Study of Efficacy and Safety of Iptacopan in Participants With IC-MPGN (APPARENT)

May 28, 2026 updated by: Novartis Pharmaceuticals

A Multicenter, Randomized, Double-blind, Parallel Group, Placebo-controlled Study to Evaluate the Efficacy and Safety of Iptacopan (LNP023) in Idiopathic Immune-complex-mediated Membranoproliferative Glomerulonephritis (IC-MPGN)

This study is designed as a multicenter, randomized, double-blind, parallel group, placebo-controlled study to evaluate the efficacy and safety of iptacopan (LNP023) in idiopathic immune complex mediated membranoproliferative glomerulonephritis.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

The purpose of this Phase III study is to evaluate the efficacy and safety of iptacopan compared to placebo (both administered in combination with standard of care) in participants (adults and adolescents aged 12-17 years) with idiopathic IC-MPGN. The study aims to demonstrate a reduction in proteinuria and improvement in estimated glomerular filtration rate (eGFR) in participants treated with iptacopan compared to placebo. Change in patient-reported fatigue will also be evaluated. Alternative complement pathway (AP) dysregulation is believed to underlie the clinical manifestations and progression of IC-MPGN. Upon completion of study treatment, participants will have the option to discontinue iptacopan treatment and enter a 30 day safety follow-up or continue iptacopan treatment by transitioning to an open label extension study (CLNP023B12001B; NCT03955445) and continue iptacopan treatment.

Study Type

Interventional

Enrollment (Estimated)

106

Phase

  • Phase 3

Expanded Access

Available 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 Backup

  • Name: Novartis Pharmaceuticals
  • Phone Number: +41613241111

Study Locations

  • Argentina
      • Buenos Aires, Argentina, W3400ABH
        • Recruiting
        • Novartis Investigative Site
      • CABA, Argentina, C1181ACH
        • Recruiting
        • Novartis Investigative Site
      • Santa Fe, Argentina, S3000EPV
        • Recruiting
        • Novartis Investigative Site
    • Buenos Aires
      • CABA, Buenos Aires, Argentina, C1425AGC
        • Recruiting
        • Novartis Investigative Site
      • CABA, Buenos Aires, Argentina, C1425EFD
        • Recruiting
        • Novartis Investigative Site
    • Córdoba Province
      • Córdoba, Córdoba Province, Argentina, X5000
        • Recruiting
        • Novartis Investigative Site
  • Brazil
      • Salvador, Brazil, 40323-010
        • Recruiting
        • Novartis Investigative Site
    • Ceará
      • Fortaleza, Ceará, Brazil, 60430 370
        • Recruiting
        • Novartis Investigative Site
    • Federal District
      • Brasília, Federal District, Brazil, 71635-580
        • Withdrawn
        • Novartis Investigative Site
    • Minas Gerais
      • Belo Horizonte, Minas Gerais, Brazil, 30150-221
        • Recruiting
        • Novartis Investigative Site
    • Pernambuco
      • Recife, Pernambuco, Brazil, 50740-900
        • Recruiting
        • Novartis Investigative Site
    • Rio Grande do Norte
      • Natal, Rio Grande do Norte, Brazil, 59012 300
        • Recruiting
        • Novartis Investigative Site
    • Rio Grande do Sul
      • Porto Alegre, Rio Grande do Sul, Brazil, 90035-074
        • Recruiting
        • Novartis Investigative Site
    • Rio de Janeiro
      • Niterói, Rio de Janeiro, Brazil, 24020 096
        • Withdrawn
        • Novartis Investigative Site
      • Rio de Janeiro, Rio de Janeiro, Brazil, 22211-230
        • Withdrawn
        • Novartis Investigative Site
    • São Paulo
      • Botucatu, São Paulo, Brazil, 18618-970
        • Recruiting
        • Novartis Investigative Site
      • Santo André, São Paulo, Brazil, 09090-790
        • Recruiting
        • Novartis Investigative Site
      • Sao Jose Rio Preto, São Paulo, Brazil, 15090-000
        • Recruiting
        • Novartis Investigative Site
      • São Paulo, São Paulo, Brazil, 04038-002
        • Recruiting
        • Novartis Investigative Site
      • São Paulo, São Paulo, Brazil, 05403-000
        • Recruiting
        • Novartis Investigative Site
      • São Paulo, São Paulo, Brazil, 05403 000
        • Withdrawn
        • Novartis Investigative Site
  • Canada
    • Ontario
      • Etobicoke, Ontario, Canada, M9W 6V1
        • Recruiting
        • Novartis Investigative Site
      • Toronto, Ontario, Canada, M5G 2C4
        • Recruiting
        • Novartis Investigative Site
    • Quebec
      • Montreal, Quebec, Canada, H3T 1C5
        • Recruiting
        • Novartis Investigative Site
      • Montreal, Quebec, Canada, H2X 1R9
        • Recruiting
        • Novartis Investigative Site
  • Czechia
      • Prague, Czechia, 128 08
        • Recruiting
        • Novartis Investigative Site
  • Denmark
      • Aarhus N, Denmark, 8200
        • Recruiting
        • Novartis Investigative Site
      • Copenhagen, Denmark, DK-2100
        • Recruiting
        • Novartis Investigative Site
  • France
      • Marseille, France, 13005
        • Recruiting
        • Novartis Investigative Site
      • Montpellier, France, 34295
        • Recruiting
        • Novartis Investigative Site
      • Paris, France, 75015
        • Recruiting
        • Novartis Investigative Site
      • Rennes, France, 35033
        • Recruiting
        • Novartis Investigative Site
      • Toulouse, France, 31054
        • Recruiting
        • Novartis Investigative Site
  • Germany
      • Berlin, Germany, 13353
        • Recruiting
        • Novartis Investigative Site
      • Essen, Germany, 45147
        • Recruiting
        • Novartis Investigative Site
      • Hamburg, Germany, 20246
        • Recruiting
        • Novartis Investigative Site
      • Hanover, Germany, 30625
        • Recruiting
        • Novartis Investigative Site
      • Mainz, Germany, 55131
        • Recruiting
        • Novartis Investigative Site
      • Ulm, Germany, 89081
        • Recruiting
        • Novartis Investigative Site
    • Bavaria
      • Munich, Bavaria, Germany, 81377
        • Recruiting
        • Novartis Investigative Site
      • Würzburg, Bavaria, Germany, 97080
        • Recruiting
        • Novartis Investigative Site
    • Saxony
      • Dresden, Saxony, Germany, 01307
        • Recruiting
        • Novartis Investigative Site
    • Thuringia
      • Jena, Thuringia, Germany, 07740
        • Recruiting
        • Novartis Investigative Site
  • Greece
      • Athens, Greece, 115 27
        • Recruiting
        • Novartis Investigative Site
      • Chaïdári, Greece, 124 62
        • Recruiting
        • Novartis Investigative Site
      • Heraklion Crete., Greece, 715 00
        • Recruiting
        • Novartis Investigative Site
      • Ioannina, Greece, 455 00
        • Recruiting
        • Novartis Investigative Site
      • Pátrai, Greece, 265 04
        • Recruiting
        • Novartis Investigative Site
      • Thessaloniki, Greece, 54636
        • Recruiting
        • Novartis Investigative Site
      • Thessaloniki, Greece, 570 10
        • Recruiting
        • Novartis Investigative Site
  • India
    • Karnataka
      • Bangalore, Karnataka, India, 560004
        • Recruiting
        • Novartis Investigative Site
    • Maharashtra
      • Nagpur, Maharashtra, India, 440015
        • Recruiting
        • Novartis Investigative Site
      • Pune, Maharashtra, India, 411011
        • Recruiting
        • Novartis Investigative Site
    • National Capital Territory of Delhi
      • New Delhi, National Capital Territory of Delhi, India, 110029
        • Recruiting
        • Novartis Investigative Site
    • Telangana
      • Hyderabad, Telangana, India, 500082
        • Recruiting
        • Novartis Investigative Site
  • Israel
      • Haifa, Israel, 3109601
        • Recruiting
        • Novartis Investigative Site
      • Jerusalem, Israel, 9103102
        • Recruiting
        • Novartis Investigative Site
      • Petah Tikva, Israel, 4920235
        • Recruiting
        • Novartis Investigative Site
  • Italy
      • Naples, Italy, 80131
        • Recruiting
        • Novartis Investigative Site
    • BA
      • Bari, BA, Italy, 70124
        • Recruiting
        • Novartis Investigative Site
    • BG
      • Ranica, BG, Italy, 24020
        • Recruiting
        • Novartis Investigative Site
    • BS
      • Brescia, BS, Italy, 25123
        • Recruiting
        • Novartis Investigative Site
    • MI
      • Milan, MI, Italy, 20122
        • Recruiting
        • Novartis Investigative Site
    • RM
      • Roma, RM, Italy, 00165
        • Recruiting
        • Novartis Investigative Site
    • TO
      • Torino, TO, Italy, 10126
        • Recruiting
        • Novartis Investigative Site
  • Japan
      • Okayama, Japan, 7008558
        • Recruiting
        • Novartis Investigative Site
      • Osaka, Japan, 558-8558
        • Recruiting
        • Novartis Investigative Site
    • Aichi-ken
      • Toyoake, Aichi-ken, Japan, 4701192
        • Recruiting
        • Novartis Investigative Site
    • Tokyo
      • Fuchū, Tokyo, Japan, 1838561
        • Recruiting
        • Novartis Investigative Site
      • Hachiōji, Tokyo, Japan, 193-0998
        • Recruiting
        • Novartis Investigative Site
  • Netherlands
      • Groningen, Netherlands, 9713 GZ
        • Recruiting
        • Novartis Investigative Site
  • Poland
      • Bialystok, Poland, 15-540
        • Recruiting
        • Novartis Investigative Site
      • Krakow, Poland, 30-688
        • Recruiting
        • Novartis Investigative Site
      • Olsztyn, Poland, 10-561
        • Recruiting
        • Novartis Investigative Site
      • Warsaw, Poland, 02-006
        • Recruiting
        • Novartis Investigative Site
      • Warsaw, Poland, 02-097
        • Recruiting
        • Novartis Investigative Site
      • Wroclaw, Poland, 50-417
        • Withdrawn
        • Novartis Investigative Site
    • Greater Poland Voivodeship
      • Poznan, Greater Poland Voivodeship, Poland, 60-355
        • Recruiting
        • Novartis Investigative Site
  • Slovakia
      • Banská Bystrica, Slovakia, 975 17
        • Recruiting
        • Novartis Investigative Site
      • Košice, Slovakia, 041 90
        • Recruiting
        • Novartis Investigative Site
    • Slovakia
      • Martin, Slovakia, Slovakia, 036 59
        • Recruiting
        • Novartis Investigative Site
  • South Korea
      • Seoul, South Korea, 03722
        • Recruiting
        • Novartis Investigative Site
    • Seoul
      • Seoul, Seoul, South Korea, 03080
        • Recruiting
        • Novartis Investigative Site
  • Spain
      • Almería, Spain, 04009
        • Recruiting
        • Novartis Investigative Site
      • Barcelona, Spain, 08035
        • Recruiting
        • Novartis Investigative Site
      • Barcelona, Spain, 08036
        • Recruiting
        • Novartis Investigative Site
      • Madrid, Spain, 28041
        • Recruiting
        • Novartis Investigative Site
      • Madrid, Spain, 28040
        • Recruiting
        • Novartis Investigative Site
      • Madrid, Spain, 280796
        • Recruiting
        • Novartis Investigative Site
      • Salamanca, Spain, 37007
        • Recruiting
        • Novartis Investigative Site
    • Navarre
      • Pamplona, Navarre, Spain, 31008
        • Recruiting
        • Novartis Investigative Site
  • Switzerland
      • Bern, Switzerland, 3010
        • Recruiting
        • Novartis Investigative Site
      • Lausanne, Switzerland, 1011
        • Withdrawn
        • Novartis Investigative Site
      • Zurich, Switzerland, 8091
        • Recruiting
        • Novartis Investigative Site
  • Taiwan
      • Kaohsiung City, Taiwan, 81346
        • Recruiting
        • Novartis Investigative Site
  • Turkey (Türkiye)
    • Fatih
      • Istanbul, Fatih, Turkey (Türkiye), 34093
        • Recruiting
        • Novartis Investigative Site
    • Karsiyaka
      • Izmir, Karsiyaka, Turkey (Türkiye), 35575
        • Recruiting
        • Novartis Investigative Site
    • Kocaeli
      • Köseköy, Kocaeli, Turkey (Türkiye), 41380
        • Recruiting
        • Novartis Investigative Site
    • Melikgazi
      • Kayseri, Melikgazi, Turkey (Türkiye), 38039
        • Recruiting
        • Novartis Investigative Site
    • Yenimahalle
      • Ankara, Yenimahalle, Turkey (Türkiye), 06500
        • Recruiting
        • Novartis Investigative Site
    • Yenisehir
      • Mersin, Yenisehir, Turkey (Türkiye), 33110
        • Recruiting
        • Novartis Investigative Site
  • United Kingdom
      • Belfast, United Kingdom, BT9 7AB
        • Recruiting
        • Novartis Investigative Site
      • Cardiff, United Kingdom, CF14 4XW
        • Recruiting
        • Novartis Investigative Site
      • London, United Kingdom, WC1N 3JH
        • Recruiting
        • Novartis Investigative Site
      • London, United Kingdom, NW3 2QG
        • Recruiting
        • Novartis Investigative Site
      • Manchester, United Kingdom, M13 9WL
        • Recruiting
        • Novartis Investigative Site
      • Salford, United Kingdom, M6 8HD
        • Recruiting
        • Novartis Investigative Site
  • United States
    • California
      • Los Angeles, California, United States, 90095
        • Recruiting
        • Ronald Reagan UCLA Medical Center
        • Principal Investigator:
          • Lama Abdelnour
        • Contact:
      • Orange, California, United States, 92868
        • Recruiting
        • Univ Cali Irvine ALS Neuromuscular
        • Contact:
        • Principal Investigator:
          • Ramy Hanna
      • San Francisco, California, United States, 94115
        • Recruiting
        • UCSF
        • Principal Investigator:
          • Raymond Hsu
        • Contact:
      • Sylmar, California, United States, 91342
        • Recruiting
        • Olive View UCLA Medical Center
        • Principal Investigator:
          • Phuong-Chi Pham
        • Contact:
    • Colorado
      • Aurora, Colorado, United States, 80045
        • Recruiting
        • Childrens Hospital Colorado
        • Principal Investigator:
          • Bradley Dixon
        • Contact:
    • Florida
      • Miami, Florida, United States, 33155
        • Recruiting
        • Nicklaus Childrens Hospital
        • Contact:
        • Principal Investigator:
          • Ana Paredes.
    • Georgia
      • Atlanta, Georgia, United States, 30322
        • Recruiting
        • Emory University School of Medicine-Winship Cancer Institute
        • Contact:
        • Principal Investigator:
          • Laurence Larry Greenbaum
    • Massachusetts
      • Boston, Massachusetts, United States, 02114
        • Recruiting
        • Massachusetts General Hospital
        • Principal Investigator:
          • Meghan Sise
        • Contact:
      • Boston, Massachusetts, United States, 02118
        • Recruiting
        • Boston Univ School of Medicine
        • Contact:
        • Principal Investigator:
          • Jean Francis
    • Minnesota
      • Minneapolis, Minnesota, United States, 55455
        • Recruiting
        • University of Minnesota
        • Principal Investigator:
          • Nattawat Klomjit
        • Contact:
    • Missouri
      • St Louis, Missouri, United States, 63110
        • Recruiting
        • Washington University in St Louis
        • Principal Investigator:
          • Tingting Li
        • Contact:
    • New Mexico
      • Albuquerque, New Mexico, United States, 87131-0001
        • Recruiting
        • University of New Mexico
        • Principal Investigator:
          • Namita Singh
        • Contact:
    • New York
      • New York, New York, United States, 10032
        • Recruiting
        • Col Uni Med Center New York Presby
        • Principal Investigator:
          • Andrew S Bomback
        • Contact:
    • Ohio
      • Cincinnati, Ohio, United States, 45267
        • Recruiting
        • University of Cincinnati
        • Principal Investigator:
          • Manish Anand
        • Contact:
    • Oregon
      • Portland, Oregon, United States, 97239
        • Recruiting
        • OHSU Dept of Nephrology
        • Contact:
        • Principal Investigator:
          • Rupali Avasare
    • Pennsylvania
      • Philadelphia, Pennsylvania, United States, 19104
    • South Carolina
      • Lancaster, South Carolina, United States, 29720
        • Recruiting
        • MUSC Health Lancaster Med Ctr
        • Contact:
        • Principal Investigator:
          • Prince Anand
    • Texas
      • Dallas, Texas, United States, 75235
        • Recruiting
        • UT Southwestern Medical Center
        • Contact:
        • Principal Investigator:
          • Jyothsna Gattineni
      • Houston, Texas, United States, 77054
        • Recruiting
        • Prolato Clinical Research Center
        • Contact:
        • Principal Investigator:
          • Sreedhar Mandayam.
      • Temple, Texas, United States, 76502
        • Recruiting
        • Baylor Scott and White Research
        • Principal Investigator:
          • Mohanram Narayanan
        • Contact:
    • Utah
      • Salt Lake City, Utah, United States, 84113
        • Recruiting
        • University of Utah
        • Principal Investigator:
          • Raoul Nelson
        • Contact:
    • Wisconsin
      • Madison, Wisconsin, United States, 53792
        • Recruiting
        • University of Wisconsin
        • Principal Investigator:
          • Sharon Bartosh
        • Contact:
  • Vietnam
      • Ho Chi Minh City, Vietnam, 700000
        • 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

Ages Eligible for Study

12 years to 60 years (Child, Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Male and female patients including adults (aged at least 18 years to ≤ 60 years) and adolescents (12 -17 years in non-EU countries at screening and 16-17 years in EU countries at screening).
  • Diagnosis of idiopathic IC-MPGN as confirmed by kidney biopsy within 12 months prior to screening in adults and within 3 years of screening in adolescents (a biopsy report, review and confirmation by the Investigator is required). If such a biopsy is not available in an adult participant, this must be obtained at screening (performed and assessed locally for adults only).
  • Prior to randomization, all participants must have been on a maximally recommended or tolerated dose of renin angiotensin system inhibitors (RASi), e.g an ACEi or ARB for at least 90 days (or as according to local guidelines). The doses of other drugs administered to reduce proteinuria and control the disease including mycophenolic acids (MPAs - mycophenolate mofetil or mycophenolate sodium), corticosteroids, SGLT2 inhibitors and mineralocorticoid receptor antagonists should be stable for at least 90 days prior to randomization
  • UPCR ≥ 1.0 g/g (≥ 113 mg/mmol) sampled from the first morning void urine sample at Day -75 and Day -15
  • Estimated GFR (using the chronic kidney disease [CKD]-EPI formula for adult participants and modified Schwartz formula for adolescents aged 12 to 17 years) or measured GFR ≥ 30 ml/min/1.73m2 at screening and Day -15.
  • Mandatory vaccination against Neisseria meningitidis and Streptococcus pneumoniae infection prior to the start of study treatment. If the participant has not been previously vaccinated, or if a booster is required, the vaccine should be given according to local regulations at least 2 weeks prior to the first administration of study treatment. If the study treatment has to start earlier than 2 weeks post vaccination, prophylactic antibiotic treatment should be initiated in accordance with local standard of care.
  • If not previously vaccinated, or if a booster is required, vaccination against Haemophilus influenzae infections should be given, if available and according to local regulations, at least 2 weeks prior to the first study treatment administration.

Exclusion Criteria:

  • Participants who have undergone cell or solid organ transplantation, including kidney transplantation.
  • Participants diagnosed with secondary IC-MPGN including but not limited to any of the following conditions:

  • Deposition of antigen-antibody immune complexes as a result of any chronic infections, including

    • Hepatitis C virus (HCV) including HCV-associated mixed cryoglobulinemia, hepatitis B virus (HBV);
    • Bacterial-endocarditis, infected ventriculo-atrial shunt, visceral abscesses, leprosy, meningococcal meningitis; chronic bacterial infections
    • Protozoa/other infections- malaria, schistosomiasis, mycoplasma, leishmaniasis, filariasis, histroplasmosis

Renal deposition of immune complexes as a result of a systemic autoimmune disease:

  • Systemic lupus erythematosus (SLE)
  • Sjögren syndrome
  • Rheumatoid arthritis
  • Mixed connective tissue disease Deposition of monoclonal immunoglobulins because of a monoclonal gammopathy due to plasma cell or B cell disorders. Monoclonal gammopathy of undetermined significance (MGUS) confirmed by the measurement of serum free light chains or other investigation as per local standard of care.

Fibrillary glomerulonephritis

  • Rapidly progressive crescentic glomerulonephritis defined as a 50% decline in the eGFR within 3 months with kidney biopsy findings of glomerular crescent formation seen in at least 50% of glomeruli on the most recent biopsy.
  • Kidney biopsy showing interstitial fibrosis/tubular atrophy (IF/TA) of more than 50%.
  • Participants with an active systemic bacterial, viral or fungal infection within 14 days prior to study treatment administration or the presence of fever ≥ 38°C (100.4°F) within 7 days prior to study treatment administration.
  • A history of recurrent invasive infections caused by encapsulated organisms, e.g., Neisseria meningitidis and Streptococcus pneumoniae.
  • The use of inhibitors of complement factors (e.g., Factor B, Factor D, complement 3 (C3) inhibitors, anti-Complement 5 (C5) antibodies, C5a receptor antagonists) within 3 months or 5 half-lives prior to the Screening visit.
  • The use of immunosuppressants (except MPAs), cyclophosphamide or systemic corticosteroids at a dose >7.5 mg/day (or equivalent for a similar corticosteroid medication) within 90 days of study drug administration.
  • The use of MPAs is not permitted within 90 days prior to randomization in India, as per the local health authority requirement.
  • Acute post-infectious glomerulonephritis at screening, based upon the opinion of the investigator.
  • Body mass index (BMI) >38 kg/m2 at screening and randomization. Body weight <35 kg at screening and randomization

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: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: Placebo to iptacopan 200mg b.i.d.
Drug: Placebo
Placebo to iptacopan 200mg b.i.d. (Adults 200mg b.i.d; Adolescents 2x 100mg b.i.d)
Experimental: iptacopan 200mg b.i.d
Drug: iptacopan
iptacopan 200 mg b.i.d. (Adults 200mg b.i.d; Adolescents 2x 100mg b.i.d)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Log-transformed ratio to baseline in UPCR (sampled from a 24-hour urine collection) at 6 months.
Time Frame: 6 months (double-blind)
To demonstrate the superiority of iptacopan compared to placebo in reducing proteinuria at 6 months.
6 months (double-blind)
Log-transformed ratio to baseline in UPCR at the 18-month visit (each study treatment arm)
Time Frame: 18 months
To evaluate the effect of iptacopan on proteinuria at 18 months.
18 months
Log-transformed ratio to 12-month visit in UPCR at the 18-month visit in the placebo arm.
Time Frame: 18 months
To evaluate the effect of iptacopan on proteinuria at 18 months.
18 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change from baseline in eGFR
Time Frame: 12 months and 18 months
To demonstrate the superiority of iptacopan vs. placebo in improving estimated glomerular filtration rate (eGFR).
12 months and 18 months
Change in eGFR from the 12-month visit to the 18- month visit of the placebo arm
Time Frame: 18 months
To evaluate the effect at 18 months of iptacopan in improving eGFR
18 months
Proportion of patients achieved a composite renal endpoint
Time Frame: 6 and 12 months
To demonstrate the superiority of iptacopan vs. placebo in the proportion of participant who achieved a composite renal endpoint at 6 and 12 months (each study arm).
6 and 12 months
Change from baseline in the Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-Fatigue) score.
Time Frame: 12 months
To demonstrate the superiority of iptacopan compared to placebo in improvement of patient-reported fatigue at 12 months (each study arm).
12 months
Number of participants with abnormal vital signs, ECGs and safety laboratory measurements as well as study drug discontinuation due to an AE
Time Frame: up to 18 months

To evaluate the safety and tolerability of iptacopan compared to placebo, number of participants with abnormal vital signs (msDBP/msSBP/heart rate), ECGs, safety laboratory measurements and study drug discontinuation due to an AE will be collected.

msDBP: mean sitting diastolic blood pressure msSBP: mean sitting systolic blood pressure
up to 18 months
Number of participants with clinically significant changes in heart rate, blood pressure, echocardiography parameters in adolescent patients
Time Frame: up to 18 months
To evaluate the effect of iptacopan compared to placebo, number of participants with clinically significant changes in heart rate, blood pressure (msDBP/ msSBP), echocardiography parameters in adolescent patients will be collected
up to 18 months
Annualized total eGFR slope estimated over 12 months.
Time Frame: 12 months
To demonstrate the superiority of iptacopan vs. placebo in stabilizing eGFR
12 months
Log-transformed ratio to baseline in UPCR (sampled from a 24-hour urine collection) at 12 months.
Time Frame: 12 months
To demonstrate the superiority of iptacopan compared to placebo in reducing proteinuria at 12 months of treatment.
12 months
Proportion of participants who achieved the composite renal endpoint at 18 months
Time Frame: 18 months
To evaluate the effect of iptacopan on proteinuria at 18 months
18 months

Collaborators and Investigators

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

Sponsor

Novartis Pharmaceuticals

Investigators

  • 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.

Helpful Links

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)

October 2, 2023

Primary Completion (Estimated)

October 27, 2028

Study Completion (Estimated)

May 31, 2029

Study Registration Dates

First Submitted

February 23, 2023

First Submitted That Met QC Criteria

February 23, 2023

First Posted (Actual)

March 6, 2023

Study Record Updates

Last Update Posted (Actual)

June 1, 2026

Last Update Submitted That Met QC Criteria

May 28, 2026

Last Verified

May 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CLNP023B12302
  • 2022-002328-11 (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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