UnknownPhase 2

Study to Evaluate R2R01 Plus Terlipressin Versus Terlipressin Alone in Patients With Hepatorenal Syndrome

United States95 participantsStarted 2023-06-30

Plain-language 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

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

. 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).

Exclusion criteria

. Significant co-morbidities that in the opinion of the Investigator would preclude study participation.
. QLY SCr level \> 5 mg/dL.

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Safety Evaluation Criteria - Treatment Emergent Adverse Events (TEAEs)

Timeframe: From first dose of study drug to 30 days post last dose

Safety Evaluation Criteria - Change in Weight

Timeframe: Change from screening through Day 30

Safety Evaluation Criteria - Vital Signs - Respiration Rate

Timeframe: Change from screening through Day 30

Safety Evaluation Criteria - Vital Signs - Body Temperature

Timeframe: Change from screening through Day 30

Safety Evaluation Criteria - Vital Signs - Continuous pulse oximetry (SpO2)

Timeframe: Change from baseline through Day 30

Safety Evaluation Criteria - Vital Signs - Systolic Blood Pressure (SBP)

Timeframe: Change from screening through Day 30

Safety Evaluation Criteria - Vital Signs - Diastolic Blood pressure (DBP)

Timeframe: Change from screening through Day 30

Trial details

NCT IDNCT05875948

SponsorRiver 2 Renal Corp.

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2024-12

Contact for this trial

Guido Magni, MD, PHD

+41 794563810 magniguido@yahoo.com

View on ClinicalTrials.gov More Hepatorenal Syndrome trials

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

. 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).

Exclusion criteria

. Significant co-morbidities that in the opinion of the Investigator would preclude study participation.
. QLY SCr level \> 5 mg/dL.

What they're measuring

Safety Evaluation Criteria - Treatment Emergent Adverse Events (TEAEs)

Timeframe: From first dose of study drug to 30 days post last dose

Safety Evaluation Criteria - Change in Weight

Timeframe: Change from screening through Day 30

Safety Evaluation Criteria - Vital Signs - Respiration Rate

Timeframe: Change from screening through Day 30

Safety Evaluation Criteria - Vital Signs - Body Temperature

Timeframe: Change from screening through Day 30

Safety Evaluation Criteria - Vital Signs - Continuous pulse oximetry (SpO2)

Timeframe: Change from baseline through Day 30

Safety Evaluation Criteria - Vital Signs - Systolic Blood Pressure (SBP)

Timeframe: Change from screening through Day 30

Safety Evaluation Criteria - Vital Signs - Diastolic Blood pressure (DBP)

Timeframe: Change from screening through Day 30