Acute Kidney Injury (Nontraumatic)Phase 1NCT02248051
Open-Label Safety, Tolerability, PK Study of IV CXA-10 Emulsion in Subjects in Chronic Kidney Injury
A Phase 1 study testing CXA-10 in people with Acute Kidney Injury (Nontraumatic), run by Complexa, Inc. at 2 sites in United States.
Trial summary
The main purpose of this trial is to demonstrate the safety, tolerability and pharmacokinetics (PK) of CXA-10, at potentially therapeutic doses, in the target patient population comprised of subjects with Stage 3 and 4 chronic kidney injury (CKI). Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Acute Kidney Injury (Nontraumatic)
- What is being tested?
- CXA-10
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 12 participants
- Where
- 2 sitesUnited States
- Study dates
- Sep 2014to Sep 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 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Male or female subjects of non-child bearing potential 18 to 70 years of age (inclusive).
- Moderate to severe CKI (equivalent to National Kidney Foundation Kidney Disease Outcomes Quality Initiative [NKF KDOQI] Stage 3 or 4, not receiving dialysis) as determined by estimated glomerular filtration rate (eGFR) greater than or equal to 15 and less than 60 mL/min/1.73 m2 (according to the creatinine-cystatin C equation) within less than or equal to 3 months prior to the screening visit. Cause of the CKI should be recorded where possible.
- Body mass index (BMI) between 18 and 40 kg/m2 (inclusive)
- Subjects must have resting heart rates (HR) greater than or equal to 50 beats per minute at baseline
- QTcF interval (Fredericia's correction factor) of the baseline ECG must be less than or equal to 450 msec for males and less than or equal to 470 msec for females at screening and predose. Subjects with any other clinically relevant ECG parameter abnormality (e.g., PR interval, QRS deviation) or any clinically significant ECG abnormality will be excluded from the study. Subjects with a history of congenital long QT syndrome or short QT syndrome in the subject or in the subject's family will be excluded from the study.
- Adequate bilateral venous access to allow for dose infusions and blood sampling
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- Ability to comprehend and comply with procedures
- Agree to commit to participate in the current protocol
- Provide written informed consent prior to any study procedure being performed
Who cannot join
- Female subjects who are pregnant or lactating or who are trying to conceive
- Female subjects with a positive serum β-human chorionic gonadotropin (β-hCG) test at screening or Day -1 for any dosing day
- History of renal transplantation
- History of acute dialysis or acute kidney injury within 12 wks prior to screening and dosing
- Aspartate aminotransferase (AST) and/or alanine aminotransferase (ALT) 3.0X upper limit of normal (ULN), gamma-glutamyl transferase (GGT) greater than 3X ULN, and total bilirubin greater than 2X ULN. If all liver function tests (LFTs) are within normal limits (WNL) and total bilirubin is elevated, examination of direct and indirect bilirubin may be conducted. Subjects with indirect total bilirubin up to 3X ULN are presumed to have Gilbert's syndrome and may be enrolled if all other LFTs are WNL.
- Presence of signs and symptoms of uremia
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- Past history of pancreatitis
- History of documented hypersensitivity reaction to eggs or egg products (as the vehicle contains egg phospholipids)
- History of documented hypersensitivity reaction to soy or soy products (as vehicle contains soy bean oil)
- Uncontrolled diabetes with HbA1c > 9 percent or subjects with frequent hypoglycemic attacks
- Active cardiovascular disease within 12 weeks of dosing, including unstable angina, myocardial infarction, coronary artery bypass or percutaneous transluminal angioplasty/stent, cerebrovascular accident including transient ischemic attack, any history of syncope, dizziness, cardiac arrhythmias, cardiac arrest, pacemakers, cardioversion, and clinical diagnosis of severe obstructive valvular heart disease or severe hypertrophic cardiomyopathy
- Current diagnosis of Class 3 or 4 New York Heart Association (NYHA) congestive heart failure.
- Uncontrolled hypertension with sitting blood pressure greater than 160 mmHg systolic and or greater than 100 mmHg diastolic after 5 minutes rest (feet on floor, arm held at level of heart) at the screening visit
- Resting heart rate greater than or equal to 100 beats per minute (BPM) after 5 minutes rest (as above) at the screening visit
- Any abnormalities on 12-lead ECG, as deemed by the investigator and/or medical monitor, at screening
- Any clinically significant murmurs evident on auscultation of the heart (including evidence of mitral valve prolapse)
- History of smoking or use of nicotine-containing products in excess of approximately a pack per day (estimated at 20 cigarettes per day) or equivalent within the past 2 weeks
- History of drug abuse or dependence within 6 months of the study
- History of regular alcohol consumption within 6 months of the study, defined as an average weekly intake of >21 units for males or >14 units for females. One unit is equivalent to 8 g of alcohol: a half-pint (approximately 240 mL) of beer, 1 glass (125 mL) of wine or 1 measure (25 mL) of spirits.
- A positive drug screen for drugs of abuse, including alcohol at the screening visit or at entry to the clinic
- Treatment with any investigational drug within 30 days or 5 half-lives prior to the beginning of the screening period (this includes investigational formulations of marketed products, inhaled and topical drugs)
- Blood collection of greater than 500 mL within 56 days prior to screening
- Seropositive for human immunodeficiency virus (HIV) at screening
- Positive for Hepatitis B virus surface antigen (HBsAg) or positive Hepatitis C virus antibody (HCV Ab) at screening
- Any other condition and/or situation that causes the Investigator to deem a subject unsuitable for the study (e.g., due to expected study medication non compliance, inability to medically tolerate the study procedures, or a subject's unwillingness to comply with study related procedures)
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Anaheim Clinical Trials, LLC
Anaheim, California, 92801
Jasper Clinical Research & Development, Inc.
Kalamazoo, Michigan, 49007
About this study
Official title: An Open-Label, Non-Randomized Study of Safety, Tolerability and Pharmacokinetics of Intravenous CXA-10 Emulsion in Subjects With Stage 3 and 4 Chronic Kidney Injury
The main purpose of this trial is to demonstrate the safety, tolerability and pharmacokinetics (PK) of CXA-10, at potentially therapeutic doses, in the target patient population comprised of subjects with Stage 3 and 4 chronic kidney injury (CKI). In addition, associated pharmacodynamic (PD) effects of CXA-10 will be investigated.
Read the detailed description
This will be a multi-center, open-label study, single-dose study with CXA-10 in subjects with CKI. At total of 12 subjects will be enrolled into two equal groups according to their baseline estimated glomerular filtration rate (eGFR: 15 - 39 or 40 - 59 mL/min/1.73m2). All subjects will receive a single dose infusion of CXA-10 emulsion. Since this is the first administration of CXA-10 to a non-healthy volunteer population, a conservative approach is being taken to ensure safety. Thus, the first 2 subjects from each group will be dosed at one dose level below the highest safe dose level administered in the FIH study. If this dose is found to be safe in this specific subject population, the remainder of the 4 subjects in each group will receive the highest safe dose from the FIH study; otherwise, the remainder will receive the initial dose. The doses administered in this study will not exceed the highest exposures achieved in the FIH study, and doses may need to be adjusted to lower levels, based on further evaluation of current pharmacokinetic data, to ensure the appropriate the exposure level. Safety, PK and PD assessments will be conducted over approximately 18 days following each dosing session. There will be a follow-up visit approximately 1 week after dosing.
- Conditions
- Acute Kidney Injury (Nontraumatic)
- Being tested
- CXA-10
- Medical subject headings
- Acute Kidney Injury
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CXA-10Drug
CXA-10 Injectable Emulsion is a sterile emulsion containing CXA-10 in a formulation containing soybean oil, medium chain triglycerides oil, egg phospholipids, sucrose, and disodium EDTA. CXA-10 Injectable Emulsion will be administered intravenously. The active emulsion will be diluted in a vehicle emulsion.
| Study group | Role | What they receive |
|---|---|---|
| CXA-10 | Experimental | Not described Receives: Drug: CXA-10 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of subjects with Serious and Non-Serious Adverse Events
Safety assessments will be performed prior to, during, and after dosing including a visit on Day 18
Measured: First day of dosing through 30 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Sep 2014 (estimated)
- Study startSep 2014
- Primary completionAug 2015
- Study completionSep 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute Kidney Injury (Nontraumatic)Studies 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
- 12 participants (actual)
Sponsor and investigators
- Lead sponsor
- Complexa, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02248051
- Sponsor's protocol ID
- CXA-10-002
- Status last verified
- May 2016
- First submitted
- 22 Sep 2014
- Last updated
- 1 Feb 2018
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Feb 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open-Label, Non-Randomized Study of Safety, Tolerability and Pharmacokinetics of Intravenous CXA-10 Emulsion in Subjects With Stage 3 and 4 Chronic Kidney Injury
- ClinicalTrials.gov ID
- NCT02248051
- Acronym / sponsor ID
- CXA-10-002
- Conditions
- Acute Kidney Injury (Nontraumatic)
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 12 participants (actual)
- Lead sponsor
- Complexa, Inc.Industry (pharma, biotech, devices)
- Study start
- Sep 2014
- Primary completion
- Aug 2015 (actual)
- Study completion
- Sep 2015 (actual)
- First posted
- 25 Sep 2014 (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.
The main purpose of this trial is to demonstrate the safety, tolerability and pharmacokinetics (PK) of CXA-10, at potentially therapeutic doses, in the target patient population comprised of subjects with Stage 3 and 4 chronic kidney injury (CKI). In addition, associated pharmacodynamic (PD) effects of CXA-10 will be investigated.
Detailed description
This will be a multi-center, open-label study, single-dose study with CXA-10 in subjects with CKI. At total of 12 subjects will be enrolled into two equal groups according to their baseline estimated glomerular filtration rate (eGFR: 15 - 39 or 40 - 59 mL/min/1.73m2). All subjects will receive a single dose infusion of CXA-10 emulsion. Since this is the first administration of CXA-10 to a non-healthy volunteer population, a conservative approach is being taken to ensure safety. Thus, the first 2 subjects from each group will be dosed at one dose level below the highest safe dose level administered in the FIH study. If this dose is found to be safe in this specific subject population, the remainder of the 4 subjects in each group will receive the highest safe dose from the FIH study; otherwise, the remainder will receive the initial dose. The doses administered in this study will not exceed the highest exposures achieved in the FIH study, and doses may need to be adjusted to lower levels, based on further evaluation of current pharmacokinetic data, to ensure the appropriate the exposure level. Safety, PK and PD assessments will be conducted over approximately 18 days following each dosing session. There will be a follow-up visit approximately 1 week after dosing.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| CXA-10 | Experimental | Drug: CXA-10 |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Male or female subjects of non-child bearing potential 18 to 70 years of age (inclusive).
- Moderate to severe CKI (equivalent to National Kidney Foundation Kidney Disease Outcomes Quality Initiative [NKF KDOQI] Stage 3 or 4, not receiving dialysis) as determined by estimated glomerular filtration rate (eGFR) greater than or equal to 15 and less than 60 mL/min/1.73 m2 (according to the creatinine-cystatin C equation) within less than or equal to 3 months prior to the screening visit. Cause of the CKI should be recorded where possible.
- Body mass index (BMI) between 18 and 40 kg/m2 (inclusive)
- Subjects must have resting heart rates (HR) greater than or equal to 50 beats per minute at baseline
- QTcF interval (Fredericia's correction factor) of the baseline ECG must be less than or equal to 450 msec for males and less than or equal to 470 msec for females at screening and predose. Subjects with any other clinically relevant ECG parameter abnormality (e.g., PR interval, QRS deviation) or any clinically significant ECG abnormality will be excluded from the study. Subjects with a history of congenital long QT syndrome or short QT syndrome in the subject or in the subject's family will be excluded from the study.
Key exclusion criteria (25 listed)
- Female subjects who are pregnant or lactating or who are trying to conceive
- Female subjects with a positive serum β-human chorionic gonadotropin (β-hCG) test at screening or Day -1 for any dosing day
- History of renal transplantation
- History of acute dialysis or acute kidney injury within 12 wks prior to screening and dosing
- Aspartate aminotransferase (AST) and/or alanine aminotransferase (ALT) 3.0X upper limit of normal (ULN), gamma-glutamyl transferase (GGT) greater than 3X ULN, and total bilirubin greater than 2X ULN. If all liver function tests (LFTs) are within normal limits (WNL) and total bilirubin is elevated, examination of direct and indirect bilirubin may be conducted. Subjects with indirect total bilirubin up to 3X ULN are presumed to have Gilbert's syndrome and may be enrolled if all other LFTs are WNL.
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 |
|---|---|---|
| CXA-10CXA-10 Injectable Emulsion is a sterile emulsion containing CXA-10 in a formulation containing soybean oil, medium chain triglycerides oil, egg phospholipids, sucrose, and disodium EDTA. CXA-10 Injectable Emulsion will be administered intravenously. The active emulsion will be diluted in a vehicle emulsion. | Drug | CXA-10 |
Primary outcome
Number of subjects with Serious and Non-Serious Adverse Events
Time frame: First day of dosing through 30 days
Safety assessments will be performed prior to, during, and after dosing including a visit on Day 18
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Feb 2018.
- Individual participant dataSharing planned: No
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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.
The record lists no contact. Use the official record to reach the sponsor.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing CXA-10 in people with Acute Kidney Injury (Nontraumatic), run by Complexa, Inc. at 2 sites 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 9 inclusion and 25 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: finished, as of the sponsor's last update on 1 Feb 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Number of subjects with Serious and Non-Serious Adverse Events (time frame: First day of dosing through 30 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 1 Feb 2018.