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OCE-205 for Hepatorenal Syndrome with Acute Kidney Injury
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.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowTimeline
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Trial Design
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- 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.
- 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
- 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.
Frequently Asked Questions
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."
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."
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."
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."
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."
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What portion of applicants met pre-screening criteria?
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