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OCE-205 for Hepatorenal Syndrome with Acute Kidney Injury

Phase 2
Waitlist Available
Research Sponsored by Ocelot Bio, Inc
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 5 years

Summary

This trial is testing OCE-205, a new drug, to help patients with severe liver disease that has caused their kidneys to fail. The drug is given through an IV to see if it can improve kidney function.

Who is the study for?
This trial is for adults with decompensated cirrhosis and ascites who developed Hepatorenal Syndrome-Acute Kidney Injury. They must have tried diuretic withdrawal and plasma volume expansion without improvement in kidney function. Participants need to agree to contraception use, not be pregnant or breastfeeding, and not have severe additional health issues like uncontrolled infections or recent malignancies.
What is being tested?
The study tests OCE-205's safety and effectiveness at different doses for treating Hepatorenal Syndrome-Acute Kidney Injury in cirrhosis with ascites patients. It involves intravenous infusions of either OCE-205 or a placebo until the primary endpoint is met or discontinuation criteria are reached.
What are the potential side effects?
While specific side effects of OCE-205 aren't listed, common ones from similar treatments may include reactions at the infusion site, changes in blood pressure, potential kidney function alterations, allergic responses, gastrointestinal symptoms like nausea or diarrhea.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 5 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 5 years for reporting.

Treatment Details

Trial Design

5Treatment groups
Experimental Treatment
Placebo Group
Group I: OCE-205 Cohort 5Experimental Treatment1 Intervention
OCE-205, 50 µg/hr, intravenous infusion
Group II: OCE-205 Cohort 4Experimental Treatment1 Intervention
OCE-205, 30 µg/hr, intravenous infusion
Group III: OCE-205 Cohort 3Experimental Treatment1 Intervention
OCE-205, 15 µg/hr, intravenous infusion
Group IV: OCE-205 Cohort 2Experimental Treatment1 Intervention
OCE-205, 8 µg/hr, intravenous infusion
Group V: OCE-205 Cohort 1Placebo Group1 Intervention
Placebo, intravenous infusion
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
OCE-205
2022
Completed Phase 2
~50

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.
Mechanism Of Action
Side Effect Profile
Prior Approvals
Other Research
Common treatments for liver cirrhosis include diuretics like spironolactone and furosemide, which help reduce fluid accumulation by promoting sodium and water excretion. Vasoactive agents such as terlipressin and midodrine are used to improve renal function in HRS-AKI by constricting blood vessels and increasing blood pressure, thereby enhancing renal perfusion. Albumin infusions are also employed to maintain plasma volume and improve circulatory function. These treatments are crucial for liver cirrhosis patients as they address complications like ascites and HRS-AKI, which can significantly impact morbidity and mortality.
Comparative efficacy of pharmacological strategies for management of type 1 hepatorenal syndrome: a systematic review and network meta-analysis.

Find a Location

Who is running the clinical trial?

Ocelot Bio, IncLead Sponsor
Chief Medical and Scientific OfficerStudy ChairOcelot Bio
Chief Medical OfficerStudy ChairOcelot Bio
126 Previous Clinical Trials
21,944 Total Patients Enrolled

Media Library

OCE-205 (Other) Clinical Trial Eligibility Overview. Trial Name: NCT05309200 — Phase 2
Hepatorenal Syndrome Research Study Groups: OCE-205 Cohort 1, OCE-205 Cohort 2, OCE-205 Cohort 3, OCE-205 Cohort 4, OCE-205 Cohort 5
Hepatorenal Syndrome Clinical Trial 2023: OCE-205 Highlights & Side Effects. Trial Name: NCT05309200 — Phase 2
OCE-205 (Other) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05309200 — Phase 2
~13 spots leftby Nov 2025