SLN12140 in Adult Participants With IgA Nephropathy in China

Korábbi kezelés

• A known history of hypersensitivity, allergy, or anaphylactic reaction to any component of the investigational product, including hypersensitivity to human, humanized, or murine monoclonal antibodies, or known hypersensitivity to any ingredient of the product.

Más betegség

• Secondary IgA nephropathy as determined by the investigator, such as that caused by Henoch-Schönlein purpura, systemic lupus erythematosus, hepatitis, ankylosing spondylitis, infection, or other etiologies.
• Current presence or history of nephrotic syndrome.
• Clinical suspicion or biopsy-confirmed chronic kidney disease caused by any disease other than IgA nephropathy, including other glomerulopathies or podocytopathies.
  • Other protocol-defined exclusion criteria may apply.

Laborértékek

• Clinical suspicion of IgA nephropathy with rapidly progressive glomerulonephritis in accordance with the Kidney Disease: Improving Global Outcomes (KDIGO) 2025 guidelines (≥50% decline in eGFR within 3 months prior to ICF signature, or a <50% decline but at risk of rapid renal function deterioration as assessed by the investigator).

Egyéb

• Diagnosis of IgA vasculitis.

• The subject has fully understood the purpose, nature, methods and potential adverse reactions of this trial, volunteers to participate as a subject, is able to communicate effectively with the investigators, understands and complies with all requirements of this study, and voluntarily signs the Informed Consent Form (ICF) prior to initiation of any study procedures.
• Male and female subjects aged 18 to 80 years (inclusive) at the time of signing the ICF, with body weight ≥ 50 kg for males and ≥ 45 kg for females; body mass index (BMI) 18.0-35.0 kg/m² (inclusive).
• Patients with IgA nephropathy confirmed by biopsy within the past 3 years before screening, with renal tubulointerstitial fibrosis < 50%.
• Estimated glomerular filtration rate (eGFR) ≥ 30 mL/min/1.73 m² during the screening period, calculated using the 2021 creatinine-based Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI) equation.
• During the screening period, 24-hour urine protein-to-creatinine ratio (24h UPCR) ≥ 1.0 g/g; after completion of the run-in period, UPCR ≥ 0.75 g/g or urine protein excretion (UPE) ≥ 0.75 g/day.
• Must have received standard of care therapy for at least 12 weeks (and at a stable dose for at least 4 weeks) prior to the first dose of study medication, and agree to maintain stable dosing throughout the study period. (Note: Permitted standard of care medications in this study include ACEi/ARB and SGLT2i.)
• Males and women of childbearing potential (WOCBP; as defined by the Clinical Trials Facilitation and Coordination Group [CTFG] 2020) must agree to follow the contraception guidelines specified in the protocol from the screening period until 6 months after the last dose of study medication.
• The subject is willing to receive quadrivalent meningococcal vaccine and pneumococcal vaccine at least 14 days before dosing (for subjects vaccinated within 14 days before dosing, antibiotic prophylaxis for at least 14 days is required after the first vaccination). Re-vaccination is not required for those who have received quadrivalent meningococcal vaccine within 3 years before the first dose, or pneumococcal vaccine within 5 years before the first dose.