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Active, not recruiting Phase 3 Interventional

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

ClinicalTrials.gov ID: NCT05797610

Public ClinicalTrials.gov record NCT05797610. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.

ClinicalTrials.gov public records Last synced Sep 9, 2026, 6:43 AM EDT

Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.

Official title

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

Brief summary

Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.

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 identification

NCT ID
NCT05797610
Recruitment status
Active, not recruiting
Study type
Interventional
Phase
Phase 3
Lead sponsor
Hoffmann-La Roche
Industry
Enrollment
459 participants

Conditions and interventions

Eligibility (public fields only)

Age range
18 Years and older
Sex
All
Healthy volunteers
Healthy volunteers not accepted

This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.

Study timeline

Start date
Aug 7, 2023
Primary completion
Aug 30, 2026
Completion
Mar 30, 2029
Last update posted
Aug 13, 2026

2023 – 2029

United States locations

U.S. sites
20
U.S. states
11
U.S. cities
18
Facility City State ZIP Site status
UAB Nephrology Research Clinic Birmingham Alabama 35233
Kidney Disease Medical Group Inc-1505 Wilson Ter Glendale California 91206-4032
Academic Medical Research Institute - Los Angeles Los Angeles California 90022
University of California, Los Angeles (UCLA) - Hematology/Oncology Santa Monica Los Angeles California 90025-4837
North America Research Institute-San Dimas San Dimas California 91773
Central Florida Kidney Specialists Orlando Florida 32806
L&C Professional Medical Research Institute West Miami Florida 33144
Cowry Medical Group LLC Acworth Georgia 30101
Care Institute Idaho Kidney Institute Idaho Falls Idaho 83402
Nephrology Associates of Northern Illinois Hinsdale Illinois 60521
Massachussets General Hospital Boston Massachusetts 02114
Sierra Nevada Nephrology Consultants Reno Nevada 89511
North Carolina Nephrology, PA Raleigh North Carolina 27609
Texas Kidney Institute - Dallas Dallas Texas 75231
Pioneer Research Solutions Houston Texas 077099
Prolato Clinical Research Center Houston Texas 77054
R & H Clinical Research Katy Texas 77449
Revival Research Institute - McKinney McKinney Texas 75071
Nephrology Associates of Northern Virginia Inc Fairfax Virginia 22033
Virginia Commonwealth University Richmond Virginia 23298

Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.

Non-U.S. locations

This page focuses on the U.S. directory. The official record also lists 158 non-U.S. sites.

About this trial record page

What this page shows
Public field values for ClinicalTrials.gov record NCT05797610, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
What this page does not do
No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
Where the data comes from
Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
Last refresh
Last update posted Aug 13, 2026 · Synced Sep 9, 2026

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Open the official record

The complete protocol, eligibility criteria, and contact information for NCT05797610 live on ClinicalTrials.gov.

View official ClinicalTrials.gov record →