Study on the Safety and Effectiveness of R2R01 and Terlipressin for Patients with Hepatorenal Syndrome and Acute Kidney Injury

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What is this study about?

This clinical trial is focused on studying a condition known as Hepatorenal Syndrome – Acute Kidney Injury, which affects the kidneys and liver. The study is testing a new treatment approach using a combination of two medications: R2R01, a relaxin agonist, and Terlipressin Acetate, which is already used in treating this condition. The trial aims to compare the safety and effectiveness of using both medications together versus using Terlipressin Acetate alone.

Participants in the study will receive either the combination of R2R01 and Terlipressin Acetate or just Terlipressin Acetate. The study will last for a period of up to 14 days, during which the medications will be administered through an injection into a vein. The goal is to see how well the combination treatment works in improving kidney function and overall health in patients with Hepatorenal Syndrome – Acute Kidney Injury.

The study will monitor participants for any side effects and changes in their health, including kidney and liver function, over a period of 30 days after starting the treatment. The researchers will also look at how many patients respond positively to the treatment and whether the combination of R2R01 and Terlipressin Acetate offers any additional benefits compared to Terlipressin Acetate alone. This information will help determine the potential of the new treatment approach for patients with this serious condition.

1 joining the study

Upon joining the study, the patient will be informed about the trial’s purpose and procedures. The patient must understand and sign a consent form to participate.

Eligibility criteria include being at least 18 years old, having cirrhosis and ascites, and meeting specific kidney function criteria.

2 initial assessment

The patient will undergo an initial assessment to evaluate their health status. This includes physical examinations, vital signs, and laboratory tests.

3 treatment allocation

The patient will be randomly assigned to one of two treatment groups: one receiving terlipressin acetate alone, and the other receiving a combination of terlipressin acetate and R2R01.

Both treatments are administered via intravenous injection.

4 treatment administration

The patient will receive the assigned treatment. The dosage and frequency will be determined by the study protocol and the patient’s specific needs.

The treatment period will be closely monitored to assess safety and effectiveness.

5 monitoring and follow-up

Throughout the study, the patient will have regular follow-up visits to monitor their response to the treatment. This includes checking vital signs, conducting laboratory tests, and assessing any side effects.

The patient’s kidney function will be evaluated to determine the treatment’s effectiveness.

6 end of treatment evaluation

At the end of the treatment period, the patient will undergo a final evaluation to assess the overall impact of the treatment on their health.

The study will measure outcomes such as the reversal of kidney injury and the need for further medical interventions.

7 post-study follow-up

The patient will be monitored for a period after the treatment ends to ensure their safety and to gather additional data on the treatment’s long-term effects.

This follow-up period will include assessments at 30, 60, and 90 days after treatment.

Who Can Join the Study?

The patient must be able to communicate well with the study doctor, understand and agree to follow all study requirements, and sign a written consent form.
The patient must be at least 18 years old.
The patient must have cirrhosis (a liver condition) and ascites (fluid buildup in the belly).
The patient must have Acute Kidney Injury (AKI) at stage 2 or 3. AKI is a sudden decrease in kidney function. Stage 2 means the kidney function has worsened by 2 to 3 times from normal. Stage 3 means it has worsened by more than 3 times or the kidney function level is very low.
The patient’s serum creatinine (SCr), a blood test that shows kidney function, must be at least 1.5 mg/dL.
The patient must not have had a lasting improvement in kidney function after stopping diuretics (medicines that help remove extra fluid) and starting treatment with albumin (a protein) for 48 hours.
Female patients and female partners of male patients must agree to avoid pregnancy during the study period, which is more than 90 days.

Who Cannot Join the Study?

Patients who have a history of severe allergic reactions to the study medications cannot participate.
Individuals with other serious health conditions that might interfere with the study cannot join.
Pregnant or breastfeeding women are not allowed to participate.
Patients who are currently participating in another clinical trial are excluded.
Individuals with a history of drug or alcohol abuse may not be eligible.
Patients who have had a recent major surgery may not be able to join the study.
Those with uncontrolled high blood pressure are not eligible.
Individuals with certain heart conditions may be excluded from the study.
Patients who have received an organ transplant cannot participate.
Individuals with active infections that require treatment are not eligible.

Where you can join this trial?

Verified and Recommended Sites

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Verified Sites

Site Name	City	Country	Status
University Hospital Jena KöR	Jena	Germany

Other Sites

Site Name	City	Country
Azienda Ospedaliera di Padova	Padua	Italy
ASST Grande Ospedale Metropolitano Niguarda	Milan	Italy
Westfaelische Wilhelms Universitaet Muenster	Munster	Germany
Kecusill dzg Unyddcedgnpv Mqmyucln Agf	Munich	Germany
Agktlre Ueknc Snlszqvsz Lppfbj Di Bqmluay	Bologna	Italy

Trial status

Country	Status	Recruitment Start
Germany	Not recruiting	01.09.2023
Italy	Not recruiting	01.09.2023

Trial locations

Investigated drugs:

R2R01 is a relaxin agonist being studied for its potential to help improve kidney function in patients with hepatorenal syndrome, a type of acute kidney injury. It is being tested to see if it can enhance the effects of another medication, terlipressin, in treating this condition.

Terlipressin is a medication commonly used to treat hepatorenal syndrome. It works by narrowing blood vessels, which can help improve blood flow to the kidneys and support kidney function. In this study, it is being used alone and in combination with R2R01 to assess if the combination provides better outcomes for patients.

Investigated diseases:

Hepatorenal Syndrome – Acute Kidney Injury – This condition is a serious complication that occurs in individuals with advanced liver disease, leading to a rapid decline in kidney function. It is characterized by a sudden onset of kidney failure in the context of liver cirrhosis or fulminant liver failure. The kidneys themselves are structurally normal, but their function is impaired due to changes in blood flow and circulation caused by liver dysfunction. This syndrome often progresses quickly, with a marked reduction in urine output and an increase in waste products in the blood. It is typically triggered by factors such as infections, gastrointestinal bleeding, or excessive use of diuretics. The condition requires careful management to prevent further deterioration of kidney function.

Trial ID:

2023-503504-88-00

Protocol code:

R2R01-HRS-201

NCT ID:

NCT05875948

Trial Phase:

Therapeutic exploratory (Phase II)

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Study on the Safety and Effectiveness of R2R01 and Terlipressin for Patients with Hepatorenal Syndrome and Acute Kidney Injury

What is this study about?

Who Can Join the Study?

Who Cannot Join the Study?