C3G
Conditions
Interventions
Arm A: LNP023
Arm B: Placebo to LNP023
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. 6. Estimated GFR (using the CKD-EPI formula) or measured GFR >= 30 ml/min/1.73m2 at screening and Day -15. 7. 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. 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. 3. Renal biopsy showing interstitial fibrosis/tubular atrophy (IF/TA) of more than 50%. 4. Monoclonal gammopathy of undetermined significance (MGUS) confirmed by the measurement of serum free light chains or other investigation as per local standard of care. 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 (100.4 degree Fahrenheit) 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
Argentina, Belgium, Brazil, Canada, China, Czech Republic, France, Germany, Greece, India, Israel, Italy, Japan, Netherlands, Spain, Switzerland, Turkey, UK, US
Contacts
Public ContactHideki Maruyama
Novartis Pharma. K.K.
Outcome results
None listed