Hepatorenal Syndrome Type I and Type IIPhase 1NCT01906307
A Phase 1 Study of LJPC-501 in Patients With Hepatorenal Syndrome
A Phase 1 study testing LJPC-501 in people with Hepatorenal Syndrome Type I and Type II, run by La Jolla Pharmaceutical Company at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hepatorenal Syndrome Type I and Type II
- What is being tested?
- LJPC-501
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 6 participants
- Where
- 1 siteUnited States
- Study dates
- Mar 2014to Dec 2015
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients with HRS, as defined by the International Ascites Club [1]:
- Cirrhosis with ascites
- Serum creatinine > 1.5 mg/dL
- No improvement of serum creatinine (decrease to a level of ≤ 1.5 mg/dL) after at least 2 days with diuretic withdrawal and volume expansion with albumin
- Absence of shock
- No current or recent treatment with nephrotoxic drugs
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- Absence of parenchymal kidney disease, as indicated by proteinuria > 500 mg/day, microhematuria (> 50 red blood cells per high power field) and/or abnormal renal ultrasonography
- Or patients with HRS due to acute alcoholic hepatitis
- Patient is able to undergo a reliable neurologic exam, as determined by the investigator
- Patient or legal surrogate is willing and able to provide written informed consent
- Patient is willing and able to comply with all protocol requirements
Who cannot join
- Evidence of shock
- Current or recent treatment with nephrotoxic drugs
- Use of midodrine, octreotide, or other vasopressors within 48 hours of screening
- Current treatment with dialysis
- Serum creatinine > 7 mg/dL
- Active cardiovascular disease within 3 months of screening
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- History of transient ischemic attacks or prior stroke
- History of organ transplant
- Ongoing infection requiring intravenous administration of antibiotics (patients with documented infections considered by the Investigator to be controlled within 48 hours of screening may be permitted in the study upon consultation with the Sponsor's Medical Monitor)
- Participation in a clinical trial within 30 days of screening
- Patient unlikely to survive more than 72 hours in the opinion of the investigator
- Patient is pregnant or planning to become pregnant during study
Trial locations and contacts
1 site in 1 country.
United States1 site
Annette C. & Harold C. Simmons Transplant Institute @ Baylor University Medical Center
Dallas, Texas, 75246
About this study
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.
Read the detailed description
Vasoconstrictors are considered a promising approach to treat HRS due to the significant vasodilation of the splanchnic circulation that contributes to systemic arterial underfilling and leads to functional decline of the kidney in these patients. Vasoconstrictors currently in use are associated with reduced organ perfusion and have marginal effect on sodium excretion. The vasoconstrictor angiotensin II has been shown to produce significant sodium excretion and urine output in patients with cirrhosis and ascites, supporting its potential utility in the treatment of HRS.
- Conditions
- Hepatorenal Syndrome Type I and Type II
- Being tested
- LJPC-501
- Keywords
- hepatorenal syndrome
- Medical subject headings
- Hepatorenal Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LJPC-501Drug
Patients will receive LJPC-501 at titrated doses, with a starting range from 1 to 100 ng/kg/min, by continuous infusion on Days 1 through 5. In Group 1, drug doses will be titrated to 5, 15, and 25 ng/kg/min, after which doses will be titrated in multiples of 25 ng/kg/min. In Groups 2-5, drug doses will be titrated by 25 ng/kg/min. Dose titrations will occur every 2 hours until a MAP of 110 mmHg is reached, maximum urine output is achieved, or a dose of 250 ng/kg/min is achieved. Dosing will then continue at the maximum dose achieved through Day 5.
| Study group | Role | What they receive |
|---|---|---|
| LJPC-501 | Experimental | LJPC-501, continuous infusion Receives: Drug: LJPC-501 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Adverse events through 5 days of treatment
Measured: 5 days
Secondary outcomes (5)
Maximum Tolerated Dose
Measured: 5 days
Effects on serum creatinine through 5 days of treatment
Measured: 5 days
Effects on ascites through 5 days of treatment
Measured: 5 days
Effects on urine output through 5 days of treatment
Measured: 5 days
Effects on sodium excretion through 5 days of treatment
Measured: 5 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jul 2013 (estimated)
- Study startMar 2014
- Primary completionNov 2015
- Study completionDec 2015
Why it stopped: Corporate decision
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hepatorenal Syndrome Type I and Type IIStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 6 participants (actual)
Sponsor and investigators
- Lead sponsor
- La Jolla Pharmaceutical Company
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- George Tidmarsh, MD, PhD, Study director
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01906307
- Sponsor's protocol ID
- LJPC-501-CS-5001
- Status last verified
- Mar 2016
- First submitted
- 17 Jul 2013
- Last updated
- 3 Mar 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Mar 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1 Study of LJPC-501 in Patients With Hepatorenal Syndrome
- ClinicalTrials.gov ID
- NCT01906307
- Acronym / sponsor ID
- LJPC-501-CS-5001
- Conditions
- Hepatorenal Syndrome Type I and Type II
- Keywords
- hepatorenal syndrome
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Corporate decision
- Enrolment
- 6 participants (actual)
- Lead sponsor
- La Jolla Pharmaceutical CompanyIndustry (pharma, biotech, devices)
- Study start
- Mar 2014
- Primary completion
- Nov 2015 (actual)
- Study completion
- Dec 2015 (actual)
- First posted
- 24 Jul 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Vasoconstrictors are considered a promising approach to treat HRS due to the significant vasodilation of the splanchnic circulation that contributes to systemic arterial underfilling and leads to functional decline of the kidney in these patients. Vasoconstrictors currently in use are associated with reduced organ perfusion and have marginal effect on sodium excretion. The vasoconstrictor angiotensin II has been shown to produce significant sodium excretion and urine output in patients with cirrhosis and ascites, supporting its potential utility in the treatment of HRS.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| LJPC-501 | Experimental | Drug: LJPC-501LJPC-501, continuous infusion |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- Patients with HRS, as defined by the International Ascites Club [1]:
- Or patients with HRS due to acute alcoholic hepatitis
- Patient is able to undergo a reliable neurologic exam, as determined by the investigator
- Patient or legal surrogate is willing and able to provide written informed consent
- Patient is willing and able to comply with all protocol requirements
Key exclusion criteria (12 listed)
- Evidence of shock
- Current or recent treatment with nephrotoxic drugs
- Use of midodrine, octreotide, or other vasopressors within 48 hours of screening
- Current treatment with dialysis
- Serum creatinine > 7 mg/dL
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| LJPC-501Patients will receive LJPC-501 at titrated doses, with a starting range from 1 to 100 ng/kg/min, by continuous infusion on Days 1 through 5. In Group 1, drug doses will be titrated to 5, 15, and 25 ng/kg/min, after which doses will be titrated in multiples of 25 ng/kg/min. In Groups 2-5, drug doses will be titrated by 25 ng/kg/min. Dose titrations will occur every 2 hours until a MAP of 110 mmHg is reached, maximum urine output is achieved, or a dose of 250 ng/kg/min is achieved. Dosing will then continue at the maximum dose achieved through Day 5. | Drug | LJPC-501 |
Primary outcome
Adverse events through 5 days of treatment
Time frame: 5 days
5 secondary outcomes
Maximum Tolerated Dose
Time frame: 5 days
Effects on serum creatinine through 5 days of treatment
Time frame: 5 days
Effects on ascites through 5 days of treatment
Time frame: 5 days
Effects on urine output through 5 days of treatment
Time frame: 5 days
Effects on sodium excretion through 5 days of treatment
Time frame: 5 days
Results and safety
The study was stopped early (reason given: Corporate decision). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Mar 2016.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
George Tidmarsh, MD, PhD study director
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing LJPC-501 in people with Hepatorenal Syndrome Type I and Type II, run by La Jolla Pharmaceutical Company at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 11 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 3 Mar 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was stopped early (reason given: Corporate decision). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Adverse events through 5 days of treatment (time frame: 5 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Mar 2016.