OCE-205, a selective V1a receptor mixed agonist-antagonist, for the treatment of hepatorenal syndrome-acute kidney injury: A phase 2 randomized trial.
Andrew S Allegretti, Giuseppe Cullaro, Paul Kwo et al.
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In 30 seconds
This phase 2, multicentre, randomized, double-blind, placebo-controlled dose-ranging trial evaluated OCE-205 in patients with hepatorenal syndrome–acute kidney injury. Participants received continuous infusions at one of four doses or placebo. The primary endpoint—confirmed clinical improvement based on serum creatinine—was reached by 48.6% of OCE-205 recipients and 30.0% of placebo recipients; the difference was not statistically significant (p =0.48 by Log-rank test). The trial stopped early after terlipressin approval, limiting its ability to establish efficacy. OCE-205 was reported as well tolerated, with bradycardia the most common adverse event.
Key findings
- The primary endpoint occurred in 48.6% with OCE-205 versus 30.0% with placebo (p =0.48 by Log-rank test; NS by Bayesian analysis).
- Bradycardia was the most common adverse event (21.6% vs. 0%); most events were asymptomatic and required no intervention.
- No events of ischemia or related events of respiratory failure were reported.
Why it matters
HRS-AKI is a serious condition for which treatment options are clinically important. This trial provides early randomized evidence on a selective V1a receptor agent, including its safety profile and a numerical difference in clinical improvement. The findings are informative for further evaluation, but the study does not establish efficacy because the primary comparison was not statistically significant and the trial ended early.
What to keep in mind
The study stopped early after terlipressin approval and was underpowered for statistical significance; the placebo group was small (n=10).