Study of Efficacy and Safety of Iptacopan in Participants With IC-MPGN

Exclusion Criteria

• •Participants who have undergone cell or solid organ transplantation, including kidney transplantation.
• •Participants diagnosed with secondary IC-MPGN including but not limited to any of the following conditions:
• •Deposition of antigen-antibody immune complexes as a result of any chronic infections, including
• •* Hepatitis C virus (HCV) including HCV-associated mixed cryoglobulinemia, hepatitis B virus (HBV);
• •* Bacterial-endocarditis, infected ventriculo-atrial shunt, visceral abscesses, leprosy, meningococcal meningitis; chronic bacterial infections
• •* Protozoa/other infections- malaria, schistosomiasis, mycoplasma, leishmaniasis, filariasis, histroplasmosis
• •Renal deposition of immune complexes as a result of a systemic autoimmune disease:
• •Systemic lupus erythematosus (SLE)
• •Sjögren syndrome
• •Rheumatoid arthritis
• •Mixed connective tissue disease Deposition of monoclonal immunoglobulins because of a monoclonal gammopathy due to plasma cell or B cell disorders. Monoclonal gammopathy of undetermined significance (MGUS) confirmed by the measurement of serum free light chains or other investigation as per local standard of care.
• •Fibrillary glomerulonephritis
• •Rapidly progressive crescentic glomerulonephritis defined as a 50% decline in the eGFR within 3 months with kidney biopsy findings of glomerular crescent formation seen in at least 50% of glomeruli on the most recent biopsy.
• •Kidney biopsy showing interstitial fibrosis/tubular atrophy (IF/TA) of more than 50%.
• •Participants with an active systemic bacterial, viral or fungal infection within 14 days prior to study treatment administration or the presence of fever ≥ 38°C (100.4°F) within 7 days prior to study treatment administration.
• •A history of recurrent invasive infections caused by encapsulated organisms, e.g., Neisseria meningitidis and Streptococcus pneumoniae.
• •The use of inhibitors of complement factors (e.g., Factor B, Factor D, complement 3 (C3) inhibitors, anti-Complement 5 (C5) antibodies, C5a receptor antagonists) within 3 months or 5 half-lives prior to the Screening visit.
• •The use of immunosuppressants (except MPAs), cyclophosphamide or systemic corticosteroids at a dose \>7.5 mg/day (or equivalent for a similar corticosteroid medication) within 90 days of study drug administration.
• •The use of MPAs is not permitted within 90 days prior to randomization in India, as per the local health authority requirement.
• •Acute post-infectious glomerulonephritis at screening, based upon the opinion of the investigator.
• •Body mass index (BMI) \>38 kg/m2 at screening and randomization. Body weight \<35 kg at screening and randomization