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

Join a study comparing R2R01 and Terlipressin for liver-related kidney issues.

Recruiting
18 years and older
All
Phase 2

This study is exploring a new treatment for Hepatorenal Syndrome (HRS), a serious condition where the kidneys stop working well in people with liver problems. It will test a new drug called R2R01 alongside terlipressin, a medicine already used for HRS. The study aims to find out if the combination is safer and more effective than terlipressin alone. The study will be conducted in multiple centers across Europe, the UK, the US, and Canada. Participants will take part for up to 15 weeks, including a treatment period of up to 14 days and a follow-up period lasting about 76 days. To qualify, participants need to be 18 or older, have liver cirrhosis with fluid buildup (ascites), and meet certain kidney function requirements. The study will not accept people with certain severe health conditions or those who recently took specific drugs. Participants are expected to visit the study site multiple times and must agree to use effective contraception to prevent pregnancy during the study.

  • Study duration: approximately 15 weeks.
  • Treatment includes terlipressin, possibly combined with R2R01.
  • Participants must follow specific health guidelines and contraception rules.
Study details
    Hepatorenal Syndrome
    Acute Kidney Injury

NCT05875948

River 2 Renal Corp.

13 December 2024

Step 1 Get in touch with the nearest study center
What happens next?
  • You can expect the study team to contact you via email or phone in the next few days.
  • Sign up as volunteer  to help accelerate the development of new treatments and to get notified about similar trials.

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Learn more about clinical trials

What is a clinical trial?

A clinical trial is a study designed to test specific interventions or treatments' effectiveness and safety, paving the way for new, innovative healthcare solutions.

Why should I take part in a clinical trial?

Participating in a clinical trial provides early access to potentially effective treatments and directly contributes to the healthcare advancements that benefit us all.

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The duration of clinical trials varies. Some trials last weeks, some years, depending on the phase and intention of the trial.

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Compensation varies per trial. Some offer payment or reimbursement for time and travel, while others may not.

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Clinical trials follow strict ethical guidelines and protocols to safeguard participants' health. They are closely monitored and safety reviewed regularly.
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