Part 1 - A Clinical Trial in Patients With Frequently Relapsing and Steroid-Dependent Nephrotic S… (NCT05599815) | Clinical Trial Compass
WithdrawnPhase 2
Part 1 - A Clinical Trial in Patients With Frequently Relapsing and Steroid-Dependent Nephrotic Syndrome
Stopped: Lack of enrollment.
United States0Started 2023-01
Plain-language summary
A Clinical Trial Investigating the Safety and Efficacy of ADX-629 in Subjects with Frequently Relapsing and Steroid-Dependent Nephrotic Syndrome
Who can participate
Age range18 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Adults ≥18 years of age
* History of nephrotic syndrome, characterized by heavy proteinuria and hypoalbuminemia
* Recent nephrotic relapse in the 6 months prior to screening
* Estimated glomerular filtration rate (eGFR) of ≥45 during screening
* Not pregnant, breastfeeding, or lactating and agree to use a highly effective method of acceptable contraceptive for the trial duration, if applicable
Exclusion Criteria:
* Subjects with collapsing FSGS focal segmental glomerulosclerosis (FSGS)
* Known secondary cause of nephrotic syndrome (e.g., diabetic nephropathy, systemic lupus erythematous, sickle cell anemia, malignancy, drug-induced, malaria)
* History of kidney transplantation or other solid organ transplantation
* History of any unstable chronic diseases/conditions, clinically significant abnormalities, or findings, that in the opinion of the Investigator, could compromise subject safety or affect the conduct of the trial