Phase
Condition
Lupus Nephritis
Kidney Disease
Nephritis
Treatment
Iptacopan (part 1)
Iptacopan (part 2)
Iptacopan + placebo
Clinical Study ID
Ages 18-100 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
Unequivocally positive ANA test result and/or a positive anti dsDNA at screening Active biopsy-proven lupus nephritis within 3 months of screening demonstrating Class III or IV lupus nephritis with or without co-existing features of Class V lupus nephritis.
Documentation of active renal disease at the time of screening necessitating the commencement of therapy with corticosteroids in combination with MMF/MPS.
eGFR ≥ 30 ml/min/1.73 m2 Vaccination against Neisseria meningitidis and Streptococcus pneumoniae infections Vaccination against Haemophilus influenzae infection Supportive care including stable dose regimen of anti-malarials (e.g. hydroxychloroquine) unless contraindicated, ACEi or ARB at either locally approved maximal daily dose or the maximally tolerated dose (per investigators' judgement) at screening, as per the local clinical practice. Doses should remain stable throughout the study.
First presentation or flare of lupus nephritis.
Exclusion
Exclusion Criteria:
Induction treatment with cyclophosphamide within 3 months of planned treatment for this study; treatment with calcineurin inhibitors within the previous 3 months prior to randomization.
Presence of rapidly progressive glomerulonephritis (RPGN) as defined by 50% decline in eGFR within 3 months prior to screening.
Renal biopsy presenting with interstitial fibrosis/tubular atrophy (IF/TA) or glomerulosclerosis of more than 50%, or which in the opinion of the investigator is such that it precludes likely response to immunosuppressive therapy.
Participants being treated with systemic corticosteroids (>5 mg/day prednisone or equivalent) for indications other than SLE or LN e.g. acute asthma, inflammatory bowel disease.
Participants being treated with systemic corticosteroids for SLE or LN will be excluded if they have taken more than an average of 15 mg/day prednisone (or equivalent) in the previous 4 weeks and more than an average of 30 mg/day in the previous 1 week Receipt of more than a total dose of 1000 mg equivalent i.v. pulse methylprednisolone (cumulative dose) within 2 weeks prior to enrollment (and at enrollment)
Other protocol-defined inclusion/exclusion criteria may apply
Study Design
Study Description
Connect with a study center
Novartis Investigative Site
Rosario, Santa Fe 2000
ArgentinaActive - Recruiting
Novartis Investigative Site
San Luis, 5700
ArgentinaActive - Recruiting
Novartis Investigative Site
Santa Fe, S3000EPV
ArgentinaActive - Recruiting
Novartis Investigative Site
Salvador, BA 40150 150
BrazilActive - Recruiting
Novartis Investigative Site
Belo Horizonte, MG 30150-221
BrazilActive - Recruiting
Novartis Investigative Site
Juiz de Fora, MG 36010 570
BrazilActive - Recruiting
Novartis Investigative Site
Sao Paulo, SP 05403 000
BrazilActive - Recruiting
Novartis Investigative Site
Barretos, Sao Paulo 14784 400
BrazilActive - Recruiting
Novartis Investigative Site
Nanning, Guangxi 530021
ChinaActive - Recruiting
Novartis Investigative Site
Shenyang, Liaoning 110003
ChinaActive - Recruiting
Novartis Investigative Site
Yinchuan, Ningxia 100039
ChinaActive - Recruiting
Novartis Investigative Site
Beijing, 100034
ChinaActive - Recruiting
Novartis Investigative Site
Shenzhen, 518036
ChinaActive - Recruiting
Novartis Investigative Site
Wuhan, 430022
ChinaActive - Recruiting
Novartis Investigative Site
Bogota, Cundinamarca 111411
ColombiaActive - Recruiting
Novartis Investigative Site
Bucaramanga, Santander 0001
ColombiaActive - Recruiting
Novartis Investigative Site
Barranquilla, 080020
ColombiaActive - Recruiting
Novartis Investigative Site
Monteria, 230004
ColombiaActive - Recruiting
Novartis Investigative Site
Marseille, 13385
FranceActive - Recruiting
Novartis Investigative Site
Nantes Cedex 1, 44093
FranceActive - Recruiting
Novartis Investigative Site
Paris, 75015
FranceActive - Recruiting
Novartis Investigative Site
Strasbourg Cedex, 67091
FranceActive - Recruiting
Novartis Investigative Site
Frankfurt am Main, Hessen 60590
GermanySite Not Available
Novartis Investigative Site
Braunschweig, Niedersachsen 38126
GermanyActive - Recruiting
Novartis Investigative Site
Koeln, Nordrhein-Westfalen 51109
GermanyActive - Recruiting
Novartis Investigative Site
Berlin, 13353
GermanyActive - Recruiting
Novartis Investigative Site
Frankfurt, 60590
GermanySite Not Available
Novartis Investigative Site
Ludwigshafen, 67063
GermanyActive - Recruiting
Novartis Investigative Site
Mainz, 55131
GermanyActive - Recruiting
Novartis Investigative Site
Muenchen, 81377
GermanyActive - Recruiting
Novartis Investigative Site
Pokfulam,
Hong KongActive - Recruiting
Novartis Investigative Site
Budapest, H-1083
HungaryActive - Recruiting
Novartis Investigative Site
Debrecen, 4032
HungaryActive - Recruiting
Novartis Investigative Site
Szeged, 6720
HungaryActive - Recruiting
Novartis Investigative Site
Ahmedabad, Gujarat 380015
IndiaSite Not Available
Novartis Investigative Site
Kozhikode, Kerala 673008
IndiaActive - Recruiting
Novartis Investigative Site
Vellore, Tamil Nadu 632 004
IndiaActive - Recruiting
Novartis Investigative Site
Hyderabad, Telangana 500082
IndiaActive - Recruiting
Novartis Investigative Site
Lucknow, Uttar Pradesh 226014
IndiaActive - Recruiting
Novartis Investigative Site
New Delhi, 110029
IndiaActive - Recruiting
Novartis Investigative Site
Puducherry, 607403
IndiaSite Not Available
Novartis Investigative Site
Ashkelon, 78278
IsraelSite Not Available
Novartis Investigative Site
Jerusalem, 9112001
IsraelActive - Recruiting
Novartis Investigative Site
Ramat Gan, 52621
IsraelActive - Recruiting
Novartis Investigative Site
Kuantan, Pahang 25100
MalaysiaActive - Recruiting
Novartis Investigative Site
Taiping, Perak 34000
MalaysiaActive - Recruiting
Novartis Investigative Site
Selangor Darul Ehsan, 68100
MalaysiaActive - Recruiting
Novartis Investigative Site
Tampico, Tamaulipas 89440
MexicoActive - Recruiting
Novartis Investigative Site
Merida, Yucatan 97070
MexicoActive - Recruiting
Novartis Investigative Site
Aguascalientes, 20230
MexicoActive - Recruiting
Novartis Investigative Site
Veracruz, 91900
MexicoActive - Recruiting
Novartis Investigative Site
Makati, Metro Manila 1218
PhilippinesActive - Recruiting
Novartis Investigative Site
Iloilo, 5000
PhilippinesActive - Recruiting
Novartis Investigative Site
Quezon, 1102
PhilippinesActive - Recruiting
Novartis Investigative Site
Carnaxide, Lisboa 2799 523
PortugalActive - Recruiting
Novartis Investigative Site
Carnaxide - Linda-A-Velha, Lisboa 2790-134
PortugalSite Not Available
Novartis Investigative Site
Coimbra, 3000 075
PortugalActive - Recruiting
Novartis Investigative Site
Lisboa, 1649 035
PortugalActive - Recruiting
Novartis Investigative Site
Porto, 4200 319
PortugalActive - Recruiting
Novartis Investigative Site
Vila Nova De Gaia, 4434 502
PortugalActive - Recruiting
Novartis Investigative Site
Vila Nova de Gaia, 4434 502
PortugalActive - Recruiting
FDI Clinical Research
San Juan, 00927
Puerto RicoActive - Recruiting
Novartis Investigative Site
San Juan, 00927
Puerto RicoActive - Recruiting
Novartis Investigative Site
Singapore, S308433
SingaporeActive - Recruiting
Novartis Investigative Site
Sevilla, Andalucia 41009
SpainActive - Recruiting
Novartis Investigative Site
Barcelona, Catalunya 08036
SpainActive - Recruiting
Novartis Investigative Site
Puerto De Sagunto, Comunidad Valenciana 46520
SpainActive - Recruiting
Novartis Investigative Site
Ciudad Real, 13005
SpainActive - Recruiting
Novartis Investigative Site
Madrid, 28040
SpainActive - Recruiting
Novartis Investigative Site
Ankara, Cankaya 06800
TurkeyActive - Recruiting
Novartis Investigative Site
Bursa, Gorukle 16059
TurkeyActive - Recruiting
Novartis Investigative Site
Istanbul, 34093
TurkeyActive - Recruiting
Novartis Investigative Site
Mersin, 33110
TurkeyActive - Recruiting
Novartis Investigative Site
Talas / Kayseri, 38039
TurkeySite Not Available
Novartis Investigative Site
Talas Kayseri, 38039
TurkeyActive - Recruiting
Novartis Investigative Site
Cambridge, CB2 0QQ
United KingdomActive - Recruiting
Novartis Investigative Site
Leicester, LE5 4PW
United KingdomActive - Recruiting
AKDHC Medical Research ServicesLLC
Phoenix, Arizona 85016
United StatesSite Not Available
Novartis Investigative Site
Phoenix, Arizona 85016
United StatesActive - Recruiting
Kaiser Permanente Fontana
Fontana, California 92335
United StatesActive - Recruiting
Univ Calif Irvine
Irvine, California 92697
United StatesActive - Recruiting
Loma Linda University
Loma Linda, California 92354
United StatesActive - Recruiting
Ronald Reagan UCLA Medical Center
Los Angeles, California 90095
United StatesActive - Recruiting
Olive View UCLA Medical Center
Sylmar, California 91342
United StatesActive - Recruiting
University of Colorado Denver
Aurora, Colorado 80045
United StatesActive - Recruiting
Royal Research Corp
Hollywood, Florida 33021
United StatesActive - Recruiting
Mayo Clinic Jacksonville
Jacksonville, Florida 32224
United StatesActive - Recruiting
Nephrology Associates Of Central FL
Orlando, Florida 32806
United StatesActive - Recruiting
Florida Kidney Physicians
Riverview, Florida 33578
United StatesActive - Recruiting
Nep Assoc of Northern Illinois
Hinsdale, Illinois 60521
United StatesActive - Recruiting
Novartis Investigative Site
Hinsdale, Illinois 60521
United StatesActive - Recruiting
Wichita Community Clcl Onco Program
Wichita, Kansas 67214
United StatesActive - Recruiting
Ochsner Health System
New Orleans, Louisiana 70121
United StatesActive - Recruiting
Johns Hopkins Hospital
Baltimore, Maryland 21287
United StatesActive - Recruiting
Novartis Investigative Site
Baltimore, Maryland 21287
United StatesActive - Recruiting
Brigham and Womens Hosp Harvard Med School
Boston, Massachusetts 02115
United StatesActive - Recruiting
Mayo Clinic Rochester
Rochester, Minnesota 55905
United StatesActive - Recruiting
University of Nebraska Medical Center
Omaha, Nebraska 68198
United StatesActive - Recruiting
Stony Brook Internists PC
East Setauket, New York 11733
United StatesActive - Recruiting
Temple University
Philadelphia, Pennsylvania 19140
United StatesActive - Recruiting
Allegheny Health Network
Pittsburgh, Pennsylvania 15212
United StatesActive - Recruiting
Dallas Nephrology Associates
Dallas, Texas 75204
United StatesActive - Recruiting
Prolato Clinical Research Center
Houston, Texas 77054
United StatesActive - Recruiting
Virginia Commonwealth University
Richmond, Virginia 23298
United StatesActive - Recruiting
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