Recruiting
Phase 3

Iptacopan

Sponsor:

Novartis Pharmaceuticals

Code:

NCT05755386

Conditions

IC-MPGN

Eligibility Criteria

Sex: All

Age: 12 - 60

Healthy Volunteers: Not accepted

Interventions

Placebo

iptacopan

Study Details

Brief 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.

Conditions

IC-MPGN

Study ID

NCT05755386

Start date

Oct 2, 2023

Status verified date

Jul, 2026

Completion date

May 31, 2029

Anticipated

Primary completion date

Oct 27, 2028

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 12 - 60

Healthy Volunteers: Not accepted

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 Design

Enrollment

106 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: iptacopan 200mg b.i.d

iptacopan 200mg b.i.d

placebo comparator: Placebo to iptacopan 200mg b.i.d.

Placebo to iptacopan 200mg b.i.d.

Interventions

Placebo

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

iptacopan

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

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) ]
  • Log-transformed ratio to baseline in UPCR at the 18-month visit (each study treatment arm) [ Time Frame: 18 months ]
  • Log-transformed ratio to 12-month visit in UPCR at the 18-month visit in the placebo arm. [ Time Frame: 18 months ]

Central Contacts and Locations

Central contacts

Novartis Pharmaceuticals

1-888-669-6682novartis.email@novartis.com

Novartis Pharmaceuticals

+41613241111

Locations

Ronald Reagan UCLA Medical Center

Recruiting

Los Angeles, California, United States, 90095

Contacts

Ahad Qureshi

ahadqureshi@mednet.ucla.edu

Principal Investigator:

Lama Abdelnour

Univ Cali Irvine ALS Neuromuscular

Recruiting

Orange, California, United States, 92868

Contacts

Nancy Ortega

nghernan@hs.uci.edu

Principal Investigator:

Ramy Hanna

UCSF

Recruiting

San Francisco, California, United States, 94115

Contacts

Juan Espinoza

+1 415 476 5892juan.espinoza@ucsf.edu

Principal Investigator:

Raymond Hsu

Olive View UCLA Medical Center

Recruiting

Sylmar, California, United States, 91342

Contacts

Rosario Machicado

RMachicado@dhs.lacounty.gov

Principal Investigator:

Phuong-Chi Pham

Childrens Hospital Colorado

Recruiting

Aurora, Colorado, United States, 80045

Contacts

Kati Dugan

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

Principal Investigator:

Bradley Dixon

Nicklaus Childrens Hospital

Recruiting

Miami, Florida, United States, 33155

Contacts

Moya Chang

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

Principal Investigator:

Ana Paredes

Emory University School of Medicine-Winship Cancer Institute

Recruiting

Atlanta, Georgia, United States, 30322

Contacts

Heather Jung

heather.jung@emory.edu

Principal Investigator:

Laurence Larry Greenbaum

Massachusetts General Hospital

Recruiting

Boston, Massachusetts, United States, 02114

Contacts

Andrew Cao

acao6@mgh.harvard.edu

Principal Investigator:

Meghan Sise

Boston Univ School of Medicine

Recruiting

Boston, Massachusetts, United States, 02118

Contacts

Kemberlie Adolphe

kemberlie.adolphe@bmc.org

Principal Investigator:

Jean Francis

University of Minnesota

Recruiting

Minneapolis, Minnesota, United States, 55455

Contacts

Karen Omlung

+1 612 262 2750seve0024@umn.edu

Principal Investigator:

Nattawat Klomjit

Washington University in St Louis

Recruiting

St Louis, Missouri, United States, 63110

Contacts

Michelle Bloom

+1 314 362 5298mbloom@wustl.edu

Principal Investigator:

Tingting Li

University of New Mexico

Recruiting

Albuquerque, New Mexico, United States, 87131-0001

Contacts

Susan L Tigert

+1 505 272 9992STigert@salud.unm.edu

Principal Investigator:

Namita Singh

Col Uni Med Center New York Presby

Recruiting

New York, New York, United States, 10032

Contacts

Anup Pradhan

+1 212 304 5684arp2209@cumc.columbia.edu

Principal Investigator:

Andrew S Bomback

University Of Cincinnati

Recruiting

Cincinnati, Ohio, United States, 45267

Contacts

Leksi Travitz

Leksi.travitz@uc.edu

Principal Investigator:

Indraneel Reddy

OHSU Dept of Nephrology

Recruiting

Portland, Oregon, United States, 97239

Contacts

Madison Stanaway

+1 503 494 4233stanaway@ohsu.edu

Principal Investigator:

Rupali Avasare

Univ of Pennsylvania Medical Center

Recruiting

Philadelphia, Pennsylvania, United States, 19104

Contacts

Cammy Truong

cammy.truong@pennmedicine.upenn.edu

Principal Investigator:

Gaia Coppock

MUSC Health Lancaster Med Ctr

Recruiting

Lancaster, South Carolina, United States, 29720

Contacts

Darann Wiegand

wiegandd@musc.edu

Principal Investigator:

Prince Anand

UT Southwestern Medical Center

Recruiting

Dallas, Texas, United States, 75235

Contacts

Melaku Lemma

melaku.lemma@childrens.com

Principal Investigator:

Jyothsna Gattineni

Prolato Clinical Research Center

Recruiting

Houston, Texas, United States, 77054

Contacts

Romeo Parada

+1 832 338 9118rparada@prolato.org

Principal Investigator:

Sreedhar Mandayam

Baylor Scott and White Research

Recruiting

Temple, Texas, United States, 76502

Contacts

Stephanie McMeen

+1 254 935 5838stephanie.mcmeen@bswhealth.org

Principal Investigator:

Mohanram Narayanan

University of Utah

Recruiting

Salt Lake City, Utah, United States, 84113

Contacts

Gabriella Gourdin

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

Principal Investigator:

Raoul Nelson

University of Wisconsin

Recruiting

Madison, Wisconsin, United States, 53792

Contacts

Alana Quackenbush

+1 608 265 6020akquackenbus@wisc.edu

Principal Investigator:

Sharon Bartosh

Novartis Investigative Site

Recruiting

Etobicoke, Ontario, Canada, M9W 6V1

Novartis Investigative Site

Recruiting

London, Ontario, Canada, N6A 5W9

Novartis Investigative Site

Recruiting

Toronto, Ontario, Canada, M5G 2C4

Novartis Investigative Site

Recruiting

Montreal, Quebec, Canada, H2X 1R9

Novartis Investigative Site

Recruiting

Montreal, Quebec, Canada, H3T 1C5

More Information

Sponsor

Novartis Pharmaceuticals

Last update posted

Jul 13, 2026

Last verified

Jul, 2026

Keywords

  • LNP023
  • IC-MPGN
  • iptacopan
  • UPCR
  • eGFR
  • proteinuria

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-08. This information was provided to ClinicalTrials.gov by Novartis Pharmaceuticals on 2026-07-13.