What the trial was testing
The CONFIRM enrolled 300 patients with liver disease. The study was sponsored by Mallinckrodt and tracked outcomes across the full group of patients who matched the trial's eligibility profile.
It was a large trial designed to confirm whether the treatment works well enough for wider use. Trials at this stage are designed to produce evidence regulators and physicians can act on — not just observations to follow up later.
What the results showed
32% of patients regained kidney function with terlipressin, nearly double the rate seen with standard care.
The New England journal of medicine · 2021 · NCT02770716
These findings — that regained kidney function vs. 17% with standard care — were published in the The New England journal of medicine and represent the headline result of the study.
Researchers tracked outcomes across 300 patients enrolled in the trial. The result was consistent enough across the group that the team felt confident reporting it.
What this means for patients
For patients with liver disease, this result changes the calculus on what to ask their care team about. Whether it changes day-to-day care depends on factors like disease subtype, prior treatments, and where the patient is in their care journey.
What you can do now
If you or someone you care for has cirrhosis and kidney failure, this treatment may help. Terlipressin is already used in Europe and other parts of the world for this condition. However, it carries risks including breathing problems and was linked to more deaths from respiratory issues in this trial. Talk to your liver specialist about whether the potential benefits outweigh the risks in your specific situation.
Eligibility for the treatments mentioned above depends on specific test results and clinical history. Bring this summary, the trial name, and your most recent labs or pathology report to your next visit.
Open liver disease trials
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