A Phase III, Multicenter, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of Sefaxersen, an Antisense Inhibitor of Complement Factor B, in Patients With Primary IgA Nephropathy at High Risk of Progression
Hoffmann-La Roche
Summary
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.
Eligibility
- Age range
- 18+ years
- Sex
- All
- Healthy volunteers
- No
Inclusion Criteria: * Primary IgAN, as evidenced by a kidney biopsy performed within 10 years prior to or during screening, without known secondary cause * Treatment with maximum tolerated doses of angiotensin-converting enzyme (ACE) inhibitors or angiotensin II receptor blockers (ARBs) for at least 90 days immediately prior to screening, and without an intent to modify the dose during the study, except for interruptions due to illness (not greater than 7 consecutive days), unless the potential participant is intolerant to these medications * Urine Protein-to-Creatinine Ratio (UPCR) ≥ 1 gram…
Interventions
- DrugSefaxersen (RO7434656)
Sefaxersen (RO7434656) will be administered as SC injection per schedule as specified.
- DrugPlacebo
Matching placebo will be administered as SC injection per schedule as specified.
Locations (202)
- Alabama Kidney Research - ERN - PPDSAlabaster, Alabama
- UAB Nephrology Research ClinicBirmingham, Alabama
- Sunrise Medical Management LLCSurprise, Arizona
- Tucson Neuroscience Research - M3 WRTucson, Arizona
- Kidney Disease Medical Group Inc-1505 Wilson TerGlendale, California
- Southern California Medical Research CenterLa Palma, California