Hepatorenal SyndromePhase 2NCT05875948
Study to Evaluate R2R01 Plus Terlipressin Versus Terlipressin Alone in Patients With Hepatorenal Syndrome
A Phase 2 study testing R2R01 and Terlipressin in people with Hepatorenal Syndrome and Acute Kidney Injury, run by River 2 Renal Corp. at 7 sites in United States.
Trial summary
This study aims to evaluate the safety, tolerability and efficacy of R2R01 combined with terlipressin as compared to terlipressin alone in the treatment of patients with HRS-AKI Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hepatorenal Syndrome, Acute Kidney Injury
- What is being tested?
- R2R01 and Terlipressin
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 95 participants
- Where
- 7 sitesUnited States
- Study dates
- 30 Jun 2023to Dec 2024
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patient is able to communicate well with the Investigator, understands and is willing to comply with all requirements of the study, and understands and signs the written informed consent form (ICF).
- At least 18 years of age.
- Cirrhosis and ascites.
- AKI stage 2 or 3. AKI defined by any of the following: 1) increase in SCr (SCr) ≥ 0.3 mg/dl (or ≥ 26.5 micromolar/L) within 48 h, or 2) increase ≥ 50% in baseline SCr, which is known or presumed to have occurred within the prior seven days.
- QLY SCr ≥ to 1.5 mg/dl.
- No sustained improvement in renal function (less than 20% decrease in SCr and SCr => 1.5 mg/dL) after 48 h of diuretic withdrawal and the beginning of plasma volume expansion with albumin.
- Female patients as well as female partners of male patients must be willing to avoid pregnancy for the duration of the study (>90 days).
Who cannot join
- Significant co-morbidities that in the opinion of the Investigator would preclude study participation.
- QLY SCr level > 5 mg/dL.
- AKI stage 1.
- ACLF stage 3.
- Model for End-Stage Liver Disease (MELD) score >35.
- At least one event of large volume paracentesis (LVP) > 4 Liters in the last 4 days before enrollment.
Show all 25Show fewer
- Current or recent (within 4 weeks) treatment with nephrotoxic drugs (e.g., aminoglycosides, amphotericin, cyclosporine, NSAIDS (e.g., ibuprofen, naproxen, celecoxib), significant exposure to radiographic contrast agents (large doses or multiple injections of iodinated contrast media).
- Shock (hypovolemic-, cardiogenic-, or vasodilatory/distributive shock) with mean arterial blood pressure (MAP) ≤70 mmHg or systolic blood pressure ≤90 mmHg along with hypoperfusion.
- Sepsis or uncontrolled bacterial infection (e.g., persisting bacteremia, persisting ascitic fluid leucocytosis, fever, increasing leucocytosis with vasomotor instability) as measured with the quick sepsis-related organ dysfunction assessment (qSOFA) score.
- Fewer than two days of anti-infective therapy for documented or suspected infection.
- Superimposed acute liver injury induced by drugs, herbal preparation or dietary supplements, with the exception of alcoholic hepatitis.
- Estimated life expectancy less than 5 days.
- Hypoxia (<90%) or worsening respiratory symptoms.
- Proteinuria > 500 mg/day.
- Tubular epithelial casts, heme granular casts.
- Haematuria or microhaematuria (more than 50 red blood cells per high power field).
- Abnormal renal ultra-sonography unless there is a known chronic structural disease (e.g., diabetic or hypertensive nephropathy).
- Current or recent (within 4 weeks) renal replacement therapy (RRT).
- Severe cardiovascular and pulmonary diseases including, but not limited to, unstable angina, pulmonary edema, congestive heart failure requiring increasing doses of drug therapy, persisting symptomatic peripheral vascular disease, or any other cardiovascular disease judged by the Investigator to be severe.
- Transjugular intra-hepatic systemic shunt (TIPS) unless it is known to be non-functioning or occluded.
- Ongoing use of vasopressors, unless used for only 48 h before screening; in this case a wash-out period of 8 h before enrollment will be necessary. Patients receiving midodrine and octreotide may be enrolled but treatment must be discontinued prior to enrollment.
- Known allergy or hypersensitivity to terlipressin or other component of the study treatment.
- Subject is not suitable to participate in the study for any reason (including, but not limited to co-morbidities, history of non-compliance with study visits, procedures, or drug administration) in the opinion of the Investigator.
- Females of childbearing potential (those who are not surgically sterilized or post-menopausal for at least 1 year) are excluded from participation in the study unless they agree to use highly effective contraception.
- Males who have no sterilization history and whose female partners have child-bearing potential must agree to use a highly effective method of contraception during the period from the time of signing the informed consent form (ICF) through 90 days after the last dose of study drug. A male patient must agree to immediately inform the Investigator if his partner becomes pregnant during the study.
Trial locations and contacts
7 sites in 1 country.
7 sites in 1 country
United States7 sites, 7 recruiting
- Recruiting
Piedmont Healthcare, Inc
Atlanta, Georgia, 30309
- Not yet recruiting
Beth Israel Deaconess Medical Center
Boston, Massachusetts, 02215
- Recruiting
Baylor Scott and White All Saints Medical Center
Fort Worth, Texas, 76104
- Recruiting
Vanderbilt University Medical Center
Nashville, Tennessee, 37232
- Recruiting
Hospital of the University of Pennsylvania
Philadelphia, Pennsylvania, 19104
- Recruiting
Mayo Clinic
Rochester, Minnesota, 55905
- Not yet recruiting
California Pacific Medical Center
San Francisco, California, 94114
About this study
Official title: A Single-blind, Phase 2, Multi-center, Randomized Study to Assess Safety, Tolerability, Efficacy and Pharmacokinetics of the R2R01 Plus Terlipressin Versus Terlipressin Alone in Patients With Hepatorenal Syndrome - Acute Kidney Injury
This study aims to evaluate the safety, tolerability and efficacy of R2R01 combined with terlipressin as compared to terlipressin alone in the treatment of patients with HRS-AKI
Read the detailed description
This is a phase 2 randomized, single-blind, placebo-controlled, two group, multicenter trial preceded by a safety run-in, in patients with Hepatorenal Syndrome (HRS) - Acute Kidney Injury (HRS-AKI).
The study consists of:
- an Open-Label Safety Run-In Part with 3 Cohorts of patients, followed by
- a Single-Blind Placebo-Controlled Randomized Part with two Cohorts of patients treated in parallel, and
- an Open-Label Terlipressin Non-Responder Cohort.
All patients in all Cohorts will be treated with terlipressin, administered as a slow intravenous (IV) bolus 1 mg over 2 minutes every 6 hours (h) to be increased if clinically appropriate to 2.0 mg every 6 h. Terlipressin dosing should continue up to 24 h after achievement of an HRS response (either Partial or Full) based on Serum Creatinine (SCr)/AKI stage or up to day 14.
For those Cohorts where terlipressin will be administered combined with R2R01 (i.e., Cohorts 1, 2, 3, 4, and 6), the first R2R01 administration will commence immediately following the first terlipressin administration. Like terlipressin treatment, R2R01 dosing should continue up to 24 h after achievement of an HRS response (either Partial or Full) based on SCr/AKI stage or up to day 14.
All patients in all Cohorts will be followed for up to 90 days after the first dose of study drug.
This study will be conducted across approximately 25 centers in EU, UK, US, and Canada.
The screening period will occur within 14 days prior to the first dose administration.
The treatment duration is up to 14 days with a follow-up period of approximately 76 days.
The expected total duration of study participation is up to 15 weeks for each subject.
- Conditions
- Hepatorenal Syndrome, Acute Kidney Injury
- Being tested
- R2R01, Terlipressin
- Keywords
- HRS-AKI, HRS, Renal Failure, Kidney Failure, Single-blind, Open-Label, Phase 2, R2R01
- Medical subject headings
- Hepatorenal Syndrome, Acute Kidney Injury, Renal Insufficiency
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
R2R01Drug
Pharmaceutical form: sterile 2R vials containing 10 mg of R2R01.
TerlipressinDrug
In the US, terlipressin is supplied as a sterile, preservative-free, lyophilized, white-to- off-white powder for intravenous (IV) administration. Each vial contains 0.85 mg Terlivaz, equivalent to 1 mg terlipressin acetate, and 10.0 mg mannitol. Terlivaz requires reconstituting in saline (5mL).
In the EU, terlipressin is supplied in a clear glass vial with 5 ml of injection solution, containing 1 mg terlipressin acetate corresponding to 0.85 mg terlipressin.
| Study group | Role | What they receive |
|---|---|---|
| An Open-Label Safety Run-In Part | Experimental | 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. Receives: Drug: R2R01; Drug: Terlipressin |
| Single-blind Placebo-controlled Randomized period | Placebo comparator | 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. Receives: Drug: R2R01; Drug: Terlipressin |
| An Open-Label Terlipressin Non-Responder Cohort | Experimental | 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. Receives: Drug: R2R01; Drug: Terlipressin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety Evaluation Criteria - Treatment Emergent Adverse Events (TEAEs)
Safety and tolerability will be assessed by occurrence of TEAEs. Outcome will be reported as the count of participant experiencing TEAEs.
Measured: From first dose of study drug to 30 days post last dose
Safety Evaluation Criteria - Change in Weight
Safety and tolerability will be assessed by change in body weight
Measured: Change from screening through Day 30
Safety Evaluation Criteria - Vital Signs - Respiration Rate
Safety and tolerability will be assessed by change in respiration rate
Measured: Change from screening through Day 30
Safety Evaluation Criteria - Vital Signs - Body Temperature
Safety and tolerability will be assessed by change in body temperature
Measured: Change from screening through Day 30
Safety Evaluation Criteria - Vital Signs - Continuous pulse oximetry (SpO2)
Safety and tolerability will be assessed by change in SpO2
Measured: Change from baseline through Day 30
Safety Evaluation Criteria - Vital Signs - Systolic Blood Pressure (SBP)
Safety and tolerability will be assessed by change in SBP
Measured: Change from screening through Day 30
Safety Evaluation Criteria - Vital Signs - Diastolic Blood pressure (DBP)
Safety and tolerability will be assessed by change in DBP
Measured: Change from screening through Day 30
Safety Evaluation Criteria - Vital Signs - Heart Rate (HR)
Safety and tolerability will be assessed by change in Heart Rate (HR)
Measured: Change from screening through Day 30
Safety Evaluation Criteria - ECGs - PR interval
Safety and tolerability will be assessed by occurrence of ECGs
Measured: Change from screening to Day 14 or hospital discharge
Safety Evaluation Criteria - ECGs - RR interval
Safety and tolerability will be assessed by occurrence of ECGs
Measured: Change from screening to Day 14 or hospital discharge
Safety Evaluation Criteria - ECGs - QRS duration
Safety and tolerability will be assessed by occurrence of ECGs
Measured: Change from screening to Day 14 or hospital discharge
Safety Evaluation Criteria - ECGs - QT interval
Safety and tolerability will be assessed by occurrence of ECGs
Measured: Change from screening to Day 14 or hospital discharge
Safety Evaluation Criteria - ECGs - QTcF interval
Safety and tolerability will be assessed by occurrence of ECGs
Measured: Change from screening to Day 14 or hospital discharge
Safety Evaluation Criteria - ECGs - QTcB interval
Safety and tolerability will be assessed by occurrence of ECGs
Measured: Change from screening to Day 14 or hospital discharge
The incidence of Responders
The incidence of Responders (Established HRS reversal defined as patients with a Full or Partial HRS response (based on SCr/AKI stage) AND are alive without Renal Replacement Therapy (RRT) for at least 30 days after the first dose of study medication), evaluated separately as two different outcome groups and combined. In case of recurrence and retreatment during the first 30 days, the second treatment period will be evaluated for response
Measured: 90 days
Secondary outcomes (2)
Mortality Rate
Number of patients who died at day 30, 60, and 90.
Measured: 30, 60, 90 days
Liver Transplant Rates
Number of patients undergoing a liver transplant at day 30, 60, and 90.
Measured: 30, 60, 90 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 May 2023
- Study start30 Jun 2023
- Primary completionDec 2024 (estimated)
- Study completionDec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hepatorenal SyndromeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Model description
- A. An Open-Label Safety Run-In Part with 3 Cohorts of patients, followed by B. A Single-Blind Placebo-Controlled Randomized Part with two Cohorts of patients treated in parallel, and C. An Open-Label Terlipressin Non-Responder Cohort.
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 95 participants (estimated)
Sponsor and investigators
- Lead sponsor
- River 2 Renal Corp.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05875948
- Sponsor's protocol ID
- R2R01-HRS-201
- Status last verified
- May 2023
- First submitted
- 1 May 2023
- Last updated
- 3 Oct 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Oct 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Single-blind, Phase 2, Multi-center, Randomized Study to Assess Safety, Tolerability, Efficacy and Pharmacokinetics of the R2R01 Plus Terlipressin Versus Terlipressin Alone in Patients With Hepatorenal Syndrome - Acute Kidney Injury
- ClinicalTrials.gov ID
- NCT05875948
- Acronym / sponsor ID
- R2R01-HRS-201
- Conditions
- Hepatorenal Syndrome, Acute Kidney Injury
- Keywords
- HRS-AKI, HRS, Renal Failure, Kidney Failure, Single-blind, Open-Label, Phase 2, R2R01
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 95 participants (estimated)
- Lead sponsor
- River 2 Renal Corp.Industry (pharma, biotech, devices)
- Study start
- 30 Jun 2023 (actual)
- Primary completion
- Dec 2024 (estimated)
- Study completion
- Dec 2024 (estimated)
- First posted
- 25 May 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study aims to evaluate the safety, tolerability and efficacy of R2R01 combined with terlipressin as compared to terlipressin alone in the treatment of patients with HRS-AKI
Detailed description
This is a phase 2 randomized, single-blind, placebo-controlled, two group, multicenter trial preceded by a safety run-in, in patients with Hepatorenal Syndrome (HRS) - Acute Kidney Injury (HRS-AKI).
The study consists of:
- an Open-Label Safety Run-In Part with 3 Cohorts of patients, followed by
- a Single-Blind Placebo-Controlled Randomized Part with two Cohorts of patients treated in parallel, and
- an Open-Label Terlipressin Non-Responder Cohort.
All patients in all Cohorts will be treated with terlipressin, administered as a slow intravenous (IV) bolus 1 mg over 2 minutes every 6 hours (h) to be increased if clinically appropriate to 2.0 mg every 6 h. Terlipressin dosing should continue up to 24 h after achievement of an HRS response (either Partial or Full) based on Serum Creatinine (SCr)/AKI stage or up to day 14.
For those Cohorts where terlipressin will be administered combined with R2R01 (i.e., Cohorts 1, 2, 3, 4, and 6), the first R2R01 administration will commence immediately following the first terlipressin administration. Like terlipressin treatment, R2R01 dosing should continue up to 24 h after achievement of an HRS response (either Partial or Full) based on SCr/AKI stage or up to day 14.
All patients in all Cohorts will be followed for up to 90 days after the first dose of study drug.
This study will be conducted across approximately 25 centers in EU, UK, US, and Canada.
The screening period will occur within 14 days prior to the first dose administration.
The treatment duration is up to 14 days with a follow-up period of approximately 76 days.
The expected total duration of study participation is up to 15 weeks for each subject.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- Single blind (participant)
- Number of arms
- 3
- Model description
- A. An Open-Label Safety Run-In Part with 3 Cohorts of patients, followed by B. A Single-Blind Placebo-Controlled Randomized Part with two Cohorts of patients treated in parallel, and C. An Open-Label Terlipressin Non-Responder Cohort.
| Arm | Type | Receives |
|---|---|---|
| An Open-Label Safety Run-In Part | Experimental | Drug: R2R01, Drug: TerlipressinThree 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. |
| Single-blind Placebo-controlled Randomized period | Placebo comparator | Drug: R2R01, Drug: TerlipressinAfter 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. |
| An Open-Label Terlipressin Non-Responder Cohort | Experimental | Drug: R2R01, Drug: TerlipressinIn 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Patient is able to communicate well with the Investigator, understands and is willing to comply with all requirements of the study, and understands and signs the written informed consent form (ICF).
- At least 18 years of age.
- Cirrhosis and ascites.
- AKI stage 2 or 3. AKI defined by any of the following: 1) increase in SCr (SCr) ≥ 0.3 mg/dl (or ≥ 26.5 micromolar/L) within 48 h, or 2) increase ≥ 50% in baseline SCr, which is known or presumed to have occurred within the prior seven days.
- QLY SCr ≥ to 1.5 mg/dl.
Key exclusion criteria (25 listed)
- Significant co-morbidities that in the opinion of the Investigator would preclude study participation.
- QLY SCr level > 5 mg/dL.
- AKI stage 1.
- ACLF stage 3.
- Model for End-Stage Liver Disease (MELD) score >35.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| R2R01Pharmaceutical form: sterile 2R vials containing 10 mg of R2R01. | Drug | An Open-Label Safety Run-In Part, An Open-Label Terlipressin Non-Responder Cohort, Single-blind Placebo-controlled Randomized period |
| TerlipressinIn the US, terlipressin is supplied as a sterile, preservative-free, lyophilized, white-to- off-white powder for intravenous (IV) administration. Each vial contains 0.85 mg Terlivaz, equivalent to 1 mg terlipressin acetate, and 10.0 mg mannitol. Terlivaz requires reconstituting in saline (5mL). In the EU, terlipressin is supplied in a clear glass vial with 5 ml of injection solution, containing 1 mg terlipressin acetate corresponding to 0.85 mg terlipressin. | Drug | An Open-Label Safety Run-In Part, An Open-Label Terlipressin Non-Responder Cohort, Single-blind Placebo-controlled Randomized period |
Primary outcome
Safety Evaluation Criteria - Treatment Emergent Adverse Events (TEAEs)
Time frame: From first dose of study drug to 30 days post last dose
Safety and tolerability will be assessed by occurrence of TEAEs. Outcome will be reported as the count of participant experiencing TEAEs.
Safety Evaluation Criteria - Change in Weight
Time frame: Change from screening through Day 30
Safety and tolerability will be assessed by change in body weight
Safety Evaluation Criteria - Vital Signs - Respiration Rate
Time frame: Change from screening through Day 30
Safety and tolerability will be assessed by change in respiration rate
Safety Evaluation Criteria - Vital Signs - Body Temperature
Time frame: Change from screening through Day 30
Safety and tolerability will be assessed by change in body temperature
Safety Evaluation Criteria - Vital Signs - Continuous pulse oximetry (SpO2)
Time frame: Change from baseline through Day 30
Safety and tolerability will be assessed by change in SpO2
Safety Evaluation Criteria - Vital Signs - Systolic Blood Pressure (SBP)
Time frame: Change from screening through Day 30
Safety and tolerability will be assessed by change in SBP
Safety Evaluation Criteria - Vital Signs - Diastolic Blood pressure (DBP)
Time frame: Change from screening through Day 30
Safety and tolerability will be assessed by change in DBP
Safety Evaluation Criteria - Vital Signs - Heart Rate (HR)
Time frame: Change from screening through Day 30
Safety and tolerability will be assessed by change in Heart Rate (HR)
Safety Evaluation Criteria - ECGs - PR interval
Time frame: Change from screening to Day 14 or hospital discharge
Safety and tolerability will be assessed by occurrence of ECGs
Safety Evaluation Criteria - ECGs - RR interval
Time frame: Change from screening to Day 14 or hospital discharge
Safety and tolerability will be assessed by occurrence of ECGs
Safety Evaluation Criteria - ECGs - QRS duration
Time frame: Change from screening to Day 14 or hospital discharge
Safety and tolerability will be assessed by occurrence of ECGs
Safety Evaluation Criteria - ECGs - QT interval
Time frame: Change from screening to Day 14 or hospital discharge
Safety and tolerability will be assessed by occurrence of ECGs
Safety Evaluation Criteria - ECGs - QTcF interval
Time frame: Change from screening to Day 14 or hospital discharge
Safety and tolerability will be assessed by occurrence of ECGs
Safety Evaluation Criteria - ECGs - QTcB interval
Time frame: Change from screening to Day 14 or hospital discharge
Safety and tolerability will be assessed by occurrence of ECGs
The incidence of Responders
Time frame: 90 days
The incidence of Responders (Established HRS reversal defined as patients with a Full or Partial HRS response (based on SCr/AKI stage) AND are alive without Renal Replacement Therapy (RRT) for at least 30 days after the first dose of study medication), evaluated separately as two different outcome groups and combined. In case of recurrence and retreatment during the first 30 days, the second treatment period will be evaluated for response
2 secondary outcomes
Mortality Rate
Time frame: 30, 60, 90 days
Liver Transplant Rates
Time frame: 30, 60, 90 days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Oct 2023.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
7 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing R2R01 and Terlipressin in people with Hepatorenal Syndrome and Acute Kidney Injury, run by River 2 Renal Corp. at 7 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 25 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 3 Oct 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 7 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Guido Magni, MD, PHD (+41 794563810, magniguido@yahoo.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Safety Evaluation Criteria - Treatment Emergent Adverse Events (TEAEs) (time frame: From first dose of study drug to 30 days post last dose). The study lists 15 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Oct 2023.