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A Study to Evaluate the Efficacy and Safety of Sefaxersen (RO7434656) in Participants With Primary Immunoglobulin A (IgA) Nephropathy at High Risk of Progression | Clinical Trials | Clareo Health

RECRUITINGPHASE3

A Study to Evaluate the Efficacy and Safety of Sefaxersen (RO7434656) in Participants With Primary Immunoglobulin A (IgA) Nephropathy at High Risk of Progression

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

NCT05797610•Hoffmann-La Roche

View on ClinicalTrials.gov

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

18 - No limit years

Sex

ALL

Healthy Volunteers

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 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
+13 more criteria

Locations (200)

Alabama Kidney Research - ERN - PPDS

Alabaster, Alabama, United States

UAB Nephrology Research Clinic

Birmingham, Alabama, United States

Sunrise Medical Management LLC

Surprise, Arizona, United States

Tucson Neuroscience Research - M3 WR

Tucson, Arizona, United States

Kidney Disease Medical Group Inc-1505 Wilson Ter

Glendale, California, United States

Southern California Medical Research Center

La Palma, 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

Los Angeles County Nephrology

Montebello, California, United States

North America Research Institute-San Dimas

San Dimas, California, United States

Key Dates

Start Date

August 8, 2023

Primary Completion Date

August 31, 2026

Completion Date

March 31, 2029

Last Updated

March 13, 2026

Enrollment

428

ESTIMATED participants

Conditions

Primary IgA Nephropathy

Interventions

Sefaxersen (RO7434656)

DRUG

Placebo

DRUG

Contacts

WA43966 https://forpatients.roche.com/

CONTACT

888-662-6728 (U.S. Only)global-roche-genentech-trials@gene.com

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: March 13, 2026Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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A Study to Evaluate the Efficacy and Safety of Sefaxersen (RO7434656) in Participants With Primary Immunoglobulin A (IgA) Nephropathy at High Risk of Progression

Inclusion Criteria

Exclusion Criteria

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Efficacy and Safety of Nefecon in Patients With Primary IgA (Immunoglobulin A) Nephropathy

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