This study is exploring a new treatment for Hepatorenal Syndrome (HRS), a serious condition where the kidneys stop working well in people with liver problems. It will test a new drug called R2R01 alongside terlipressin, a medicine already used for HRS. The study aims to find out if the combination is safer and more effective than terlipressin alone. The study will be conducted in multiple centers across Europe, the UK, the US, and Canada. Participants will take part for up to 15 weeks, including a treatment period of up to 14 days and a follow-up period lasting about 76 days. To qualify, participants need to be 18 or older, have liver cirrhosis with fluid buildup (ascites), and meet certain kidney function requirements. The study will not accept people with certain severe health conditions or those who recently took specific drugs. Participants are expected to visit the study site multiple times and must agree to use effective contraception to prevent pregnancy during the study.
- Study duration: approximately 15 weeks.
- Treatment includes terlipressin, possibly combined with R2R01.
- Participants must follow specific health guidelines and contraception rules.