IgA nephropathy
Conditions
Interventions
Placebo Comparator : Placebo : Placebo identical to LNP023 twice a day
LNP023 10 mg BID : 10 mg taken twice a day.
LNP023 50 mg BID : 50 mg taken twice a day.
LNP023 100 mg BID - Part 2 : 100 mg taken
Sponsors
Novartis Pharma. K.K.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: - Female and male patients above 18 years of age with a biopsy-verified IgA nephropathy and where the biopsy was performed within the prior three years. - Patients must weigh at least 35 kg to participate in the study, and must have a body mass index (BMI) within the range of 15 - 38 kg/m2. BMI = Body weight (kg) / [Height (m)]2 - Measured Glomerular Filtration Rate (GFR) or estimated GFR (using the CKD-EPI formula) >=30 mL/min per 1.73 m2 - Urine protein >=1 g/24hr at screening and >=0.75 g / 24h after the run- in period Vaccination against Neisseria meningitidis types A, C, Y and W-135 is required at least 30 days prior to first dosing with LNP023. Vaccination against N. meningitidis type B, S. pneumoniae and H. influenzae should be conducted if available and acceptable by local regulations, at least 30 days prior to first dosing with LNP023 - All patients must have been on supportive care including a maximally tolerated dose of ACEi or ARB therapy for the individual, antihypertensive therapy or diuretics for at least 90 days before dosing
Exclusion criteria
Exclusion criteria: - Presence of crescent formation in >=50% of glomeruli assessed on renal biopsy - Patients previously treated with immunosuppressive agents such as cyclophosphamide or mycophenolate mofetil (MMF), or cyclosporine, systemic corticosteroids exposure within 90 days prior to start of LNP023/Placebo dosing - All transplanted patients (any organ, including bone marrow) - Chronic infection with Hepatitis B (HBV) or Hepatitis C (HCV). A positive HBV surface antigen (HBsAg) test, or if standard local practice, a positive HBV core antigen test, excludes a patient. Patients with a positive HCV antibody test should have HCV RNA levels measured. Subjects with positive (detectable) HCV RNA should be excluded - Women of child-bearing potential, defined as all women physiologically capable of becoming pregnant, unless they are using highly effective methods of contraception during dosing and for 1 week after stopping of investigational drug.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| efficacy Estimates of the Ratio to Baseline of Urine Protein to Creatinine Ratio (UPCR) (g/Mol) - Parts 1 and 2 at Day 90 [ Time Frame: Baseline and Day 90 ] | — |
Countries
Asia except Japan, Europe, Japan, North America, Oceania, South America
Contacts
Public ContactHiroyuki Yamada
Novartis Pharma. K.K.
Outcome results
None listed