Open-Label Safety, Tolerability, PK Study of IV CXA-10 Emulsion in Subjects in Chronic Kidney Injury (NCT02248051) | Clinical Trial Compass
CompletedPhase 1
Open-Label Safety, Tolerability, PK Study of IV CXA-10 Emulsion in Subjects in Chronic Kidney Injury
United States12 participantsStarted 2014-09
Plain-language 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.
Who can participate
Age range
18 Years – 70 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. 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.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Number of subjects with Serious and Non-Serious Adverse Events
. 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
Exclusion criteria
. 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)