Participant eligibility includes age, gender, type and stage of disease, and previous treatments or health concerns. Guidelines differ from study to study, and identify who can or cannot participate. There is no guarantee that every individual who qualifies and wants to participate in a trial will be enrolled. Contact the study team to discuss study eligibility and potential participation.
Inclusion Criteria:
- Male and female patients ≥ 18 years of age .
- At screening, subjects must have an uPCR ≥ 0.75 g/g or urine protein ≥ 1.0 g/day, as measured from 24-hour urine samples (geometric mean of the two 24-hour urine samples collected up to 2 weeks apart at screening), and eGFR ≥ 30 mL/min/1.73 m^2.
- Subjects with an eGFR of 30 to 44 mL/min/1.73 m^2 are required to have had a kidney biopsy performed within 36 months of the screening visit.
For the exploratory cohort only: subjects must have an eGFR of 20 to 29 mL/min/1.73 m^2.
- Stable and maximally tolerated dose of ACEI and/or ARB for at least 3 months prior to screening. Patients who are on a stable dose of SGLT2i may participate if treatment was initiated ≥ 3 months prior to screening. Patients who are unable to take an ACEI or ARB may participate if their overall management conforms with standards of care and other protocol requirements.
- Screening urine protein/creatinine ratio (uPCR) ≥ 0.75 g/g or urine protein ≥ 1.0 g/day
- eGFR ≥ 30 mL/min/1.73 m^2, (for the exploratory cohort only: eGFR 20- < 30 mL/min/1.73 m^2), calculated using the CKD-EPI equation.)
Exclusion Criteria:
- Secondary forms of IgAN or IgA vasculitis.
- Coexisting chronic kidney disease other than IgAN.
- Kidney biopsy findings in addition to IgAN including those of diabetic nephropathy, membranous nephropathy, or lupus nephritis. Hypertensive vascular changes are acceptable.
- Kidney biopsy MEST or MEST-C score of T2 or C2 (Oxford IgAN classification). If MEST-scoring was not performed, the presence of > 50% tubulo-interstitial fibrosis, or crescents in > 25% of glomeruli is exclusionary. This does not apply to the
exploratory cohort.
- Subjects with a kidney biopsy with a mesangial cellularity, endocapillary proliferation, segmental sclerosis, tubular atrophy (MEST) or MEST-crescents (MEST-C) score of T2 or C2 will also be excluded.
Note: this criterion does not apply to the exploratory cohort.
- Nephrotic syndrome
- Serum IgG < 600 mg/dL at screening.
- Chronic systemic immunosuppression, including glucocorticoids, within 16 weeks of
randomization
- Participation in another interventional clinical trial and receipt of another
investigational drug within 30 days prior to the administration of IMP or 5 half-lives
from last investigational drug administration, whichever is longer.
- Chronic infectious disease, or acute infectious disease at time of screening.
- Type 1 diabetes, or poorly controlled Type 2 diabetes
- Uncontrolled hypertension
Note: Other protocol defined Inclusion/Exclusion Criteria may apply.
Eligibility last updated 11/20/23. Questions regarding updates should be directed to the study team contact.