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 range18 Years β 70 Years
SexALL
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Inclusion criteria
β. Male or female subjects of non-child bearing potential 18 to 70 years of age (inclusive).
β. 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.
β. Body mass index (BMI) between 18 and 40 kg/m2 (inclusive)
β. Subjects must have resting heart rates (HR) greater than or equal to 50 beats per minute at baseline
β. 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.
β. Adequate bilateral venous access to allow for dose infusions and blood sampling
β. Ability to comprehend and comply with procedures
β. Agree to commit to participate in the current protocol
Exclusion criteria
β. Female subjects who are pregnant or lactating or who are trying to conceive
What they're measuring
1
Number of subjects with Serious and Non-Serious Adverse Events
β. Female subjects with a positive serum Ξ²-human chorionic gonadotropin (Ξ²-hCG) test at screening or Day -1 for any dosing day
β. History of renal transplantation
β. History of acute dialysis or acute kidney injury within 12 wks prior to screening and dosing
β. 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.
β. Presence of signs and symptoms of uremia
β. Past history of pancreatitis
β. History of documented hypersensitivity reaction to eggs or egg products (as the vehicle contains egg phospholipids)