The study will assess how ARGX-121 affects immunoglobulin A nephropathy (IgAN) disease outcomes, such as renal function, how it is distributed and eliminated from the body, and how the immune system responds in adults with IgAN.
While in the study, participants will continue to receive their usual medical care and medications for IgA nephropathy, unless the study doctor confirms otherwise.
The study will include a double blinded period, followed by an active drug period, and conclude with a follow up period. The total study duration for participants will be approximately 72 weeks, with a maximum of 52 weeks on ARGX-121.
Males and females (not pregnant)
At least 18 years old
Clinically diagnosed with IgAN with biopsy confirmation
Diagnosis of another autoimmune disease or known medical condition that would interfere with accurate assessment of clinical systems of IgAN
Has secondary form of IgAN leading to IgA deposits
History of Malignancy
Active infection of concern
Parallel
ARGX-121
Biological/VaccineSubcutaneous Injection of ARGX-121
Placebo
Biological/VaccineSubcutaneous Injection of Placebo
Change in proteinuria from baseline to week 24 as measured by the log-transformed urine protein-to-creatinine ratio (UPCR) derived from 24-h urine collection.
UPCR is urine protein-to-creatinine ratio
Total annualized rate of change (slope) in the estimated glomerular filtration rate (eGFR) at week 52
Incidence of Adverse Events (AEs) and Serious Adverse Events (SAEs)
Cmax (ARGX-121 maximum observed concentration) in serum
Percentage change in total IgA from baseline over time in serum
This trial is not recruiting at the moment. You can still explore other options:
