A Study to Evaluate the Efficacy and Safety of Sefaxersen (RO7434656) in Participants With Primary Immunoglobulin A (IgA) Nephropathy at High Risk of Progression
Sefaxersen (RO7434656): Sefaxersen (RO7434656) will be administered as SC injection per schedule as specified.
Placebo: Matching placebo will be administered as SC injection per schedule as specified.
Study 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
Sex
ALL
Min age
18 Years
Max age
—
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 per gram (g/g) or urine protein excretion ≥ 1 gram per day (g/day) (with UPCR ≥ 0.8 g/g), all measured from a 24-hour urine collection during screening
* eGFR ≥ 20 mL/min/1.73 m\^2, as calculated by the 2021 CKD-EPI creatinine equation (Inker et al. 2021a)
* Vaccination against Neisseria meningitidis, Streptococcus pneumoniae and Haemophilus influenzae according to national vaccination recommendations
* Female participants of childbearing potential must use adequate contraception
Exclusion Criteria:
* Pregnancy or breastfeeding, or intention of becoming pregnant during the study or within 12 weeks after the final dose of sefaxersen
* Histopathologic or other evidence of another autoimmune glomerular disease
* Presence of ≥ 50% crescents on kidney biopsy, sustained doubling of serum creatinine within 3 months prior to screening, or rapidly progressive glomerulonephritis in the opinion of the investigator
* History of kidney transplantation
* Glycated Hemoglobin (HbA1c) ≥ 6.5% or a clinical diagnosis of diabetes mellitus of any type
* Systolic blood pressure \>140 millimetre of mercury (mmHg) or diastolic blood pressure \>90 mmHg from the average of two measurements performed at least 1 minute apart during screening
* Initiation of sodium-glucose cotransporter-2 (SGLT2) inhibitors within 16 weeks prior to screening or during screening
* Initiation of endothelin receptor antagonists within 90 days prior to screening or during screening
* Initiation of mineralocorticoid receptor antagonists or non-dihydropyridine calcium channel blockers within 90 days prior to screening or during screening
* Use of herbal therapies within 90 days prior to or during screening
* Treatment with investigational therapy within 28 days prior to screening or 5.5 drug-elimination half-lives of that investigational product prior to screening
* Treatment with an investigational therapy planned during the treatment period
* Previous treatment with sefaxersen
* Treatment with oral or intravenous (IV) corticosteroids with a dose equivalent to ≥ 7.5 milligrams per day (mg/day) of prednisone for 7 days or equivalent to ≥ 5 mg/day of prednisone for 14 days within 90 days prior to screening
* Treatment with corticosteroids with systemic effects during screening
* Treatment with a systemic calcineurin inhibitor within 2 months prior to screening or during screening
* Treatment with anti-CD20 therapy within 9 months of screening or during screening
* Treatment with other systemic immunosuppressive agents within 6 months of randomization including, but not limited to, complement inhibitors, alkylating agents (e.g., cyclophosphamide or chlorambucil), azathioprine, or mycophenolate
* Planned major procedure or major surgery during screening or the study
* Substance abuse within 12 months prior to screening or during screening
* Any serious medical condition or abnormality in clinical laboratory tests that precludes an individual's safe participation in and completion of the study
* History of malignancy within \< 5 years prior to screening, with the exception of malignancies with a negligible risk of metastasis or death
* Usage of Glucagon-like Peptide-1 (GLP-1)-based therapy (i.e., GLP-1 mono-agonists, GLP-1/GIP dual agonists, etc.) within 90 days prior to screening or during screening, or intent to initiate during the study period
Primary outcome measure(s)
Change From Baseline in the Urine Protein-to-Creatinine Ratio (UPCR) at Week 37 — Baseline, Week 37 UPCR will be assessed in urine sampled over 24 hours.
Trial sites (178)
Facility
City
Region
Status
UAB Nephrology Research Clinic
Birmingham
Alabama
Kidney Disease Medical Group Inc-1505 Wilson Ter
Glendale
California
Academic Medical Research Institute - Los Angeles
Los Angeles
California
University of California, Los Angeles (UCLA) - Hematology/Oncology Santa Monica
Los Angeles
California
North America Research Institute-San Dimas
San Dimas
California
Central Florida Kidney Specialists
Orlando
Florida
L&C Professional Medical Research Institute
West Miami
Florida
Cowry Medical Group LLC
Acworth
Georgia
Care Institute Idaho Kidney Institute
Idaho Falls
Idaho
Nephrology Associates of Northern Illinois
Hinsdale
Illinois
Massachussets General Hospital
Boston
Massachusetts
Sierra Nevada Nephrology Consultants
Reno
Nevada
North Carolina Nephrology, PA
Raleigh
North Carolina
Texas Kidney Institute - Dallas
Dallas
Texas
Pioneer Research Solutions
Houston
Texas
Prolato Clinical Research Center
Houston
Texas
R & H Clinical Research
Katy
Texas
Revival Research Institute - McKinney
McKinney
Texas
Nephrology Associates of Northern Virginia Inc
Fairfax
Virginia
Virginia Commonwealth University
Richmond
Virginia
Centro Medico Dra. Laura Maffei- Investigacion Clinica Aplicada
Ciudad Autonoma Buenos Aires
Argentina
Consultorios Médicos Dr. Doreski
Ciudad Autonoma Buenos Aires
Argentina
Sanatorio Mayo Privado
Córdoba
Argentina
Sanatorio Allende
Córdoba
Argentina
Instituto Medico de la Fundacion Estudios Clinicos
Rosario
Argentina
Nepean Hospital
Kingswood
New South Wales
St George Hospital
Kogarah
New South Wales
Liverpool Hospital
Liverpool
New South Wales
Princess Alexandra Hospital
Woolloongabba
Queensland
Royal Adelaide Hospital
Adelaide
South Australia
Royal Melbourne Hospital
Parkville
Victoria
Sunshine Hospital
St Albans
Victoria
Santa Casa de Misericordia de Belo Horizonte - PPDS
Belo Horizonte
Minas Gerais
Freire Pesquisa Clinica
Belo Horizonte
Minas Gerais
Hospital de Clinicas de Porto Alegre HCPA PPDS
Porto Alegre
Rio Grande do Sul
Faculdade de Medicina da Universidade de Sao Paulo
São Paulo
São Paulo
Hospital Do Rim E Hipertensao Fundacao Oswaldo Ramos
São Paulo
São Paulo
Instituto D?Or Pesquisa e Ensino - Hospital Gloria D?Or
Rio de Janeiro
Brazil
Vancouver General Hospital
Vancouver
British Columbia
Cape Breton Regional Hospital
Sydney
Nova Scotia
+ 138 more sites — see the full list on the official registry below.
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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