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

Sponsor

Ocelot Bio, Inc (Industry)

Overall Status

Recruiting

CT.gov ID

NCT05309200

Collaborator

(none)

100

Enrollment

Locations

Arms

14.1

Anticipated Duration (Months)

14.3

Patients Per Site

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Cirrhosis Ascites Hepatorenal Syndrome Acute Kidney Injury	Drug: OCE-205 Drug: Placebo	Phase 2

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.

Study Design

Study Type:

Interventional

Anticipated Enrollment :

100 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

Primary Purpose:

Treatment

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)

Actual Study Start Date :

Apr 28, 2022

Anticipated Primary Completion Date :

Jul 1, 2023

Anticipated Study Completion Date :

Jul 1, 2023

Arms and Interventions

Arm	Intervention/Treatment
Placebo Comparator: OCE-205 Cohort 1 Placebo, intravenous infusion	Drug: Placebo Placebo to match OCE-205 is a sterile solution to be used for intravenous infusion.
Experimental: OCE-205 Cohort 2 OCE-205, 8 µg/hr, intravenous infusion	Drug: OCE-205 The drug product, OCE-205, is a sterile solution to be used for intravenous infusion.
Experimental: OCE-205 Cohort 3 OCE-205, 15 µg/hr, intravenous infusion	Drug: OCE-205 The drug product, OCE-205, is a sterile solution to be used for intravenous infusion.
Experimental: OCE-205 Cohort 4 OCE-205, 30 µg/hr, intravenous infusion	Drug: OCE-205 The drug product, OCE-205, is a sterile solution to be used for intravenous infusion.
Experimental: OCE-205 Cohort 5 OCE-205, 50 µg/hr, intravenous infusion	Drug: OCE-205 The drug product, OCE-205, is a sterile solution to be used for intravenous infusion.

Outcome Measures

Primary Outcome Measures

Time to measurement of serum creatinine (sCr) value less than 1.5 mg/dL on 2 consecutive days [From Day 1 infusion start to Last Day of infusion end]

Secondary Outcome Measures

Average Steady State Concentration (Css) of OCE-205 [From Day 1 infusion start to Last Day of infusion end]
Total Body Clearance (CL) of OCE-205 [From Day 1 infusion start to Last Day of infusion end]
Elimination Half-Life (t1/2) of OCE-205 [From Day 1 infusion start to Last Day of infusion end]
Steady-State Volume of Distribution (Vss) of OCE-205 [From Day 1 infusion start to Last Day of infusion end]
Change in Mean Arterial Pressure (MAP) measurement [From Day 1 infusion start to Last Day of infusion end]
Change in Mean Arterial Pressure (MAP) Percentage [From Day 1 infusion start to Last Day of infusion end]
Change in Pulse Measurement [From Day 1 infusion start to Last Day of infusion end]
Change in Pulse Percentage [From Day 1 infusion start to Last Day of infusion end]
Change in Serum Creatinine (sCr) Measurement [From Day 1 infusion start to Last Day of infusion end]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 70 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

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 48 hrs 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 appropriate contraceptive methods during the study and up to 30 days after the end of treatment.

Exclusion Criteria:

Serum Creatinine >3.5 mg/dL.
Large volume paracentesis (LVP ≥4L) 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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	University of California, San Francisco Liver Clinic	San Francisco	California	United States	94143
2	Piedmont Atlanta Hospital	Atlanta	Georgia	United States	30309
3	Indiana University Hospital	Indianapolis	Indiana	United States	46202
4	University of Maryland Medical Center	Baltimore	Maryland	United States	21201
5	Massachusetts General Hospital	Boston	Massachusetts	United States	02144
6	M Health Fairview University of Minnesota Medical Center	Minneapolis	Minnesota	United States	55455
7	Virginia Commonwealth University Health System	Richmond	Virginia	United States	23298