FIRSTx - A Study of Oral CXA-10 in Primary Focal Segmental Glomerulosclerosis (FSGS) (NCT03422510) | Clinical Trial Compass
CompletedPhase 2
FIRSTx - A Study of Oral CXA-10 in Primary Focal Segmental Glomerulosclerosis (FSGS)
United States33 participantsStarted 2018-04-15
Plain-language summary
This is a multicenter, open label, randomized study investigating two dose titration regimens of CXA-10 in subjects at least 18 years of age with primary FSGS.
The study will be performed at approximately 25 study centers across the United States of America (USA). The recruitment period is anticipated to be up to approximately 16 months. Approximately 30 subjects will be randomized to ensure 26 subjects complete the study. An optional 9 month open label is available
Who can participate
Age range13 Years
SexALL
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Inclusion criteria
â. have a diagnosis of primary FSGS confirmed with biopsy.
â. eGFR or 24-hour creatinine clearance ⼠40 mL/min/1.73 m2 at Screening.
â. The subject has a Up/c ratio ⼠2 g protein/g creatinine based on a 24 hour urine sample collected during Screening (one 24-hour collection between Day -30 and Day -8).
â. Unless there is an allergy or intolerance, subject must be on an ACEi and/or ARB regimen for a minimum of 4 weeks prior to their screening Up/c assessment. The ACEi and/or ARB regimen must be stable for a minimum of 2 weeks prior to screening Up/c assessment (and there are no plans to change the ACEi/ARB regimen over the course of the study).
â. If receiving simvastatin containing products: simvastatin (Zocor), Vytorin, or any other combination therapy containing simvastatin, the simvastatin dose should not exceed 20 mg/day.
â. Non-pregnant, non-lactating, female of childbearing potential who agrees to use a reliable method of contraception or female is of non-childbearing potential defined as surgically sterile (hysterectomy or bilateral tubal ligation) or post-menopausal.
Exclusion criteria
â. The subject has collapsing variant of FSGS on renal biopsy.
â. The subject has secondary FSGS.
â. The subject has diabetic nephropathy.
â. The subject has any other form of acquired (including biopsy proven obesity-induced FSGS) or hereditary glomerular nephropathy.
â. The subject has a history of clinically significant cardiovascular events, arrhythmias, recurrent fainting, palpitations, or family history of congenital prolonged QT syndromes or sudden unexpected death due to a cardiac reason.
â. The subject has any known bleeding disorders or significant active peptic ulceration in the opinion of the investigator that precludes enrollment into this study.