Study of Efficacy and Safety of LNP023 in Primary IgA Nephropathy Patients (APPLAUSE-IgAN)

A Multi-center, Randomized, Double-blind, Placebo-controlled, Parallel Group, Phase III Study to Evaluate the Efficacy and Safety of LNP023 in Primary IgA Nephropathy Patients

The study is designed as a multicenter, randomized, double-blind, placebo controlled study to demonstrate the superiority of iptacopan (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.

Study Overview

• Status: Active, not recruiting
• Conditions: IgA Nephropathy
• Intervention / Treatment: Drug: LNP023; Drug: Placebo

Detailed Description

The purpose of the study is to evaluate the efficacy and safety of iptacopan (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 470 participants; 430 biopsy-proven IgAN participants with eGFR ≥30 mL /min/1.73m2 (main study population) and up to approximately 40 participants with eGFR 20 to <30 mL/min/1.73m2 (severe renal impairment (SRI) population).

• Study Type: Interventional
• Enrollment (Actual): 518
• Phase: Phase 3

Contacts and Locations

• Study Contact: Name: Novartis Pharmaceuticals; Phone Number: 1-888-669-6682; Email: novartis.email@novartis.com
• Study Contact Backup: Name: Novartis Pharmaceuticals; Phone Number: +41613241111

Study Locations

• Argentina
  • Ciudad Autonoma de Buenos Aire, Argentina, 1426
    • Novartis Investigative Site
  • Cordoba, Argentina, X5016KEH
    • Novartis Investigative Site
  • Cordoba, Argentina, X5016JDA
    • Novartis Investigative Site
  • Santa Fe, Argentina, S3000EPV
    • Novartis Investigative Site
  • Buenos Aires
    • Caba, Buenos Aires, Argentina, C1181ACH
      • Novartis Investigative Site
• Australia
  • New South Wales
    • Westmead, New South Wales, Australia, 2145
      • Novartis Investigative Site
  • Queensland
    • Woolloongabba, Queensland, Australia, 4102
      • Novartis Investigative Site
  • South Australia
    • Adelaide, South Australia, Australia, 5000
      • Novartis Investigative Site
  • Victoria
    • Parkville, Victoria, Australia, 3065
      • Novartis Investigative Site
    • St Albans, Victoria, Australia, 3021
      • Novartis Investigative Site
• Belgium
  • Leuven, Belgium, 3000
    • Novartis Investigative Site
  • Roeselare, Belgium, 8800
    • Novartis Investigative Site
  • Antwerpen
    • Edegem, Antwerpen, Belgium, 2650
      • Novartis Investigative Site
• Brazil
  • Sao Jose do Rio Preto, Brazil, 15090 000
    • Novartis Investigative Site
  • MG
    • Belo Horizonte, MG, Brazil, 30150-221
      • Novartis Investigative Site
  • PR
    • Curitiba, PR, Brazil, 80440-020
      • Novartis Investigative Site
  • RS
    • Porto Alegre, RS, Brazil, 90020-090
      • Novartis Investigative Site
  • SP
    • Sao Paulo, SP, Brazil, 05403 000
      • Novartis Investigative Site
    • São Paulo, SP, Brazil, 04038-002
      • Novartis Investigative Site
• Canada
  • Ontario
    • Oshawa, Ontario, Canada, L1G 2B9
      • Novartis Investigative Site
• Chile
  • Temuco, Chile, 4790084
    • Novartis Investigative Site
• China
  • Beijing, China, 100029
    • Novartis Investigative Site
  • Beijing, China, 100034
    • Novartis Investigative Site
  • Guang Zhou, China, 510080
    • Novartis Investigative Site
  • Ningbo, China, 315010
    • Novartis Investigative Site
  • Qingdao, China, 266000
    • Novartis Investigative Site
  • Shanghai, China, 200025
    • Novartis Investigative Site
  • Shanghai, China, 200040
    • Novartis Investigative Site
  • Shanxi, China, 710063
    • Novartis Investigative Site
  • Shenzhen, China, 518036
    • Novartis Investigative Site
  • Zhejiang, China, 315016
    • Novartis Investigative Site
  • Beijing
    • Beijing, Beijing, China, 102218
      • Novartis Investigative Site
  • Guangdong
    • Guangzhou, Guangdong, China, 510080
      • Novartis Investigative Site
    • Guangzhou, Guangdong, China, 510630
      • Novartis Investigative Site
    • Shenzhen, Guangdong, China, 518000
      • Novartis Investigative Site
  • Henan
    • Luoyang, Henan, China, 471003
      • Novartis Investigative Site
    • Zhengzhou, Henan, China, 450052
      • Novartis Investigative Site
  • Hunan
    • Changsha, Hunan, China, 410011
      • Novartis Investigative Site
  • Jilin
    • Changchun, Jilin, China, 130041
      • Novartis Investigative Site
  • Ningxia
    • Yinchuan, Ningxia, China, 100039
      • Novartis Investigative Site
  • Shanxi
    • Taiyuan, Shanxi, China, 030001
      • Novartis Investigative Site
    • Xi'an, Shanxi, China, 710004
      • Novartis Investigative Site
  • Xinjiang
    • Urumqi, Xinjiang, China, 830001
      • Novartis Investigative Site
  • Zhejiang
    • Hangzhou, Zhejiang, China, 310003
      • Novartis Investigative Site
    • Wenzhou, Zhejiang, China, 325000
      • Novartis Investigative Site
• Colombia
  • Barranquilla, Colombia, 080020
    • Novartis Investigative Site
  • Antioquia
    • Medellin, Antioquia, Colombia, 050001
      • Novartis Investigative Site
• Czechia
  • Praha, Czechia, 12808
    • Novartis Investigative Site
• Denmark
  • Aalborg, Denmark, 9000
    • Novartis Investigative Site
  • Arhus N, Denmark, DK-8200
    • Novartis Investigative Site
  • Copenhagen, Denmark, DK-2100
    • Novartis Investigative Site
  • Odense, Denmark, 5000
    • Novartis Investigative Site
• France
  • Marseille, France, 13385
    • Novartis Investigative Site
  • Montpellier, France, 34295
    • Novartis Investigative Site
  • Paris, France, 75015
    • Novartis Investigative Site
• Germany
  • Aachen, Germany, 52074
    • Novartis Investigative Site
  • Berlin, Germany, 13353
    • Novartis Investigative Site
  • Dresden, Germany, 01307
    • Novartis Investigative Site
  • Essen, Germany, 45147
    • Novartis Investigative Site
  • Freiburg, Germany, 79106
    • Novartis Investigative Site
  • Gottingen, Germany, 37075
    • Novartis Investigative Site
  • Hannover, Germany, 30625
    • Novartis Investigative Site
  • Kiel, Germany, 24105
    • Novartis Investigative Site
  • Magdeburg, Germany, 39120
    • Novartis Investigative Site
  • Mainz, Germany, 55131
    • Novartis Investigative Site
  • Stuttgart, Germany, 70376
    • Novartis Investigative Site
  • Tuebingen, Germany, 72076
    • Novartis Investigative Site
  • Ulm, Germany, 89081
    • Novartis Investigative Site
• Hungary
  • Debrecen, Hungary, 4032
    • Novartis Investigative Site
  • Pecs, Hungary, 7623
    • Novartis Investigative Site
  • Szeged, Hungary, 6720
    • Novartis Investigative Site
• India
  • New Delhi, India, 110029
    • Novartis Investigative Site
  • Delhi
    • New Delhi, Delhi, India, 110 017
      • Novartis Investigative Site
  • Karnataka
    • Bangalore, Karnataka, India, 560004
      • Novartis Investigative Site
  • Telangana
    • Hyderabad, Telangana, India, 500082
      • Novartis Investigative Site
• Israel
  • Ashkelon, Israel, 78278
    • Novartis Investigative Site
  • Jerusalem, Israel, 9112001
    • Novartis Investigative Site
  • Petach Tikva, Israel, 4941492
    • Novartis Investigative Site
• Italy
  • Napoli, Italy, 80100
    • Novartis Investigative Site
  • BO
    • Bologna, BO, Italy, 40138
      • Novartis Investigative Site
• Japan
  • Kyoto, Japan, 605-0981
    • Novartis Investigative Site
  • Niigata, Japan, 951 8520
    • Novartis Investigative Site
  • Osaka, Japan, 534-0021
    • Novartis Investigative Site
  • Aichi
    • Kasugai, Aichi, Japan, 486-8510
      • Novartis Investigative Site
    • Toyoake city, Aichi, Japan, 470 1192
      • Novartis Investigative Site
    • Toyota, Aichi, Japan, 471-8513
      • Novartis Investigative Site
  • Chiba
    • Chiba-city, Chiba, Japan, 260-8712
      • Novartis Investigative Site
  • Hokkaido
    • Sapporo, Hokkaido, Japan, 060-8604
      • Novartis Investigative Site
    • Sapporo-city, Hokkaido, Japan, 006-8555
      • Novartis Investigative Site
  • Kanagawa
    • Kawasaki, Kanagawa, Japan, 213-8587
      • Novartis Investigative Site
    • Yokohama, Kanagawa, Japan, 224-8503
      • Novartis Investigative Site
    • Yokohama-city, Kanagawa, Japan, 236-0004
      • Novartis Investigative Site
  • Nagano
    • Matsumoto, Nagano, Japan, 390-8621
      • Novartis Investigative Site
  • Okayama
    • Okayama-city, Okayama, Japan, 700-8558
      • Novartis Investigative Site
  • Osaka
    • Osaka-city, Osaka, Japan, 530-0012
      • Novartis Investigative Site
  • Shiga
    • Omihachiman, Shiga, Japan, 523-0082
      • Novartis Investigative Site
• Korea, Republic of
  • Busan, Korea, Republic of, 47392
    • Novartis Investigative Site
  • Seoul, Korea, Republic of, 03080
    • Novartis Investigative Site
  • Seoul, Korea, Republic of, 03722
    • Novartis Investigative Site
  • Seoul, Korea, Republic of, 02841
    • Novartis Investigative Site
  • Seoul, Korea, Republic of, 06973
    • Novartis Investigative Site
  • Seoul, Korea, Republic of, 134 727
    • Novartis Investigative Site
  • Taegu, Korea, Republic of, 41944
    • Novartis Investigative Site
  • Chungcheongbuk Do
    • Cheongju si, Chungcheongbuk Do, Korea, Republic of, 28644
      • Novartis Investigative Site
  • Gyeonggi Do
    • Bundang Gu, Gyeonggi Do, Korea, Republic of, 13620
      • Novartis Investigative Site
  • Korea
    • Seoul, Korea, Korea, Republic of, 03312
      • Novartis Investigative Site
  • Seocho Gu
    • Seoul, Seocho Gu, Korea, Republic of, 06591
      • Novartis Investigative Site
• Malaysia
  • Kuala Lumpur, Malaysia, 59100
    • Novartis Investigative Site
  • Kuala Lumpur, Malaysia, 50589
    • Novartis Investigative Site
• Mexico
  • Cdmx, Mexico, 03100
    • Novartis Investigative Site
  • Queretaro, Mexico, 76000
    • Novartis Investigative Site
  • Baja California Norte
    • Mexicali, Baja California Norte, Mexico, 21200
      • Novartis Investigative Site
• Netherlands
  • Groningen, Netherlands, 9713 GZ
    • Novartis Investigative Site
• Norway
  • Bergen, Norway, 5021
    • Novartis Investigative Site
  • Oslo
    • Nordbyhagen, Oslo, Norway, 1478
      • Novartis Investigative Site
• Russian Federation
  • Omsk, Russian Federation, 644112
    • Novartis Investigative Site
  • Rostov On Don, Russian Federation, 344022
    • Novartis Investigative Site
  • St. Petersburg, Russian Federation, 197110
    • Novartis Investigative Site
• Singapore
  • Singapore, Singapore, 119228
    • Novartis Investigative Site
  • Singapore, Singapore, 169608
    • Novartis Investigative Site
• Slovakia
  • Kosice, Slovakia, 04011
    • Novartis Investigative Site
• Slovenia
  • Ljubljana, Slovenia, 1000
    • Novartis Investigative Site
  • Maribor, Slovenia, 2000
    • Novartis Investigative Site
• South Africa
  • Free State
    • Bloemfontein, Free State, South Africa, 9301
      • Novartis Investigative Site
• Spain
  • Andalucia
    • Sevilla, Andalucia, Spain, 41013
      • Novartis Investigative Site
  • Castilla Y Leon
    • Salamanca, Castilla Y Leon, Spain, 37007
      • Novartis Investigative Site
  • Catalunya
    • Barcelona, Catalunya, Spain, 08036
      • Novartis Investigative Site
  • Navarra
    • Pamplona, Navarra, Spain, 31008
      • Novartis Investigative Site
• Sweden
  • Danderyd, Sweden, 182 88
    • Novartis Investigative Site
  • Stockholm, Sweden, 141 86
    • Novartis Investigative Site
• Taiwan
  • Kaohsiung, Taiwan, 83301
    • Novartis Investigative Site
  • New Taipei, Taiwan, 22060
    • Novartis Investigative Site
  • New Taipei City, Taiwan, 23561
    • Novartis Investigative Site
  • Taichung, Taiwan, 40447
    • Novartis Investigative Site
  • Taipei, Taiwan, 10048
    • Novartis Investigative Site
  • Taoyuan, Taiwan, 33305
    • Novartis Investigative Site
• Thailand
  • Bangkok, Thailand, 10330
    • Novartis Investigative Site
  • Bangkok, Thailand, 10700
    • Novartis Investigative Site
  • Bangkok, Thailand, 10400
    • Novartis Investigative Site
• Turkey
  • Ankara, Turkey, 06500
    • Novartis Investigative Site
  • Antalya, Turkey, 07070
    • Novartis Investigative Site
  • Istanbul, Turkey, 34093
    • Novartis Investigative Site
  • Istanbul, Turkey, 34371
    • Novartis Investigative Site
  • Kocaeli, Turkey, 41380
    • Novartis Investigative Site
  • Mersin, Turkey, 33079
    • Novartis Investigative Site
  • Talas / Kayseri, Turkey, 38039
    • Novartis Investigative Site
  • Sultangazi
    • Istanbul, Sultangazi, Turkey, 34265
      • Novartis Investigative Site
  • TUR
    • Istanbul, TUR, Turkey, 34098
      • Novartis Investigative Site
• United Kingdom
  • Leicester, United Kingdom, LE5 4PW
    • Novartis Investigative Site
  • London, United Kingdom, SW17 0QT
    • Novartis Investigative Site
  • London, United Kingdom, SE5 9RS
    • Novartis Investigative Site
  • Newcastle Upon Tyne, United Kingdom, NE7 7DN
    • Novartis Investigative Site
  • Manchester
    • Salford, Manchester, United Kingdom, M6 8HD
      • Novartis Investigative Site
• United States
  • Arizona
    • Glendale, Arizona, United States, 85308
      • Novartis Investigative Site
    • Phoenix, Arizona, United States, 85016
      • Novartis Investigative Site
  • California
    • Los Angeles, California, United States, 90095
      • Novartis Investigative Site
    • San Diego, California, United States, 92111
      • Novartis Investigative Site
    • San Dimas, California, United States, 91773
      • Novartis Investigative Site
  • Colorado
    • Aurora, Colorado, United States, 80045
      • Novartis Investigative Site
  • Delaware
    • Newark, Delaware, United States, 19713
      • Novartis Investigative Site
  • Idaho
    • Chubbuck, Idaho, United States, 83202
      • Novartis Investigative Site
    • Nampa, Idaho, United States, 83687
      • Novartis Investigative Site
  • Illinois
    • Hinsdale, Illinois, United States, 60521
      • Novartis Investigative Site
  • Louisiana
    • Baton Rouge, Louisiana, United States, 80808
      • Novartis Investigative Site
  • Maryland
    • Baltimore, Maryland, United States, 21287
      • Novartis Investigative Site
  • Massachusetts
    • Boston, Massachusetts, United States, 02115
      • Novartis Investigative Site
  • Michigan
    • Ann Arbor, Michigan, United States, 48109
      • Novartis Investigative Site
  • Minnesota
    • Rochester, Minnesota, United States, 55905
      • Novartis Investigative Site
  • Missouri
    • Kansas City, Missouri, United States, 64111
      • Novartis Investigative Site
  • Nevada
    • Las Vegas, Nevada, United States, 89106
      • Novartis Investigative Site
  • New Jersey
    • Jersey City, New Jersey, United States, 07305
      • Novartis Investigative Site
  • New York
    • New York, New York, United States, 10032
      • Novartis Investigative Site
  • Texas
    • Dallas, Texas, United States, 75230
      • Novartis Investigative Site
    • Houston, Texas, United States, 77054
      • Novartis Investigative Site
  • Washington
    • Seattle, Washington, United States, 98104
      • Novartis Investigative Site
• Vietnam
  • Ho Chi Minh, Vietnam, 700000
    • Novartis Investigative Site
  • VNM
    • Ho Chi Minh, VNM, Vietnam, 700000
      • Novartis Investigative Site

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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 and Streptococcus pneumoniae 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 Haemophilus influenzae infections should be given, if available and according to local regulations, at least 2 weeks prior to first study drug administration.
• 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 approximately 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 approximately 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 immunomodulatory 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. Participants previously or currently treated with oral budesonide. Participants treated with endothelin (receptor) antagonists within 90 days prior to first study drug administration.
• Prior use of iptacopan (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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: LNP023 200mg b.i.d	Drug: LNP023; LNP023 200mg b.i.d; Other Names: iptacopan
Placebo Comparator: Placebo to LNP023 200mg b.i.d	Drug: Placebo; Placebo to LNP023 200mg b.i.d

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Ratio to baseline in Urine Protein to Creatinine Ratio (sampled from 24h urine collection) at 9 months	Evaluated at interim analysis - To demonstrate superiority of LNP023 vs. placebo in the change of proteinuria at 9 months by measuring Urine Protein to Creatinine Ratio sampled from a 24h urine collection.	Baseline and 9 months
Annualized total estimated Glomerular Filtration Rate (eGFR) slope over 24 months).	Evaluated at the final analysis - to demonstrate superiority of LNP023 vs. placebo in slowing IgAN progression measured by the annualized total slope of Estimated Glomerular Filtration Rate (eGFR) change over 24 months.	Baseline and 24 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Proportion of participants reaching Urine Protein To Creatinine Ratio <1g/g without receiving Corticosteroids/Immunosuppressant or other newly approved drugs or initiating new background therapy for treatment of IgAN or Kidney Replacement Therapy (KRT)	Evaluated at interim analysis - To assess the effect of LNP023 vs. placebo on the proportion of study participants reaching proteinuria below 1g/g of Urine Protein To Creatinine Ratio (sampled from 24h urine collection) at 9 months.	Baseline and 9 months
Annualized total Estimated Glomerular Filtration Rate slope estimated over 12 months	Evaluated at interim analysis - To evaluate the effect of LNP023 vs. placebo on slowing IgAN progression measured by the annualized total slope of Estimated Glomerular Filtration Rate change over 1 year.	Baseline and 12 months
Change from baseline to 9 months in the fatigue scale measured by the Functional Assessment Of Chronic Illness Therapy-Fatigue questionnaire	Evaluated at interim analysis - To assess the effect of LNP023 vs. placebo on the change from baseline to 9 months in fatigue scale measured by the Functional Assessment Of Chronic Illness Therapy-Fatigue questionnaire.	Baseline and 9 months
Time from randomization to first occurrence of composite kidney failure endpoint event	Evaluated at final analysis - demonstrate the superiority of LNP023 vs. placebo on delaying the time to first occurrence of a composite kidney failure endpoint, defined as reaching either sustained ≥30% decline in Estimated Glomerular Filtration Rate (eGFR) relative to baseline or sustained eGFR <15 mL/min/1.73m2 or maintenance dialysis or receipt of kidney transplant or death from kidney failure.	Up to 24 months
Ratio to baseline in Urine Protein-To-Creatinine Ratio (sampled from 24h urine collection) at 9 months	Evaluated at final analysis - To demonstrate superiority of LNP023 vs. placebo in the change of proteinuria at 9 months by measuring Urine Protein To Creatinine Ratio sampled from a 24h urine collection.	Baseline and 9 months
Proportion of participants reaching Urine Protein-To-Creatinine Ratio <1g/g without receiving Corticosteroids/Immunosuppressant Therapy or other newly approved drugs or initiating new background therapy for treatment of IgAN or initiating KRT	Evaluated at final analysis - To demonstrate the superiority of LNP023 vs. placebo on the proportion of study participants reaching proteinuria below 1g/g of Urine Protein To Creatinine Ratio (sampled from 24h urine collection) at 9 months.	Baseline and 9 months
Change from baseline to 9 months in the fatigue scale measured by the Functional Assessment Of Chronic Illness Therapy-Fatigue questionnaire.	Evaluated at final analysis - To demonstrate the superiority of LNP023 vs. placebo on the change from baseline to 9 months in the fatigue scale measured by Functional Assessment Of Chronic Illness Therapy-Fatigue questionnaire.	Baseline and 9 months
Change from baseline in estimated glomerular filtration rate at 9 months	Evaluated at interim analysis - To evaluate the effect of LNP023 vs. placebo on slowing estimated glomerular filtration rate decrease as measured by the change from baseline in eGFR	Baseline and 9 months

Collaborators and Investigators

• Sponsor: Novartis Pharmaceuticals
• Investigators: Study Director: Novartis Pharmaceuticals, Novartis Pharmaceuticals

Publications and helpful links

General Publications

• Reich HN, Floege J. How I Treat IgA Nephropathy. Clin J Am Soc Nephrol. 2022 Aug;17(8):1243-1246. doi: 10.2215/CJN.02710322. Epub 2022 Jun 8. No abstract available.

Study record dates

Study Major Dates

• Study Start (Actual): January 25, 2021
• Primary Completion (Estimated): January 7, 2025
• Study Completion (Estimated): October 15, 2025

Study Registration Dates

• First Submitted: September 9, 2020
• First Submitted That Met QC Criteria: October 1, 2020
• First Posted (Actual): October 8, 2020

Study Record Updates

• Last Update Posted (Estimated): January 19, 2024
• Last Update Submitted That Met QC Criteria: January 18, 2024
• Last Verified: January 1, 2024

More Information

Terms related to this study

• Keywords: IgA nephropathy; eGFR; UPCR; LNP023; IgAN, proteinuria; eGFR slope; kidney function decline
• Additional Relevant MeSH Terms: Immune System Diseases; Autoimmune Diseases; Urologic Diseases; Nephritis; Glomerulonephritis; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Kidney Diseases; Glomerulonephritis, IGA
• Other Study ID Numbers: CLNP023A2301

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES

IPD Plan Description

Novartis is committed to sharing with qualified external researchers, access to patient-level data and supporting clinical documents from eligible studies. These requests are reviewed and approved by an independent review panel on the basis of scientific merit. All data provided is anonymized to respect the privacy of patients who have participated in the trial in line with applicable laws and regulations.

This trial data availability is according to the criteria and process described on www.clinicalstudydatarequest.com

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No