Immunoglobulin A Nephropathy (IgAN)
Conditions
Brief summary
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.
Interventions
BIOLOGICALARGX-121
Subcutaneous Injection of ARGX-121
BIOLOGICALPlacebo
Subcutaneous Injection of Placebo
Sponsors
argenx
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Males and females (not pregnant) * At least 18 years old * Clinically diagnosed with IgAN with biopsy confirmation
Exclusion criteria
* 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 * Recent Major surgery or organ transplant
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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. | Up to 24 weeks | UPCR is urine protein-to-creatinine ratio |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Total annualized rate of change (slope) in the estimated glomerular filtration rate (eGFR) at week 52 | 52 weeks | — |
| Incidence of Adverse Events (AEs) and Serious Adverse Events (SAEs) | Up to 68 weeks | — |
| Cmax (ARGX-121 maximum observed concentration) in serum | Up to 68 weeks | — |
| Percentage change in total IgA from baseline over time in serum | Up to 68 weeks | — |
| Percentage change in Gd-IgA1 from baseline over time in serum | Up to 68 weeks | Gd-IgA1 means galactose-deficient immunoglobulin A1 |
| Percentage change in total IgG from baseline over time in serum | Up to 68 weeks | — |
| Incidence of antidrug antibodies (ADA) against ARGX-121 in serum | Up to 68 weeks | — |
Countries
United States
Contacts
CONTACTSabine Coppieters, MD
Outcome results
None listed