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

Acute Kidney Injury Clinical Trial

Official title: 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)

Status Completed

Clinical Trial 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.

Clinical Trial 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. ;

Related Conditions & MeSH terms

• Acute Kidney Injury
• Ascites
• Cirrhosis
• Fibrosis
• Hepatorenal Syndrome
• Liver Cirrhosis
• Syndrome
• Wounds and Injuries

• NCT number: NCT05309200
• Study type: Interventional
• Source: Ocelot Bio, Inc
• Status: Completed
• Phase: Phase 2
• Start date: April 28, 2022
• Completion date: October 13, 2023