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)

Status: Recruiting
Location: See all (104) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 3
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 12
Maximum Age: 60
Healthy Volunteers: f
View:

• 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.

Locations
United States
California
Ronald Reagan UCLA Medical Center
RECRUITING
Los Angeles
Univ Cali Irvine ALS Neuromuscular
RECRUITING
Orange
UCSF
RECRUITING
San Francisco
Olive View UCLA Medical Center
RECRUITING
Sylmar
Colorado
Childrens Hospital Colorado
RECRUITING
Aurora
Florida
Nicklaus Childrens Hospital
RECRUITING
Miami
Massachusetts
Boston Univ School of Medicine
RECRUITING
Boston
Massachusetts General Hospital
RECRUITING
Boston
Minnesota
University of Minnesota
RECRUITING
Minneapolis
New Mexico
University of New Mexico
RECRUITING
Albuquerque
New York
Col Uni Med Center New York Presby
RECRUITING
New York
Pennsylvania
Univ of Pennsylvania Medical Center
RECRUITING
Philadelphia
Texas
Prolato Clinical Research Center
RECRUITING
Houston
Baylor Scott and White Research
RECRUITING
Temple
Utah
University of Utah
RECRUITING
Salt Lake City
Wisconsin
University of Wisconsin
RECRUITING
Madison
Other Locations
Argentina
Novartis Investigative Site
RECRUITING
Buenos Aires
Novartis Investigative Site
RECRUITING
Buenos Aires
Novartis Investigative Site
RECRUITING
Caba
Novartis Investigative Site
RECRUITING
Caba
Brazil
Novartis Investigative Site
RECRUITING
Belo Horizonte
Novartis Investigative Site
RECRUITING
Botucatu
Novartis Investigative Site
WITHDRAWN
Brasília
Novartis Investigative Site
WITHDRAWN
Niterói
Novartis Investigative Site
RECRUITING
Porto Alegre
Novartis Investigative Site
RECRUITING
Recife
Novartis Investigative Site
WITHDRAWN
Rio De Janeiro
Novartis Investigative Site
RECRUITING
Salvador
Novartis Investigative Site
RECRUITING
Santo André
Novartis Investigative Site
RECRUITING
São Paulo
Novartis Investigative Site
RECRUITING
São Paulo
Novartis Investigative Site
RECRUITING
São Paulo
Novartis Investigative Site
WITHDRAWN
São Paulo
Canada
Novartis Investigative Site
RECRUITING
Etobicoke
Novartis Investigative Site
RECRUITING
Montreal
Novartis Investigative Site
RECRUITING
Montreal
Novartis Investigative Site
RECRUITING
Toronto
France
Novartis Investigative Site
RECRUITING
Marseille
Novartis Investigative Site
RECRUITING
Montpellier
Novartis Investigative Site
RECRUITING
Paris
Novartis Investigative Site
RECRUITING
Rennes
Novartis Investigative Site
RECRUITING
Toulouse
Germany
Novartis Investigative Site
RECRUITING
Berlin
Novartis Investigative Site
RECRUITING
Dresden
Novartis Investigative Site
RECRUITING
Essen
Novartis Investigative Site
RECRUITING
Hamburg
Novartis Investigative Site
RECRUITING
Hanover
Novartis Investigative Site
RECRUITING
Jena
Novartis Investigative Site
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Mainz
Novartis Investigative Site
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Munich
Novartis Investigative Site
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Ulm
Novartis Investigative Site
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Würzburg
Greece
Novartis Investigative Site
RECRUITING
Chaïdári
Novartis Investigative Site
RECRUITING
Pátrai
India
Novartis Investigative Site
RECRUITING
Bangalore
Novartis Investigative Site
RECRUITING
Hyderabad
Novartis Investigative Site
RECRUITING
Nagpur
Novartis Investigative Site
RECRUITING
New Delhi
Novartis Investigative Site
RECRUITING
Pune
Israel
Novartis Investigative Site
RECRUITING
Haifa
Novartis Investigative Site
RECRUITING
Jerusalem
Novartis Investigative Site
RECRUITING
Petah Tikva
Italy
Novartis Investigative Site
RECRUITING
Bari
Novartis Investigative Site
RECRUITING
Brescia
Novartis Investigative Site
RECRUITING
Milan
Novartis Investigative Site
RECRUITING
Napoli
Novartis Investigative Site
RECRUITING
Ranica
Novartis Investigative Site
RECRUITING
Roma
Novartis Investigative Site
RECRUITING
Torino
Japan
Novartis Investigative Site
RECRUITING
Fuchū
Novartis Investigative Site
RECRUITING
Hachiōji
Novartis Investigative Site
RECRUITING
Okayama
Novartis Investigative Site
RECRUITING
Osaka
Poland
Novartis Investigative Site
RECRUITING
Bialystok
Novartis Investigative Site
RECRUITING
Krakow
Novartis Investigative Site
RECRUITING
Olsztyn
Novartis Investigative Site
RECRUITING
Poznan
Novartis Investigative Site
RECRUITING
Warsaw
Novartis Investigative Site
RECRUITING
Warsaw
Novartis Investigative Site
WITHDRAWN
Wroclaw
Spain
Novartis Investigative Site
RECRUITING
Almería
Novartis Investigative Site
RECRUITING
Barcelona
Novartis Investigative Site
RECRUITING
Barcelona
Novartis Investigative Site
RECRUITING
Madrid
Novartis Investigative Site
RECRUITING
Madrid
Novartis Investigative Site
RECRUITING
Madrid
Novartis Investigative Site
RECRUITING
Pamplona
Novartis Investigative Site
RECRUITING
Salamanca
Switzerland
Novartis Investigative Site
RECRUITING
Bern
Novartis Investigative Site
RECRUITING
Lausanne
Novartis Investigative Site
RECRUITING
Zurich
Taiwan
Novartis Investigative Site
RECRUITING
Kaohsiung City
Turkey
Novartis Investigative Site
RECRUITING
Ankara
Novartis Investigative Site
RECRUITING
Istanbul
Novartis Investigative Site
RECRUITING
Izmir
Novartis Investigative Site
RECRUITING
Kayseri
Novartis Investigative Site
RECRUITING
Kocaeli
Novartis Investigative Site
RECRUITING
Mersin
United Kingdom
Novartis Investigative Site
RECRUITING
Belfast
Novartis Investigative Site
RECRUITING
Cardiff
Novartis Investigative Site
RECRUITING
London
Novartis Investigative Site
RECRUITING
Manchester
Viet Nam
Novartis Investigative Site
RECRUITING
Ho Chi Minh City
Novartis Investigative Site
RECRUITING
Ho Chi Minh City
Contact Information
Primary
Novartis Pharmaceuticals
novartis.email@novartis.com
1-888-669-6682
Backup
Novartis Pharmaceuticals
+41613241111
Time Frame
Start Date: 2023-10-02
Estimated Completion Date: 2029-05-31
Participants
Target number of participants: 106
Treatments
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.
Sponsors
Leads: Novartis Pharmaceuticals

This content was sourced from clinicaltrials.gov