Angiotensin 2 for Hepatorenal Syndrome

What Was Tested

This registered phase 2 trial tested Octreotide and Angiotensin II.

Hepatorenal syndrome (HRS) is a disease in which patients with cirrhosis (end stage liver failure) develop secondary kidney injury and failure.

It had two arms (groups): Midodrine/Octreotide (active comparator) and Angiotensin 2 (experimental).

This arm will receive standard of care treatment of midodrine, octreotide, and albumin.

This arm will receive the experimental treatment of angiotensin 2 infusion and albumin.

The registry classes the interventions as drug.

Who Took Part

It was open to people of any sex aged from 18 years with no upper age limit.

Healthy volunteers were not accepted; participants needed the condition being studied.

Examples of who could join: Presence of cirrhosis and ascites. Absence of other causes such as shock, nephrotoxic drugs, or other suspected causes of kidney injury.

The full record lists 4 inclusion and 11 exclusion criteria; among the exclusions: age \<18 years; current or anticipated (within 24 hours) need for renal replacement therapy (rrt); renal transplantation status.

How the Study Was Run

The set-up was randomized, parallel-group and open-label.

Because people in this Octreotide study were split into groups at random, differences between the groups are less likely to reflect who happened to join each one.

The Octreotide group and the comparison group ran side by side rather than switching.

Everyone knew when Octreotide was being given (open label), which is simpler to run but leaves more room for expectations to affect what is reported.

It started in 2021-07-01 with completion listed for 2023-06-30.

Its stated primary purpose is treatment.

What Was Measured

Primary outcome: Reversal of hepatorenal syndrome (time frame: 4 days).

It also tracked 4 secondary outcomes, for example Need for renal replacement therapy, Mortality, Serum sodium and Relapse of hepatorenal syndrome.

What This Means in Plain Language

Put simply, this is a phase 2, randomized trial of Octreotide and Angiotensin II in people.

It was withdrawn before enrolling anyone; no results are posted to the registry yet, so nothing here describes outcomes.

More context: the Octreotide compound page and the Angiotensin II compound page, all human trials.