NCT05875948

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

A Single-blind, Phase 2, Multi-center, Randomized Study to Assess Safety, Tolerability, Efficacy and Pharmacokinetics of the R2R01 Plus Terlipressin Versus Terlipressin Alone in Patients With Hepatorenal Syndrome - Acute Kidney Injury

• Status: Unknown
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 95 (estimated)
• Sponsor: River 2 Renal Corp. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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

Detailed description

This is a phase 2 randomized, single-blind, placebo-controlled, two group, multicenter trial preceded by a safety run-in, in patients with Hepatorenal Syndrome (HRS) - Acute Kidney Injury (HRS-AKI). The study consists of: A. an Open-Label Safety Run-In Part with 3 Cohorts of patients, followed by B. a Single-Blind Placebo-Controlled Randomized Part with two Cohorts of patients treated in parallel, and C. an Open-Label Terlipressin Non-Responder Cohort. All patients in all Cohorts will be treated with terlipressin, administered as a slow intravenous (IV) bolus 1 mg over 2 minutes every 6 hours (h) to be increased if clinically appropriate to 2.0 mg every 6 h. Terlipressin dosing should continue up to 24 h after achievement of an HRS response (either Partial or Full) based on Serum Creatinine (SCr)/AKI stage or up to day 14. For those Cohorts where terlipressin will be administered combined with R2R01 (i.e., Cohorts 1, 2, 3, 4, and 6), the first R2R01 administration will commence immediately following the first terlipressin administration. Like terlipressin treatment, R2R01 dosing should continue up to 24 h after achievement of an HRS response (either Partial or Full) based on SCr/AKI stage or up to day 14. All patients in all Cohorts will be followed for up to 90 days after the first dose of study drug. This study will be conducted across approximately 25 centers in EU, UK, US, and Canada. The screening period will occur within 14 days prior to the first dose administration. The treatment duration is up to 14 days with a follow-up period of approximately 76 days. The expected total duration of study participation is up to 15 weeks for each subject.

Conditions

• Hepatorenal Syndrome
• Acute Kidney Injury

Interventions

Type	Name	Description
DRUG	R2R01	Pharmaceutical form: sterile 2R vials containing 10 mg of R2R01.
DRUG	Terlipressin	In the US, terlipressin is supplied as a sterile, preservative-free, lyophilized, white-to- off-white powder for intravenous (IV) administration. Each vial contains 0.85 mg Terlivaz, equivalent to 1 mg terlipressin acetate, and 10.0 mg mannitol. Terlivaz requires reconstituting in saline (5mL). In the EU, terlipressin is supplied in a clear glass vial with 5 ml of injection solution, containing 1 mg terlipressin acetate corresponding to 0.85 mg terlipressin.

Timeline

• Start date: 2023-06-30
• Primary completion: 2024-12-01
• Completion: 2024-12-01
• First posted: 2023-05-25
• Last updated: 2023-10-03

Locations

7 sites across 1 country: United States

Regulatory

• FDA-regulated drug study