal in the high v. low MAP-target groups? Participants will be: 1) Randomized to a clinical algorithm that will either target a low (<80 mmHg) or high (≥80 mmHg) MAP. 2) Depending on their group, investigators will titrate commonly used medications to a specific MAP target. Researchers will compare the high and low MAP-target groups to see if these algorithms lead to significant changes in MAP, if they have any impact on AKI reversal, and if there are any adverse events in the high MAP-target group.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
- Model description
- This is a single-blind, randomized control, parallel-group, pragmatic trial.
| Arm | Type | Receives |
|---|---|---|
| Low MAP-Target | Active comparator | Drug: MAP-Target AlgorithmThis group will be randomized to a treatment algorithm that utilizes a low MAP-target (<80 mmHg) to determine if titration of vasoconstrictors is needed. |
| High MAP-Target | Active comparator | Drug: MAP-Target AlgorithmThis group will be randomized to a treatment algorithm that utilizes a high MAP-target (≥80 mmHg) to determine if titration of vasoconstrictors is needed. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Hospitalized patients with decompensated cirrhosis, defined as a Child-Pugh Score ≥ 7
- Acute Kidney Injury: a ≥50% increase in sCr from an outpatient baseline sCr measured 7 to 365 days prior to admission
Key exclusion criteria (4 listed)
- Patients without a baseline (7 - 365 days prior to AKI development) sCr measurement;
- Patients who are already on kidney replacement therapy (KRT) at the time of enrollment;
- Patients with an oxygen requirement greater than 6L via nasal cannula;
- Patients with a serum creatinine level exceeding 5 mg/dL.
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 |
|---|---|---|
| MAP-Target AlgorithmThis is a clinical treatment algorithm that will determine the escalation and deescalation of vasoconstrictor utilization based on a target MAP, either high (≥80 mmHg) in the treatment group and low (< 80 mmHg) in the comparator group. | Drug | High MAP-Target, Low MAP-Target |
Primary outcome
Differences in Mean Arterial Pressure.
Time frame: Baseline and End of Study or Day 14.
1 secondary outcome
Acute Kidney Injury Reversal, Which Was Defined as a Decrease in sCr to Within 0.3 mg/dL of Baseline.
Time frame: 14 days
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Sep 2026.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- 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.
Giuseppe Cullaro, MD, MAS 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 2/3 study testing MAP-Target Algorithm in people with Acute Kidney Injury and Cirrhosis, 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 2 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: stopped early, as of the sponsor's last update on 24 Sep 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.
What does this combined phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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 24 Sep 2026). 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?
Differences in Mean Arterial Pressure. (time frame: Baseline and End of Study or Day 14.). 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 24 Sep 2026.