Los requisitos de elegibilidad de los participantes incluyen la edad, el sexo, el tipo y el estadio de la enfermedad, y los problemas de salud o tratamientos previos. Las pautas difieren de un estudio a otro e identifican quiénes pueden o no pueden participar. No hay garantía de que cada persona elegible que desee participar en un ensayo se inscribirá. Comunícate con el equipo del estudio para analizar la elegibilidad del estudio y la posible participación.
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.