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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
Receiving albumin and has had appropriate diuretic withdrawal for at least 2 days prior to randomization into the study
No sustained improvement in renal function after both diuretic withdrawal and plasma volume expansion with albumin
Timeline
Screening 3 weeks
Treatment Varies
Follow Up from day 1 infusion start to last day of infusion end
Awards & highlights

Study Summary

This trial is testing a new drug to treat people who have developed a complication of cirrhosis called acute kidney injury. The drug will be given through an IV, and the goal is to see if it is safe and effective.

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.Check my eligibility
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.See study design
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.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
You are receiving albumin and have stopped taking diuretics for at least 2 days before joining the study.
Select...
Your kidney function did not get better even after stopping diuretics and getting extra fluid with albumin.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~from day 1 infusion start to last day of infusion end
This trial's timeline: 3 weeks for screening, Varies for treatment, and from day 1 infusion start to last day of infusion end for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Time to measurement of concentration serum creatinine (sCr) value of less than 1.5 mg/dL on 2 consecutive days
Secondary outcome measures
Systemic arterial pressure
Change in Pulse Rate
Change in concentration of Serum Creatinine (sCr)
+6 more

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

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
122 Previous Clinical Trials
21,522 Total Patients Enrolled

Media Library

OCE-205 (Other) Clinical Trial Eligibility Overview. Trial Name: NCT05309200 — Phase 2
Liver Cirrhosis Research Study Groups: OCE-205 Cohort 1, OCE-205 Cohort 2, OCE-205 Cohort 3, OCE-205 Cohort 4, OCE-205 Cohort 5
Liver Cirrhosis 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

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What is the geographical scope of this experiment?

"The current research program is enrolling patients from 15 different medical centres. These include Cincinnati, Rochester and Newark as well as 12 other cities. To minimise travel costs, it is best to select the most proximal clinic if you choose to sign up for this trial."

Answered by AI

Does your research encompass individuals beyond the age of thirty?

"Eligibility criteria for this medical trial mandates a minimum of 18 years old and the maximum age cap is 75 years."

Answered by AI

How many people are enrolled in this medical study currently?

"This medical trial requires 100 qualified participants. The study is backed by Ocelot Bio, Inc and will be run out of the University of Cincinnati Medical Centre in Ohio and Mayo Clinic located in Minnesota."

Answered by AI

Is this investigation currently enrolling participants?

"Affirmative. Clinicaltrials.gov indicates that this research project, initially posted on April 28th 2022, is recruiting participants in earnest. A total of 100 individuals will be accepted from 15 clinical sites."

Answered by AI

Who is eligible to join this research experiment?

"This medical trial seeks to recruit 100 individuals diagnosed with acute kidney injury between the age range of 18 and 75. To be eligible, applicants must meet these essential requirements: demonstrate no sustained improvement in renal function after diuretic withdrawal and plasma volume expansion; provide signed informed consent form (ICF); possess a diagnosis of decompensated cirrhosis with ascites; receive albumin therapy prior to randomization into the study; discontinue beta-blocker use 48 hours before randomization unless medically necessary; female participants require negative pregnancy test results while male participants need appropriate contraception during the course of this research project and 30 days following its conclusion."

Answered by AI

What potential adverse effects should be considered when administering OCE-205?

"Our team's assessment of OCE-205's safety was a 2, as this is only at the Phase 2 stage. There is some research that indicates its safety, but no evidence it can produce meaningful results yet."

Answered by AI

Who else is applying?

How old are they?
18 - 65
What site did they apply to?
Toronto General Hospital
What portion of applicants met pre-screening criteria?
Did not meet criteria
Recent research and studies
~16 spots leftby Mar 2025