Treatment Of Hrs-Aki As A Complication Of Cirrhosis With Ascites
Posted Date: Aug 30, 2022
- Investigator: Khurram Bari
- Specialties: Kidney Disease, Liver Disease
- Type of Study: Drug
This is a multi-center, double-blind, placebo-controlled, randomized, parallel-arm study investigating the safety, efficacy, PK and PD of OCE-205 in the treatment of HRS-AKI. The study is comprised of 4 active doses and a placebo arm utilizing a Bayesian adaptive design. A maximum of 100 subjects and approximately 40 sites in Canada and the United States will participate in the study. Patient with liver cirrhosis and ascites admitted to the hospital that meet the diagnostic criteria for HRS-AKI will be included in the study and receive IV infusion (placebo or one of the 4 doses of study drug) for up to 10 days.
Anyone Between Ages 18 And 70 With Liver Cirrhosis, Ascites Admitted To The Hospital With Acute Kidney Injury And Meets The Diagnostic Criteria Of Hepatorenal Syndrome-Aki Will Be Eligible For Enrollment. Patient With Meld-Na Score Of 35 Or Higher Will Not Be Eligible.
Hepatorenal Syndrome, Cirrhosis, Acute Kidney Injury
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