NEPH-ROSIS (NEPHrology in CirRhOSIS) Pilot Trial: A Trial to Treat Acute Kidney Injury Among Hospitalized Cirrhosis Patients

NCT06000748 | Terminated Phase 2 DMC FDA Drug

• 1 other identifier: 23-39806
• Study Type: interventional
• Target: 6
• Locations: 1 country
• Sites: 1

Brief 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. 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

Keywords

PRAGMATIC; FEASIBILITY

Outcome Measures

Primary Outcomes (1)

• Differences in mean arterial pressure.

  The investigators will determine if a high, as compared to a low, MAP-target algorithm leads to significantly different changes in MAP. This will be completed by comparing the change in MAP from the baseline to the completion of the study.

  14 days.

Secondary Outcomes (1)

• Acute kidney injury reversal.

  14 days

Study Arms (2)

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.

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.

Drug: MAP-Target Algorithm

Interventions

MAP-Target Algorithm DRUG

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.

High MAP-Target; Low MAP-Target

Eligibility Criteria

• Age: 18 Years+
• Gender Eligibility Details: Participant eligibility is based on self-representation of gender identity.
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of California, San Francisco: lead

Study Sites (1)

University of California San Francisco

San Francisco, California, 94143, United States

Location

MeSH Terms

Conditions

Acute Kidney Injury; Fibrosis; Hypertension, Portal; Hepatorenal Syndrome; Kidney Cortex Necrosis

Condition Hierarchy (Ancestors)

Renal Insufficiency; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Liver Diseases; Digestive System Diseases

Study Officials

• Giuseppe Cullaro, MD, MAS

  University of California, San Francisco

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Masking Details: This is single blind. The participants will be blinded to their intervention arm. The treating providers will not be blinded as they will receive either the low or high MAP-target treatment algorithm.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: This is a single-blind, randomized control, parallel-group, pragmatic trial.

Study Record Dates

• First Submitted: August 14, 2023
• First Posted: August 21, 2023
• Study Start: February 1, 2024
• Primary Completion: July 31, 2024
• Study Completion: July 31, 2024
• Last Updated: May 15, 2025

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)