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
Investigating Treatment Options for Kidney Disorders: Focal Segmental Glomerulosclerosis and Minimal Change Disease
Study Overview
This is a parallel, Phase 2a, double-blind, 6-arm study for the treatment of primary focal segmental glomerulosclerosis (FSGS) or primary minimal change disease (MCD).
The purpose of this study is to measure the change in proteinuria and its impact on the rates of remission of nephrotic syndrome with frexalimab, SAR442970, or rilzabrutinib compared with placebo in participants with primary FSGS or primary MCD aged 16 to 75 years.
Study details for each participant include:
The study duration will be up to 76 weeks. The treatment duration will be 24 weeks. There will be up to 18 visits.
Eligibility Criteria
You may be eligible for this study if you meet the following criteria:
- Conditions: Focal Segmental Glomerulosclerosis, Glomerulonephritis Minimal Lesion
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Age: 16 years - 75 years
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Gender: All
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 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.
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.
This study investigates the effects of investigational medications on primary focal segmental glomerulosclerosis (FSGS) and primary minimal change disease (MCD). FSGS and MCD are kidney disorders that cause proteinuria, which is an excess of protein in the urine. The purpose of this study is to see how these investigational medications affect proteinuria and remission rates of nephrotic syndrome, a kidney disorder that causes the body to excrete too much protein in the urine.
Participants in this study will be assigned to one of six study arms, receiving either an investigational medication or a placebo. A placebo is an inactive substance that looks like the investigational medication but does not contain any medicine. The study will involve regular monitoring of protein levels in the urine and other health assessments.
- Who can participate: Individuals aged 16 to 75 years with biopsy-proven primary FSGS or primary MCD can participate. Key eligibility criteria include having a UPCR of 3 g/g or higher and an eGFR of 45 mL/min/1.73 m^2 or higher at screening.
- Study details: Participants will receive treatment for 24 weeks and will be monitored for changes in proteinuria. They will be assigned to one of six study arms, receiving either an investigational medication or a placebo. A placebo is an inactive substance that looks like the investigational medication but does not contain any medicine.
- Study Timelines and Visits: The study will last 76 weeks. The study requires 18 visits.
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