BridgeMD
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
EU CTIS ID: 2023-503504-88-00
What this study is testing
To evaluate the tolerability and safety R2R01 in combination with terlipressin versus terlipressin alone. To evaluate the efficacy of R2R01 in combination with terlipressin versus terlipressin alone based on the number of responding patients. Established HRS reversal (clinical responders) are defined as patients with a Full or Partial HRS response based on SCr and AKI stage AND are alive without Renal Replacement Therapy (RRT) for at least 30 days after the first dose of study medication. To evaluate the efficacy of the addition of R2R01 to terlipressin in terlipressin-non-responders.
- Therapeutic exploratory (Phase II)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- 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 μmol/L) within 48 h, or 2) increase ≥ 50% in BL SCr, which is known or presumed to have occurred within the prior seven days. - Stage 2 is defined as an increase in sCr > 2 fold to 3 fold from baseline. - Stage 3 is defined as increase of sCr > 3 fold from baseline or sCr ≥ 4.0 mg/dl (353.6 μmol/L) with an or initiation acute increase ≥ 0.3 mg/dl (26.5 μmol/L)
- 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.
You likely can't join if
- Significant co-morbidities that in the opinion of the Investigator would preclude study participation.
- Fewer than two days of anti-infective therapy for documented or suspected infection.
- Superimposed acute liver injury induced by drugs, herbal preparation or dietary supplements, with the exception of alcoholic hepatitis.
- Estimated life expectancy less than 5 days.
- Hypoxia (<90%) or worsening respiratory symptoms
- Proteinuria > 500 mg/day.
See the full eligibility 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 μmol/L) within 48 h, or 2) increase ≥ 50% in BL SCr, which is known or presumed to have occurred within the prior seven days. - Stage 2 is defined as an increase in sCr > 2 fold to 3 fold from baseline. - Stage 3 is defined as increase of sCr > 3 fold from baseline or sCr ≥ 4.0 mg/dl (353.6 μmol/L) with an or initiation acute increase ≥ 0.3 mg/dl (26.5 μmol/L)
- 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).
- Significant co-morbidities that in the opinion of the Investigator would preclude study participation.
- Fewer than two days of anti-infective therapy for documented or suspected infection.
- Superimposed acute liver injury induced by drugs, herbal preparation or dietary supplements, with the exception of alcoholic hepatitis.
- Estimated life expectancy less than 5 days.
- Hypoxia (<90%) or worsening respiratory symptoms
- Proteinuria > 500 mg/day.
- Tubular epithelial casts, heme granular casts.
- Haematuria or microhaematuria (more than 50 red blood cells per high power field).
- Abnormal renal ultra-sonography unless there is a known chronic structural disease (e.g., diabetic or hypertensive nephropathy).
- Current or recent (within 4 weeks) renal replacement therapy (RRT).
- Severe cardiovascular and pulmonary diseases including, but not limited to, unstable angina, pulmonary edema, congestive heart failure requiring increasing doses of drug therapy, persisting symptomatic peripheral vascular disease, or any other cardiovascular disease judged by the Investigator to be severe.
- QLY SCr level > 5 mg/dL.
- Transjugular intra-hepatic systemic shunt (TIPS) unless it is known to be non-functioning or occluded.
- Ongoing use of vasopressors, unless used for only 48 h before screening; in this case a wash-out period of 8 h before enrollment will be necessary. Patients receiving midodrine and octreotide may be enrolled but treatment must be discontinued prior to enrollment.
- Known allergy or hypersensitivity to terlipressin or other component of the study treatment.
- Subject is not suitable to participate in the study for any reason (including, but not limited to co-morbidities, history of non-compliance with study visits, procedures, or drug administration) in the opinion of the Investigator.
- Females of childbearing potential (those who are not surgically sterilized or post-menopausal for at least 1 year) are excluded from participation in the study unless they agree to use highly effective contraception as described in Section 11.3.
- Males who have no sterilization history and whose female partners have child-bearing potential must agree to use a highly effective method of contraception during the period from the time of signing the informed consent form (ICF) through 90 days after the last dose of study drug. A male patient must agree to immediately inform the Investigator if his partner becomes pregnant during the study.
- AKI stage 1 (see Table 13).
- ACLF stage 3.
- Model for End-Stage Liver Disease (MELD) score >35.
- At least one event of large volume paracentesis (LVP) > 4 Liters in the last 4 days before enrollment.
- Current or recent (within 4 weeks) treatment with nephrotoxic drugs (e.g., aminoglycosides, amphotericin, cyclosporine, NSAIDS (e.g., ibuprofen, naproxen, celecoxib), significant exposure to radiographic contrast agents (large doses or multiple injections of iodinated contrast media).
- Shock (hypovolemic-, cardiogenic-, or vasodilatory/distributive shock) with mean arterial blood pressure (MAP) ≤70 mmHg or systolic blood pressure ≤90 mmHg along with hypoperfusion.
- Sepsis or uncontrolled bacterial infection (e.g., persisting bacteremia, persisting ascitic fluid leucocytosis, fever, increasing leucocytosis with vasomotor instability) as measured with the quick sepsis-related organ dysfunction assessment (qSOFA) score.
The study team makes the final eligibility decision.
Where it's taking place
- United Kingdom
- United States
- Canada
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18-64 years, 65+ years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include United Kingdom; United States; Canada. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.