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NCT06935357 · ClinicalTrials.gov registry record · Phase 3
A Study to Learn About the Effects of Felzartamab Infusions on Adults With Immunoglobulin A Nephropathy (IgAN)
A Phase 3 study of Immunoglobulin A Nephropathy (IgAN), sponsored by Biogen.
- Recruiting
- Registry status
- Phase 3
- Development phase
- 454
- Enrollment target
- 20
- Study locations
NCT06935357 is a Phase 3 study of Immunoglobulin A Nephropathy (IgAN) that is actively recruiting participants, run by Biogen. The registered enrollment target is 454 participants. The trial reports 20 study locations across 11 states.
The verdict
NCT06935357, a Phase 3 study of Immunoglobulin A Nephropathy (IgAN), is actively recruiting participants, sponsored by Biogen.
- RECRUITING
- Registry status
- Phase 3
- Development phase
- 454 participants
- Enrollment target
- 20
- Study locations
Study Summary
In this study, researchers will learn more about the use of felzartamab in participants with immunoglobulin A nephropathy (IgAN). This study will focus on participants who have protein in their urine (proteinuria) as a result of damaged kidneys. The main goal of the study is to learn about the effect felzartamab has on proteinuria. The main question that researchers want to answer is: • How much does the amount of protein in the urine change from the start of the study to Week 36? Researchers will learn about the effect felzartamab has on the kidneys' ability to filter blood. They will also learn more about the safety of felzartamab and how it is processed by the body. The study will be done as follows: * Participants will be screened to check if they can join the study. * Participants will be randomized to receive either felzartamab or a placebo. A placebo looks like the study drug but contains no real medicine. * Neither the researchers nor the participants will know what the participants will receive. * Participants will receive felzartamab or placebo as intravenous (IV) infusions. The treatment period will last 24 weeks. * Afterwards, participants will enter a follow-up period which will last 80 weeks. * In total, participants will have 17 study visits. Participants will stay in the study for about 2 years.
Conditions Studied
Interventions
- DRUG Placebo
- DRUG Felzartamab
Study Locations (20)
California
- Kidney & Hypertension Center - Apple Valley - Apple Valley
- Scripps Green Hospital - Carlsbad
- National Institute of clinical Research Administration Office - Garden Grove
- FOMAT Medical Research - FOMAT - PPDS - Oxnard
- North America Research Institute-San Dimas - San Dimas
Florida
- Nova Clinical Research, LLC - Bradenton
- Royal Research, Corp. - Hollywood
- Central Florida Kidney Specialists - Orlando
- CDC Research Institute, LLC - Port Saint Lucie
Massachusetts
- The Vasculitis and Glomerulonephritis Center at Massachusetts General Hospital - Boston
- Brigham and Women's Hospital - Boston
Michigan
- Henry Ford Hospital - Detroit
- Elixia Health - Michigan Kidney Consultants, LLC - Elixia - PPDS - Pontiac
Arkansas
- Applied Research Center of Arkansas - Little Rock
Georgia
- American Clinical Trials LLC - Acworth
Mississippi
- Anointed Nephrology and HTN - SKYCRNG - PPDS - Brookhaven
Missouri
- Midwest Nephrology Associates,Inc. - City of Saint Peters
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 454 participants |
| Start Date | 2025-05-08 |
| Est. Completion | 2029-06-05 |
| Phase | Phase 3 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT06935357
The ClinicalTrials.gov registry entry for NCT06935357 describes a study currently listed as recruiting, categorized as Phase 3. The registered enrollment target is 454 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Biogen, which has 334 total studies on file at ClinicalTrials.gov.
The record links to 1 condition, with Immunoglobulin A Nephropathy (IgAN) appearing as the primary indexed condition, and to 2 interventions - of which Placebo is the first listed.
NCT06935357 reports 20 study locations spanning 11 distinct geographic areas - top geographies include California, Florida, Massachusetts.
Frequently Asked Questions
What is clinical trial NCT06935357 about?
NCT06935357 is a clinical study titled "A Study to Learn About the Effects of Felzartamab Infusions on Adults With Immunoglobulin A Nephropathy (IgAN)". In this study, researchers will learn more about the use of felzartamab in participants with immunoglobulin A nephropathy (IgAN). This study will focus on participants who have protein in their urine (proteinuria) as a result of damaged kidneys. The main goal of the study is to learn about the effe...
What is the current status of trial NCT06935357?
This trial is currently recruiting. It is a Phase 3 study. The enrollment target is 454 participants. The study started on 2025-05-08. Estimated completion is 2029-06-05.
What conditions does trial NCT06935357 study?
This clinical trial studies the following conditions: Immunoglobulin A Nephropathy (IgAN).
What interventions are being tested in trial NCT06935357?
The interventions under investigation include: Placebo (DRUG), Felzartamab (DRUG).
Who is sponsoring clinical trial NCT06935357?
This trial is sponsored by Biogen, which has 334 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT06935357 being conducted?
This trial has 20 study locations across Arkansas, California, Florida, Georgia, Massachusetts. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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