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Vasoconstrictor
LJPC-501 for Acute Kidney Injury
Phase 1
Waitlist Available
Research Sponsored by La Jolla Pharmaceutical Company
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 5 years
Awards & highlights
No Placebo-Only Group
Summary
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.
Eligible Conditions
- Acute Kidney Injury
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 5 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 5 years
Treatment Details
Side effects data
From 2017 Phase 3 trial • 344 Patients • NCT0233884315%
Multi-organ failure
11%
Septic shock
10%
Atrial fibrillation
9%
Thrombocytopenia
8%
Hypokalaemia
8%
Hypotension
7%
Anaemia
6%
Delirium
6%
Hypertension
5%
Respiratory failure
5%
Acute kidney injury
5%
Pleural effusion
4%
Hypophosphataemia
4%
Agitation
4%
Bradycardia
4%
Cardiac arrest
3%
Peripheral ischaemia
3%
Ventricular tachycardia
2%
Deep vein thrombosis
2%
Sepsis
2%
Cardio-respiratory arrest
2%
Shock
2%
Acute respiratory failure
1%
Hepatic vascular thrombosis
1%
Haematemesis
1%
Intestinal ischaemia
1%
Hepatic function abnormal
1%
Liver disorder
1%
Pneumonia
1%
Hemiparesis
1%
Abdominal infection
1%
Enterobacter bacteraemia
1%
Necrotising fasciitis
1%
Mental status change
1%
Brain hypoxia
1%
Pulmonary sepsis
1%
Pancreatic carcinoma metastatic
1%
Brain injury
1%
Liver abscess
1%
Hypoxic-ischaemic encephalopathy
1%
Ischaemic stroke
1%
Toxic leukoencephalopathy
1%
Atrioventricular block
1%
Acute myocardial infarction
1%
Right ventricular dysfunction
1%
Cardiogenic shock
1%
Cardiopulmonary failure
1%
Supraventricular tachycardia
1%
Tachycardia
1%
Ventricular fibrillation
1%
Distributive shock
1%
Aspiration
1%
Pneumothorax
1%
Pulmonary oedema
1%
Respiratory arrest
1%
Muscle necrosis
1%
Electrocardiogram ST segment elevation
1%
Staphylococcus test positive
1%
Gastrointestinal anastomotic leak
1%
Gastrostomy tube site complication
1%
Bronchomalacia
1%
Hypoxia
1%
Pharyngeal haemorrhage
1%
Pneumonia aspiration
1%
Failure to thrive
1%
Cerebral infarction
1%
Shock haemorrhagic
1%
Vasospasm
1%
Acute pulmonary oedema
1%
Hepatic failure
1%
Skin discolouration
1%
Skin necrosis
1%
Rhabdomyolysis
1%
Device dislocation
1%
Pyrexia
1%
Blood lactic acid increased
1%
Depressed level of conciousness
1%
Abdominal abscess
1%
Tracheobronchitis
1%
Hepatic cancer
1%
Metabolic acidosis
1%
Arrhythmia
1%
Renal impairment
1%
Alanine aminotransferase increased
1%
Gastrointestinal mucosal exfoliation
1%
Renal failure
1%
Liver function test abnormal
100%
80%
60%
40%
20%
0%
Study treatment Arm
Placebo (0.9% Sodium Chloride Solution)
LJPC-501 (Angiotensin II)
Awards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Trial Design
1Treatment groups
Experimental Treatment
Group I: LJPC-501Experimental Treatment1 Intervention
LJPC-501, continuous infusion
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
LJPC-501
2015
Completed Phase 3
~350
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Who is running the clinical trial?
La Jolla Pharmaceutical CompanyLead Sponsor
23 Previous Clinical Trials
2,710 Total Patients Enrolled
George Tidmarsh, MD, PhDStudy Director
4 Previous Clinical Trials
224 Total Patients Enrolled
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