In short
There is currently 1 ongoing clinical trial investigating new treatment approaches for hepatorenal syndrome, a serious complication affecting both liver and kidney function. This trial is being conducted in Germany and Italy, testing a combination therapy that may improve outcomes for patients with this life-threatening condition.
Clinical trial locations
- Germany
- Italy
Study on the Safety and Effectiveness of R2R01 and Terlipressin for Patients with Hepatorenal Syndrome and Acute Kidney Injury
This clinical trial is examining a new approach to treating hepatorenal syndrome with acute kidney injury, a serious condition where advanced liver disease causes the kidneys to suddenly stop working properly. The study compares two treatment options: using terlipressin acetate alone versus using it in combination with a new medication called R2R01.
Main inclusion criteria:
- Patients must be at least 18 years old
- Must have cirrhosis (chronic liver scarring) and ascites (fluid buildup in the abdomen)
- Must have stage 2 or 3 acute kidney injury, meaning kidney function has suddenly decreased by 2 times or more compared to normal levels
- Blood tests must show a serum creatinine level of at least 1.5 mg/dL, indicating reduced kidney function
- Kidney function must not have improved after stopping diuretics and receiving albumin treatment for 48 hours
- Must be able to communicate effectively with doctors and understand study requirements
- Women of childbearing age and partners of male participants must agree to prevent pregnancy during the study period
Main exclusion criteria:
- History of severe allergic reactions to the study medications
- Other serious health conditions that could interfere with study results
- Pregnant or breastfeeding women
- Currently participating in another clinical trial
- History of drug or alcohol abuse
- Recent major surgery
- Uncontrolled high blood pressure or certain heart conditions
- Previous organ transplant
- Active infections requiring treatment
Focus and goal of the trial:
The study aims to determine whether combining R2R01 with terlipressin provides better results than terlipressin alone for patients with this life-threatening condition. Researchers will monitor participants for up to 14 days during treatment, then follow them for 30 days afterward to assess improvements in kidney function, overall health, and any side effects. The trial will measure how many patients respond positively to treatment and whether the combination therapy offers additional benefits in reversing kidney injury and improving survival.
Investigational drugs:
The trial is testing R2R01, a relaxin agonist that may help improve kidney function by promoting better blood flow and reducing inflammation. It is administered through an intravenous injection and is being studied for the first time in this condition. The second medication is Terlipressin Acetate, an established treatment for hepatorenal syndrome that works by narrowing blood vessels to improve blood flow to the kidneys. Both medications are given as injections directly into a vein, and researchers want to see if using them together produces better outcomes than using terlipressin alone.
Summary
Currently, there is only one active clinical trial for hepatorenal syndrome, reflecting the rarity and complexity of this serious condition. This trial is being conducted in two European countries, Germany and Italy, and represents an important effort to improve treatment options for patients facing this life-threatening complication of advanced liver disease.
The study focuses on combination therapy, exploring whether adding the experimental drug R2R01 to the standard treatment terlipressin can provide better results for patients. This approach reflects current research trends in attempting to enhance existing treatments rather than replacing them entirely. The trial's emphasis on both safety and effectiveness is particularly important given the vulnerable state of patients with both liver and kidney failure.
Patients interested in this trial should discuss their eligibility with their healthcare providers, particularly if they have advanced liver disease with recent kidney function decline. The trial requires careful monitoring and specific criteria to ensure patient safety throughout the treatment period.
