Study of Efficacy and Safety of Iptacopan in Participants With IC-MPGN
NCT ID: NCT05755386
Last Updated: 2025-12-30
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE3
106 participants
INTERVENTIONAL
2023-10-02
2029-05-31
Brief Summary
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Detailed Description
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Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
TRIPLE
Study Groups
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iptacopan 200mg b.i.d
iptacopan 200mg b.i.d
iptacopan
iptacopan 200 mg b.i.d. (Adults 200mg b.i.d; Adolescents 2x 100mg b.i.d)
Placebo to iptacopan 200mg b.i.d.
Placebo to iptacopan 200mg b.i.d.
Placebo
Placebo to iptacopan 200mg b.i.d. (Adults 200mg b.i.d; Adolescents 2x 100mg b.i.d)
Interventions
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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)
Eligibility Criteria
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Inclusion Criteria
* 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 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
12 Years
60 Years
ALL
No
Sponsors
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Novartis Pharmaceuticals
INDUSTRY
Responsible Party
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Principal Investigators
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Novartis Pharmaceuticals
Role: STUDY_DIRECTOR
Novartis Pharmaceuticals
Locations
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Ronald Reagan UCLA Medical Center
Los Angeles, California, United States
Univ Cali Irvine ALS Neuromuscular
Orange, California, United States
UCSF
San Francisco, California, United States
Olive View UCLA Medical Center
Sylmar, California, United States
Childrens Hospital Colorado
Aurora, Colorado, United States
Nicklaus Childrens Hospital
Miami, Florida, United States
Massachusetts General Hospital
Boston, Massachusetts, United States
Boston Univ School of Medicine
Boston, Massachusetts, United States
University of Minnesota
Minneapolis, Minnesota, United States
University of New Mexico
Albuquerque, New Mexico, United States
Col Uni Med Center New York Presby
New York, New York, United States
Univ of Pennsylvania Medical Center
Philadelphia, Pennsylvania, United States
Prolato Clinical Research Center
Houston, Texas, United States
Baylor Scott and White Research
Temple, Texas, United States
University of Utah
Salt Lake City, Utah, United States
University of Wisconsin
Madison, Wisconsin, United States
Novartis Investigative Site
CABA, Buenos Aires, Argentina
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CABA, Buenos Aires, Argentina
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Buenos Aires, , Argentina
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CABA, , Argentina
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Brasília, Federal District, Brazil
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Belo Horizonte, Minas Gerais, Brazil
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Recife, Pernambuco, Brazil
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Niterói, Rio de Janeiro, Brazil
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Rio de Janeiro, Rio de Janeiro, Brazil
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Porto Alegre, Rio Grande do Sul, Brazil
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Botucatu, São Paulo, Brazil
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Santo André, São Paulo, Brazil
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Sao Jose Rio Preto, São Paulo, Brazil
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São Paulo, São Paulo, Brazil
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São Paulo, São Paulo, Brazil
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São Paulo, São Paulo, Brazil
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Salvador, , Brazil
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Etobicoke, Ontario, Canada
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Toronto, Ontario, Canada
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Montreal, Quebec, Canada
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Montreal, Quebec, Canada
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Prague, , Czechia
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Marseille, , France
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Montpellier, , France
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Paris, , France
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Rennes, , France
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Toulouse, , France
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Munich, Bavaria, Germany
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Würzburg, Bavaria, Germany
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Dresden, Saxony, Germany
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Jena, Thuringia, Germany
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Berlin, , Germany
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Essen, , Germany
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Hamburg, , Germany
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Hanover, , Germany
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Mainz, , Germany
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Ulm, , Germany
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Athens, , Greece
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Chaïdári, , Greece
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Heraklion Crete., , Greece
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Ioannina, , Greece
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Pátrai, , Greece
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Thessaloniki, , Greece
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Bangalore, Karnataka, India
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Nagpur, Maharashtra, India
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Pune, Maharashtra, India
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New Delhi, National Capital Territory of Delhi, India
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Hyderabad, Telangana, India
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Haifa, , Israel
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Jerusalem, , Israel
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Petah Tikva, , Israel
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Bari, BA, Italy
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Ranica, BG, Italy
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Brescia, BS, Italy
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Milan, MI, Italy
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Roma, RM, Italy
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Torino, TO, Italy
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Napoli, , Italy
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Fuchū, Tokyo, Japan
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Hachiōji, Tokyo, Japan
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Okayama, , Japan
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Osaka, , Japan
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Groningen, , Netherlands
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Poznan, Greater Poland Voivodeship, Poland
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Bialystok, , Poland
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Krakow, , Poland
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Olsztyn, , Poland
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Warsaw, , Poland
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Warsaw, , Poland
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Wroclaw, , Poland
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Martin, Slovakia, Slovakia
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Košice, , Slovakia
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Seoul, Korea, South Korea
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Seoul, , South Korea
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Pamplona, Navarre, Spain
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Almería, , Spain
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Barcelona, , Spain
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Barcelona, , Spain
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Madrid, , Spain
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Madrid, , Spain
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Madrid, , Spain
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Salamanca, , Spain
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Bern, , Switzerland
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Lausanne, , Switzerland
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Zurich, , Switzerland
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Kaohsiung City, , Taiwan
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Istanbul, Fatih, Turkey (Türkiye)
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Izmir, Karsiyaka, Turkey (Türkiye)
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Köseköy, Kocaeli, Turkey (Türkiye)
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Kayseri, Melikgazi, Turkey (Türkiye)
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Ankara, Yenimahalle, Turkey (Türkiye)
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Mersin, Yenisehir, Turkey (Türkiye)
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Belfast, , United Kingdom
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Cardiff, , United Kingdom
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London, , United Kingdom
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Manchester, , United Kingdom
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Salford, , United Kingdom
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Ho Chi Minh City, , Vietnam
Countries
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Central Contacts
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Novartis Pharmaceuticals
Role: CONTACT
Phone: +41613241111
Facility Contacts
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Ahad Qureshi
Role: primary
Nancy Ortega
Role: primary
Juan Espinoza
Role: primary
Rosario Machicado
Role: primary
Kati Dugan
Role: primary
Moya Chang
Role: primary
Andrew Cao
Role: primary
Beth Hakamy
Role: primary
Karen Omlung
Role: primary
Susan L Tigert
Role: primary
Anup Pradhan
Role: primary
Fabrizio Angeles
Role: primary
Romeo Parada
Role: primary
Stephanie McMeen
Role: primary
Gabriella Gourdin
Role: primary
Alana Quackenbush
Role: primary
Related Links
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WCN24-1146 SAFETY AND EFFICACY OF IPTACOPAN IN ADOLESCENT PATIENTS WITH IC-MPGN in Elsivier Journal
Other Identifiers
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2022-002328-11
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
CLNP023B12302
Identifier Type: -
Identifier Source: org_study_id