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Angiotensin II for Liver Transplant Complications (AngLT-1 Trial)
Phase 2 & 3
Recruiting
Led By Erika L Brinson, M.D.
Research Sponsored by University of California, San Francisco
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Patient requiring > 0.05 mcg/kg/min of norepinephrine (NE) during LT
Liver transplantation from a deceased donor
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 1 year
Awards & highlights
AngLT-1 Trial Summary
This trial will test whether Angiotensin II is effective and safe as a second-line vasopressor during liver transplantation.
Who is the study for?
Adults over 18 needing a liver transplant from a deceased donor with severe liver disease (MELD-Na score >=25) can join. They must need certain blood pressure support during the transplant. Excluded are those with portal vein thrombosis, angiotensin II allergy, pre-transplant ventilation, other safety or data quality risks, active bronchospasm, specific types of transplants or re-transplants, recent certain heart or blood pressure meds use, portopulmonary hypertension, significant heart dysfunction, clotting disorders or anticoagulation therapy.Check my eligibility
What is being tested?
This trial tests Angiotensin II as an additional medication to increase blood pressure in patients undergoing liver transplantation who aren't responding well enough to standard treatments. It compares its effectiveness and safety against saline (a placebo).See study design
What are the potential side effects?
Angiotensin II may cause side effects such as increased blood pressure that could lead to potential complications like abnormal heart rhythms or damage to organs due to excessive constriction of the blood vessels.
AngLT-1 Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I need a specific medication at a certain rate during my lung treatment.
Select...
I received a liver transplant from a deceased donor.
Select...
I am 18 years old or older.
AngLT-1 Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 1 year
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~1 year
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Total dose of norepinephrine (NE), averaged over case duration and total body weight, utilized during liver transplantation (LT) to maintain mean arterial pressure (MAP) greater than or equal to 65 mmHg.
Secondary outcome measures
Body Weight Changes
Change in intraoperative urine output in mL/kg/hr before and after initiation of study drug
Dose of epinephrine administered during LT, excluding boluses within the 5 min immediately following portal reperfusion, averaged over case duration and TBW.
+12 moreAngLT-1 Trial Design
2Treatment groups
Experimental Treatment
Placebo Group
Group I: Angiotensin II (Giapreza)Experimental Treatment1 Intervention
Giapreza (synthetic human angiotensin II), initiated at 5 ng/kg/min and titrated to between 1.25 ng/kg/min and 40 ng/kg/min, administered by continuous intravenous infusion.
Group II: SalinePlacebo Group1 Intervention
Sterile 0.9% saline, initiated and titrated at an equivalent volume infusion rate to the study drug, administered by continuous intravenous infusion.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Angiotensin II
2010
Completed Phase 4
~260
Find a Location
Who is running the clinical trial?
University of California, San FranciscoLead Sponsor
2,506 Previous Clinical Trials
15,238,505 Total Patients Enrolled
La Jolla Pharmaceutical CompanyIndustry Sponsor
23 Previous Clinical Trials
2,666 Total Patients Enrolled
Erika L Brinson, M.D.Principal InvestigatorDepartment of Anesthesia and Perioperative Care, University of California, San Francisco
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Eligibility Criteria:
This trial includes the following eligibility criteria:- I have a history of blood clots or am on blood thinners.I have a narrowing in my celiac artery.I need a specific medication at a certain rate during my lung treatment.I have taken blood pressure medication before surgery.I have received a liver transplant from a living donor.I am receiving a part of a liver in my transplant.I have high blood pressure in the lungs due to liver issues.My organ donation will be after heart stops, without a warming machine.I have a blood clot in the vein to my liver.I was on a breathing machine before my lung transplant surgery.I received a liver transplant from a deceased donor.I am currently experiencing severe asthma or wheezing.I am experiencing sudden liver failure.I have had a liver transplant before.My heart's pumping ability is reduced.I have advanced kidney disease requiring regular dialysis.I have a history of Raynaud's disease.Your MELD-Na score is 25 or higher at the time of transplant.I am 18 years old or older.I am listed for or am receiving a liver and kidney transplant at the same time.
Research Study Groups:
This trial has the following groups:- Group 1: Angiotensin II (Giapreza)
- Group 2: Saline
Awards:
This trial has 0 awards, including:Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
When you say 'participants,' how many people does that include?
"The answer is affirmative, according to information available on clinicaltrials.gov. This particular clinical trial began recruiting on 6/28/2022 and was updated as recently as 6/29/2022. They are looking for 50 patients total from 1 location."
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