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Last Updated: May 22, 2024

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CLINICAL TRIALS PROFILE FOR GIAPREZA


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All Clinical Trials for Giapreza

Trial ID Title Status Sponsor Phase Start Date Summary
NCT03431077 ↗ A Study of LJPC-501 in Pediatric Patients With Hypotension Completed La Jolla Pharmaceutical Company Phase 2 2018-02-11 The objective of this study is to evaluate the effect of LJPC-501 infusion on mean arterial pressure (MAP) or reduction in sum norepinephrine (NE) equivalent dosing, at Hour 2 after the start of LJPC-501, in pediatric patients who remain hypotensive despite receiving fluid therapy and vasopressor therapy. In addition, this study will evaluate the safety and tolerability of LJPC-501 in pediatric patients, the change in MAP over 24 hours after the start of LJPC-501, the change in serum lactate concentrations, and the change in Pediatric Logistic Organ Dysfunction (PELOD) scores.
NCT03733145 ↗ Angiotensin II in General Anesthesia Recruiting La Jolla Pharmaceutical Company Phase 1 2019-10-03 Hypotension in adult patients undergoing general anesthesia is common. This can lead to hypoperfusion of vital organs, organ damage, and states of increased metabolic duress. This may be worse in patients with underlying essential hypertension and worse in patients taking Angiotensin Converting Enzyme Inhibitors (ACE) and Angiotensin Receptor Blockers (ARBs). Intravenous (IV) administration of Ang II may be an effective treatment of hypotension in this patient population.
NCT03733145 ↗ Angiotensin II in General Anesthesia Recruiting Wake Forest University Health Sciences Phase 1 2019-10-03 Hypotension in adult patients undergoing general anesthesia is common. This can lead to hypoperfusion of vital organs, organ damage, and states of increased metabolic duress. This may be worse in patients with underlying essential hypertension and worse in patients taking Angiotensin Converting Enzyme Inhibitors (ACE) and Angiotensin Receptor Blockers (ARBs). Intravenous (IV) administration of Ang II may be an effective treatment of hypotension in this patient population.
NCT04048707 ↗ Angiotensin 2 for Hepatorenal Syndrome Not yet recruiting University of California, Los Angeles Phase 2 2021-07-01 Hepatorenal syndrome (HRS) is a disease in which patients with cirrhosis (end stage liver failure) develop secondary kidney injury and failure. The current treatment available in the United States is a combination of octreotide and midodrine, which are meant to decrease the release of those hormones and raise the blood pressure, respectively, which would increase blood flow to the kidneys. Angiotensin 2 (Ang2) is a new vasopressor drug that was approved by the FDA in December 2017 for patients with low blood pressure and has been shown to have similar effects to octreotide and midodrine. This study will investigate whether Ang2 reverses HRS among patients admitted to the intensive care unit (ICU) at Ronald Reagan Medical Center. Our study population will be patients with HRS who are already or will be admitted to the ICU. HRS will be defined by new internationally accepted guidelines published by the International Club of Ascites. All patients who are consented will undergo an Ang2 response trial, where low-dose Ang2 will be administered for 4 hours to see how the patients respond. This will help us characterize the nature of the patients' kidney failure for later analysis. Patients will then be randomized into the control group or the study group. Patients in the control group will receive octreotide (a subcutaneous injection) and midodrine (an oral drug). Patients in the study group will continue receiving intravenous infusion of Ang2. Patients in both groups will also receive albumin, a protein found commonly in human blood. Treatment will continue in both groups for four days, until complete reversal of HRS, dialysis, or death. Our primary outcome will be rate of reversal of HRS, defined as improvement in kidney function.
NCT04529005 ↗ Angiotensin II in the Perioperative Management of Hypotension in Kidney Transplant Recipients Completed La Jolla Pharmaceutical Company Phase 4 2020-08-13 The current standard of catecholamine vasopressor management of perioperative hypotension in kidney transplant patients carries significant risks and falls short in many ways. Currently, there is an absence in the scientific literature and research describing the hemodynamic effectiveness and safety of novel pharmacologic agents such as angiotensin II (Giapreza - Ang II) in perioperative kidney transplant patients. Phase 3 registration trials have demonstrated the superior safety and efficacy of Ang II (Giapreza) in distributive shock patients compared to traditional vasopressor agents and the novel mechanism of action may provide additional protection in renal transplant patients. The pilot study entails giving informed and consenting kidney transplant recipients Ang II (Giapreza) as their first vasopressor if the need for vasopressors emerge either intraoperatively or postoperatively in kidney transplant recipients. The primary objective is to evaluate the safety and hemodynamic effects of Ang II (Giapreza) in the renal transplant population.
NCT04529005 ↗ Angiotensin II in the Perioperative Management of Hypotension in Kidney Transplant Recipients Completed University of Illinois at Chicago Phase 4 2020-08-13 The current standard of catecholamine vasopressor management of perioperative hypotension in kidney transplant patients carries significant risks and falls short in many ways. Currently, there is an absence in the scientific literature and research describing the hemodynamic effectiveness and safety of novel pharmacologic agents such as angiotensin II (Giapreza - Ang II) in perioperative kidney transplant patients. Phase 3 registration trials have demonstrated the superior safety and efficacy of Ang II (Giapreza) in distributive shock patients compared to traditional vasopressor agents and the novel mechanism of action may provide additional protection in renal transplant patients. The pilot study entails giving informed and consenting kidney transplant recipients Ang II (Giapreza) as their first vasopressor if the need for vasopressors emerge either intraoperatively or postoperatively in kidney transplant recipients. The primary objective is to evaluate the safety and hemodynamic effects of Ang II (Giapreza) in the renal transplant population.
NCT04904562 ↗ Angiotensin II for Distributive Shock Not yet recruiting La Jolla Pharmaceutical Company Phase 4 2021-06-15 This is a single-center, randomized, double-blind, placebo-controlled pilot study. A total of 40 patients who develop distributive shock, intra-operatively or post-operatively within 48 hours of heart transplant or left ventricular assist device placement will be enrolled. Participants will be randomized to Angiotensin II (Giapreza) vs. placebo plus standard of care, as a first line agent for vasoplegia. Two groups of patients will be enrolled: - Group A: Heart Transplant (10 control, 10 treatment) - Group B: LVAD implant (10 control, 10 treatment)
>Trial ID >Title >Status >Phase >Start Date >Summary

Clinical Trial Conditions for Giapreza

Condition Name

Condition Name for Giapreza
Intervention Trials
Septic Shock 2
Distributive Shock 2
Hypotension and Shock 1
Intraoperative Hypotension 1
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Condition MeSH

Condition MeSH for Giapreza
Intervention Trials
Shock 5
Hypotension 3
Shock, Septic 2
Hepatorenal Syndrome 1
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Clinical Trial Locations for Giapreza

Trials by Country

Trials by Country for Giapreza
Location Trials
United States 8
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Trials by US State

Trials by US State for Giapreza
Location Trials
New Mexico 2
Illinois 2
North Carolina 2
Texas 1
Ohio 1
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Clinical Trial Progress for Giapreza

Clinical Trial Phase

Clinical Trial Phase for Giapreza
Clinical Trial Phase Trials
Phase 4 4
Phase 2 2
Phase 1 1
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Clinical Trial Status

Clinical Trial Status for Giapreza
Clinical Trial Phase Trials
Not yet recruiting 3
Recruiting 2
Completed 2
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Clinical Trial Sponsors for Giapreza

Sponsor Name

Sponsor Name for Giapreza
Sponsor Trials
La Jolla Pharmaceutical Company 6
University of New Mexico 2
Northwestern University 1
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Sponsor Type

Sponsor Type for Giapreza
Sponsor Trials
Industry 6
Other 6
NIH 1
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