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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: Recruiting Phase 3 study of Primary IgA Nephropathy, sponsored by Hoffmann-La Roche.
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, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (45% lower). The trial reports 20 study locations across 9 states. According to ClinicalTrials.gov, the official US trial registry.
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.
Primary Outcome
UPCR will be assessed in urine sampled over 24 hours.
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 |
What NCT05797610 shows while recruiting
NCT05797610 is an interventional study that assigns participants to a tested intervention. The registered 428 participants enrollment target is mid-sized for trials with a published cap, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (45% lower).
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 names 20 study sites across 9 states, led by 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.
Learn More About Clinical Trials
Similar trials for Primary IgA Nephropathy
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT05797610's enrollment target sits among peer trials
428 879th of 2000 higher than 1,121 of 2,000 other Phase 3 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 3 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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