The purpose of this study is to evaluate the efficacy, safety, and pharmacokinetics of sefaxersen (RO7434656), a novel Antisense Oligonucleotide (ASO) therapy in participants with primary IgA nephropathy (IgAN) who are at high risk of progressive kidney disease despite optimized supportive care.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
459
Sefaxersen (RO7434656) will be administered as SC injection per schedule as specified.
Matching placebo will be administered as SC injection per schedule as specified.
Change From Baseline in the Urine Protein-to-Creatinine Ratio (UPCR) at Week 37
UPCR will be assessed in urine sampled over 24 hours.
Time frame: Baseline, Week 37
Estimated Glomerular Filtration Rate (eGFR) Slope at Week 105 from Baseline
eGFR will be calculated using the 2021 Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI) creatinine equation.
Time frame: Baseline, Week 105
Percentage of Participants Achieving Hematuria Resolution at Week 37
Time frame: At Week 37
Time to the Composite Kidney Failure Endpoint
Time to the composite kidney failure endpoint is defined as receipt of kidney transplantation, need for kidney replacement therapy, or a sustained decline in eGFR of ≥ 30% or a sustained eGFR \< 15 milliliters/minutes/1.73m\^2 (mL/min/1.73m\^ 2) over at least 4 weeks (both eGFR criteria requires two consecutive central laboratory eGFR values meeting criteria ≥ 4 weeks apart), whichever occurs first.
Time frame: Up to approximately 36 months
Change From Baseline in Fatigue at Week 105
Fatigue will be assessed with the Functional Assessment of Chronic Illness Therapy-Fatigue subscale (FACIT-F). The FACIT-F Scale is a 13-item scale used to measure self-reported fatigue. Items are assessed on a 5-point Likert scale, with responses ranging from 0 for "not at all" to 4 for "very much". The total raw score is the sum of the values of each scored question and ranges from 0 to 52. A higher score indicates less fatigue.
Time frame: Baseline, Week 105
Percentage of Participants with Treatment-Emergent Adverse Events (TEAEs)
Time frame: Up to approximately 36 months
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UAB Nephrology Research Clinic
Birmingham, Alabama, United States
Kidney Disease Medical Group Inc-1505 Wilson Ter
Glendale, California, United States
Academic Medical Research Institute - Los Angeles
Los Angeles, California, United States
University of California, Los Angeles (UCLA) - Hematology/Oncology Santa Monica
Los Angeles, California, United States
North America Research Institute-San Dimas
San Dimas, California, United States
Central Florida Kidney Specialists
Orlando, Florida, United States
L&C Professional Medical Research Institute
West Miami, Florida, United States
Cowry Medical Group LLC
Acworth, Georgia, United States
Care Institute Idaho Kidney Institute
Idaho Falls, Idaho, United States
Nephrology Associates of Northern Illinois
Hinsdale, Illinois, United States
...and 168 more locations
Plasma Concentration of Sefaxersen
Time frame: Up to approximately 36 months