Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 2:06 AM
Ignite Modification Date:
2025-12-25 @ 2:06 AM
NCT ID:
NCT07213960
Eligibility Criteria:
Inclusion Criteria:
* Age
* Phase 2: adults aged ≥18 years
* Phase 3: adults aged ≥18 years; if and where approved, adolescents (aged 12--17 years) at the time of signing the informed consent and assent form
* Weight ≥30 kg and ≤100 kg at screening
* FSGS diagnosis
* Phase 2: primary, genetic, or undetermined FSGS diagnosed by kidney biopsy
* Phase 3: primary, genetic, or undetermined FSGS diagnosed by kidney biopsy or by recognized podocyte genetic mutation
* At least 1.5 g/day of proteinuria on a screening 24-hour urine collection and a uPCR of at least 1.5 g/g in at least 2 FMU samples collected during screening
* Estimated glomerular filtration rate (eGFR) ≥25 mL/min/1.73 m2
* Stable regimen for FSGS treatment for at least 12 weeks prior to randomization, with no planned or anticipated adjustments or dose changes to the stable treatment regimen
Exclusion Criteria:
* Previous exposure to APL2
* Evidence of improving kidney disease in the 8 weeks prior to screening or during the screening period according to available data
* FSGS secondary to another condition (eg, infectious, diabetic, drug-induced, obesity, prematurity, sickle-cell, vesicoureteral reflux, congenital anomalies of the kidney, and urinary tract)
* Type 1 or uncontrolled (HbA1C ≥8%) type 2 diabetes mellitus
* History of kidney transplant
* Current or prior diagnosis of HIV, hepatitis B, or hepatitis C infection or positive serology or viral load during screening that is indicative of active infection with any of these viruses
* Hypersensitivity to APL2 or to any of the excipients
* Significant other kidney disease that would, in the opinion of the investigator, confound interpretation of study results
* Use of rituximab, belimumab, or any approved or investigational anticomplement therapy within 5 half-lives of that product prior to the screening period
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT07213960
Study Brief:
Protocol Section:
NCT07213960