Phase
Condition
Kidney Disease
Glomerulonephritis
Nephrotic Syndrome
Treatment
placebo
frexalimab
rilzabrutinib
Clinical Study ID
Ages 16-75 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
Biopsy-proven primary FSGS or primary MCD.
UPCR ≥3 g/g at screening.
eGFR ≥45 mL/min/1.73 m^2 at screening.
Documented history of UPCR reduction by ≥40% in response to corticosteroid or otherimmunosuppressive therapy when pre-treatment UPCR was ≥3.5 g/g.
≤10 mg/day prednisone or equivalent and stable starting at least 1 week prior torandomization.
On stable dose of RAAS inhibitors for ≥4 weeks prior to screening (if applicable);starting RAAS inhibitors treatment will not be allowed during the double-blind orOLE treatment period.
On stable dose of SGLT2 inhibitor for ≥4 weeks prior to screening (if applicable);starting SGLT2 inhibitor treatment will not be allowed during the double-blind orOLE 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 : 0320002
Cordoba, Córdoba X5016KET
ArgentinaActive - Recruiting
Investigational Site Number : 0360001
Parkville, Victoria 3050
AustraliaActive - Recruiting
Investigational Site Number : 0760001
São Paulo, 05403-000
BrazilActive - Recruiting
Investigational Site Number : 1240001
Montreal, Quebec H1T 2M4
CanadaActive - Recruiting
Investigational Site Number : 1240006
Quebec City, Quebec G1R 2J6
CanadaActive - Recruiting
Investigational Site Number : 1520002
Santiago, 8320000
ChileActive - Recruiting
Investigational Site Number : 1560001
Beijing, 100034
ChinaActive - Recruiting
Investigational Site Number : 1560003
Chengdu, 610072
ChinaActive - Recruiting
Investigational Site Number : 1560004
Shanghai, 200080
ChinaActive - Recruiting
Investigational Site Number : 2500002
Créteil, 94010
FranceActive - Recruiting
Investigational Site Number : 2500001
Paris, 75015
FranceActive - Recruiting
Investigational Site Number : 2760002
Berlin, 10117
GermanyActive - Recruiting
Investigational Site Number : 2760003
Hannover, 30625
GermanyActive - Recruiting
Investigational Site Number : 3000002
Athens, 115 27
GreeceActive - Recruiting
Investigational Site Number : 3000001
Heraklion, 711 10
GreeceActive - Recruiting
Investigational Site Number : 3800003
Naples, Napoli 80131
ItalyActive - Recruiting
Investigational Site Number : 3800001
Brescia, 25123
ItalyActive - Recruiting
Investigational Site Number : 5280001
Amsterdam, 1105 AZ
NetherlandsActive - Recruiting
Investigational Site Number : 6160002
Opole, 45-401
PolandActive - Recruiting
Investigational Site Number : 6200001
Matosinhos, 4464-513
PortugalActive - Recruiting
Investigational Site Number : 6200002
Porto, 4434-502
PortugalActive - Recruiting
Investigational Site Number : 7240001
Barcelona, Barcelona [Barcelona] 08035
SpainActive - Recruiting
Investigational Site Number : 7240004
Barcelona, Catalunya [Cataluña] 08025
SpainActive - Recruiting
Investigational Site Number : 7240005
Seville, Sevilla 41013
SpainActive - Recruiting
Investigational Site Number : 7240002
Córdoba, 14004
SpainActive - Recruiting
Investigational Site Number : 7240003
Valencia, 46026
SpainActive - Recruiting
Investigational Site Number : 1580001
Taichung, 404
TaiwanActive - Recruiting
Investigational Site Number : 1580002
Taipei City, 100
TaiwanActive - Recruiting
Investigational Site Number : 8260004
Salford, Manchester M6 8HD
United KingdomSite Not Available
Investigational Site Number : 8260005
Oxford, Oxfordshire OX3 7LE
United KingdomSite Not Available
Investigational Site Number : 8400012
San Francisco, California 94143
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 : 8400010
Ann Arbor, Michigan 48109
United StatesActive - Recruiting
Investigational Site Number : 8400019
Edina, Minnesota 55435
United StatesActive - Recruiting
Investigational Site Number : 8400001
New York, New York 10032
United StatesActive - Recruiting
Investigational Site Number : 8400005
El Paso, Texas 79902
United StatesActive - Recruiting
Investigational Site Number: 8400016
Houston, Texas 77054
United StatesActive - Recruiting
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