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 range
13 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
. have a diagnosis of primary FSGS confirmed with biopsy.
. eGFR or 24-hour creatinine clearance ≥ 40 mL/min/1.73 m2 at Screening.
. The subject has a Up/c ratio ≥ 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).
. 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).
. If receiving simvastatin containing products: simvastatin (Zocor), Vytorin, or any other combination therapy containing simvastatin, the simvastatin dose should not exceed 20 mg/day.
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.
. 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
. The subject has collapsing variant of FSGS on renal biopsy.
. The subject has secondary FSGS.
. The subject has diabetic nephropathy.
. The subject has any other form of acquired (including biopsy proven obesity-induced FSGS) or hereditary glomerular nephropathy.
. The subject has a prolonged QTcF interval.
. The subject is hypertensive.
. 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.
. The subject has any known bleeding disorders or significant active peptic ulceration in the opinion of the investigator that precludes enrollment into this study.