A Multicenter Rollover Extension Program (REP) to Evaluate the Long-term Safety and Tolerability of Open Label Iptacopan in Adult Participants With Primary IgA Nephropathy Who Have Completed Study CLNP023X2203 or CLNP023A2301

Who is this study for? Adults with primary IgA nephropathy
What treatments are being studied? LNP023
Status: Recruiting
Location: See all (145) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 3
SUMMARY

The purpose of this study is to evaluate the long-term safety and tolerability, of open label iptacopan in primary IgA nephropathy participants who have completed either the CLNP023X2203 or CLNP023A2301 clinical trials. The open-label design of the current study is appropriate to provide study participants the opportunity to receive treatment with iptacopan until marketing authorizations are received and the drug product becomes commercially available while enabling collection of long-term safety and tolerability data for the investigational drug. Furthermore efficacy assessments conducted every 6 months will afford the opportunity to evaluate the clinical effects of iptacopan on long-term disease progression.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 100
Healthy Volunteers: f
View:

• For LNP023X2203, participants must have completed part 1 or part 2 of the trial. For LNP023A2301, participants must have completed the entire core trial defined as the full 24 month treatment period.

• eGFR\* ≥ 20 ml/min/1.73m2

• \*eGFR calculated using the CKD-EPI formula (or modified MDRD formula according to specific ethnic groups and local practice guidelines)

• Per investigator's clinical judgement, the participant may benefit from receiving the open-label treatment of iptacopan 200 mg b.i.d.

• Prior Vaccination against Neisseria meningitidis, Streptococcus pneumoniae and Haemophilus influenzae infections should be up to date (i.e. any boosters required administered according to local regulations.

• All participants must be on supportive care regimen of ACEi or ARB\* as per KDIGO guidelines.

⁃ participants who are not taking KDIGO guideline doses because they have documented allergies or intolerance to ACEi and ARB are eligible for the study

Locations
United States
Arizona
AZ Kidney Dise and Hypertension Ctr
RECRUITING
Glendale
California
Kaiser Permanente
RECRUITING
San Diego
North America Research Institute
RECRUITING
San Dimas
Colorado
University of Colorado Anschutz
ACTIVE_NOT_RECRUITING
Aurora
Delaware
Nephrology Associates PA
WITHDRAWN
Newark
Idaho
CaRe Research
RECRUITING
Chubbuck
Illinois
Nep Assoc of Northern Illinois
RECRUITING
Hinsdale
Massachusetts
Brigham and Womens Hosp Harvard Med School
RECRUITING
Boston
Maryland
Johns Hopkins Hospital
RECRUITING
Baltimore
Minnesota
Mayo Clinic Rochester
RECRUITING
Rochester
Missouri
Clinical Research Consultants LLC
ACTIVE_NOT_RECRUITING
Kansas City
New Jersey
New Jersey Kidney Care
RECRUITING
Jersey City
Nevada
DaVita Clinical Research
RECRUITING
Las Vegas
New York
Col Uni Med Center New York Presby
RECRUITING
New York
Texas
Prolato Clinical Research Center
WITHDRAWN
Houston
Other Locations
Argentina
Novartis Investigative Site
RECRUITING
Caba
Novartis Investigative Site
RECRUITING
Ciudad Autonoma De Buenos Aire
Novartis Investigative Site
ACTIVE_NOT_RECRUITING
Córdoba
Novartis Investigative Site
RECRUITING
Córdoba
Novartis Investigative Site
RECRUITING
Santa Fe
Australia
Novartis Investigative Site
RECRUITING
Adelaide
Novartis Investigative Site
RECRUITING
Parkville
Novartis Investigative Site
RECRUITING
Woolloongabba
Belgium
Novartis Investigative Site
RECRUITING
Edegem
Novartis Investigative Site
ACTIVE_NOT_RECRUITING
Leuven
Novartis Investigative Site
RECRUITING
Roeselare
Brazil
Novartis Investigative Site
RECRUITING
Belo Horizonte
Novartis Investigative Site
RECRUITING
Curitiba
Novartis Investigative Site
RECRUITING
Porto Alegre
Novartis Investigative Site
RECRUITING
São José Do Rio Preto
Novartis Investigative Site
RECRUITING
São Paulo
Novartis Investigative Site
RECRUITING
São Paulo
Canada
Novartis Investigative Site
WITHDRAWN
Oshawa
China
Novartis Investigative Site
ACTIVE_NOT_RECRUITING
Beijing
Novartis Investigative Site
RECRUITING
Beijing
Novartis Investigative Site
RECRUITING
Beijing
Novartis Investigative Site
RECRUITING
Changchun
Novartis Investigative Site
RECRUITING
Changsha
Novartis Investigative Site
RECRUITING
Guangzhou
Novartis Investigative Site
RECRUITING
Guangzhou
Novartis Investigative Site
RECRUITING
Luoyang
Novartis Investigative Site
RECRUITING
Qingdao
Novartis Investigative Site
RECRUITING
Shanghai
Novartis Investigative Site
RECRUITING
Shanghai
Novartis Investigative Site
RECRUITING
Shanxi
Novartis Investigative Site
RECRUITING
Shenzhen
Novartis Investigative Site
RECRUITING
Taiyuan
Novartis Investigative Site
RECRUITING
Ürümqi
Novartis Investigative Site
RECRUITING
Wenzhou
Novartis Investigative Site
RECRUITING
Yinchuan
Colombia
Novartis Investigative Site
RECRUITING
Barranquilla
Novartis Investigative Site
RECRUITING
Medellín
Denmark
Novartis Investigative Site
ACTIVE_NOT_RECRUITING
Aalborg
Novartis Investigative Site
ACTIVE_NOT_RECRUITING
Arhus N
Novartis Investigative Site
RECRUITING
Copenhagen
Novartis Investigative Site
RECRUITING
Odense C
France
Novartis Investigative Site
ACTIVE_NOT_RECRUITING
Marseille
Novartis Investigative Site
RECRUITING
Montpellier
Novartis Investigative Site
ACTIVE_NOT_RECRUITING
Paris
Germany
Novartis Investigative Site
ACTIVE_NOT_RECRUITING
Aachen
Novartis Investigative Site
ACTIVE_NOT_RECRUITING
Berlin
Novartis Investigative Site
RECRUITING
Essen
Novartis Investigative Site
ACTIVE_NOT_RECRUITING
Freiburg Im Breisgau
Novartis Investigative Site
ACTIVE_NOT_RECRUITING
Hanover
Novartis Investigative Site
ACTIVE_NOT_RECRUITING
Heidelberg
Novartis Investigative Site
ACTIVE_NOT_RECRUITING
Magdeburg
Novartis Investigative Site
RECRUITING
Mainz
Novartis Investigative Site
ACTIVE_NOT_RECRUITING
Stuttgart
Novartis Investigative Site
ACTIVE_NOT_RECRUITING
Tübingen
Novartis Investigative Site
RECRUITING
Ulm
Hong Kong Special Administrative Region
Novartis Investigative Site
RECRUITING
Pokfulam
Hungary
Novartis Investigative Site
RECRUITING
Debrecen
India
Novartis Investigative Site
ACTIVE_NOT_RECRUITING
Bangalore
Novartis Investigative Site
RECRUITING
New Delhi
Novartis Investigative Site
RECRUITING
New Delhi
Israel
Novartis Investigative Site
ACTIVE_NOT_RECRUITING
Ashkelon
Novartis Investigative Site
ACTIVE_NOT_RECRUITING
Jerusalem
Novartis Investigative Site
RECRUITING
Petah Tikva
Italy
Novartis Investigative Site
RECRUITING
Bologna
Novartis Investigative Site
RECRUITING
Napoli
Japan
Novartis Investigative Site
RECRUITING
Chiba
Novartis Investigative Site
RECRUITING
Kasugai
Novartis Investigative Site
ACTIVE_NOT_RECRUITING
Kawasaki
Novartis Investigative Site
RECRUITING
Kyoto
Novartis Investigative Site
RECRUITING
Matsumoto
Novartis Investigative Site
RECRUITING
Niigata
Novartis Investigative Site
RECRUITING
Okayama
Novartis Investigative Site
RECRUITING
Ōmihachiman
Novartis Investigative Site
RECRUITING
Osaka
Novartis Investigative Site
RECRUITING
Osaka
Novartis Investigative Site
RECRUITING
Osaka
Novartis Investigative Site
RECRUITING
Sapporo
Novartis Investigative Site
RECRUITING
Sapporo
Novartis Investigative Site
WITHDRAWN
Sendai
Novartis Investigative Site
RECRUITING
Toyoake
Novartis Investigative Site
RECRUITING
Toyota
Novartis Investigative Site
RECRUITING
Yokohama
Novartis Investigative Site
RECRUITING
Yokohama
Malaysia
Novartis Investigative Site
RECRUITING
Kuala Lumpur
Novartis Investigative Site
RECRUITING
Kuala Lumpur
Mexico
Novartis Investigative Site
RECRUITING
Querétaro
Netherlands
Novartis Investigative Site
RECRUITING
Groningen
Norway
Novartis Investigative Site
ACTIVE_NOT_RECRUITING
Bergen
Novartis Investigative Site
ACTIVE_NOT_RECRUITING
Nordbyhagen
Republic of Korea
Novartis Investigative Site
RECRUITING
Busan
Novartis Investigative Site
RECRUITING
Cheongju-si
Novartis Investigative Site
RECRUITING
Seoul
Novartis Investigative Site
RECRUITING
Seoul
Novartis Investigative Site
RECRUITING
Seoul
Novartis Investigative Site
RECRUITING
Seoul
Novartis Investigative Site
RECRUITING
Seoul
Novartis Investigative Site
RECRUITING
Seoul
Novartis Investigative Site
RECRUITING
Seoul
Novartis Investigative Site
RECRUITING
Taegu
Russian Federation
Novartis Investigative Site
ACTIVE_NOT_RECRUITING
Rostov-on-don
Novartis Investigative Site
ACTIVE_NOT_RECRUITING
Saint Petersburg
Singapore
Novartis Investigative Site
RECRUITING
Singapore
Slovakia
Novartis Investigative Site
ACTIVE_NOT_RECRUITING
Košice
Slovenia
Novartis Investigative Site
RECRUITING
Ljubljana
Novartis Investigative Site
RECRUITING
Maribor
Spain
Novartis Investigative Site
RECRUITING
Barcelona
Novartis Investigative Site
RECRUITING
Pamplona
Novartis Investigative Site
RECRUITING
Salamanca
Sweden
Novartis Investigative Site
RECRUITING
Stockholm
Taiwan
Novartis Investigative Site
RECRUITING
Kaohsiung City
Novartis Investigative Site
RECRUITING
New Taipei City
Novartis Investigative Site
RECRUITING
New Taipei City
Novartis Investigative Site
RECRUITING
Taichung
Novartis Investigative Site
COMPLETED
Taichung
Novartis Investigative Site
RECRUITING
Taipei
Novartis Investigative Site
RECRUITING
Taoyuan District
Thailand
Novartis Investigative Site
ACTIVE_NOT_RECRUITING
Bangkok
Novartis Investigative Site
RECRUITING
Bangkok
Turkey
Novartis Investigative Site
RECRUITING
Ankara
Novartis Investigative Site
ACTIVE_NOT_RECRUITING
Istanbul
Novartis Investigative Site
ACTIVE_NOT_RECRUITING
Istanbul
Novartis Investigative Site
RECRUITING
Kocaeli
Novartis Investigative Site
RECRUITING
Mersin
Novartis Investigative Site
RECRUITING
Talas Kayseri
United Kingdom
Novartis Investigative Site
ACTIVE_NOT_RECRUITING
Cambridge
Novartis Investigative Site
ACTIVE_NOT_RECRUITING
Leicester
Novartis Investigative Site
RECRUITING
London
Novartis Investigative Site
ACTIVE_NOT_RECRUITING
Newcastle Upon Tyne
Novartis Investigative Site
RECRUITING
Salford
Viet Nam
Novartis Investigative Site
ACTIVE_NOT_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: 2021-09-20
Estimated Completion Date: 2032-11-11
Participants
Target number of participants: 540
Treatments
Experimental: LNP023
All participants are receiving 200 mg b.i.d
Related Therapeutic Areas
Sponsors
Leads: Novartis Pharmaceuticals

This content was sourced from clinicaltrials.gov