A Rollover Extension Program (REP) to Evaluate the Long-term Safety and Tolerability of Open Label Iptacopan/LNP023 in Participants With Primary IgA Nephropathy

October 1, 2026 updated by: Novartis Pharmaceuticals

A Multicenter Rollover Extension Program (REP) to Evaluate the Long-term Safety and Tolerability of Open Label Iptacopan in Adult Participants With Primary IgA Nephropathy Who Have Completed Study CLNP023X2203 or CLNP023A2301

The purpose of this study is to evaluate the long-term safety and tolerability, of open label iptacopan in primary IgA nephropathy participants who have completed either the CLNP023X2203 or CLNP023A2301 clinical trials. The open-label design of the current study is appropriate to provide study participants the opportunity to receive treatment with iptacopan until marketing authorizations are received and the drug product becomes commercially available while enabling collection of long-term safety and tolerability data for the investigational drug. Furthermore efficacy assessments conducted every 6 months will afford the opportunity to evaluate the clinical effects of iptacopan on long-term disease progression.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

This is an open-label, non-randomized, multicenter roll-over extension program (REP) to:

  • CLNP023X2203, a Phase II trial investigating the dose ranging effects of LNP023 on efficacy, pharmacokinetics (PK), pharmacodynamics (PD), safety and tolerability in primary IgAN patients, and
  • CLNP023A2301, a Phase III trial, investigating the efficacy, pharmacokinetics (PK), pharmacodynamics (PD), safety and tolerability of LNP023 in patients with primary IgAN.

Subjects completing the CLNP023X2203 and CLNP023A2301 trials on study drug, who want to continue treatment and who meet the inclusion/exclusion requirements of the roll over extension program, will have the opportunity to receive iptacopan until:

  • 3 years from LPFV of this study CLNP023A2002B, or
  • the participant no longer derives benefit from iptacopan according to the Investigator, or
  • the benefit-risk profile of the product in IgAN is no longer positive, or
  • initiation of maintenance hemodialysis, kidney transplantation or eGFR < 15 mL/min/1.73m2 , or
  • the product becomes commercially available in a specific country following product launch and subsequent reimbursement for IgAN, where applicable, or
  • if a marketing application or reimbursement of an investigational product is rejected/not pursued in a region/country for the indication under study or which ever is sooner

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
540

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 3

Expanded Access

Expanded Access

A way for patients with serious diseases or conditions who cannot participate in a clinical trial to gain access to a medical product that has not been approved by the U.S. Food and Drug Administration (FDA). Also called compassionate use. There are different expanded access types.
Available

Available

  • Available: Expanded access is currently available for this investigational treatment, and patients who are not participants in the clinical study may be able to gain access to the drug, biologic, or medical device being studied.
  • No longer available: Expanded access was available for this intervention previously but is not currently available and will not be available in the future.
  • Temporarily not available: Expanded access is not currently available for this intervention but is expected to be available in the future.
  • Approved for marketing: The intervention has been approved by the U.S. Food and Drug Administration for use by the public.
 outside the clinical trial. See expanded access record.

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

  • Name: Novartis Pharmaceuticals
  • Phone Number: +41613241111

Study Locations

  • Argentina
      • CABA, Argentina, C1181ACH
        • Active, not recruiting
        • Novartis Investigative Site
      • CABA, Argentina, C1426ABP
        • Active, not recruiting
        • Novartis Investigative Site
      • Santa Fe, Argentina, S3000EPV
        • Active, not recruiting
        • Novartis Investigative Site
    • Córdoba Province
      • Córdoba, Córdoba Province, Argentina, X5016KEH
        • Active, not recruiting
        • Novartis Investigative Site
      • Córdoba, Córdoba Province, Argentina, X5016KET
        • Active, not recruiting
        • Novartis Investigative Site
  • Australia
    • Queensland
      • Woolloongabba, Queensland, Australia, 4102
        • Active, not recruiting
        • Novartis Investigative Site
    • South Australia
      • Adelaide, South Australia, Australia, 5000
        • Active, not recruiting
        • Novartis Investigative Site
    • Victoria
      • Parkville, Victoria, Australia, 3065
        • Active, not recruiting
        • Novartis Investigative Site
  • Belgium
      • Edegem, Belgium, 2650
        • Active, not recruiting
        • Novartis Investigative Site
      • Leuven, Belgium, 3000
        • Active, not recruiting
        • Novartis Investigative Site
    • West Vlaanderen
      • Roeselare, West Vlaanderen, Belgium, 8800
        • Active, not recruiting
        • Novartis Investigative Site
  • Brazil
    • Minas Gerais
      • Belo Horizonte, Minas Gerais, Brazil, 30150-221
        • Active, not recruiting
        • Novartis Investigative Site
    • Paraná
      • Curitiba, Paraná, Brazil, 80440-020
        • Active, not recruiting
        • Novartis Investigative Site
    • Rio Grande do Sul
      • Porto Alegre, Rio Grande do Sul, Brazil, 90035-074
        • Active, not recruiting
        • Novartis Investigative Site
    • São Paulo
      • São José do Rio Preto, São Paulo, Brazil, 15090 000
        • Active, not recruiting
        • Novartis Investigative Site
      • São Paulo, São Paulo, Brazil, 04038-002
        • Active, not recruiting
        • Novartis Investigative Site
      • São Paulo, São Paulo, Brazil, 05403-000
        • Active, not recruiting
        • Novartis Investigative Site
  • Canada
    • Ontario
      • Oshawa, Ontario, Canada, L1G 2B9
        • Withdrawn
        • Novartis Investigative Site
  • Chile
      • Temuco, Chile, 4781151
        • Active, not recruiting
        • Novartis Investigative Site
  • China
      • Beijing, China, 100034
        • Active, not recruiting
        • Novartis Investigative Site
      • Guangzhou, China, 510080
        • Active, not recruiting
        • Novartis Investigative Site
      • Ningbo, China, 315010
        • Active, not recruiting
        • Novartis Investigative Site
      • Qingdao, China, 266000
        • Active, not recruiting
        • Novartis Investigative Site
      • Shanghai, China, 200040
        • Active, not recruiting
        • Novartis Investigative Site
      • Shanghai, China, 200025
        • Active, not recruiting
        • Novartis Investigative Site
      • Shenzhen, China, 518036
        • Active, not recruiting
        • Novartis Investigative Site
    • Beijing Municipality
      • Beijing, Beijing Municipality, China, 100013
        • Active, not recruiting
        • Novartis Investigative Site
      • Beijing, Beijing Municipality, China, 102218
        • Active, not recruiting
        • Novartis Investigative Site
    • Guangdong
      • Guangzhou, Guangdong, China, 510080
        • Active, not recruiting
        • Novartis Investigative Site
    • Henan
      • Luoyang, Henan, China, 471003
        • Completed
        • Novartis Investigative Site
      • Zhengzhou, Henan, China, 450003
        • Active, not recruiting
        • Novartis Investigative Site
    • Hunan
      • Changsha, Hunan, China, 410011
        • Active, not recruiting
        • Novartis Investigative Site
    • Jilin
      • Changchun, Jilin, China, 130041
        • Active, not recruiting
        • Novartis Investigative Site
    • Ningxia
      • Yinchuan, Ningxia, China, 750004
        • Active, not recruiting
        • Novartis Investigative Site
    • Shanxi
      • Taiyuan, Shanxi, China, 030001
        • Active, not recruiting
        • Novartis Investigative Site
      • Xian, Shanxi, China, 710061
        • Active, not recruiting
        • Novartis Investigative Site
    • Xinjiang
      • Ürümqi, Xinjiang, China, 830001
        • Active, not recruiting
        • Novartis Investigative Site
    • Zhejiang
      • Ningbo, Zhejiang, China, 315016
        • Active, not recruiting
        • Novartis Investigative Site
      • Wenzhou, Zhejiang, China, 325000
        • Active, not recruiting
        • Novartis Investigative Site
  • Colombia
    • Antioquia
      • Medellín, Antioquia, Colombia, 050001
        • Active, not recruiting
        • Novartis Investigative Site
    • Atlántico
      • Barranquilla, Atlántico, Colombia, 080020
        • Active, not recruiting
        • Novartis Investigative Site
  • Czechia
      • Prague, Czechia, 128 08
        • Active, not recruiting
        • Novartis Investigative Site
  • Denmark
      • Aalborg, Denmark, 9000
        • Active, not recruiting
        • Novartis Investigative Site
      • Aarhus N, Denmark, 8200
        • Active, not recruiting
        • Novartis Investigative Site
      • Copenhagen, Denmark, 2100
        • Active, not recruiting
        • Novartis Investigative Site
      • Odense C, Denmark, 5000
        • Active, not recruiting
        • Novartis Investigative Site
  • France
      • Marseille, France, 13005
        • Active, not recruiting
        • Novartis Investigative Site
      • Montpellier, France, 34295
        • Active, not recruiting
        • Novartis Investigative Site
      • Paris, France, 75015
        • Active, not recruiting
        • Novartis Investigative Site
  • Germany
      • Aachen, Germany, 52074
        • Active, not recruiting
        • Novartis Investigative Site
      • Berlin, Germany, 13353
        • Active, not recruiting
        • Novartis Investigative Site
      • Essen, Germany, 45147
        • Active, not recruiting
        • Novartis Investigative Site
      • Hanover, Germany, 30625
        • Active, not recruiting
        • Novartis Investigative Site
      • Heidelberg, Germany, 69120
        • Withdrawn
        • Novartis Investigative Site
      • Kiel, Germany, 24105
        • Active, not recruiting
        • Novartis Investigative Site
      • Magdeburg, Germany, 39120
        • Active, not recruiting
        • Novartis Investigative Site
      • Mainz, Germany, 55131
        • Active, not recruiting
        • Novartis Investigative Site
      • Tübingen, Germany, 72076
        • Active, not recruiting
        • Novartis Investigative Site
      • Ulm, Germany, 89081
        • Active, not recruiting
        • Novartis Investigative Site
    • Baden-Wurttemberg
      • Freiburg im Breisgau, Baden-Wurttemberg, Germany, 79106
        • Active, not recruiting
        • Novartis Investigative Site
      • Stuttgart, Baden-Wurttemberg, Germany, 70376
        • Active, not recruiting
        • Novartis Investigative Site
  • Hong Kong
    • Hong Kong
      • Hong Kong, Hong Kong, Hong Kong, 999077
        • Active, not recruiting
        • Novartis Investigative Site
  • Hungary
    • Baranya
      • Pécs, Baranya, Hungary, 7623
        • Active, not recruiting
        • Novartis Investigative Site
    • Hajdu Bihar Megye
      • Debrecen, Hajdu Bihar Megye, Hungary, 4032
        • Active, not recruiting
        • Novartis Investigative Site
  • India
    • Karnataka
      • Bangalore, Karnataka, India, 560004
        • Active, not recruiting
        • Novartis Investigative Site
    • National Capital Territory of Delhi
      • New Delhi, National Capital Territory of Delhi, India, 110029
        • Active, not recruiting
        • Novartis Investigative Site
      • New Delhi, National Capital Territory of Delhi, India, 110017
        • Active, not recruiting
        • Novartis Investigative Site
    • Telangana
      • Hyderabad, Telangana, India, 500082
        • Active, not recruiting
        • Novartis Investigative Site
  • Israel
      • Ashkelon, Israel, 7830604
        • Active, not recruiting
        • Novartis Investigative Site
      • Jerusalem, Israel, 9112001
        • Active, not recruiting
        • Novartis Investigative Site
      • Petah Tikva, Israel, 4941492
        • Active, not recruiting
        • Novartis Investigative Site
  • Italy
      • Naples, Italy, 80131
        • Active, not recruiting
        • Novartis Investigative Site
    • BO
      • Bologna, BO, Italy, 40138
        • Active, not recruiting
        • Novartis Investigative Site
  • Japan
      • Chiba, Japan, 2608712
        • Active, not recruiting
        • Novartis Investigative Site
      • Niigata, Japan, 9518520
        • Active, not recruiting
        • Novartis Investigative Site
      • Okayama, Japan, 7008558
        • Active, not recruiting
        • Novartis Investigative Site
      • Osaka, Japan, 5300012
        • Active, not recruiting
        • Novartis Investigative Site
      • Osaka, Japan, 5308480
        • Active, not recruiting
        • Novartis Investigative Site
    • Aichi-ken
      • Kasugai, Aichi-ken, Japan, 4868510
        • Active, not recruiting
        • Novartis Investigative Site
      • Toyoake, Aichi-ken, Japan, 4701192
        • Active, not recruiting
        • Novartis Investigative Site
      • Toyota, Aichi-ken, Japan, 4718513
        • Active, not recruiting
        • Novartis Investigative Site
    • Hokkaido
      • Sapporo, Hokkaido, Japan, 0068555
        • Active, not recruiting
        • Novartis Investigative Site
      • Sapporo, Hokkaido, Japan, 0608604
        • Completed
        • Novartis Investigative Site
    • Kanagawa
      • Kawasaki, Kanagawa, Japan, 2138587
        • Active, not recruiting
        • Novartis Investigative Site
      • Yokohama, Kanagawa, Japan, 2360004
        • Active, not recruiting
        • Novartis Investigative Site
      • Yokohama, Kanagawa, Japan, 2248503
        • Active, not recruiting
        • Novartis Investigative Site
    • Kyoto
      • Kyoto, Kyoto, Japan, 6050981
        • Active, not recruiting
        • Novartis Investigative Site
    • Miyagi
      • Sendai, Miyagi, Japan, 9813205
        • Withdrawn
        • Novartis Investigative Site
    • Nagano
      • Matsumoto, Nagano, Japan, 3908621
        • Active, not recruiting
        • Novartis Investigative Site
    • Osaka
      • Osaka, Osaka, Japan, 5340021
        • Active, not recruiting
        • Novartis Investigative Site
    • Shiga
      • Ōmihachiman, Shiga, Japan, 5230082
        • Active, not recruiting
        • Novartis Investigative Site
  • Malaysia
      • Kuala Lumpur, Malaysia, 59100
        • Active, not recruiting
        • Novartis Investigative Site
    • Kuala Lumpur
      • Kuala Lumpur, Kuala Lumpur, Malaysia, 50586
        • Active, not recruiting
        • Novartis Investigative Site
  • Mexico
      • Querétaro, Mexico, 76000
        • Active, not recruiting
        • Novartis Investigative Site
    • Mexico City
      • Benito Juárez, Mexico City, Mexico, 03100
        • Active, not recruiting
        • Novartis Investigative Site
  • Netherlands
    • Provincie Groningen
      • Groningen, Provincie Groningen, Netherlands, 9713 GZ
        • Active, not recruiting
        • Novartis Investigative Site
  • Norway
      • Bergen, Norway, NO-5021
        • Active, not recruiting
        • Novartis Investigative Site
    • Oslo
      • Nordbyhagen, Oslo, Norway, 1478
        • Active, not recruiting
        • Novartis Investigative Site
  • Russia
      • Rostov-on-Don, Russia, 344022
        • Active, not recruiting
        • Novartis Investigative Site
      • Saint Petersburg, Russia, 197110
        • Active, not recruiting
        • Novartis Investigative Site
  • Singapore
      • Singapore, Singapore, 119074
        • Active, not recruiting
        • Novartis Investigative Site
      • Singapore, Singapore, 169608
        • Active, not recruiting
        • Novartis Investigative Site
  • Slovakia
      • Košice, Slovakia, 040 11
        • Active, not recruiting
        • Novartis Investigative Site
  • Slovenia
      • Ljubljana, Slovenia, 1000
        • Active, not recruiting
        • Novartis Investigative Site
    • Slovenia
      • Maribor, Slovenia, Slovenia, 2000
        • Withdrawn
        • Novartis Investigative Site
  • South Africa
    • Free State
      • Bloemfontein, Free State, South Africa, 9301
        • Active, not recruiting
        • Novartis Investigative Site
  • South Korea
      • Busan, South Korea, 47392
        • Active, not recruiting
        • Novartis Investigative Site
      • Seoul, South Korea, 03722
        • Active, not recruiting
        • Novartis Investigative Site
      • Seoul, South Korea, 06591
        • Active, not recruiting
        • Novartis Investigative Site
      • Seoul, South Korea, 06973
        • Active, not recruiting
        • Novartis Investigative Site
      • Seoul, South Korea, 05278
        • Active, not recruiting
        • Novartis Investigative Site
      • Taegu, South Korea, 41944
        • Active, not recruiting
        • Novartis Investigative Site
    • Gyeonggi-do
      • Bundang Gu, Gyeonggi-do, South Korea, 13620
        • Active, not recruiting
        • Novartis Investigative Site
    • Korea
      • Seoul, Korea, South Korea, 02841
        • Completed
        • Novartis Investigative Site
      • Seoul, Korea, South Korea, 03312
        • Active, not recruiting
        • Novartis Investigative Site
    • North Chungcheong
      • Cheongju-si, North Chungcheong, South Korea, 28644
        • Active, not recruiting
        • Novartis Investigative Site
    • Seoul
      • Seoul, Seoul, South Korea, 03080
        • Active, not recruiting
        • Novartis Investigative Site
  • Spain
      • Barcelona, Spain, 08036
        • Active, not recruiting
        • Novartis Investigative Site
      • Salamanca, Spain, 37007
        • Active, not recruiting
        • Novartis Investigative Site
    • Navarre
      • Pamplona, Navarre, Spain, 31008
        • Active, not recruiting
        • Novartis Investigative Site
  • Sweden
      • Stockholm, Sweden, 141 86
        • Active, not recruiting
        • Novartis Investigative Site
  • Taiwan
      • Kaohsiung City, Taiwan, 833
        • Active, not recruiting
        • Novartis Investigative Site
      • New Taipei City, Taiwan, 23561
        • Active, not recruiting
        • Novartis Investigative Site
      • New Taipei City, Taiwan, 22060
        • Active, not recruiting
        • Novartis Investigative Site
      • Taichung, Taiwan, 40447
        • Active, not recruiting
        • Novartis Investigative Site
      • Taichung, Taiwan, 407219
        • Completed
        • Novartis Investigative Site
      • Taipei, Taiwan, 10002
        • Active, not recruiting
        • Novartis Investigative Site
      • Taoyuan, Taiwan, 33305
        • Active, not recruiting
        • Novartis Investigative Site
  • Thailand
      • Bangkok, Thailand, 10330
        • Active, not recruiting
        • Novartis Investigative Site
      • Bangkok, Thailand, 10400
        • Active, not recruiting
        • Novartis Investigative Site
      • Bangkok, Thailand, 10700
        • Active, not recruiting
        • Novartis Investigative Site
  • Turkey (Türkiye)
    • Fatih
      • Istanbul, Fatih, Turkey (Türkiye), 34098
        • Active, not recruiting
        • Novartis Investigative Site
    • Kocaeli
      • Köseköy, Kocaeli, Turkey (Türkiye), 41380
        • Active, not recruiting
        • Novartis Investigative Site
    • Konyaalti
      • Antalya, Konyaalti, Turkey (Türkiye), 07070
        • Completed
        • Novartis Investigative Site
    • Melikgazi
      • Kayseri, Melikgazi, Turkey (Türkiye), 38039
        • Active, not recruiting
        • Novartis Investigative Site
    • Sariyer
      • Istanbul, Sariyer, Turkey (Türkiye), 34396
        • Active, not recruiting
        • Novartis Investigative Site
    • Yenimahalle
      • Ankara, Yenimahalle, Turkey (Türkiye), 06500
        • Active, not recruiting
        • Novartis Investigative Site
    • Yenisehir
      • Mersin, Yenisehir, Turkey (Türkiye), 33110
        • Active, not recruiting
        • Novartis Investigative Site
  • United Kingdom
      • Cambridge, United Kingdom, CB2 0QQ
        • Completed
        • Novartis Investigative Site
      • Leicester, United Kingdom, LE5 4PW
        • Active, not recruiting
        • Novartis Investigative Site
      • London, United Kingdom, SE5 9RS
        • Active, not recruiting
        • Novartis Investigative Site
      • Salford, United Kingdom, M6 8HD
        • Active, not recruiting
        • Novartis Investigative Site
    • Tyne and Wear
      • Newcastle upon Tyne, Tyne and Wear, United Kingdom, NE7 7DN
        • Active, not recruiting
        • Novartis Investigative Site
  • United States
    • Arizona
      • Glendale, Arizona, United States, 85306
        • Active, not recruiting
        • AZ Kidney Dise and Hypertension Ctr
    • California
      • San Diego, California, United States, 92111
        • Active, not recruiting
        • Kaiser Permanente
      • San Dimas, California, United States, 91773
        • Active, not recruiting
        • North America Research Institute
    • Colorado
      • Aurora, Colorado, United States, 80045
        • Active, not recruiting
        • University of Colorado Anschutz
    • Delaware
      • Newark, Delaware, United States, 19713
        • Withdrawn
        • Nephrology Associates PA
    • Idaho
      • Chubbuck, Idaho, United States, 83202
        • Active, not recruiting
        • CaRe Research
    • Illinois
      • Hinsdale, Illinois, United States, 60521
        • Active, not recruiting
        • Nep Assoc of Northern Illinois
    • Maryland
      • Baltimore, Maryland, United States, 21287
        • Active, not recruiting
        • Johns Hopkins Hospital
    • Massachusetts
      • Boston, Massachusetts, United States, 02115
        • Completed
        • Brigham and Womens Hosp Harvard Med School
    • Minnesota
      • Rochester, Minnesota, United States, 55905
        • Active, not recruiting
        • Mayo Clinic Rochester
    • Missouri
      • Kansas City, Missouri, United States, 64112
        • Completed
        • Clin Rsrch Consult a JCCT Company
    • Nevada
      • Las Vegas, Nevada, United States, 89146
        • Active, not recruiting
        • DaVita Clinical Research
    • New Jersey
      • Jersey City, New Jersey, United States, 07305
        • Active, not recruiting
        • New Jersey Kidney Care
    • New York
      • New York, New York, United States, 10032
        • Recruiting
        • Col Uni Med Center New York Presby
        • Principal Investigator:
          • Pietro Canetta
        • Contact:
    • Texas
      • Dallas, Texas, United States, 75230
        • Active, not recruiting
        • Dallas Renal Group
      • Houston, Texas, United States, 77054
        • Withdrawn
        • Prolato Clinical Research Center
  • Vietnam
      • Ho Chi Minh City, Vietnam, 700000
        • Active, not recruiting
        • Novartis Investigative Site
    • VNM
      • Ho Chi Minh City, VNM, Vietnam, 700000
        • Active, not recruiting
        • Novartis Investigative Site

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years to 100 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • For LNP023X2203, participants must have completed part 1 or part 2 of the trial. For LNP023A2301, participants must have completed the entire core trial defined as the full 24 month treatment period.

  • eGFR* ≥ 20 ml/min/1.73m2

    *eGFR calculated using the CKD-EPI formula (or modified MDRD formula according to specific ethnic groups and local practice guidelines)

  • Per investigator's clinical judgement, the participant may benefit from receiving the open-label treatment of iptacopan 200 mg b.i.d.

  • Prior Vaccination against Neisseria meningitidis, Streptococcus pneumoniae and Haemophilus influenzae infections should be up to date (i.e. any boosters required administered according to local regulations.

  • All participants must be on supportive care regimen of ACEi or ARB* as per KDIGO guidelines.

    • participants who are not taking KDIGO guideline doses because they have documented allergies or intolerance to ACEi and ARB are eligible for the study

Exclusion Criteria:

  • participants who screen or baseline failed in the CLNP023X2203 Part 1 or Part 2, or CLNP023A2301 studies or who prematurely withdrew from either study for any reason.
  • Evidence of severe urinary obstruction or difficulty in voiding; any urinary tract disorder other than IgAN at screening and before dosing with LNP023.
  • Current (within 4 weeks of study drug administration in the REP) acute kidney injury (AKI)
  • Presence of Rapidly Progressive Glomerulonephritis (RPGN) as defined by 50% decline in eGFR within the last 3 months.
  • Participants 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 and/or systemic corticosteroids exposure (>7.5 mg/d prednisone/prednisolone equivalent) within 5 half-lives of respective medication or 90 days prior to first study drug administration, whichever is shorter. Rituximab requires 180 days wash out.
  • Use of other investigational drugs at the time of enrolment, or within 5 half-lives of enrolment or within 30 days whichever is longer.
  • History of recurrent invasive infections caused by encapsulated organisms, such as meningococcus and pneumococcus.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: LNP023

All participants are receiving 200 mg b.i.d
Drug: LNP023

Capsule 200 mg (b.i.d.) taken orally twice a day

Other Names:
  • iptacopan

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Number and percentage of participants with serious adverse event
Time Frame: Date of first administration of (Day 1) to 7 days after the date of the last actual administration of study treatment

Summary statistics on serious adverse events
Date of first administration of (Day 1) to 7 days after the date of the last actual administration of study treatment
Number and percentage of participants with adverse event
Time Frame: Date of first administration of study treatment (Day 1) to 7 days after the date of the last actual administration of study treatment

Summary statistics on adverse events
Date of first administration of study treatment (Day 1) to 7 days after the date of the last actual administration of study treatment
Number and percentage of participants with adverse events of special interest
Time Frame: Date of first administration of study treatment (Day 1) to 7 days after the date of the last actual adminstration of study treatment

Summary statistics on adverse events of special interest
Date of first administration of study treatment (Day 1) to 7 days after the date of the last actual adminstration of study treatment
Number and percentage of participants with abnormalities in vital signs
Time Frame: Date of first administration of study treatment (Day 1) to 7 days after the date of the last actual administration of study treatment

Summary statistics on abnormalities in vital sign parameters
Date of first administration of study treatment (Day 1) to 7 days after the date of the last actual administration of study treatment
Number and percentage of participants with abnormalities in ECG
Time Frame: Date of first administration of study treatment (Day 1) to 7 days after the date of the last actual administration of study treatment

Summary statistics in abnormalities in ECG parameters
Date of first administration of study treatment (Day 1) to 7 days after the date of the last actual administration of study treatment
Number and percentage of participants with abnormalities in clinical laboratory evaluations
Time Frame: Date of first administration of study treatment (Day 1) to 7 days after the date of the last actual administration of study treatment

Summary statistics on abnormalities in clinical laboratory evaluations
Date of first administration of study treatment (Day 1) to 7 days after the date of the last actual administration of study treatment

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Annualized total eGFR slope
Time Frame: Screening visit, Months 1, 3, 6, 9, 12 and every 6 months thereafter

Annualized rate of renal disease progression as measured by mean eGFR slope at post baseline visits
Screening visit, Months 1, 3, 6, 9, 12 and every 6 months thereafter
Change from baseline in eGFR
Time Frame: Screening visit, Months 1, 3, 6, 9, 12 and every 6 months thereafter

Average change from baseline in eGFR at post-baseline visits
Screening visit, Months 1, 3, 6, 9, 12 and every 6 months thereafter
Log transformed ratio to baseline in UPCR, UACR
Time Frame: Screening visit, Months 1, 3, 6, 9, 12 and every 6 months thereafter

Log transformed ratio to baseline in UPCR, UACR at post-baseline visits. The log transformation refers to the natural log (base on e)
Screening visit, Months 1, 3, 6, 9, 12 and every 6 months thereafter

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Novartis Pharmaceuticals

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Study Director: Novartis Pharmaceuticals, Novartis Pharmaceuticals

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
September 20, 2021

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 4, 2030

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 4, 2030

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
September 15, 2020

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 15, 2020

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
September 21, 2020

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
October 5, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
October 1, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
September 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • CLNP023A2002B
  • 2020-002200-40 (EudraCT Number)

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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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