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R2R01 + Terlipressin for Hepatorenal Syndrome
Phase 2
Recruiting
Research Sponsored by River 2 Renal Corp.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Cirrhosis and ascites.
At least 18 years of age.
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 30, 60, 90 days
Awards & highlights
Study Summary
This trial studies a new drug to treat patients with a kidney condition. It will measure safety, tolerability, and effectiveness.
Who is the study for?
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.Check my eligibility
What is being tested?
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.See study design
What are the potential side effects?
Possible side effects include allergic reactions to medication components, potential worsening of cardiovascular or pulmonary conditions due to drug interactions or underlying diseases. Specific side effects of R2R01 aren't listed but may be similar or additive to those known for terlipressin.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I have cirrhosis and fluid buildup in my abdomen.
Select...
I am 18 years old or older.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 30, 60, 90 days
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~30, 60, 90 days
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Safety Evaluation Criteria - Change in Weight
Safety Evaluation Criteria - ECGs - PR interval
Safety Evaluation Criteria - ECGs - QRS duration
+12 moreSecondary outcome measures
Liver Transplant Rates
Mortality Rate
Trial Design
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.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Terlipressin
2006
Completed Phase 4
~2720
Find a Location
Who is running the clinical trial?
River 2 Renal Corp.Lead Sponsor
1 Previous Clinical Trials
32 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- Doctors think you will live for less than 5 days.I have cirrhosis and fluid buildup in my abdomen.Your blood test shows a creatinine level higher than 1.5 mg/dl.You have more than 500 milligrams of protein in your urine every day.My kidney function hasn't improved despite treatment.You have blood in your urine or a high amount of red blood cells seen under a microscope.I agree to use effective birth control during and up to 90 days after the study.You have a TIPS procedure, unless it is not working properly or blocked.I have liver damage from drugs, herbs, or supplements, not from alcohol.I am 18 years old or older.Your kidney function has significantly decreased in the past week, as shown by a blood test.I have mild kidney injury.I am not currently on vasopressors, or if I was, I stopped them at least 8 hours before enrolling.My liver disease is in its most severe stage.I understand and agree to follow the study's requirements and have signed the consent form.Your MELD score is higher than 35.I had a procedure to remove more than 4 liters of fluid from my abdomen recently.I am currently on or recently had kidney replacement therapy.I do not have sepsis or any uncontrolled infection.My kidney ultrasound was abnormal, but I have a known condition like diabetes or high blood pressure affecting my kidneys.I do not have severe heart or lung diseases.I am using or agree to use effective birth control if I can have children.I haven't taken kidney-damaging drugs or had certain scans, and my blood pressure hasn't been very low recently.I have taken antibiotics for an infection for less than two days.I am willing to avoid pregnancy for more than 90 days during the study.I have low oxygen levels or my breathing is getting worse.Your blood test shows creatinine level above 5 mg/dL.
Research Study Groups:
This trial has the following groups:- Group 1: Single-blind Placebo-controlled Randomized period
- Group 2: An Open-Label Safety Run-In Part
- Group 3: An Open-Label Terlipressin Non-Responder Cohort
Awards:
This trial has 0 awards, including:Timeline:
This trial has the following timeline:- 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
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Are there any risks associated with participating in a safety run-in phase of the research study?
"Taking into account the Phase 2 nature of this safety run-in, our team at Power assigned a score of 2 to An Open-Label Safety Run-In Part due to its limited efficacy data but solidified safety evidence."
Answered by AI
How many healthcare establishments are engaged in this research endeavor?
"Patients can join this clinical trial at several enrolment sites, including Piedmont Healthcare in Atlanta, Beth Israel Deaconess Medical Center in Boston, and Baylor Scott and White All Saints Medical Centre in Fort Worth. Additionally, there are 7 other centres offering participation opportunities."
Answered by AI
Is the research team still gathering participants for this experiment?
"The clinicaltrials.gov page for this medical trial indicates that it is not currently accepting patients, having been last updated on May 16th 2023 since its original posting date of June 1st 2023. Nevertheless, there are an abundance of other trials actively recruiting at the moment - 1588 to be exact."
Answered by AI
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