IC-MPGN
Conditions
Interventions
Arm A: iptacopan 200mg b.i.d.
Arm B: Placebo to iptacopan 200mg b.i.d.
Sponsors
Maruyama Hideki
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Male and female participants age >= 12 and == 1.0 g/g sampled from the first morning void urine sample at Day -75 and Day -15. 5. Estimated GFR (using the CKD-EPI formula) or measured GFR >= 30 ml/min/1.73m2 at screening and Day -15. 6. Vaccination against Neisseria meningitidis infection prior to the start of study treatment. Vaccination against Streptococcus pneumoniae and Haemophilus influenzae infections should be given, if available and according to local regulations.
Exclusion criteria
Exclusion criteria: 1. Participants who have received any cell or organ transplantation, including a kidney transplantation. 2.Patients 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 infection, including Viral- hepatitis C including HCV-associated mixed cryoglobulinemia, hepatitis B; Bacterial-endocarditis, infected ventriculo-atrial shunt, visceral abscesses, leprosy, meningococcal meningitis; chronic bacterial infections Protozoa/other infections- malaria, schistosomiasis, mycoplasma, leishmaniasis, filariasis, histroplasmosis) - Deposition of immune complexes as a result of an autoimmune disease: SLE Sjogren syndrome Rheumatoid arthritis Mixed connective tissue disease, etc - Disposition of monoclonal Ig 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 3. Rapidly progressive crescentic glomerulonephritis defined as a 50% decline in the eGFR within 3 months with renal biopsy findings of glomerular crescent formation seen in at least 50% of glomeruli. 4. Renal biopsy showing interstitial fibrosis/tubular atrophy (IF/TA) of more than 50%. 5. Participants with an active systemic bacterial, viral or fungal infection within 14 days prior to study treatment administration 6. The presence of fever >= 38 degree celsius (100.4 degree farenheit) within 7 days prior to study treatment administration. 7. A history of recurrent invasive infections caused by encapsulated organisms, e.g., N. meningitidis and S. pneumoniae. 8. The use of inhibitors of complement factors (e.g., Factor B, Factor D, C3 inhibitors, anti C5 antibodies, C5a receptor antagonists) within 6 months prior to the Screening visit. 9. The use of immunosuppressants (except mycophenolic acids), cyclophosphamide or systemic corticosteroids at a dose >7.5 mg/day (or equivalent for a similar medication) within 90 days of study drug administration.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change from baseline in eGFR. [ Time Frame: 6 months (double-blind) ] - To demonstrate the superiority of iptacopan vs. placebo in improving eGFR | — |
Countries
Canada, Japan, Turkey, US, Vietnam
Contacts
Public ContactHideki Maruyama
Novartis Pharma. K.K.
Outcome results
None listed