AzTrials
AzTrials

IC-MPGNPhase 3APPARENTNCT05755386

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

A Phase 3 study testing iptacopan in people with IC-MPGN, run by Novartis Pharmaceuticals at 131 sites in 23 countries.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial summary

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. Read more about this study

Who is it for?
Ages 12 to 60 years
Conditions the study is for
IC-MPGN
What is being tested?
iptacopan
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
106 participants
Where
131 sitesin 23 countries
Study dates
2 Oct 2023to 31 May 2029
Phase
Phase 3
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 12 to 60 years
  • All sexes
  • No healthy volunteers
  • Child, Adult

Who may be able to join

  • 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.

Who cannot join

  • 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
Show all 21Show fewer
  • 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

Trial locations and contacts

131 sites in 23 countries. Contact the study team or a site near you to ask about taking part.

Novartis Pharmaceuticals contact

1-888-669-6682

novartis.email@novartis.com

Novartis Pharmaceuticals contact

+41613241111

131 sites in 23 countries

United States22 sites, 22 recruiting

  • University of New Mexico

    Albuquerque, New Mexico, 87131-0001

    Susan L Tigert, +1 505 272 9992, STigert@salud.unm.edu

    Namita Singh

    Recruiting

  • Emory University School of Medicine-Winship Cancer Institute

    Atlanta, Georgia, 30322

    Heather Jung, heather.jung@emory.edu

    Laurence Larry Greenbaum

    Recruiting

  • Childrens Hospital Colorado

    Aurora, Colorado, 80045

    Kati Dugan, +1 720 777 1234, Kati.Dugan@childrenscolorado.org

    Bradley Dixon

    Recruiting

  • Massachusetts General Hospital

    Boston, Massachusetts, 02114

    Andrew Cao, acao6@mgh.harvard.edu

    Meghan Sise

    Recruiting

  • Boston Univ School of Medicine

    Boston, Massachusetts, 02118

    Kemberlie Adolphe, kemberlie.adolphe@bmc.org

    Jean Francis

    Recruiting

  • University Of Cincinnati

    Cincinnati, Ohio, 45267

    Leksi Travitz, Leksi.travitz@uc.edu

    Indraneel Reddy

    Recruiting

  • UT Southwestern Medical Center

    Dallas, Texas, 75235

    Melaku Lemma, melaku.lemma@childrens.com

    Jyothsna Gattineni

    Recruiting

  • Prolato Clinical Research Center

    Houston, Texas, 77054

    Romeo Parada, +1 832 338 9118, rparada@prolato.org

    Sreedhar Mandayam

    Recruiting

  • MUSC Health Lancaster Med Ctr

    Lancaster, South Carolina, 29720

    Darann Wiegand, wiegandd@musc.edu

    Prince Anand

    Recruiting

  • Ronald Reagan UCLA Medical Center

    Los Angeles, California, 90095

    Ahad Qureshi, ahadqureshi@mednet.ucla.edu

    Lama Abdelnour

    Recruiting

  • University of Wisconsin

    Madison, Wisconsin, 53792

    Alana Quackenbush, +1 608 265 6020, akquackenbus@wisc.edu

    Sharon Bartosh

    Recruiting

  • Nicklaus Childrens Hospital

    Miami, Florida, 33155

    Moya Chang, +1 786 624 4908, Moya.chang@nicklaushealth.org

    Ana Paredes

    Recruiting

  • University of Minnesota

    Minneapolis, Minnesota, 55455

    Karen Omlung, +1 612 262 2750, seve0024@umn.edu

    Nattawat Klomjit

    Recruiting

  • Col Uni Med Center New York Presby

    New York, New York, 10032

    Anup Pradhan, +1 212 304 5684, arp2209@cumc.columbia.edu

    Andrew S Bomback

    Recruiting

  • Univ Cali Irvine ALS Neuromuscular

    Orange, California, 92868

    Nancy Ortega, nghernan@hs.uci.edu

    Ramy Hanna

    Recruiting

  • Univ of Pennsylvania Medical Center

    Philadelphia, Pennsylvania, 19104

    Cammy Truong, cammy.truong@pennmedicine.upenn.edu

    Gaia Coppock

    Recruiting

  • OHSU Dept of Nephrology

    Portland, Oregon, 97239

    Madison Stanaway, +1 503 494 4233, stanaway@ohsu.edu

    Rupali Avasare

    Recruiting

  • University of Utah

    Salt Lake City, Utah, 84113

    Gabriella Gourdin, +1 415 515 8212, gabriella.gourdin@hsc.utah.edu

    Raoul Nelson

    Recruiting

  • UCSF

    San Francisco, California, 94115

    Juan Espinoza, +1 415 476 5892, juan.espinoza@ucsf.edu

    Raymond Hsu

    Recruiting

  • Washington University in St Louis

    St Louis, Missouri, 63110

    Michelle Bloom, +1 314 362 5298, mbloom@wustl.edu

    Tingting Li

    Recruiting

  • Olive View UCLA Medical Center

    Sylmar, California, 91342

    Rosario Machicado, RMachicado@dhs.lacounty.gov

    Phuong-Chi Pham

    Recruiting

  • Baylor Scott and White Research

    Temple, Texas, 76502

    Stephanie McMeen, +1 254 935 5838, stephanie.mcmeen@bswhealth.org

    Mohanram Narayanan

    Recruiting

Other trials in United States

Brazil15 sites, 11 recruiting

  • Novartis Investigative Site

    Belo Horizonte, Minas Gerais, 30150-221

    Recruiting

  • Novartis Investigative Site

    Botucatu, São Paulo, 18618-970

    Recruiting

  • Novartis Investigative Site

    Brasília, Federal District, 71635-580

    Withdrawn

  • Novartis Investigative Site

    Fortaleza, Ceará, 60430 370

    Recruiting

  • Novartis Investigative Site

    Natal, Rio Grande do Norte, 59012 300

    Recruiting

  • Novartis Investigative Site

    Niterói, Rio de Janeiro, 24020 096

    Withdrawn

  • Novartis Investigative Site

    Porto Alegre, Rio Grande do Sul, 90035-074

    Recruiting

  • Novartis Investigative Site

    Recife, Pernambuco, 50740-900

    Recruiting

  • Novartis Investigative Site

    Rio de Janeiro, Rio de Janeiro, 22211-230

    Withdrawn

  • Novartis Investigative Site

    Salvador, 40323-010

    Recruiting

  • Novartis Investigative Site

    Santo André, São Paulo, 09090-790

    Recruiting

  • Novartis Investigative Site

    Sao Jose Rio Preto, São Paulo, 15090-000

    Recruiting

  • Novartis Investigative Site

    São Paulo, São Paulo, 04038-002

    Recruiting

  • Novartis Investigative Site

    São Paulo, São Paulo, 05403 000

    Withdrawn

  • Novartis Investigative Site

    São Paulo, São Paulo, 05403-000

    Recruiting

Other trials in Brazil

Germany10 sites, 10 recruiting

  • Novartis Investigative Site

    Berlin, 13353

    Recruiting

  • Novartis Investigative Site

    Dresden, Saxony, 01307

    Recruiting

  • Novartis Investigative Site

    Essen, 45147

    Recruiting

  • Novartis Investigative Site

    Hamburg, 20246

    Recruiting

  • Novartis Investigative Site

    Hanover, 30625

    Recruiting

  • Novartis Investigative Site

    Jena, Thuringia, 07740

    Recruiting

  • Novartis Investigative Site

    Mainz, 55131

    Recruiting

  • Novartis Investigative Site

    Munich, Bavaria, 81377

    Recruiting

  • Novartis Investigative Site

    Ulm, 89081

    Recruiting

  • Novartis Investigative Site

    Würzburg, Bavaria, 97080

    Recruiting

Other trials in Germany

Spain8 sites, 8 recruiting

  • Novartis Investigative Site

    Almería, 04009

    Recruiting

  • Novartis Investigative Site

    Barcelona, 08035

    Recruiting

  • Novartis Investigative Site

    Barcelona, 08036

    Recruiting

  • Novartis Investigative Site

    Madrid, 28040

    Recruiting

  • Novartis Investigative Site

    Madrid, 28041

    Recruiting

  • Novartis Investigative Site

    Madrid, 280796

    Recruiting

  • Novartis Investigative Site

    Pamplona, Navarre, 31008

    Recruiting

  • Novartis Investigative Site

    Salamanca, 37007

    Recruiting

Other trials in Spain

Greece7 sites, 7 recruiting

  • Novartis Investigative Site

    Athens, 115 27

    Recruiting

  • Novartis Investigative Site

    Chaïdári, 124 62

    Recruiting

  • Novartis Investigative Site

    Heraklion Crete., 715 00

    Recruiting

  • Novartis Investigative Site

    Ioannina, 455 00

    Recruiting

  • Novartis Investigative Site

    Pátrai, 265 04

    Recruiting

  • Novartis Investigative Site

    Thessaloniki, 54636

    Recruiting

  • Novartis Investigative Site

    Thessaloniki, 570 10

    Recruiting

Other trials in Greece

Italy7 sites, 7 recruiting

  • Novartis Investigative Site

    Bari, BA, 70124

    Recruiting

  • Novartis Investigative Site

    Brescia, BS, 25123

    Recruiting

  • Novartis Investigative Site

    Milan, MI, 20122

    Recruiting

  • Novartis Investigative Site

    Naples, 80131

    Recruiting

  • Novartis Investigative Site

    Ranica, BG, 24020

    Recruiting

  • Novartis Investigative Site

    Roma, RM, 00165

    Recruiting

  • Novartis Investigative Site

    Torino, TO, 10126

    Recruiting

Other trials in Italy

Poland7 sites, 6 recruiting

  • Novartis Investigative Site

    Bialystok, 15-540

    Recruiting

  • Novartis Investigative Site

    Krakow, 30-688

    Recruiting

  • Novartis Investigative Site

    Olsztyn, 10-561

    Recruiting

  • Novartis Investigative Site

    Poznan, Greater Poland Voivodeship, 60-355

    Recruiting

  • Novartis Investigative Site

    Warsaw, 02-006

    Recruiting

  • Novartis Investigative Site

    Warsaw, 02-097

    Recruiting

  • Novartis Investigative Site

    Wroclaw, 50-417

    Withdrawn

Other trials in Poland

Argentina6 sites, 6 recruiting

  • Novartis Investigative Site

    Buenos Aires, W3400ABH

    Recruiting

  • Novartis Investigative Site

    CABA, Buenos Aires, C1425AGC

    Recruiting

  • Novartis Investigative Site

    CABA, Buenos Aires, C1425EFD

    Recruiting

  • Novartis Investigative Site

    CABA, C1181ACH

    Recruiting

  • Novartis Investigative Site

    Córdoba, Córdoba Province, X5000

    Recruiting

  • Novartis Investigative Site

    Santa Fe, S3000EPV

    Recruiting

Other trials in Argentina

Turkey (Türkiye)6 sites, 6 recruiting

  • Novartis Investigative Site

    Ankara, Yenimahalle, 06500

    Recruiting

  • Novartis Investigative Site

    Istanbul, Fatih, 34093

    Recruiting

  • Novartis Investigative Site

    Izmir, Karsiyaka, 35575

    Recruiting

  • Novartis Investigative Site

    Kayseri, Melikgazi, 38039

    Recruiting

  • Novartis Investigative Site

    Köseköy, Kocaeli, 41380

    Recruiting

  • Novartis Investigative Site

    Mersin, Yenisehir, 33110

    Recruiting

Other trials in Turkey (Türkiye)

United Kingdom6 sites, 6 recruiting

  • Novartis Investigative Site

    Belfast, BT9 7AB

    Recruiting

  • Novartis Investigative Site

    Cardiff, CF14 4XW

    Recruiting

  • Novartis Investigative Site

    London, NW3 2QG

    Recruiting

  • Novartis Investigative Site

    London, WC1N 3JH

    Recruiting

  • Novartis Investigative Site

    Manchester, M13 9WL

    Recruiting

  • Novartis Investigative Site

    Salford, M6 8HD

    Recruiting

Other trials in United Kingdom

Canada5 sites, 5 recruiting

  • Novartis Investigative Site

    Etobicoke, Ontario, M9W 6V1

    Recruiting

  • Novartis Investigative Site

    London, Ontario, N6A 5W9

    Recruiting

  • Novartis Investigative Site

    Montreal, Quebec, H2X 1R9

    Recruiting

  • Novartis Investigative Site

    Montreal, Quebec, H3T 1C5

    Recruiting

  • Novartis Investigative Site

    Toronto, Ontario, M5G 2C4

    Recruiting

Other trials in Canada

France5 sites, 5 recruiting

  • Novartis Investigative Site

    Marseille, 13005

    Recruiting

  • Novartis Investigative Site

    Montpellier, 34295

    Recruiting

  • Novartis Investigative Site

    Paris, 75015

    Recruiting

  • Novartis Investigative Site

    Rennes, 35033

    Recruiting

  • Novartis Investigative Site

    Toulouse, 31054

    Recruiting

Other trials in France

India5 sites, 5 recruiting

  • Novartis Investigative Site

    Bangalore, Karnataka, 560004

    Recruiting

  • Novartis Investigative Site

    Hyderabad, Telangana, 500082

    Recruiting

  • Novartis Investigative Site

    Nagpur, Maharashtra, 440015

    Recruiting

  • Novartis Investigative Site

    New Delhi, National Capital Territory of Delhi, 110029

    Recruiting

  • Novartis Investigative Site

    Pune, Maharashtra, 411011

    Recruiting

Other trials in India

Japan5 sites, 5 recruiting

  • Novartis Investigative Site

    Fuchū, Tokyo, 1838561

    Recruiting

  • Novartis Investigative Site

    Hachiōji, Tokyo, 193-0998

    Recruiting

  • Novartis Investigative Site

    Okayama, 7008558

    Recruiting

  • Novartis Investigative Site

    Osaka, 558-8558

    Recruiting

  • Novartis Investigative Site

    Toyoake, Aichi-ken, 4701192

    Recruiting

Other trials in Japan

Israel3 sites, 3 recruiting

  • Novartis Investigative Site

    Haifa, 3109601

    Recruiting

  • Novartis Investigative Site

    Jerusalem, 9103102

    Recruiting

  • Novartis Investigative Site

    Petah Tikva, 4920235

    Recruiting

Other trials in Israel

Slovakia3 sites, 3 recruiting

  • Novartis Investigative Site

    Banská Bystrica, 975 17

    Recruiting

  • Novartis Investigative Site

    Košice, 041 90

    Recruiting

  • Novartis Investigative Site

    Martin, Slovakia, 036 59

    Recruiting

Other trials in Slovakia

Switzerland3 sites, 2 recruiting

  • Novartis Investigative Site

    Bern, 3010

    Recruiting

  • Novartis Investigative Site

    Lausanne, 1011

    Withdrawn

  • Novartis Investigative Site

    Zurich, 8091

    Recruiting

Other trials in Switzerland

Denmark2 sites, 2 recruiting

  • Novartis Investigative Site

    Aarhus N, 8200

    Recruiting

  • Novartis Investigative Site

    Copenhagen, DK-2100

    Recruiting

Other trials in Denmark

South Korea2 sites, 2 recruiting

  • Novartis Investigative Site

    Seoul, Seoul, 03080

    Recruiting

  • Novartis Investigative Site

    Seoul, 03722

    Recruiting

Other trials in South Korea

Czechia1 site, 1 recruiting

  • Novartis Investigative Site

    Prague, 128 08

    Recruiting

Other trials in Czechia

Netherlands1 site, 1 recruiting

  • Novartis Investigative Site

    Groningen, 9713 GZ

    Recruiting

Other trials in Netherlands

Taiwan1 site, 1 recruiting

  • Novartis Investigative Site

    Kaohsiung City, 81346

    Recruiting

Other trials in Taiwan

Vietnam1 site, 1 recruiting

  • Novartis Investigative Site

    Ho Chi Minh City, 700000

    Recruiting

Other trials in Vietnam

About this study

Official title: 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.

Read the 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.

Conditions
IC-MPGN
Being tested
Placebo, iptacopan
Keywords
LNP023, IC-MPGN, iptacopan, UPCR, eGFR, proteinuria
Medical subject headings
Proteinuria

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • PlaceboDrug

    Placebo to iptacopan 200mg b.i.d. (Adults 200mg b.i.d; Adolescents 2x 100mg b.i.d)

  • iptacopanDrug

    iptacopan 200 mg b.i.d. (Adults 200mg b.i.d; Adolescents 2x 100mg b.i.d)

Study groups in NCT05755386
Study groupRoleWhat they receive
iptacopan 200mg b.i.dExperimentaliptacopan 200mg b.i.d
Receives: Drug: iptacopan
Placebo to iptacopan 200mg b.i.d.Placebo comparatorPlacebo to iptacopan 200mg b.i.d.
Receives: Drug: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Log-transformed ratio to baseline in UPCR (sampled from a 24-hour urine collection) at 6 months.

    To demonstrate the superiority of iptacopan compared to placebo in reducing proteinuria at 6 months.

    Measured: 6 months (double-blind)

  2. Log-transformed ratio to baseline in UPCR at the 18-month visit (each study treatment arm)

    To evaluate the effect of iptacopan on proteinuria at 18 months.

    Measured: 18 months

  3. Log-transformed ratio to 12-month visit in UPCR at the 18-month visit in the placebo arm.

    To evaluate the effect of iptacopan on proteinuria at 18 months.

    Measured: 18 months

Secondary outcomes (9)

  1. Change from baseline in eGFR

    To demonstrate the superiority of iptacopan vs. placebo in improving estimated glomerular filtration rate (eGFR).

    Measured: 12 months and 18 months

  2. Change in eGFR from the 12-month visit to the 18- month visit of the placebo arm

    To evaluate the effect at 18 months of iptacopan in improving eGFR

    Measured: 18 months

  3. Proportion of patients achieved a composite renal endpoint

    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).

    Measured: 6 and 12 months

  4. Change from baseline in the Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-Fatigue) score.

    To demonstrate the superiority of iptacopan compared to placebo in improvement of patient-reported fatigue at 12 months (each study arm).

    Measured: 12 months

  5. Number of participants with abnormal vital signs, ECGs and safety laboratory measurements as well as study drug discontinuation due to an AE

    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

    Measured: up to 18 months

  6. Number of participants with clinically significant changes in heart rate, blood pressure, echocardiography parameters in adolescent patients

    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

    Measured: up to 18 months

  7. Annualized total eGFR slope estimated over 12 months.

    To demonstrate the superiority of iptacopan vs. placebo in stabilizing eGFR

    Measured: 12 months

  8. Log-transformed ratio to baseline in UPCR (sampled from a 24-hour urine collection) at 12 months.

    To demonstrate the superiority of iptacopan compared to placebo in reducing proteinuria at 12 months of treatment.

    Measured: 12 months

  9. Proportion of participants who achieved the composite renal endpoint at 18 months

    To evaluate the effect of iptacopan on proteinuria at 18 months

    Measured: 18 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted6 Mar 2023
  2. Study start2 Oct 2023
  3. Primary completion27 Oct 2028 (estimated)
  4. Study completion31 May 2029 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Triple blind
Who is masked
Participant, Care provider, Investigator
Enrolment
106 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05755386
Sponsor's protocol ID
CLNP023B12302
Other IDs
2022-002328-11
Acronym
APPARENT
Status last verified
Jul 2026
First submitted
23 Feb 2023
Last updated
13 Jul 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
Yes: 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
Expanded access
Available

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing iptacopan in people with IC-MPGN, run by Novartis Pharmaceuticals at 131 sites in 23 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 7 inclusion and 21 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 13 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 131 sites in United States, Brazil, Germany, Spain, Greece and 18 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Novartis Pharmaceuticals (1-888-669-6682, novartis.email@novartis.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Log-transformed ratio to baseline in UPCR (sampled from a 24-hour urine collection) at 6 months. (time frame: 6 months (double-blind)). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05755386.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Jul 2026.

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