A Study of OCE-205 in Participants With Cirrhosis With Ascites Who Developed Hepatorenal Syndrome-Acute Kidney Injury
- Conditions
- AscitesAcute Kidney InjuryCirrhosisHepatorenal Syndrome
- Interventions
- Drug: Placebo
- Registration Number
- NCT05309200
- Lead Sponsor
- Ocelot Bio, Inc
- Brief 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 47
- 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.
- 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.
- Impaired cardiac function as evidenced by symptoms consistent with New York Heart Association Classification Class 2 or worse.
- Received Renal Replacement Therapy (RRT) within 4 weeks of randomization.
- Has had a Trans Jugular Intrahepatic Porto-systemic shunt (TIPS).
- Pregnant or breastfeeding.
- Diagnosed with a malignancy within the past 5 years.
- History or current evidence of any condition (COVID-19 positive with respiratory/cardiac complications), therapy or laboratory abnormality that might confound the results of the study, interfere with the participation for the full duration of the study, or is not in the best interest to participate in the opinion of the investigator.
- Participated in a study of an investigational medical product or device within the last 8 weeks preceding screening.
- Experienced a major blood loss (≥500 mL) within the last 4 weeks prior to screening.
- Is stuporous or comatose at screening (West Haven scores III and IV). exhibiting bradycardia.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description OCE-205 Cohort 2 OCE-205 OCE-205, 8 µg/hr, intravenous infusion OCE-205 Cohort 3 OCE-205 OCE-205, 15 µg/hr, intravenous infusion OCE-205 Cohort 4 OCE-205 OCE-205, 30 µg/hr, intravenous infusion OCE-205 Cohort 5 OCE-205 OCE-205, 50 µg/hr, intravenous infusion OCE-205 Cohort 1 Placebo Placebo, intravenous infusion
- Primary Outcome Measures
Name Time Method Time to measurement of concentration serum creatinine (sCr) value of less than 1.5 mg/dL on 2 consecutive days From Day 1 infusion start to Last Day of infusion end
- Secondary Outcome Measures
Name Time Method Change in concentration of Serum Creatinine (sCr) From Day 1 infusion start to Last Day of infusion end Change in Pulse Rate From Day 1 infusion start to Last Day of infusion end Volume of Steady-State Volume of Distribution (Vss) of OCE-205 From Day 1 infusion start to Last Day of infusion end Rate of Total Body Clearance (CL) of OCE-205 From Day 1 infusion start to Last Day of infusion end Change in Mean Arterial Pressure (MAP) rate From Day 1 infusion start to Last Day of infusion end Percentage Change in rate of Mean Arterial Pressure (MAP) From Day 1 infusion start to Last Day of infusion end Percentage Change in Pulse Rate From Day 1 infusion start to Last Day of infusion end Mean Concentration of OCE-205 at Steady State Concentration (Css) From Day 1 infusion start to Last Day of infusion end Time to Elimination Half-Life (t1/2) of OCE-205 From Day 1 infusion start to Last Day of infusion end
Trial Locations
- Locations (23)
Piedmont Atlanta Hospital
🇺🇸Atlanta, Georgia, United States
University of Missouri
🇺🇸Columbia, Missouri, United States
Toronto General Hospital
🇨🇦Toronto, Ontario, Canada
Indiana University Hospital
🇺🇸Indianapolis, Indiana, United States
Northwestern Medicine
🇺🇸Chicago, Illinois, United States
University of Maryland Medical Center
🇺🇸Baltimore, Maryland, United States
Rutgers New Jersey Medical School
🇺🇸Newark, New Jersey, United States
Tampa General Medical Group
🇺🇸Tampa, Florida, United States
Baylor University
🇺🇸Dallas, Texas, United States
Stanford Hospital
🇺🇸Stanford, California, United States
McGuire VA Medical Center
🇺🇸Richmond, Virginia, United States
Medical University of South Carolina
🇺🇸Charleston, South Carolina, United States
Mayo Clinic
🇺🇸Rochester, Minnesota, United States
M Health Fairview University of Minnesota Medical Center
🇺🇸Minneapolis, Minnesota, United States
University of Cincinnati Medical Center
🇺🇸Cincinnati, Ohio, United States
Keck Medical Center of USC
🇺🇸Los Angeles, California, United States
Mayo Clinic - Phoenix
🇺🇸Phoenix, Arizona, United States
Massachusetts General Hospital
🇺🇸Boston, Massachusetts, United States
New York-Presbyterian Hospital
🇺🇸New York, New York, United States
CHI St Luke's Health Baylor College of Medicine Medical Center
🇺🇸Houston, Texas, United States
Virginia Commonwealth University Health System
🇺🇸Richmond, Virginia, United States
University of California, San Francisco Liver Clinic
🇺🇸San Francisco, California, United States
MedStar Georgetown University Hospital
🇺🇸Washington, District of Columbia, United States