Phase 2 R2R01 Plus Terlipressin Versus Terlipressin in Hepatorenal Syndrome – AKI
Research type
Research Study
Full title
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 in Hepatorenal Syndrome – Acute Kidney Injury.
IRAS ID
1007203
Contact name
Minh-Nguyêt Duong
Contact email
Sponsor organisation
River 2 Renal Corp.
Eudract number
2022-003777-40
Research summary
Study is being done to compare the safety and effectiveness of terlipressin alone to the combination of terlipressin and R2R01 in improving or reversing Acute kidney injury in the setting of cirrhosis (hepatorenal syndrome), HRS-AKI.The study will be split into 3
A. an open-label part with 3 groups of participants
B. a single-blind placebo-controlled randomised part with 2 groups of participants being treated at the same time, and
C. an open-label terlipressin non-responder group.
All participants will either participate in Part A or Part B. If you participate in Part B and your kidney function does not improve, you and your doctor will decide if you can participate in Part C.
If your doctor is participating in Part A, you will receive 1 of 3 R2R01 dose schedules plus terlipressin. The first group of 3 participants will receive terlipressin plus R2R01 at a low dose, the second group (6 participants) will receive terlipressin plus a medium R2R01 dose and the third group (6 particiapnts) will receive R2R01 at the highest dose. Part A is open-label, which means that you and your study doctor will know which drugs and doses you are receiving.Part B of the study will start after Part A has completed. In order to help us know the effect of terlipressin alone and terlipressin in combination with R2R01, all participating in Part B will be divided into 2 groups - one will receive terlipressin and placebo and 1 will receive terlipressin and R2R01. A placebo looks like the study drug but does not contain any active medication. Approximately 80 participants will be randomly assigned to 1 of the 2 groups. Random assignment means that you are put into a group by chance. Participants will have an equal chance of receiving terlipressin and placebo or terlipressin combined with R2R01. The dose schedule in Part B will be determined by the results obtained in Part A of the study. You will continue to receive IV fluids and standard of care treatments while participating.
REC name
South Central - Oxford A Research Ethics Committee
REC reference
23/SC/0153
Date of REC Opinion
30 Oct 2023
REC opinion
Further Information Favourable Opinion