Testing iptacopan against a placebo for IC-MPGN

Exclusion

• −Hepatitis C virus (HCV) including HCV-associated mixed cryoglobulinemia, hepatitis B virus (HBV);
• −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
• −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 careStandard of careThe treatment normally given for a condition outside a study.Read more →.
• −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 visitScreeningThe checks done before joining, to see whether a study fits.Read more →.
• −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 randomizationRandomisedWhich group you go into is decided by chance, not by you or your doctor.Read more → in India, as per the local health authority requirement.
• −Acute post-infectious glomerulonephritis at screening, based upon the opinion of the investigatorPrincipal investigatorThe doctor or researcher responsible for running the study at a site.Read more →.
• −Body mass index (BMI) \>38 kg/m2 at screening and randomization. Body weight \<35 kg at screening and randomization