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A Phase 1 Study of LJPC-501 in Patients With Hepatorenal Syndrome
Plain-language guide to NCT01906307: phase 1 interventional trial of Angiotensin II, 6 participants. Who took part, design and what was measured.
Key Facts
- Registry ID
- NCT01906307
- Phase
- phase 1
- Status
- terminated early
- Start
- 2014-03
- Completion (planned or actual)
- 2015-11
- Participants
- 6 (actual)
- Design
- na, open label (everyone knows who gets what), treatment
- Conditions studied
- Hepatorenal Syndrome Type I and Type II
- Results posted
- not yet
What This Study Did, in Plain Language
What Was Tested
This registered phase 1 trial tested Angiotensin II.
Hepatorenal syndrome (HRS) is a life-threatening condition marked by rapid decline in kidney function in patients with liver cirrhosis or fulminant liver failure.
Vasodilation in the gastrointestinal region is largely thought to contribute to the disease.
LJPC-501 is a vasoconstrictor that may restore proper circulation and kidney function in patients with HRS.
It had 1 arm (groups): LJPC-501 (experimental).
LJPC-501, continuous infusion.
The registry classes the interventions as drug.
Who Took Part
6 actual participants 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: Patients with HRS, as defined by the International Ascites Club \[1\]:. Cirrhosis with ascites. Absence of shock. No current or recent treatment with nephrotoxic drugs. Patient is able to undergo a reliable neurologic exam, as determined by the investigator.
The full record lists 10 inclusion and 12 exclusion criteria; among the exclusions: evidence of shock; current or recent treatment with nephrotoxic drugs; use of midodrine, octreotide, or other vasopressors within 48 hours of screening.
How the Study Was Run
Design: single-group and open-label.
Being open-label, the Angiotensin II study did not mask who received what.
Everyone received the same intervention, so there was no separate comparison group inside the trial.
It started in 2014-03 with completion listed for 2015-11.
It ran at 1 site in United States.
Its stated primary purpose is treatment.
What Was Measured
Primary outcome: Adverse events through 5 days of treatment (time frame: 5 days).
It also tracked 5 secondary outcomes, for example Effects on serum creatinine through 5 days of treatment, Effects on ascites through 5 days of treatment, Effects on urine output through 5 days of treatment and Effects on sodium excretion through 5 days of treatment.
What This Means in Plain Language
Put simply, this is a phase 1 trial of Angiotensin II in 6 people.
Its size is small, so on its own it can only give an early look.
It ended early (terminated); no results are posted to the registry yet, so nothing here describes outcomes.
More context: the Angiotensin II compound page, all human trials.
Our Notes on the Compound
Angiotensin II: An 8-amino-acid hormone that narrows blood vessels; synthetic angiotensin II (Giapreza) is used for low blood pressure in shock.
Related Pages
Source: ClinicalTrials.gov record. This explanation is written by PeptideWhiz from the public record. For research and education only. Not medical advice; no dosing information is given.