R2R01 + Terlipressin for Hepatorenal Syndrome
Trial Summary
Will I have to stop taking my current medications?
The trial requires that patients stop taking certain medications, such as nephrotoxic drugs and vasopressors, before enrollment. If you are on midodrine or octreotide, you must discontinue them prior to joining the study.
What data supports the effectiveness of the drug R2R01 + Terlipressin for treating hepatorenal syndrome?
Research shows that terlipressin, when used with albumin, can improve kidney function in patients with hepatorenal syndrome, although its long-term survival benefits are unclear. Studies indicate that terlipressin is effective in reversing hepatorenal syndrome, especially when combined with liver transplantation, which significantly improves survival rates.12345
Is the treatment with R2R01 + Terlipressin safe for humans?
How is the drug R2R01 + Terlipressin different from other treatments for hepatorenal syndrome?
The combination of R2R01 with Terlipressin is unique because Terlipressin is a vasoconstrictor (a drug that narrows blood vessels) commonly used to treat hepatorenal syndrome, but it is often expensive and not available everywhere. The addition of R2R01 may offer a novel approach, potentially enhancing the effectiveness or availability of treatment for this condition.3781011
What is the purpose of this trial?
This trial is testing a new drug called R2R01 combined with an existing drug, terlipressin, to treat patients with severe kidney problems related to liver disease (HRS-AKI). The goal is to see if this combination works better than using terlipressin alone. Terlipressin helps improve blood flow to the kidneys, and R2R01 might make this treatment even more effective. Terlipressin has been used for many years in Europe and has shown to be effective in improving kidney function.
Eligibility Criteria
Adults with cirrhosis, ascites, and severe kidney injury related to liver disease (HRS-AKI) can join this trial. They must understand the study and agree to its rules, including avoiding pregnancy. People with allergies to terlipressin or other serious health issues, recent infections without proper treatment, high MELD scores (>35), or those on certain medications are excluded.Inclusion Criteria
Exclusion Criteria
Timeline
Screening
Participants are screened for eligibility to participate in the trial
Open-Label Safety Run-In
Three initial cohorts treated with an open-label combination of terlipressin and R2R01 to ascertain safety
Single-Blind Placebo-Controlled Randomized
Patients receive terlipressin and are randomized to either R2R01 or placebo
Open-Label Terlipressin Non-Responder
Non-responders to terlipressin enter this cohort to receive R2R01
Follow-up
Participants are monitored for safety and effectiveness after treatment
Treatment Details
Interventions
- R2R01
- Terlipressin
Find a Clinic Near You
Who Is Running the Clinical Trial?
River 2 Renal Corp.
Lead Sponsor