Open-Label Safety, Tolerability, PK Study of IV CXA-10 Emulsion in Subjects in Chronic Kidney Injury

NCT02248051 | Completed Phase 1

• 1 other identifier: CXA-10-002
• Study Type: interventional
• Target: 12
• Locations: 1 country
• Sites: 2

Brief 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). In addition, associated pharmacodynamic (PD) effects of CXA-10 will be investigated.

Conditions

Acute Kidney Injury (Nontraumatic)

Outcome Measures

Primary Outcomes (1)

• 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

  First day of dosing through 30 days

Study Arms (1)

CXA-10

EXPERIMENTAL

Drug: CXA-10

Interventions

CXA-10 DRUG

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.

CXA-10

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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
• 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

You may not qualify if:

• 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
• 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

Sponsors & Collaborators

• Complexa, Inc.: lead

Study Sites (2)

Anaheim Clinical Trials, LLC

Anaheim, California, 92801, United States

Location

Jasper Clinical Research & Development, Inc.

Kalamazoo, Michigan, 49007, United States

Location

MeSH Terms

Conditions

Acute Kidney Injury

Interventions

CXA-10

Condition Hierarchy (Ancestors)

Renal Insufficiency; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 22, 2014
• First Posted: September 25, 2014
• Study Start: September 1, 2014
• Primary Completion: August 1, 2015
• Study Completion: September 1, 2015
• Last Updated: February 1, 2018

Record last verified: 2016-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (2)