Phase
Condition
Nephrotic Syndrome
Glomerulosclerosis
Kidney Disease
Treatment
SAR442970
brivekimig
placebo
Clinical Study ID
Ages 16-75 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
Biopsy report indicative of primary FSGS or primary MCD, with supportive clinicalpresentation per Investigator's judgement.
UPCR ≥3 g/g at screening, or ≥ 1.5 g/g in those with eGFR ≥ 60.
eGFR ≥45 mL/min/1.73 m^2 at screening.
Documented history of UPCR (or 24-hour urine protein) reduction by >40% in responseto corticosteroid or other immunosuppressive therapy when pre-treatment UPCR was ≥3.5 g/g (or pre-treatment 24-hr urine protein was ≥3.5 g/day if 24-hour urineprotein is used).
≤10 mg/day prednisone or equivalent and stable starting at least 1 week prior torandomization.
For those on a RAAS inhibitor prior to screening, the dose must be stable ≥4 weeksprior to screening; starting RAAS inhibitors or changing the dose will not beallowed during the double-blind or OLE treatment period.
For those on an SGLT2 inhibitor prior to screening, the dose must be stable ≥4 weeksprior to screening; starting SGLT2 inhibitor treatment or changing the dose will notbe allowed during the double-blind or OLE treatment periods.
Body weight within 45 to 120 kg (inclusive) at screening.
Exclusion
Exclusion Criteria:
Genetic or secondary FSGS or MCD. Those with APOL1 risk alleles are eligible.
Collapsing variant of FSGS.
ESKD requiring dialysis or transplantation.
The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.
Study Design
Connect with a study center
Investigational Site Number : 0320001
CABA, Buenos Aires F.D. 3433955 C1425ASG
ArgentinaSite Not Available
Investigational Site Number : 0320002
Cordoba, Córdoba X5016KET
ArgentinaSite Not Available
Investigational Site Number : 0320001
Buenos Aires, 1431
ArgentinaActive - Recruiting
Investigational Site Number : 0320001
Buenos Aires 3435910, 1431
ArgentinaSite Not Available
Investigational Site Number : 0320002
Córdoba, 5016
ArgentinaActive - Recruiting
Investigational Site Number : 0320002
Córdoba 3860259, 5016
ArgentinaSite Not Available
Investigational Site Number : 0360003
Canberra, Australian Capital Territory 2605
AustraliaSite Not Available
Investigational Site Number : 0360003
Garran, Australian Capital Territory 2605
AustraliaActive - Recruiting
Investigational Site Number : 0360003
Garran 9973428, Australian Capital Territory 2177478 2605
AustraliaSite Not Available
Investigational Site Number : 0360001
Parkville, Victoria 3050
AustraliaActive - Recruiting
Investigational Site Number : 0360001
Parkville 2153770, Victoria 2145234 3050
AustraliaSite Not Available
Investigational Site Number: 0760004
Botucatu, São Paulo 18618-970
BrazilActive - Recruiting
Investigational Site Number : 0760002
Sao Paulo, São Paulo 04038-002
BrazilSite Not Available
Hospital das Clinicas da Faculdade de Medicina da Universidade de Sao Paulo - HCFMUSP- Site Number : 0760001
São Paulo 3448439, São Paulo 3448433 05403-010
BrazilActive - Recruiting
Investigational Site Number : 0760001
São Paulo, 05403-000
BrazilActive - Recruiting
Investigational Site Number : 0760002
São Paulo, 04038-002
BrazilActive - Recruiting
Investigational Site Number: 0760001
São Paulo, 05403-000
BrazilSite Not Available
Hospital das Clinicas da Faculdade de Medicina da Universidade de Sao Paulo- Site Number : 0760001
São Paulo 3448439, 05403-000
BrazilActive - Recruiting
Hospital do Rim e Hipertensão- Site Number : 0760002
São Paulo 3448439, 04038-002
BrazilActive - Recruiting
Investigational Site Number : 0760001
São Paulo 3448439, 05403-000
BrazilActive - Recruiting
Investigational Site Number : 0760002
São Paulo 3448439, 04038-002
BrazilSite Not Available
Investigational Site Number: 0760001
São Paulo 3448439, 05403-000
BrazilActive - Recruiting
Investigational Site Number: 0760002
São Paulo 3448439, 04038-002
BrazilActive - Recruiting
Investigational Site Number : 1240002
London, Ontario N6A 5A5
CanadaActive - Recruiting
Investigational Site Number : 1240002
London 6058560, Ontario 6093943 N6A 5A5
CanadaSite Not Available
Investigational Site Number : 1240001
Montreal, Quebec H1T 2M4
CanadaActive - Recruiting
Investigational Site Number : 1240005
Montreal, Quebec H3T 1C5
CanadaActive - Recruiting
Investigational Site Number : 1240006
Quebec City, Quebec G1R 2J6
CanadaSite Not Available
Investigational Site Number : 1240006
Québec, Quebec G1R 2J6
CanadaActive - Recruiting
Investigational Site Number : 1240001
Montreal 6077243, Quebec 6115047 H1T 2M4
CanadaSite Not Available
Investigational Site Number : 1240006
Québec 6325494, Quebec 6115047 G1R 2J6
CanadaSite Not Available
Investigational Site Number : 1520003
Temuco, La Araucanía 4781151
ChileActive - Recruiting
Investigational Site Number : 1520003
Temuco 3870011, La Araucanía 4781151
ChileSite Not Available
Investigational Site Number : 1520002
Santiago, Reg Metropolitana de Santiago 8330034
ChileActive - Recruiting
Investigational Site Number : 1520002
Santiago 3871336, Reg Metropolitana de Santiago 8330034
ChileSite Not Available
Investigational Site Number : 1560001
Beijing, 100034
ChinaActive - Recruiting
Investigational Site Number : 1560001
Beijing 1816670, 100034
ChinaSite Not Available
Investigational Site Number : 1560003
Chengdu, 610072
ChinaActive - Recruiting
Investigational Site Number : 1560003
Chengdu 1815286, 610072
ChinaSite Not Available
Investigational Site Number : 1560004
Shanghai, 200080
ChinaActive - Recruiting
Investigational Site Number : 1560004
Shanghai 1796236, 200080
ChinaSite Not Available
Investigational Site Number : 2030002
Olomouc, 779 00
CzechiaActive - Recruiting
Investigational Site Number : 2030002
Olomouc 3069011, 779 00
CzechiaSite Not Available
Investigational Site Number : 2030001
Prague, 128 08
CzechiaActive - Recruiting
Investigational Site Number : 2030001
Prague 3067696, 128 08
CzechiaSite Not Available
Investigational Site Number : 2500002
Créteil, 94010
FranceActive - Recruiting
Investigational Site Number : 2500002
Créteil 3022530, 94010
FranceSite Not Available
Investigational Site Number : 2500001
Paris, 75015
FranceActive - Recruiting
Investigational Site Number : 2500001
Paris 2988507, 75015
FranceSite Not Available
Investigational Site Number : 2760002
Berlin, 10117
GermanyActive - Recruiting
Investigational Site Number : 2760002
Berlin 2950159, 10117
GermanySite Not Available
Investigational Site Number : 2760006
Dresden, 01307
GermanyActive - Recruiting
Investigational Site Number : 2760003
Hannover, 30625
GermanySite Not Available
Investigational Site Number : 2760003
Hanover, 30625
GermanyActive - Recruiting
Investigational Site Number : 2760003
Hanover 2910831, 30625
GermanySite Not Available
Investigational Site Number : 3000002
Athens, 115 27
GreeceActive - Recruiting
Investigational Site Number : 3000002
Athens 264371, 115 27
GreeceSite Not Available
Investigational Site Number : 3000001
Heraklion, 711 10
GreeceActive - Recruiting
Investigational Site Number : 3000001
Heraklion 261745, 711 10
GreeceSite Not Available
Investigational Site Number : 3000001
Heraklion Crete, 715 00
GreeceSite Not Available
Investigational Site Number : 3000003
Ioannina, 455 00
GreeceActive - Recruiting
Investigational Site Number : 3000003
Ioannina 261779, 455 00
GreeceSite Not Available
Investigational Site Number : 3480001
Budapest, 1085
HungaryActive - Recruiting
Investigational Site Number : 3480001
Budapest 3054643, 1085
HungarySite Not Available
Investigational Site Number : 3800002
Florence, Firenze 50134
ItalyActive - Recruiting
Investigational Site Number : 3800002
Florence 3176959, Firenze 50134
ItalySite Not Available
Investigational Site Number : 3800003
Naples, Napoli 80131
ItalyActive - Recruiting
Investigational Site Number : 3800003
Naples 3172394, Napoli 80131
ItalySite Not Available
Investigational Site Number : 3800001
Brescia, 25123
ItalyActive - Recruiting
Investigational Site Number : 3800001
Brescia 3181554, 25123
ItalySite Not Available
Investigational Site Number : 4840001
Mexico City, Mexico City 14080
MexicoActive - Recruiting
Investigational Site Number : 4840005
Mexico City, Mexico City 06720
MexicoActive - Recruiting
Investigational Site Number : 4840001
Mexico City 3530597, Mexico City 3527646 14080
MexicoActive - Recruiting
Investigational Site Number : 4840005
Mexico City 3530597, Mexico City 3527646 06720
MexicoSite Not Available
Investigational Site Number : 4840003
Monterrey, Nuevo León 64460
MexicoActive - Recruiting
Investigational Site Number : 4840003
Monterrey 3995465, Nuevo León 3522542 64460
MexicoSite Not Available
Investigational Site Number : 5280001
Amsterdam, 1105 AZ
NetherlandsActive - Recruiting
Investigational Site Number : 5280001
Amsterdam 2759794, 1105 AZ
NetherlandsSite Not Available
Investigational Site Number : 6160004
Poznan, Greater Poland Voivodeship 60-780
PolandActive - Recruiting
Investigational Site Number : 6160001
Lodz, Lódzkie 02-213
PolandActive - Recruiting
Investigational Site Number : 6160001
Lodz 3093133, Lódzkie 02-213
PolandSite Not Available
Investigational Site Number : 6160002
Opole, Opole Voivodeship 45-418
PolandActive - Recruiting
Investigational Site Number : 6160002
Opole 3090048, Opole Voivodeship 3337495 45-418
PolandSite Not Available
Investigational Site Number : 6200003
Lisbon, 1050-099
PortugalActive - Recruiting
Investigational Site Number : 6200003
Lisbon 2267057, 1050-099
PortugalSite Not Available
Investigational Site Number : 6200001
Matosinhos, 4464-513
PortugalSite Not Available
Investigational Site Number : 6200001
Matosinhos Municipality, 4464-513
PortugalSite Not Available
Investigational Site Number : 6200001
Matosinhos Municipality 2737824, 4464-513
PortugalSite Not Available
Investigational Site Number : 6200002
Porto, 4434-502
PortugalActive - Recruiting
Investigational Site Number : 6200002
Porto 2735943, 4434-502
PortugalSite Not Available
Investigational Site Number : 6200002
Vila Nova Gaia, 4434-502
PortugalSite Not Available
Investigational Site Number : 7030003
Banská Bystrica, 975 17
SlovakiaActive - Recruiting
Investigational Site Number : 7030003
Banská Bystrica 3061186, 975 17
SlovakiaSite Not Available
Investigational Site Number : 7030004
Bratislava, 833 05
SlovakiaSite Not Available
Investigational Site Number : 7030004
Bratislava 3060972, 833 05
SlovakiaSite Not Available
Investigational Site Number : 7030004
Bratislava - Kramare, 831 01
SlovakiaActive - Recruiting
Investigational Site Number : 7030001
Martin, 036 01
SlovakiaActive - Recruiting
Investigational Site Number : 7030001
Martin 3058780, 036 01
SlovakiaSite Not Available
Investigational Site Number : 7240001
Barcelona, Barcelona [Barcelona] 08035
SpainActive - Recruiting
Investigational Site Number : 7240001
Barcelona 3128760, Barcelona [Barcelona] 08035
SpainActive - Recruiting
Investigational Site Number : 7240004
Barcelona, Catalunya [Cataluña] 08025
SpainActive - Recruiting
Investigational Site Number : 7240004
Barcelona 3128760, Catalunya [Cataluña] 08025
SpainSite Not Available
Investigational Site Number : 7240005
Seville, Sevilla 41013
SpainActive - Recruiting
Investigational Site Number : 7240005
Seville 2510911, Sevilla 41013
SpainSite Not Available
Investigational Site Number : 7240002
Córdoba, 14004
SpainActive - Recruiting
Investigational Site Number : 7240002
Córdoba 2519240, 14004
SpainSite Not Available
Investigational Site Number : 7240007
Madrid, 28040
SpainActive - Recruiting
Investigational Site Number : 7240008
Madrid, 28007
SpainActive - Recruiting
Investigational Site Number : 7240007
Madrid 3117735, 28040
SpainActive - Recruiting
Investigational Site Number : 7240008
Madrid 3117735, 28007
SpainSite Not Available
Investigational Site Number : 7240003
Valencia, 46026
SpainSite Not Available
Investigational Site Number : 7240003
Valencia 2509954, 46026
SpainSite Not Available
Investigational Site Number : 1580001
Taichung, 404
TaiwanActive - Recruiting
Investigational Site Number : 1580001
Taichung 1668399, 404
TaiwanSite Not Available
Investigational Site Number : 1580002
Taipei, 100
TaiwanActive - Recruiting
Investigational Site Number : 1580002
Taipei 1668341, 100
TaiwanSite Not Available
Investigational Site Number : 1580002
Taipei City, 100
TaiwanSite Not Available
Investigational Site Number : 7920001
Izmit, 41001
TurkeySite Not Available
Investigational Site Number : 7920002
Kayseri, 38030
TurkeySite Not Available
Investigational Site Number : 7920002
Kayseri, 38039
Turkey (Türkiye)Active - Recruiting
Investigational Site Number : 7920002
Kayseri 308464, 38039
Turkey (Türkiye)Site Not Available
Investigational Site Number : 7920001
Kocaeli 306970, 41100
Turkey (Türkiye)Site Not Available
Investigational Site Number : 7920001
İzmit, 41001
Turkey (Türkiye)Active - Recruiting
Investigational Site Number : 7920001
İzmit 745028, 41001
Turkey (Türkiye)Site Not Available
Investigational Site Number : 8260001
Leicester, Leicestershire LE5 4PW
United KingdomActive - Recruiting
Investigational Site Number : 8260001
Leicester 2644668, Leicestershire LE5 4PW
United KingdomSite Not Available
Investigational Site Number : 8260004
Salford, Manchester M6 8HD
United KingdomActive - Recruiting
Investigational Site Number : 8260004
Salford 2638671, Manchester M6 8HD
United KingdomSite Not Available
Investigational Site Number : 8260005
Oxford, Oxfordshire OX3 7LE
United KingdomActive - Recruiting
Investigational Site Number : 8260005
Oxford 2640729, Oxfordshire OX3 7LE
United KingdomSite Not Available
Investigational Site Number : 8400007
Birmingham, Alabama 35233
United StatesActive - Recruiting
Investigational Site Number: 8400007
Birmingham, Alabama 35233
United StatesSite Not Available
Investigational Site Number : 8400007
Birmingham 4049979, Alabama 4829764 35233
United StatesActive - Recruiting
Investigational Site Number: 8400007
Birmingham 4049979, Alabama 4829764 35233
United StatesSite Not Available
University of Alabama -The Kirklin Clinic- Site Number : 8400007
Birmingham 4049979, Alabama 4829764 35233
United StatesActive - Recruiting
Investigational Site Number : 8400015
Orange, California 92868
United StatesActive - Recruiting
Investigational Site Number : 8400012
San Francisco, California 94143
United StatesActive - Recruiting
Investigational Site Number : 8400015
Orange 5379513, California 5332921 92868
United StatesActive - Recruiting
Investigational Site Number: 8400015
Orange 5379513, California 5332921 92868
United StatesSite Not Available
University of California Irvine Medical Center- Site Number : 8400015
Orange 5379513, California 5332921 92868
United StatesActive - Recruiting
Investigational Site Number : 8400012
San Francisco 5391959, California 5332921 94143
United StatesActive - Recruiting
Investigational Site Number: 8400012
San Francisco 5391959, California 5332921 94143
United StatesSite Not Available
University of California San Francisco - Parnassus Heights- Site Number : 8400012
San Francisco 5391959, California 5332921 94143
United StatesActive - Recruiting
Investigational Site Number : 8400025
Tampa, Florida 33612
United StatesActive - Recruiting
Investigational Site Number : 8400014
Chicago, Illinois 60611
United StatesActive - Recruiting
Northwestern Memorial Hospital Arkes Pavilion- Site Number : 8400014
Chicago, Illinois 60611
United StatesActive - Recruiting
Investigational Site Number : 8400017
Hinsdale, Illinois 60521
United StatesActive - Recruiting
Investigational Site Number : 8400014
Chicago 4887398, Illinois 4896861 60611
United StatesActive - Recruiting
Investigational Site Number: 8400014
Chicago 4887398, Illinois 4896861 60611
United StatesSite Not Available
Northwestern Memorial Hospital- Site Number : 8400014
Chicago 4887398, Illinois 4896861 60611
United StatesActive - Recruiting
Investigational Site Number : 8400017
Hinsdale 4896012, Illinois 4896861 60521
United StatesActive - Recruiting
Investigational Site Number: 8400017
Hinsdale 4896012, Illinois 4896861 60521
United StatesSite Not Available
Nephrology Associates of Northern Illinois and Indiana (NANI) - Hinsdale- Site Number : 8400017
Hinsdale 4896012, Illinois 4896861 60521
United StatesActive - Recruiting
Investigational Site Number : 8400010
Ann Arbor, Michigan 48109
United StatesActive - Recruiting
Investigational Site Number : 8400010
Ann Arbor 4984247, Michigan 5001836 48109
United StatesActive - Recruiting
Investigational Site Number: 8400010
Ann Arbor 4984247, Michigan 5001836 48109
United StatesSite Not Available
University of Michigan Health System - Ann Arbor- Site Number : 8400010
Ann Arbor 4984247, Michigan 5001836 48109
United StatesActive - Recruiting
Investigational Site Number : 8400019
Edina, Minnesota 55435
United StatesActive - Recruiting
InterMed Consultants - Edina Clinic- Site Number : 8400019
Edina 5025264, Minnesota 5037779 55435
United StatesActive - Recruiting
Investigational Site Number : 8400019
Edina 5025264, Minnesota 5037779 55435
United StatesActive - Recruiting
Investigational Site Number: 8400019
Edina 5025264, Minnesota 5037779 55435
United StatesSite Not Available
Investigational Site Number : 8400018
Las Vegas, Nevada 89107
United StatesActive - Recruiting
Investigational Site Number : 8400018
Las Vegas 5506956, Nevada 5509151 89107
United StatesActive - Recruiting
Investigational Site Number: 8400018
Las Vegas 5506956, Nevada 5509151 89107
United StatesSite Not Available
Investigational Site Number: 8400028
Albuquerque, New Mexico 87109
United StatesActive - Recruiting
Investigational Site Number: 8400028
Albuquerque 5454711, New Mexico 5481136 87109
United StatesSite Not Available
Investigational Site Number : 8400001
New York, New York 10032
United StatesActive - Recruiting
Columbia University Irving Medical Center- Site Number : 8400001
New York 5128581, New York 5128638 10032
United StatesActive - Recruiting
Investigational Site Number : 8400001
New York 5128581, New York 5128638 10032
United StatesActive - Recruiting
Investigational Site Number: 8400001
New York 5128581, New York 5128638 10032
United StatesSite Not Available
Investigational Site Number : 8400021
Chapel Hill, North Carolina 27599
United StatesActive - Recruiting
Investigational Site Number : 8400021
Chapel Hill 4460162, North Carolina 4482348 27599
United StatesSite Not Available
Investigational Site Number : 8400024
Dallas, Texas 75204
United StatesActive - Recruiting
Investigational Site Number : 8400005
El Paso, Texas 79902
United StatesActive - Recruiting
Investigational Site Number: 8400016
Houston, Texas 77054
United StatesActive - Recruiting
Investigational Site Number : 8400024
Dallas 4684888, Texas 4736286 75204
United StatesSite Not Available
Investigational Site Number: 8400024
Dallas 4684888, Texas 4736286 75204
United StatesActive - Recruiting
Renal Disease Research Institute - Dallas - Live Oak Street- Site Number : 8400024
Dallas 4684888, Texas 4736286 75204
United StatesActive - Recruiting
Investigational Site Number : 8400005
El Paso 5520993, Texas 4736286 79902
United StatesSite Not Available
Investigational Site Number: 8400016
Houston 4699066, Texas 4736286 77054
United StatesSite Not Available
Prolato Clinical Research Center- Site Number : 8400016
Houston 4699066, Texas 4736286 77054
United StatesActive - Recruiting

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