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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
Awards & highlights
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 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 5 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 5 years
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.
Comparative efficacy of pharmacological strategies for management of type 1 hepatorenal syndrome: a systematic review and network meta-analysis.
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Who is running the clinical trial?
Ocelot Bio, IncLead Sponsor
Chief Medical and Scientific OfficerStudy ChairOcelot Bio
Chief Medical OfficerStudy ChairOcelot Bio
124 Previous Clinical Trials
21,784 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- You are taking albumin and have stopped taking diuretics for at least 48 hours before joining the study.You have severe liver disease with fluid buildup in the abdomen.Your blood creatinine level is higher than 3.8 mg/dL.You have a severe infection that is not under control.You have very high levels of protein in your urine.You have had a procedure called Trans Jugular Intrahepatic Porto-systemic shunt (TIPS).You have been diagnosed with cancer in the last 5 years.Beta-blockers should be discontinued 48 hours prior to randomization, unless doctor deems necessary for appropriate medical treatment.Your kidney function did not get better even after stopping diuretics and receiving fluid expansion with albumin.You had a procedure to drain a large amount of fluid from your abdomen within 4 days before the study starts.Your pulse oximeter reading is less than 90% while using 2 liters of oxygen or less.You have advanced liver disease with fluid buildup in the belly.You are receiving albumin and have stopped taking diuretics for at least 2 days before joining the study.Your kidney function did not get better even after stopping diuretics and getting extra fluid with albumin.Your MELD score is higher than 35.You have been recently treated with certain medications that can harm your kidneys, or have had a certain type of X-ray dye within the last 3 days.You have liver damage caused by drugs or toxins, except for acute alcoholic hepatitis.You have heart problems that cause symptoms like shortness of breath or fatigue, rated as Class 2 or worse by the New York Heart Association.You have received kidney dialysis within the 4 weeks before the study starts.You have lost a lot of blood (more than 500 milliliters) in the past 4 weeks before screening.You have had a severe drop in blood flow within the last 3 days before being screened.Your blood pressure is too high, with the top number (systolic) above 140 or the bottom number (diastolic) above 100.You are in a deep state of unconsciousness or coma with slow heart rate.
Research Study Groups:
This trial has the following groups:- Group 1: OCE-205 Cohort 1
- Group 2: OCE-205 Cohort 2
- Group 3: OCE-205 Cohort 3
- Group 4: OCE-205 Cohort 4
- Group 5: OCE-205 Cohort 5
Awards:
This trial has 0 awards, including:Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
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