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NCT05797610 · ClinicalTrials.gov registry record · Phase 3
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 3 study of Primary IgA Nephropathy, sponsored by Hoffmann-La Roche.
- Recruiting
- Registry status
- Phase 3
- Development phase
- 428
- Enrollment target
- 20
- Study locations
NCT05797610 is a Phase 3 study of Primary IgA Nephropathy that is actively recruiting participants, run by Hoffmann-La Roche. The registered enrollment target is 428 participants. The trial reports 20 study locations across 9 states.
The verdict
NCT05797610, a Phase 3 study of Primary IgA Nephropathy, is actively recruiting participants, sponsored by Hoffmann-La Roche.
- RECRUITING
- Registry status
- Phase 3
- Development phase
- 428 participants
- Enrollment target
- 20
- Study locations
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.
Conditions Studied
Interventions
- DRUG Placebo
- DRUG Sefaxersen (RO7434656)
Study Locations (20)
California
- Kidney Disease Medical Group Inc-1505 Wilson Ter - Glendale
- Southern California Medical Research Center - La Palma
- Academic Medical Research Institute - Los Angeles - Los Angeles
- University of California, Los Angeles (UCLA) - Hematology/Oncology Santa Monica - Los Angeles
- Los Angeles County Nephrology - Montebello
- North America Research Institute-San Dimas - San Dimas
Florida
- Hope Clinic & Research Center - Hialeah
- LCC Medical Research - Miami - ClinEdge - PPDS - Miami
- Central Florida Kidney Specialists - Orlando
- L&C Professional Medical Research Institute - West Miami
Alabama
- Alabama Kidney Research - ERN - PPDS - Alabaster
- UAB Nephrology Research Clinic - Birmingham
Arizona
- Sunrise Medical Management LLC - Surprise
- Tucson Neuroscience Research - M3 WR - Tucson
Idaho
- Care Institute Idaho Kidney Institute - Chubbuck
- Care Institute Idaho Kidney Institute - Idaho Falls
Georgia
- Cowry Medical Group LLC - Acworth
Illinois
- Nephrology Associates of Northern Illinois - Hinsdale
Iowa
- University of Iowa - Iowa City
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 428 participants |
| Start Date | 2023-08-08 |
| Est. Completion | 2029-03-31 |
| Phase | Phase 3 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT05797610
The ClinicalTrials.gov registry entry for NCT05797610 describes a study currently listed as recruiting, categorized as Phase 3. The registered enrollment target is 428 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Hoffmann-La Roche, which has 909 total studies on file at ClinicalTrials.gov.
The record links to 1 condition, with Primary IgA Nephropathy appearing as the primary indexed condition, and to 2 interventions - of which Placebo is the first listed.
NCT05797610 reports 20 study locations spanning 9 distinct geographic areas - top geographies include California, Florida, Alabama.
Frequently Asked Questions
What is clinical trial NCT05797610 about?
NCT05797610 is a clinical study titled "A Study to Evaluate the Efficacy and Safety of Sefaxersen (RO7434656) in Participants With Primary Immunoglobulin A (IgA) Nephropathy at High Risk of Progression". 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.
What is the current status of trial NCT05797610?
This trial is currently recruiting. It is a Phase 3 study. The enrollment target is 428 participants. The study started on 2023-08-08. Estimated completion is 2029-03-31.
What conditions does trial NCT05797610 study?
This clinical trial studies the following conditions: Primary IgA Nephropathy.
What interventions are being tested in trial NCT05797610?
The interventions under investigation include: Placebo (DRUG), Sefaxersen (RO7434656) (DRUG).
Who is sponsoring clinical trial NCT05797610?
This trial is sponsored by Hoffmann-La Roche, which has 909 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT05797610 being conducted?
This trial has 20 study locations across Alabama, Arizona, California, Florida, Georgia. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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Related
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