Ongoing, recruitingTherapeutic exploratory (Phase II)Interventional

A Single-blind, Phase 2, Multi-center, Randomized Study to Assess Safety, Tolerability, Efficacy and Pharmacokinetics of the Relaxin Agonist R2R01 Plus Terlipressin Versus Terlipressin Alone in Patients with Hepatorenal Syndrome – Acute Kidney Injury

This research study is investigating a new treatment, R2R01, when given alongside an existing medication called Terlipressin. The study is for people who have a serious kidney problem known as hepatorenal syndrome - acute kidney injury (HRS-AKI). This condition affects the kidneys in people who also have severe liver disease. The main goals are to check if the new combination of treatments is safe and doesn't cause too many side effects, to see if it helps improve kidney function, and to understand how the body uses and gets rid of the medicine. Researchers will compare patients receiving the new combination with those receiving only Terlipressin, to find the best way to help people with this condition.

At a glance

Status

Ongoing, recruiting

Phase

Therapeutic exploratory (Phase II)

Sponsor

River 2 Renal Corp.

Enrolment target

Start

17 Oct 2023

Hepatorenal Syndrome – Acute Kidney Injury

What is this study about?

This study is designed to help people who have a serious condition called hepatorenal syndrome – acute kidney injury, often shortened to HRS-AKI. This is a severe kidney problem that can happen in people who already have very serious liver disease. When the liver is badly damaged, it can sometimes affect how the kidneys work, leading to them suddenly failing. This condition needs urgent treatment.

The researchers want to see if adding a new medicine, called R2R01, to a treatment already sometimes used, called Terlipressin, can be more effective. Terlipressin helps improve blood flow to the kidneys. R2R01 is a 'relaxin agonist', which means it works on pathways in the body similar to a natural hormone called relaxin, potentially helping improve kidney function and reducing damage. This study is in an early stage (Phase 2), so it's focused on finding out if the new combination is safe, how well patients tolerate it, and if it shows promise in helping the kidneys recover.

To do this, some patients will receive the new medicine R2R01 plus Terlipressin, while others will just receive Terlipressin alone. This allows the doctors to compare the two groups and see if the new combination offers better results, without causing too many unwanted side effects. The study will pay close attention to whether patients' kidney function improves and if they can avoid needing more intrusive treatments like dialysis.

Key takeaways

This study is for adults with severe liver disease and sudden kidney failure (HRS-AKI).
It tests a new medicine combination (R2R01 + Terlipressin) against an existing treatment (Terlipressin alone).
The main aims are to check safety, how well patients cope with the treatment, and if it helps kidney function.
Patients will have regular medical checks, blood tests, and heart monitoring.
Participation is voluntary, and you can leave the study at any time.

Who may be eligible?

To be part of this study, you must be at least 18 years old. The study is open to both men and women.

More detailed eligibility criteria will be discussed by your doctor, as certain health conditions or medicines might mean the study isn't suitable for you. This is to ensure your safety and that the study results are clear.

Quick self-check

Are you 18 years old or older?
Do you have severe liver disease?
Have you recently experienced acute kidney injury (sudden kidney failure)?
Are you currently undergoing treatment for HRS-AKI?

This is a guide only — the research team will confirm whether you can take part.

What does participation involve?

If you join this study, you will be given study medication, either the new combination or Terlipressin alone. You will have regular check-ups, which include physical exams, checking your vital signs (like heart rate and blood pressure), and having regular ECGs (heart tracings) and blood tests. These tests help the doctors monitor how you are responding to the treatment and check for any side effects.

Researchers will regularly assess your kidney function and overall health during the study. You will also have follow-up visits after your treatment ends to make sure your health continues to be monitored. The exact number of visits and tests will be explained in detail by the study team, and it's important to understand these before you agree to take part.

Potential risks and benefits

Participating in a study like this means you might be one of the first people to benefit from a new treatment that could improve kidney function for HRS-AKI. However, there are also potential risks, as any new medicine can have unexpected side effects. The medical team will carefully monitor you for any problems. You will be told about all known risks and discomforts before you decide to join. Remember, your participation is completely voluntary, and you have the right to withdraw from the study at any time, for any reason, without it affecting your medical care.

Locations (2)

—
Italy
—
Germany

Common questions

What is hepatorenal syndrome – acute kidney injury (HRS-AKI)?

It's a serious kidney problem that can happen suddenly in people who already have severe liver disease.

What is the new medicine being tested?

The new medicine is called R2R01. It's being tested alongside an existing treatment called Terlipressin.

Will I know which treatment I'm receiving?

This is a 'single-blind' study, meaning you won't know if you're getting R2R01 plus Terlipressin or Terlipressin alone, but your doctors will know.

What are the main goals of this study?

The main goals are to check the safety of the new treatment, how well patients tolerate it, and if it helps improve kidney function.

Can I leave the study if I change my mind?

Yes, you can withdraw from the study at any time, for any reason, and it won't affect your regular medical care.