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Vasopressor

Angiotensin II for AKI after Liver Transplantation

Phase 4

Waitlist Available

Research Sponsored by University of California, Los Angeles

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Adult patients > 18 years old

End stage liver disease (ESLD) with acceptance of organ allocation offer

Must not have

Multiple organ transplantation

Active use of renal replacement therapies

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 14 days

Awards & highlights

Drug Has Already Been Approved

Pivotal Trial

No Placebo-Only Group

Summary

This trial will investigate whether the administration of angiotensin 2, a new vasopressor drug, during liver transplant surgery can decrease the rate of kidney injury after transplantation.

Who is the study for?

This trial is for adults over 18 with end-stage liver disease who are about to receive a liver transplant and have had stable kidney function in the last 48 hours. It's not for those on dialysis, recent stroke or heart attack survivors, people with clotting disorders, heart failure patients, or those allergic to study drugs.

What is being tested?

The trial tests if Angiotensin II (Ang 2), a new vasopressor drug given during liver transplant surgery can reduce kidney injury after the operation. Patients will be randomly assigned to either get Ang 2 plus standard treatment or just standard treatment alone.

What are the potential side effects?

Possible side effects of Angiotensin II include increased blood pressure, potential impact on kidney function and interactions with other medications used during surgery. Close monitoring will occur to manage any adverse reactions.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am older than 18 years.

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I have end-stage liver disease and have been accepted for a liver transplant.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have had more than one organ transplant.

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I am currently on dialysis.

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I have been diagnosed with liver cancer.

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My heart's pumping ability is below normal.

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I have a condition that makes my blood clot more easily.

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I am undergoing or have undergone a liver transplant and surgery in my chest area.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 14 days

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~14 days

This trial's timeline: 3 weeks for screening, Varies for treatment, and 14 days for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Incidence of Acute kidney Injury

Secondary study objectives

Adverse events

Urine output

Vasopressor doses

Awards & Highlights

Drug Has Already Been Approved

The FDA has already approved this drug, and is just seeking more data.

Pivotal Trial

The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: InterventionExperimental Treatment2 Interventions

Patients assigned to the study group will receive Ang 2 infusion in addition to standard vasopressor regimen. Ang 2 is currently approved at UCLA as a second line vasopressor and will be used as such for the purposes of our study. Hemodynamic goals will be established at the beginning of the case by the anesthesiology and surgical teams. Ang 2 will be started as a second vasopressor once the norepinephrine dose has reached 0.05mcg/kg/min. Ang 2 will be initiated at a starting dose of 5ng/kg/min. That dose will be up titrated one time to 10ng/kg/min as vasopressor requirements escalate. Once a patient is on the 10ng/kg/min dose of ang 2, no additional up titration will be performed. Hemodynamic management will continue throughout the case with titration of other vasopressors as needed. Ang 2 will be continued throughout the intraoperative period but will be weaned off prior to leaving the operating room.

Group II: ControlActive Control1 Intervention

Patients assigned to the control group will undergo intraoperative management with a standard vasopressor regimen composed of norepinephrine, vasopressin and epinephrine based on hemodynamic goals established by the surgical and anesthesia teams prior to surgery.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Angiotensin II

2010

Completed Phase 4

~260

Norepinephrine

2014

Completed Phase 4

~1780