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A Study of OCE-205 in Participants With Cirrhosis With Ascites Who Developed Hepatorenal Syndrome-Acute Kidney Injury | Clinical Trials | Clareo Health

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A Study of OCE-205 in Participants With Cirrhosis With Ascites Who Developed Hepatorenal Syndrome-Acute Kidney Injury

A Multi-Center, Randomized, Placebo-Controlled, Double-Blind, Adaptive Dose-Ranging Study to Assess Safety and Efficacy of Intravenous OCE-205 in Adults Diagnosed With Cirrhosis With Ascites Who Have Developed Hepatorenal Syndrome-Acute Kidney Injury (HRS-AKI)

NCT05309200•Ocelot Bio, Inc

View on ClinicalTrials.gov

Summary

OCE-205 is being tested to treat participants who have developed Hepatorenal Syndrome-Acute Kidney Injury as a complication of cirrhosis with ascites. The study aims are to evaluate the safety and efficacy of OCE-205 at various doses. Participants will receive treatment by intravenous infusion. Participants will continue with this treatment until participants meets primary endpoint or any discontinuation criteria.

Detailed Description

The study will include 5 treatment arms including 1 Placebo Arm and 4 active drug arms. Participants will be randomly selected to 1 of 5 arms. * Placebo * OCE-205 at 8 micrograms per hour (µg/hr) * OCE-205 at 15 micrograms per hour (µg/hr) * OCE-205 at 30 micrograms per hour (µg/hr) * OCE-205 at 50 micrograms per hour (µg/hr) This multi-center trial will be conducted in the United States and Canada. If selected for the study, participants will be randomly assigned to 1 of the 5 treatment arms.

Eligibility

Age

18 - 75 years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•Signed informed consent form (ICF) by participant or their legal/authorized representatives.
•Diagnosed with decompensated cirrhosis with ascites.
•Receiving albumin and has had appropriate diuretic withdrawal for at least 2 days prior to randomization into the study.
•Beta-blockers should be discontinued 48 hours prior to randomization, unless doctor deems necessary for appropriate medical treatment.
•No sustained improvement in renal function after both diuretic withdrawal and plasma volume expansion with albumin.
•Female participants must have a negative pregnancy test prior to randomization and agree to avoid becoming pregnant during the study and for 30 days after the end of treatment. Male participants must agree to use 2 effective contraceptive methods during the study and up to 30 days after the end of treatment.

Exclusion Criteria

•Serum Creatinine \>3.8 mg/dL.
•Large volume paracentesis (LVP ≥6L) within 4 days of randomization.
•Pulse oximeter reading of \<90% on 2L or less.
•Sepsis and/or uncontrolled bacterial infection.
•Experienced shock within 72 hrs prior to screening.
•Model for End-Stage Liver Disease (MELD) score \>35.
•Hypertension with a Systolic BP \> 140 mmHg and/ or a Diastolic BP \>100 mmHg.
•Treated with or exposed to nephrotoxic agents or has had exposure to radiographic contrast agents within 72 hrs prior to screening.
•Has superimposed acute liver injury due to drugs, or toxins except for acute alcoholic hepatitis.
•Proteinuria greater than 500 mg/dL.
+9 more criteria

Locations (23)

Mayo Clinic - Phoenix

Phoenix, Arizona, United States

Keck Medical Center of USC

Los Angeles, California, United States

University of California, San Francisco Liver Clinic

San Francisco, California, United States

Stanford Hospital

Stanford, California, United States

MedStar Georgetown University Hospital

Washington D.C., District of Columbia, United States

Tampa General Medical Group

Tampa, Florida, United States

Piedmont Atlanta Hospital

Atlanta, Georgia, United States

Northwestern Medicine

Chicago, Illinois, United States

Indiana University Hospital

Indianapolis, Indiana, United States

University of Maryland Medical Center

Baltimore, Maryland, United States

Key Dates

Start Date

April 28, 2022

Primary Completion Date

September 12, 2023

Completion Date

October 13, 2023

Last Updated

December 15, 2023

Enrollment

ACTUAL participants

Conditions

CirrhosisAscitesHepatorenal SyndromeAcute Kidney Injury

Interventions

OCE-205

DRUG

Placebo

DRUG

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RECRUITINGNA

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: December 15, 2023Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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A Study of OCE-205 in Participants With Cirrhosis With Ascites Who Developed Hepatorenal Syndrome-Acute Kidney Injury

Inclusion Criteria

Exclusion Criteria

EUS Guided Portal-systemic Pressure Gradient Measurement to Predict Treatment Response and Outcomes of Varices to Endoscopic Variceal Ligation in Patients With Chronic Hepatitis.

Remote Electrical Stimulation for Pain and Depression Treatment in Cirrhosis

Prevalence of Gastric Motor Dysfunction and Upper GI Symptoms in Gastric Antral Vascular Ectasias

Mechanism of TIPS to Improve Sarcopenia

Diagnosis of Lymphohistiocytic Hemophagocytosis in Intensive Care

Verification of Risk Factors of Thrombohemorrhagic Complications in Recipients After Related Liver Transplantation