IgA Nephropathy MedDRA version: 20.0 Level: PT Classification code 10021263 Term: IgA nephropathy System Organ Class: 10038359 - Renal and urinary disorders
Conditions
Sponsors
Novartis Pharma AG
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: •Male and female patients = 18 years of age with an eGFR level and biopsy-confirmed IgA nephropathy as follows: •For patients eGFR* = 45ml/min/1.73m2, a qualifying biopsy performed within the last 5 years is required. •For patients with eGFR* 30 to =65 years) yes F.1.3.1 Number of subjects for this age range 9
Exclusion criteria
Exclusion criteria: •Any secondary IgAN as defined by the investigator; secondary IgAN can be associated with cirrhosis, celiac disease, Human Immunodeficiency Virus (HIV) infection, herpetiformis, seronegative arthritis, small-cell carcinoma, lymphoma, disseminated tuberculosis, bronchiolitis obliterans, and inflammatory bowel disease, familial mediterranean fever, etc. •Sitting office SBP >140 mmHg or DBP >90 mmHg at the randomization visit • Patients previously treated with immunosuppressive or other immunmodulatory agents such as but not limited to cyclophosphamide, rituximab, infliximab, eculizumab, canakinumab, hydroxychloroquine, mycophenolate mofetil (MMF) or mycophenolate sodium (MPS), cyclosporine, tacrolimus, sirolimus, everolimus, or systemic corticosteroids exposure (>10 mg/d prednisone/prednisolone equivalent) within 90 days (or 180 days for rituximab) prior to first study drug administration •Prior use of LNP023 or prior enrollment in any other LNP023 clinical trial where study drug was taken, including matching placebo •History of recurrent invasive infections caused by encapsulated organisms, such as meningococcus and pneumococcus. •Active systemic bacterial, viral (including COVID-19) or fungal infection within 14 days prior to study drug administration. Other protocol-defined exclusion criteria may apply.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To demonstrate superiority of LNP023 vs. placebo in the reduction of proteinuria at 9 months by measuring UPCR sampled from a 24h urine collection. To demonstrate superiority of LNP023 vs. placebo in slowing renal disease progression measured by the annualized total slope of Estimated Glomerular Filtration Rate (eGFR) decline over 24 months.;Secondary Objective: To assess the effect of LNP023 vs. placebo on the proportion of study participants reaching proteinuria below 1g/g of UPCR (sampled from 24h urine collection) at 9 months; To evaluate the effect of LNP023 vs. placebo on slowing renal disease progression measured by the annualized total slope of eGFR decline over 1 year; To assess the effect of LNP023 vs. placebo on the change from baseline to 9 months in fatigue scale measured by the FACIT-Fatigue questionnaire; To demonstrate the superiority of LNP023 vs. placebo on: delaying the time to first occurrence of a composite renal endpoint of reaching either at least 30% decline in eGFR, ESRD or renal death; in the reduction of proteinuria by measuring UPCR sampled from a 24h urine collection; on the proportion of study participants reaching proteinuria below 1g/g of UPCR (sampled from 24h urine collection) at 9 months; on the change from baseline to 9 months in the fatigue scale measured by FACIT-Fatigue questionnaire;Primary end point(s): - Log-transformed ratio to baseline in UPCR (sampled from 24h urine collection) at 9 months - Annualized total Estimated Glomerular Filtration Rate (eGFR) slope estimated over 24 months).;Timepoint(s) of evaluation of this end point: baseline and 9 months baseline and 24 months | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): -Proportion of participants reaching Urine Protein To Creatinine Ratio <1g/g at 9 months, without receiving Corticosteroids/ Immunosuppressant or other newly approved drugs for treatment of IgAN or initiating Renal Replacement Therapy. -Annualized total Estimated Glomerular Filtration Rate slope estimated over 12 months - Change from baseline to 9 months in the fatigue scale measured by the Functional Assessment Of Chronic Illness Therapy-Fatigue questionnaire - Time from randomization to first occurrence of composite renal endpoint event, defined as reaching either =30% decline in Estimated Glomerular Filtration Rate (eGFR) relative to baseline, or End Stage Renal Disease (ESRD), or renal death -Log-transformed ratio to baseline in Urine Protein-To-Creatinine Ratio (sampled from 24h urine collection) -Proportion of participants reaching Urine Protein-To-Creatinine Ratio <1g/g at 9 months without receiving Corticosteroids/ Immunosuppressant Therapy or other newly approved drugs for treatment of IgAN or initiating renal replacement therapy -Change from baseline to 9 months in the fatigue scale measured by the Functional Assessment Of Chronic Illness Therapy-Fatigue questionnaire.;Timepoint(s) of evaluation of this end point: baseline and 9 months Baseline and 12 months baseline and 9 months up to 24 months 24 months baseline and 24 months baseline and 24 months | — |
Countries
Argentina, Australia, Belgium, Brazil, Canada, China, Colombia, Czech Republic, Denmark, Finland, France, Germany, Hungary, India, Israel, Italy, Japan, Korea, Republic of, Malaysia, Mexico, Netherlands, Norway, Russian Federation, Singapore, Slovakia, Slovenia, Spain, Sweden, Taiwan, Thailand, Turkey, United Kingdom, United States, Vietnam
Contacts
Public ContactClinical Trial Information Desk
Novartis Pharma AG
Outcome results
None listed