Phase
Condition
Kidney Disease
Nephropathy
Nephrotic Syndrome
Treatment
Methylprednisolone
Diphenhydramine Hydrochloride
MMF
Clinical Study ID
Ages 2-25 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
Diagnosis of frequently relapsing nephrotic syndrome (FRNS) or steroid dependentnephrotic syndrome (SDNS) before the age of 18 years
Must be in complete remission defined by the absence of edema, UPCR <= 0.2 g/g atscreening and have three consecutive daily urine dipstick readings of trace ornegative for protein within the week prior to randomization
Must have had at least one relapse in the 6 months prior to screening, afterdiscontinuation of or while receiving oral corticosteroids and/or immunosuppressivetherapy to prevent relapses
Participants having received cyclophosphamide in the 6 months prior to randomizationmust have experienced at least 1 relapse subsequent to cyclophosphamidediscontinuation
Estimated glomerular filtration rate (eGFR) within normal range for age
For females of childbearing potential: participants who agree to remain abstinent (refrain from heterosexual intercourse) or use highly effective contraception,during the treatment period and for 18 months after the final dose of obinutuzumaband for 6 weeks after the final dose of MMF
For males: participants who agree to remain abstinent (refrain from heterosexualintercourse) or use contraceptive methods, and agree to refrain from donating spermduring the treatment period and for 90 days after the final dose of MMF
Exclusion
Exclusion Criteria:
Secondary nephrotic syndrome
History of steroid resistant nephrotic syndrome
History of genetic defects known to directly cause nephrotic syndrome
Treatment with other immunosuppressive medications to prevent relapse, other thanMMF or oral corticosteroids within 2 months prior to randomization
Pregnancy or breastfeeding or intending to become pregnant during the study orwithin 18 months after the final dose of obinutuzumab, or within 6 weeks after thefinal dose of MMF
Females of childbearing potential, including those who have had a tubal ligation,must have a negative serum pregnancy test result within 28 days prior to initiationof study treatment and a negative urine pregnancy test at Day 1, prior torandomization
History of organ or bone marrow transplant
Participation in another therapeutic trial within 30 days of enrollment or 5half-lives of the investigational drug
Intolerance or contraindication to study therapies
Participants demonstrating prior treatment failure to MMF as defined by two or morerelapses in any 6-month period of time while receiving MMF for at least a 6-monthduration
Participants in the judgment of the investigator likely to require systemiccorticosteroids for reasons other than idiopathic nephrotic syndrome during thestudy
Active infection of any kind or any major episode of infection requiringhospitalization or treatment with IV anti-infective medications within 4 weeks priorto screening, or completion of oral anti-infectives within 2 weeks prior torandomization
History of or currently active primary or secondary immunodeficiency, includingknown history of human immunodeficiency virus (HIV) infection and other severeImmunodeficiency blood disorders
History of progressive multifocal leukoencephalopathy
History of or current cancer, including solid tumors, hematological malignancies,and carcinoma in situ within the past 5 years
Major surgery requiring hospitalization during the 4 weeks prior to screening orduring screening
High risk for clinically significant bleeding or any condition requiringplasmapheresis, intravenous immunoglobulin, or acute blood product transfusions
Evidence of any significant or uncontrolled concomitant disease that, in theinvestigator's judgment, would preclude participant's participation, including butnot limited to nervous system, respiratory, cardiac, hepatic, endocrine, malignant,or gastrointestinal disorders
Currently active alcohol or drug abuse or history of alcohol or drug abuse
Study Design
Connect with a study center
Hôpital Universitaire des Enfants Reine Fabiola
Brussels 2800866, 1090
BelgiumSite Not Available
Hôpital Universitaire des Enfants Reine Fabiola
Bruxelles, 1090
BelgiumSite Not Available
UZ Gent
Gent, 9000
BelgiumSite Not Available
UZ Gent
Ghent 2797656, 9000
BelgiumSite Not Available
Instituto Méderi de Pesquisa e Saúde
Passo Fundo, Rio Grande Do Sul 99010-120
BrazilSite Not Available
Irmandade Da Santa Casa de Misericordia de Porto Alegre
Porto Alegre, Rio Grande Do Sul 90020-090
BrazilSite Not Available
Instituto Méderi de Pesquisa e Saúde
Passo Fundo 3454857, Rio Grande do Sul 3451133 99010-120
BrazilSite Not Available
Irmandade Da Santa Casa de Misericordia de Porto Alegre
Porto Alegre 3452925, Rio Grande do Sul 3451133 90020-090
BrazilSite Not Available
Fundacao Faculdade Regional de Medicina de Sao Jose Do Rio Preto Hospital de Base - PPDS
Sao Jose Do Rio Preto, São Paulo 15090-000
BrazilSite Not Available
Hospital das Clinicas da Faculdade de Medicina da Universidade de Sao Paulo
Sao Paulo, São Paulo 05403-000
BrazilSite Not Available
Fundacao Faculdade Regional de Medicina de Sao Jose Do Rio Preto Hospital de Base - PPDS
São José do Rio Preto 3448639, São Paulo 3448433 15090-000
BrazilSite Not Available
Hospital das Clinicas da Faculdade de Medicina da Universidade de Sao Paulo
São Paulo 3448439, São Paulo 3448433 05403-000
BrazilSite Not Available
Peking University First Hospital
Beijing 1816670, 100034
ChinaSite Not Available
Peking University First Hospital
Beijing City, 100034
ChinaSite Not Available
The First Affiliated Hospital of Sun Yat-sen University
Guangzhou 1809858, 510080
ChinaSite Not Available
The First Affiliated Hospital of Sun Yat-sen University
Guangzhou City, 510080
ChinaSite Not Available
The children's hospital , Zhejiang university school of medicine
Hangzhou, 310003
ChinaSite Not Available
The children's hospital , Zhejiang university school of medicine
Hangzhou 1808926, 310003
ChinaSite Not Available
The children's hospital , Zhejiang university school of medicine
Hangzhou City, 310003
ChinaSite Not Available
Tongji Hosp, Tongji Med. Col, Huazhong Univ. of Sci. & Tech
Wuhan, 430030
ChinaSite Not Available
Tongji Hosp, Tongji Med. Col, Huazhong Univ. of Sci. & Tech
Wuhan 1791247, 430030
ChinaSite Not Available
Xi'an Children's Hospital
Xi'an 1790630, 710003
ChinaSite Not Available
Xi'an Children's Hospital
Xian, 710003
ChinaSite Not Available
Henan Children's Hospital Zhengzhou Children's Hospital
Zhengzhou, 450018
ChinaSite Not Available
Henan Children's Hospital Zhengzhou Children's Hospital
Zhengzhou 1784658, 450018
ChinaSite Not Available
CHU de Nice
Nice, Alpes-Maritimes 06000
FranceSite Not Available
CHU de Nice
Nice 2990440, Alpes-Maritimes 06000
FranceSite Not Available
Chu Toulouse
Bron, 69500
FranceSite Not Available
Hopital Femme Mere Enfants
Bron, 69500
FranceSite Not Available
Chu Toulouse
Bron 3029931, 69500
FranceSite Not Available
Hopital Femme Mere Enfants
Bron 3029931, 69500
FranceSite Not Available
Hopital Henri Mondor
Creteil, 94010
FranceSite Not Available
Hopital Henri Mondor
Créteil 3022530, 94010
FranceSite Not Available
CHU Montpellier- Hopital Arnaud de VIlleneuve
Montpellier, 34295
FranceSite Not Available
CHU Montpellier- Hopital Arnaud de VIlleneuve
Montpellier 2992166, 34295
FranceSite Not Available
CHU de Nice
Nice Cedex 1, 06001
FranceSite Not Available
CHU de Nice; Service Système Nerveux Périphérique
Nice Cedex 1, 06001
FranceSite Not Available
Hopital Necker - Enfants Malades
Paris, 75015
FranceSite Not Available
Hopital Robert Debre
Paris, 75019
FranceSite Not Available
Hopital Necker - Enfants Malades
Paris 2988507, 75015
FranceSite Not Available
Hopital Robert Debre
Paris 2988507, 75019
FranceSite Not Available
Chu Toulouse
Toulouse, 31059
FranceSite Not Available
Universitätsklinikum Essen
Essen, 45147
GermanySite Not Available
Istituto G Gaslini Ospedale Pediatrico IRCCS - INCIPIT - PIN
Genova, Liguria 16147
ItalySite Not Available
Istituto G Gaslini Ospedale Pediatrico IRCCS - INCIPIT - PIN
Genoa 3176219, Liguria 3174725 16147
ItalySite Not Available
Fondazione IRCCS Ca Granda Ospedale Maggiore Policlinico - Clinica De Marchi - INCIPIT - PIN
Milano, Lombardia 20122
ItalySite Not Available
Fondazione IRCCS Ca Granda Ospedale Maggiore Policlinico - Clinica De Marchi - INCIPIT - PIN
Milan 3173435, Lombardy 3174618 20122
ItalySite Not Available
Ospedale Infantile Regina Margherita - INCIPIT - PIN
Turin 3165524, Piedmont 3170831 10126
ItalySite Not Available
Ospedale Infantile Regina Margherita - INCIPIT - PIN
Torino, Piemonte 10126
ItalySite Not Available
Hokkaido University Hospital
Hokkaido, 060-8648
JapanSite Not Available
Kobe University Hospital
Hyogo, 650-0017
JapanSite Not Available
Hyogo prefectural Kobe Children's Hospital
Hyogoken, 6500047
JapanSite Not Available
Kobe University Hospital
Hyōgo 2129969, 650-0017
JapanSite Not Available
Kitasato University Hospital
Kanagawa, 252-0375
JapanSite Not Available
Yokohama City University Medical Center
Kanagawa, 232-0024
JapanSite Not Available
Kitasato University Hospital
Kanagawa 1860292, 252-0375
JapanSite Not Available
Yokohama City University Medical Center
Kanagawa 1860292, 232-0024
JapanSite Not Available
Dokkyo Medical University Hospital
Mibu-Machi, 321-0293
JapanSite Not Available
Shiga University Of Medical Science Hospital
Shiga, 520-2192
JapanSite Not Available
Shiga University Of Medical Science Hospital
Shiga 9115498, 520-2192
JapanSite Not Available
National Center for Child Health and Development
Tokyo, 157-8535
JapanSite Not Available
Tokyo Metropolitan Children's Medical Center
Tokyo, 1838561
JapanSite Not Available
National Center for Child Health and Development
Tokyo 1850147, 157-8535
JapanSite Not Available
Tokyo Metropolitan Children's Medical Center
Tokyo 1850147, 1838561
JapanSite Not Available
Uniwersytecki Szpital Kliniczny w Bialymstoku
Bia?ystok, 15-274
PolandSite Not Available
In-VIVO Osrodek Badan Klinicznych
Bydgoszcz, 85-048
PolandSite Not Available
In-VIVO Osrodek Badan Klinicznych
Bydgoszcz 3102014, 85-048
PolandSite Not Available
Uniwersyteckie Centrum Kliniczne
Gdansk,
PolandSite Not Available
Uniwersyteckie Centrum Kliniczne
Gdansk 3099434,
PolandSite Not Available
Dzieciecy Szpital Kliniczny UCK WUM
Warsaw 756135, 02-091
PolandSite Not Available
Dzieciecy Szpital Kliniczny UCK WUM
Warszawa, 02-091
PolandSite Not Available
Hospital Universitario Marques de Valdecilla
Santander, Cantabria 39008
SpainSite Not Available
Hospital Universitario Marques de Valdecilla
Santander 3109718, Cantabria 3336898 39008
SpainSite Not Available
Hospital Universitario Cruces
Barakaldo, Vizcaya 48903
SpainSite Not Available
Hospital Universitario Cruces
Barakaldo 3109453, Vizcaya 48903
SpainSite Not Available
Hospital Sant Joan de Deu - PIN
Barcelona, 08950
SpainSite Not Available
Hospital Sant Joan de Deu - PIN
Barcelona 3128760, 08950
SpainSite Not Available
Baskent Universitesi - Ankara Hastanesi - Bahcelie
Bahcelievler, 06490
TurkeySite Not Available
Celal Bayar University Medical Faculty
Manisa, 45010
TurkeySite Not Available
Cukurova Universitesi Tip Fakultesi Balcali Hastanesi
Saricam, 01250
TurkeySite Not Available
Celal Bayar University Medical Faculty
Manisa 304827, 45010
Turkey (Türkiye)Site Not Available
Cedars Sinai Medical Center
Los Angeles, California 90048
United StatesSite Not Available
Lucile Packard Children's Hospital - Stanford
Palo Alto, California 94304
United StatesSite Not Available
University of California Benioff Children's Hospital
San Francisco, California 94143-2350
United StatesSite Not Available
Cedars Sinai Medical Center
Los Angeles 5368361, California 5332921 90048
United StatesSite Not Available
Lucile Packard Children's Hospital - Stanford
Palo Alto 5380748, California 5332921 94304
United StatesSite Not Available
University of California Benioff Children's Hospital
San Francisco 5391959, California 5332921 94143-2350
United StatesSite Not Available
Children's National Hospital
Washington, District of Columbia 20010
United StatesSite Not Available
Children's National Hospital
Washington D.C. 4140963, District of Columbia 4138106 20010
United StatesSite Not Available
Memorial Healthcare System
Hollywood, Florida 33021
United StatesSite Not Available
Nicklaus Children's Hospital
Miami, Florida 33155-3009
United StatesSite Not Available
Nemours Children's Hospital
Orlando, Florida 32827
United StatesSite Not Available
University of South Florida
Tampa, Florida 33612
United StatesSite Not Available
Memorial Healthcare System
Hollywood 4158928, Florida 4155751 33021
United StatesSite Not Available
Nicklaus Children's Hospital
Miami 4164138, Florida 4155751 33155-3009
United StatesSite Not Available
Nemours Children's Hospital
Orlando 4167147, Florida 4155751 32827
United StatesSite Not Available
University of South Florida
Tampa 4174757, Florida 4155751 33612
United StatesSite Not Available
Children's Healthcare of Atlanta Center for Advanced Pediatrics
Atlanta, Georgia 30329-2309
United StatesSite Not Available
Children's Healthcare of Atlanta Center for Advanced Pediatrics
Atlanta 4180439, Georgia 4197000 30329-2309
United StatesSite Not Available
University of Michigan
Ann Arbor, Michigan 48109
United StatesSite Not Available
University of Michigan
Ann Arbor 4984247, Michigan 5001836 48109-0934
United StatesSite Not Available
Children's Mercy Hospital
Kansas City, Missouri 64108-4619
United StatesSite Not Available
Hackensack University Medical Center
Hackensack, New Jersey 07601
United StatesSite Not Available
Hackensack University Medical Center
Hackensack 5098706, New Jersey 5101760 07601
United StatesSite Not Available
UNC Hospitals Outpatient Center at Eastowne
Chapel Hill, North Carolina 27514-2286
United StatesSite Not Available
Levine Children's Hospital
Charlotte, North Carolina 28203-5866
United StatesSite Not Available
Duke University Health Systems
Durham, North Carolina 27710
United StatesSite Not Available
UNC Hospitals Outpatient Center at Eastowne
Chapel Hill 4460162, North Carolina 4482348 27514-2286
United StatesSite Not Available
Levine Children's Hospital
Charlotte 4460243, North Carolina 4482348 28203-5866
United StatesSite Not Available
Duke University Health Systems
Durham 4464368, North Carolina 4482348 27710
United StatesSite Not Available
University of Utah - Primary Children's Hospital - PPDS
Salt Lake City, Utah 84113-1103
United StatesSite Not Available
University of Utah - Primary Children's Hospital - PPDS
Salt Lake City 5780993, Utah 5549030 84113-1103
United StatesSite Not Available
University of Virginia Health System
Charlottesville, Virginia 22908
United StatesSite Not Available
University of Virginia Health System
Charlottesville 4752031, Virginia 6254928 22903
United StatesSite Not Available

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