95 Participants Needed

R2R01 + Terlipressin for Hepatorenal Syndrome

Recruiting at 7 trial locations
GM
KG
Overseen ByKathie Gabriel, RN, MFT
Age: 18+
Sex: Any
Trial Phase: Phase 2
Sponsor: River 2 Renal Corp.
Prior Safety DataThis treatment has passed at least one previous human trial

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?

Terlipressin has been used for many years to treat hepatorenal syndrome, but it can cause serious breathing problems in some people. It's important to monitor patients closely and choose those who are less likely to have these issues.36789

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

I have cirrhosis and fluid buildup in my abdomen.
Your blood test shows a creatinine level higher than 1.5 mg/dl.
My kidney function hasn't improved despite treatment.
See 3 more

Exclusion Criteria

Doctors think you will live for less than 5 days.
You have more than 500 milligrams of protein in your urine every day.
You have blood in your urine or a high amount of red blood cells seen under a microscope.
See 20 more

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2 weeks

Open-Label Safety Run-In

Three initial cohorts treated with an open-label combination of terlipressin and R2R01 to ascertain safety

14 days
Multiple visits as needed for safety assessment

Single-Blind Placebo-Controlled Randomized

Patients receive terlipressin and are randomized to either R2R01 or placebo

Up to 14 days
Regular visits for treatment administration and monitoring

Open-Label Terlipressin Non-Responder

Non-responders to terlipressin enter this cohort to receive R2R01

Up to 14 days
Regular visits for treatment administration and monitoring

Follow-up

Participants are monitored for safety and effectiveness after treatment

76 days
Periodic visits for safety and efficacy assessments

Treatment Details

Interventions

  • R2R01
  • Terlipressin
Trial Overview The trial is testing a combination of R2R01 and terlipressin against using just terlipressin for treating HRS-AKI. The goal is to see if adding R2R01 improves safety, tolerability, and effectiveness in patients compared to the standard treatment alone.
Participant Groups
3Treatment groups
Experimental Treatment
Placebo Group
Group I: An Open-Label Terlipressin Non-Responder CohortExperimental Treatment2 Interventions
In Cohort 5, if patients do not respond to terlipressin, they must discontinue Cohort 5. After discontinuation, they will be allowed to enter Cohort 6 (Terlipressin Non-Responder Part) to receive R2R01 with the same dosing and schedule as that for Cohort 4. No patient from any Cohort other than Cohort 5 will be allowed to enter Cohort 6.
Group II: An Open-Label Safety Run-In PartExperimental Treatment2 Interventions
Three initial cohorts (Cohort 1, N=3 patients, Cohorts 2 and 3, N=6 patients, each) will be treated with an open-label combination of terlipressin and R2R01 to ascertain the safety of the combination therapy. A Safety Review Committee (SRC) will review the safety of Cohort 1 patients based on the adverse events and laboratory abnormalities up until Day 14, prior to the start of recruitment of Cohort 2 patients, as well as the safety of Cohorts 1 and 2 patients up until Day 14 prior to the start of recruitment of Cohort 3 patients. Data from all Cohorts 1, 2, and 3 patients up until Day 14 will be reviewed by the SRC before starting the randomized part of the study (Cohorts 4 and 5), so that the SRC can decide and confirm the most appropriate R2R01 dose schedule for patients in Cohorts 4 and 5. Patients enrolled in Cohorts 1, 2, or 3 will remain in their Cohort until study completion (Day 90) or study discontinuation.
Group III: Single-blind Placebo-controlled Randomized periodPlacebo Group2 Interventions
After conclusion of the open-label safety run-in part, and after the SRC has determined the appropriate R2R01 dose schedule, approximately 80 patients will receive terlipressin and be randomized 1:1 to either R2R01 (Cohort 4) or placebo (Cohort 5). At randomization, patients will be stratified by the presence of systemic inflammatory response syndrome (SIRS), since patients with SIRS have shown a better response to terlipressin than patients without SIRS.

Find a Clinic Near You

Who Is Running the Clinical Trial?

River 2 Renal Corp.

Lead Sponsor

Trials
2
Recruited
130+

References

[A comparative study of high-or low-dose terlipressin therapy in patients with cirrhosis and type 1 hepatorenal syndrome]. [2018]
Hepatorenal syndrome:Response to terlipressin and albumin and its determinants. [2020]
[Meta-analysis of terlipressin in treatment of hepatorenal syndrome: an update]. [2018]
Survival benefits of terlipressin and non-responder state in hepatorenal syndrome: a meta-analysis. [2021]
Impact of liver transplantation on the survival of patients treated for hepatorenal syndrome type 1. [2022]
Respiratory events with terlipressin and albumin in hepatorenal syndrome: A review and clinical guidance. [2022]
Terlipressin in hepatorenal syndrome. [2018]
Noradrenaline vs terlipressin in the treatment of type 2 hepatorenal syndrome: a randomized pilot study. [2022]
Terlipressin in the treatment of hepatorenal syndrome: A systematic review and meta-analysis. [2021]
Terlipressin therapy for reversal of type 1 hepatorenal syndrome: a meta-analysis of randomized controlled trials. [2018]
11.United Statespubmed.ncbi.nlm.nih.gov
A randomized, prospective, double-blind, placebo-controlled trial of terlipressin for type 1 hepatorenal syndrome. [2022]
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