Phase
Condition
Nephritis
Lupus Nephritis
Kidney Disease
Treatment
Methylprednisolone
Acetaminophen/paracetamol
Diphenhydramine hydrochloride (HCl)
Clinical Study ID
Ages 5-17 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
Participants who are age 12 to <18 years at the time of randomization
Participants who are age 5 to <12 years (younger participant cohort) at the time ofrandomization once recruitment is open. (Investigators will be notified by theSponsor when recruitment is open to this younger population)
International Society of Nephrology and the Renal Pathology Society (ISN/RPS) 2003Class III or IV active LN demonstrated on renal biopsy performed in the 12 monthsprior to or during screening
Class V disease may be present in addition to Class III or IV LN, but participantswith isolated Class V disease are not eligible
Diagnosis of SLE according to the Systemic Lupus International Collaborating Clinics (SLICC) 2012 criteria
Significant proteinuria defined by a UPCR above > 0.5 based on a first-morning void (FMV) collection at screening
During the 12 months prior to or during screening, all participants must havereceived at least one dose of pulse-range IV methylprednisolone (typically 30 mg/kg,maximum of 1000 mg per dose) or equivalent for the treatment of the current episodeof active LN.
Exclusion
Exclusion Criteria:
Severe, active central nervous system (CNS) SLE, including retinitis, poorlycontrolled seizure disorder, acute confusional state, myelitis, stroke, cerebellarataxia, or dementia
Sclerosis in >50% of glomeruli on renal biopsy
Purely chronic Class III(c) or Class IV(c) disease on renal biopsy, defined as theabsence of any active lesions
Presence of rapidly progressive glomerulonephritis
Pure Class V LN
Intolerance or contraindication to study therapies
Active infection of any kind (excluding fungal infection of nail beds) or any majorepisode of infection requiring hospitalization or treatment with IV anti-infectivemedications within 4 weeks prior to screening, or completion of oral anti-infectiveswithin 2 weeks prior to randomization
History of or currently active primary or secondary immunodeficiency, includingknown history of HIV infection and other severe Immunodeficiency blood disorders
History of serious recurrent or chronic infection
History of or current cancer, including solid tumors, hematological malignancies,and carcinoma in situ (except basal cell carcinoma and squamous cell carcinoma ofthe skin that have been excised and cured) within the past 5 years
Significant or uncontrolled concomitant medical disease which, in the investigator'sopinion, would preclude participant participation
Currently active alcohol or drug abuse or history of alcohol or drug abuse
Study Design
Connect with a study center
Ser Servicos Especializados Em Reumatologia
Salvador, Estado de Bahia 40150-150
BrazilActive - Recruiting
Ser Servicos Especializados Em Reumatologia
Salvador 3450554, Estado de Bahia 3471168 40150-150
BrazilSite Not Available
Hospital das Clinicas - UNICAMP
Campinas, SP 13083-888
BrazilSite Not Available
Centro de Pesquisa São Lucas
Campinas, São Paulo 13060-904
BrazilActive - Recruiting
Hospital das Clinicas - FMUSP
Sao Paulo, São Paulo 05403-000
BrazilActive - Recruiting
Universidade Federal de Sao Paulo - UNIFES
Sao Paulo, São Paulo 04038-001
BrazilSite Not Available
Hospital das Clinicas - FMUSP
São Paulo, São Paulo 05403-000
BrazilActive - Recruiting
Centro de Pesquisa São Lucas
Campinas 3467865, São Paulo 3448433 13060-904
BrazilSite Not Available
Hospital das Clinicas - FMUSP
São Paulo 3448439, São Paulo 3448433 05403-000
BrazilActive - Recruiting
Universidade Federal de Sao Paulo - UNIFES
São Paulo, 04024-002
BrazilSite Not Available
Universidade Federal de Sao Paulo - UNIFES
São Paulo 3448439, 04024-002
BrazilSite Not Available
The Hospital for Sick Children
Toronto, Ontario M5G 1X8
CanadaActive - Recruiting
The Hospital for Sick Children
Toronto 6167865, Ontario 6093943 M5G 1X8
CanadaSite Not Available
Hospital Sainte-Justine
Montreal, Quebec H3T 1C5
CanadaActive - Recruiting
Hospital Sainte-Justine; Pediatrics Dept.
Montreal, Quebec H3T 1C5
CanadaActive - Recruiting
Hospital Sainte-Justine
Montreal 6077243, Quebec 6115047 H3T 1C5
CanadaSite Not Available
CH de Bicêtre
Le Kremlin Bicêtre, 94275
FranceSite Not Available
CH de Bicêtre; Pediatrie Generale
Le Kremlin Bicêtre, 94275
FranceActive - Recruiting
CH de Bicêtre
Le Kremlin-Bicêtre, 94275
FranceActive - Recruiting
CH de Bicêtre
Le Kremlin-Bicêtre 3003737, 94275
FranceSite Not Available
Hop Necker Enfants Malades
Paris, 75743
FranceActive - Recruiting
Hop Necker Enfants Malades;UIH
Paris, 75743
FranceActive - Recruiting
Hôpital Robert Debré
Paris, 75019
FranceActive - Recruiting
Hôpital Robert Debré; Nephrologie pediatrique
Paris, 75019
FranceActive - Recruiting
Hop Necker Enfants Malades
Paris 2988507, 75743
FranceSite Not Available
Hôpital Robert Debré
Paris 2988507, 75019
FranceActive - Recruiting
CHU de Toulouse - Hôpital des Enfants
Toulouse, 31000
FranceActive - Recruiting
CHU de Toulouse - Hôpital des Enfants; Nephro - Rhumato - Medecine Interne - Hypertension
Toulouse, 31000
FranceActive - Recruiting
CHU de Toulouse - Hôpital des Enfants
Toulouse 2972315, 31000
FranceSite Not Available
Ospedale Pediatrico Bambino Gesu
Roma, Lazio 00165
ItalySite Not Available
Ospedale Pediatrico Bambino Gesu; U.O. Di Nefrologia E Dialisi
Roma, Lazio 00165
ItalyActive - Recruiting
Ospedale Pediatrico Bambino Gesu
Rome, Lazio 00165
ItalyActive - Recruiting
Ospedale Pediatrico Bambino Gesu
Rome 3169070, Lazio 3174976 00165
ItalySite Not Available
IRCCS G. Gaslini
Genoa, Liguria 16148
ItalyActive - Recruiting
IRCCS G. Gaslini
Genova, Liguria 16148
ItalySite Not Available
IRCCS G. Gaslini; U.O. Nefrologia, Dialisi e Trapianto
Genova, Liguria 16148
ItalyActive - Recruiting
IRCCS G. Gaslini
Genoa 3176219, Liguria 3174725 16148
ItalySite Not Available
Clinica Pediatrica II De Marchi
Milano, Lombardia 20122
ItalySite Not Available
Clinica Pediatrica II De Marchi
Milan, Lombardy 20122
ItalyActive - Recruiting
Clinica Pediatrica II De Marchi
Milan 3173435, Lombardy 3174618 20122
ItalySite Not Available
CREA Hospital Mexico Americano
Guadalajara, Jalisco 44620
MexicoActive - Recruiting
CREA Hospital Mexico Americano; Clinica Pediatrica de Reumatologia y Enfermedades Autoinmunes
Guadalajara, Jalisco 44620
MexicoSite Not Available
CREA Hospital Mexico Americano
Guadalajara 4005539, Jalisco 4004156 44620
MexicoSite Not Available
Clinstile S.A de C.V.
Mexico City, Mexico CITY (federal District) 06700
MexicoActive - Recruiting
Clinstile S.A de C.V.
Mexico City 3530597, Mexico CITY (federal District) 06700
MexicoSite Not Available
Hospital Universitario Dr. Jose Eleuterio Gonzalez; Pediatria
Monterrey, Nuevo LEON 64460
MexicoActive - Recruiting
Hospital Universitario Dr. Jose Eleuterio Gonzalez
Monterrey, Nuevo León 64460
MexicoActive - Recruiting
Hospital Universitario Dr. Jose Eleuterio Gonzalez
Monterrey 3995465, Nuevo León 3522542 64460
MexicoSite Not Available
Instituto de Ginecología y Reproducción
Lima,
PeruSite Not Available
Instituto de Ginecología y Reproducción
Lima 3936456,
PeruSite Not Available
Clinica El Golf
San Isidro, L27 Lima
PeruSite Not Available
Clinica El Golf
San Isidro 3929631, L27 Lima
PeruSite Not Available
Uniwersyteckie Centrum Kliniczne
Gdansk, 80-294
PolandActive - Recruiting
Uniwersyteckie Centrum Kliniczne; Klinika Chorob Nerek i Nadci?nienia Dzieci i Mlodziezy
Gdansk, 80-952
PolandActive - Recruiting
Uniwersyteckie Centrum Kliniczne
Gdansk 3099434, 80-294
PolandSite Not Available
Szpital Specjalistyczny dla Dzieci i Doroslych
Torun, 87-100
PolandSite Not Available
Szpital Specjalistyczny dla Dzieci i Doroslych; Oddzial Kliniczny Pediatrii i Nefrologii
Torun, 87-100
PolandCompleted
Szpital Specjalistyczny dla Dzieci i Doroslych
Torun 3083271, 87-100
PolandSite Not Available
Narodowy Instytut Geriatrii Reumatologii i Rehabilitacji; Klinika Reumatologii Wieku Rozwojowego
Warszawa, 02-637
PolandSite Not Available
Saint-Petersburg State
St-peterburg, Sankt-Peterburg 194100
RussiaSite Not Available
FSBI "Scientific Research Institute of Rheumatology" of russian Academy of Medical Sciences
Moscow, Moskovskaja Oblast 115522
Russian FederationSite Not Available
Saint-Petersburg State
St-peterburg, Sankt Petersburg 194100
Russian FederationSite Not Available
Saint-Petersburg State; Pediatrics Medical Academy
St-peterburg, Sankt Petersburg 194100
Russian FederationSite Not Available
Saint-Petersburg State; Pediatrics Medical Academy
Saint-Petersburg, 194100
Russian FederationSite Not Available
Groote Schuur Hospital
Cape Town, 7925
South AfricaSite Not Available
Groote Schuur Hospital; Renal Unit
Cape Town, 7925
South AfricaActive - Recruiting
Red Cross War Memorial Children?s Hospital
Cape Town, 7700
South AfricaSite Not Available
Red Cross War Memorial Children?s Hospital; Nephrology Unit
Cape Town, 7700
South AfricaActive - Recruiting
Groote Schuur Hospital
Cape Town 3369157, 7925
South AfricaSite Not Available
Red Cross War Memorial Children?s Hospital
Cape Town 3369157, 7700
South AfricaSite Not Available
Panaroma Medical Center
Panorama, 7500
South AfricaActive - Recruiting
Panaroma Medical Center; Clinical Trials Department
Panorama, 7500
South AfricaSite Not Available
Panaroma Medical Center
Panorama 966305, 7500
South AfricaSite Not Available
Hospital Sant Joan De Deu; Servicio de Reumatologia Pediatrica
Esplugas DE Llobregat, Barcelona 08950
SpainActive - Recruiting
Hospital Sant Joan De Deu
Esplugas de Llobregat, Barcelona 08950
SpainActive - Recruiting
Hospital Ramon y Cajal
Madrid, 28034
SpainActive - Recruiting
Hospital Ramon y Cajal ; Servicio de Reumatologia
Madrid, 28034
SpainActive - Recruiting
Hospital de La Paz
Madrid, 28046
SpainActive - Recruiting
Hospital de La Paz; Unidad de Reumatologia Pediatrica
Madrid, 28046
SpainSite Not Available
Hospital Ramon y Cajal
Madrid 3117735, 28034
SpainSite Not Available
Hospital de La Paz
Madrid 3117735, 28046
SpainActive - Recruiting
Hospital Universitario la Fe: Servicio de Reumatologia Pediatrica
Valencia, 46026
SpainActive - Recruiting
Hospital Universitario la Fe: Servicio de Reumatologia Pediatrica
Valencia 2509954, 46026
SpainSite Not Available
Royal Hospital For Children
Glasgow, G51 4TF
United KingdomSite Not Available
Royal Hospital For Children
Glasgow 2648579, G51 4TF
United KingdomSite Not Available
Alder Hey Childrens Hospital
Liverpool, L12 2AP
United KingdomActive - Recruiting
Alder Hey Childrens Hospital
Liverpool 2644210, L12 2AP
United KingdomSite Not Available
Great Ormond Street Hospital for Children
London, WC1N 3JH
United KingdomActive - Recruiting
Great Ormond Street Hospital for Children
London 2643743, WC1N 3JH
United KingdomSite Not Available
Loma Linda University health
Loma Linda, California 92354
United StatesActive - Recruiting
UCSF Benioff Childrens Hospital
San Francisco, California 94158
United StatesActive - Recruiting
University of California San Francisco
San Francisco, California 94117
United StatesActive - Recruiting
Loma Linda University health
Loma Linda 5367696, California 5332921 92354
United StatesSite Not Available
UCSF Benioff Childrens Hospital
San Francisco 5391959, California 5332921 94158
United StatesSite Not Available
Children's Hospital Colorado, Anchutz Medical Campus
Aurora, Colorado 80045
United StatesActive - Recruiting
Children's Hospital Colorado, Anchutz Medical Campus
Aurora 5412347, Colorado 5417618 80045
United StatesSite Not Available
Emory Children's Center
Atlanta, Georgia 30322
United StatesActive - Recruiting
Emory Children's Center
Atlanta 4180439, Georgia 4197000 30322
United StatesSite Not Available
Indiana University Health University Hospital
Indianapolis, Indiana 46202
United StatesActive - Recruiting
Indiana University Health University Hospital
Indianapolis 4259418, Indiana 4921868 46202
United StatesSite Not Available
Louisiana State University
Shreveport, Louisiana 71103
United StatesActive - Recruiting
Louisiana State University
Shreveport 4341513, Louisiana 4331987 71103
United StatesSite Not Available
Hackensack University Medical Center
Hackensack, New Jersey 07601
United StatesActive - Recruiting
Hackensack University Medical Center
Hackensack 5098706, New Jersey 5101760 07601
United StatesSite Not Available
Cohen Children's Medical Center of New York
Queens, New York 11042
United StatesActive - Recruiting
Cohen Children's Medical Center of New York; Pediatrics
Queens, New York 11042
United StatesActive - Recruiting
Cohen Children's Medical Center of New York
Queens 5133273, New York 5128638 11042
United StatesSite Not Available
Cincinnati Childrens Hospital
Cincinnati, Ohio 45229
United StatesActive - Recruiting
Nationwide Children's Hospital
Columbus, Ohio 43205
United StatesSite Not Available
Cincinnati Childrens Hospital
Cincinnati 4508722, Ohio 5165418 45229
United StatesSite Not Available
Children's Hospital of Philadelphia
Philadelphia, Pennsylvania 19104
United StatesSite Not Available
Chldren's Hospital of Philadelphia
Philadelphia, Pennsylvania 19104
United StatesActive - Recruiting
Chldren?s Hospital of Philadelphia
Philadelphia, Pennsylvania 19104
United StatesSite Not Available
Chldren?s Hospital of Philadelphia
Philadelphia 4560349, Pennsylvania 6254927 19104
United StatesSite Not Available
Texas Arthritis Center
El Paso, Texas 79902
United StatesSite Not Available
Texas Arthritis Center
El Paso 5520993, Texas 4736286 79902
United StatesSite Not Available

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