Last updated 5 days ago
A Study to Evaluate the Efficacy and Safety of Frexalimab, SAR442970, or Rilzabrutinib in Participants Aged 16 to 75 Years With Primary Focal Segmental Glomerulosclerosis or Minimal Change Disease
84 patients around the world
Available in Chile
Sanofi
84Patients around the world
This study is for people with
Glomerulonephritis
Focal segmental glomerulosclerosis
Minimal change glomerulonephritis
Requirements for the patient
To 75 Years
All Gender
Medical requirements
- 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 other immunosuppressive therapy when pre-treatment UPCR was ≥3.5 g/g.≤10 mg/day prednisone or equivalent and stable starting at least 1 week prior to randomization.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 or OLE 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 or OLE treatment periods.Body weight within 45 to 120 kg (inclusive) at screening.
- Genetic or secondary FSGS or MCD. Those with APOL1 risk alleles are eligible.Collapsing variant of FSGS.ESKD requiring dialysis or transplantation.
StudyRESULT
SponsorSanofi
Study typeInterventional
Conditions
Focal segmental glomerulosclerosisMinimal change glomerulonephritis
Requirements
To 75 YearsAll Gender
Unique study IDclinicaltrials.gov
NCT06500702
