Study of Efficacy and Safety of LNP023 in Primary IgA Nephropathy Patients

  • STATUS
    Recruiting
  • End date
    Jan 14, 2025
  • participants needed
    450
  • sponsor
    Novartis Pharmaceuticals
Updated on 14 August 2021
treatment regimen
nephropathy
adrenaline
fibrosis
proteinuria
mammogram
hbeag

Summary

The study is designed as a multicenter, randomized, double-blind, placebo controlled study to demonstrate the superiority of LNP023 at a dose of 200 mg b.i.d. compared to placebo on top of maximally tolerated ACEi or ARB on reduction of proteinuria and slowing renal disease progression in primary IgA Nephropathy patients.

Description

This trial is a multicenter, randomized, double-blind, placebo controlled parallel group study. The purpose of the study is to evaluate the efficacy and safety of LNP023 compared to placebo on proteinuria reduction and slowing disease progression in primary IgAN patients. The study will be the pivotal trial for registration of LNP023 in IgA Nephropathy patients with the aim to demonstrate a clinically meaningful reduction in proteinuria by LNP023 vs. placebo as assessed by reduction in urine protein to creatinine ratio (UPCR) sampled from a 24 hour urine collection at an IA at 9 months. The trial will continue in a blinded fashion to confirm long-term efficacy based on annualized total slope of eGFR decline over 24 months to provide confirmatory evidence of LNP023 efficacy and safety in treating patients with IgAN. The trial will enroll approximately 450 participants; 430 biopsy-proven IgAN participants with eGFR 30 mL /min/1.73m2 (main study population) and approximately 20 participants with eGFR 20 to <30 mL/min/1.73m2 (severe renal impairment (SRI) population). Estimated GFR decline will be calculated using the CKD-EPI formula. The SRI population will not be included in the efficacy analyses of the main study population; it will primarily provide additional PK and safety information for SRI participants.

Details
Condition IgA nephropathy, Glomerulonephritis, Autoimmune disease
Treatment Placebo, LNP023
Clinical Study IdentifierNCT04578834
SponsorNovartis Pharmaceuticals
Last Modified on14 August 2021

Eligibility

Yes No Not Sure

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 <45ml/min/1.73m2, a qualifying biopsy performed within 2 years with < 50% tubulointerstitial fibrosis is required
For patients with eGFR 20 to <30ml/min/1.73m2, a qualifying biopsy performed at any time
In all cases, if a historical biopsy is not available, one may be performed
during screening. eGFR calculated using the CKD-EPI formula (or modified MDRD
formula according to specific ethnic groups and local practice guidelines)
Proteinuria due to primary diagnosis of IgA nephropathy as assessed at screening by UPCR 1 g/g (113 mg/mmol) sampled from FMV or 24h urine collection, as well as at the completion of the run-in period by UPCR 1 g/g (113 mg/mmol) calculated as the (geometric) mean of two 24h urine collections obtained within 14 days of each other at baseline
Vaccination against Neisseria meningitidis infection is required prior to the start of study treatment. If the patient has not been previously vaccinated, or if a booster is required, vaccine should be given according to local regulations at least 2 weeks prior to first study drug administration. If study treatment has to start earlier than 2 weeks post vaccination, prophylactic antibiotic treatment should be initiated
If not previously vaccinated, vaccination against Streptococcus pneumoniae and Haemophilus influenzae infections should be given, if available and according to local regulations, at least 2 weeks prior to first study drug administration. If study treatment has to start earlier than 2 weeks post vaccination, prophylactic antibiotic treatment should be initiated
All patients must have been on supportive care including stable dose regimen of ACEi or ARB at either the locally approved maximal daily dose or the maximally tolerated dose (per investigators' judgment) for at least 90 days before first study drug administration. In addition, if patients are taking diuretics, other antihypertensive medication, or other background medication for IgAN, the doses should also be stabilized for at least 90 days prior to the first dosing of study treatment

Exclusion Criteria

Any secondary IgAN as defined by the investigator; secondary IgAN can be associated with cirrhosis, celiac disease, Human Immunodeficiency Virus (HIV) infection, dermatitis 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, mycophenolate mofetil (MMF) or mycophenolate sodium (MPS), cyclosporine, tacrolimus, sirolimus, everolimus, or systemic corticosteroids exposure (>7.5 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 inclusion/exclusion criteria may apply
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