Study to Evaluate R2R01 Plus Terlipressin Versus Terlipressin Alone in Patients With Hepatorenal … (NCT05875948) | Clinical Trial Compass
UnknownPhase 2
Study to Evaluate R2R01 Plus Terlipressin Versus Terlipressin Alone in Patients With Hepatorenal Syndrome
United States95 participantsStarted 2023-06-30
Plain-language summary
This study aims to evaluate the safety, tolerability and efficacy of R2R01 combined with terlipressin as compared to terlipressin alone in the treatment of patients with HRS-AKI
Who can participate
Age range18 Years
SexALL
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Inclusion 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 micromolar/L) within 48 h, or 2) increase ≥ 50% in baseline SCr, which is known or presumed to have occurred within the prior seven days.
✓. 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).
Exclusion criteria
✕. Significant co-morbidities that in the opinion of the Investigator would preclude study participation.
✕. QLY SCr level \> 5 mg/dL.
✕. AKI stage 1.
✕. 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.