A Study to Learn About the Effects of Felzartamab Infusions on Adults With Immunoglobulin A Nephropathy (IgAN)
Public ClinicalTrials.gov record NCT06935357. 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.
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 3, Randomized, Double-Blind, Placebo-Controlled Study of Felzartamab in Adults With IgA Nephropathy (PREVAIL)
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
In this study, researchers will learn more about the use of felzartamab in participants with immunoglobulin A nephropathy (IgAN). IgAN is a kidney disease caused by the buildup of an antibody called IgA in the kidneys over time. In people with IgAN, abnormal IgA and other antibodies form clusters that build up in the small filters of the kidneys, which leads to inflammation and damage. Felzartamab is designed to target certain immune cells that produce these abnormal antibodies. 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.
Study identification
- NCT ID
- NCT06935357
- Recruitment status
- Recruiting
- Study type
- Interventional
- Phase
- Phase 3
- Enrollment
- 454 participants
Conditions and interventions
Conditions
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
- May 7, 2025
- Primary completion
- May 30, 2027
- Completion
- Jun 4, 2029
- Last update posted
- Sep 1, 2026
2025 – 2029
United States locations
- U.S. sites
- 28
- U.S. states
- 13
- U.S. cities
- 27
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Applied Research Center of Arkansas | Little Rock | Arkansas | 72205 | Recruiting |
| Kidney & Hypertension Center - Apple Valley | Apple Valley | California | 92307 | Recruiting |
| Scripps Green Hospital | Carlsbad | California | 92009 | Recruiting |
| National Institute of clinical Research Administration Office | Garden Grove | California | 92844-2751 | Withdrawn |
| UCLA Health David Geffen School of Medicine | Los Angeles | California | 90095 | Recruiting |
| FOMAT Medical Research - FOMAT - PPDS | Oxnard | California | 93030 | Recruiting |
| North America Research Institute-San Dimas | San Dimas | California | 91773 | Recruiting |
| Nova Clinical Research, LLC | Bradenton | Florida | 34209 | Recruiting |
| University of Florida - Gainesville - 1600 SW Archer Rd | Gainesville | Florida | 32610 | Recruiting |
| Royal Research, Corp. | Hollywood | Florida | 33024 | Recruiting |
| Central Florida Kidney Specialists | Orlando | Florida | 32806 | Recruiting |
| CDC Research Institute, LLC | Port Saint Lucie | Florida | 34952 | Recruiting |
| American Clinical Trials LLC | Acworth | Georgia | 30101 | Withdrawn |
| The Vasculitis and Glomerulonephritis Center at Massachusetts General Hospital | Boston | Massachusetts | 02114-4724 | Recruiting |
| Brigham and Women's Hospital | Boston | Massachusetts | 02115-6110 | Recruiting |
| UMass Memorial Medical Center | Worcester | Massachusetts | 01655 | Not yet recruiting |
| Henry Ford Hospital | Detroit | Michigan | 48202 | Recruiting |
| Elixia Health - Michigan Kidney Consultants, LLC - Elixia - PPDS | Pontiac | Michigan | 48341 | Withdrawn |
| Anointed Nephrology and HTN - SKYCRNG - PPDS | Brookhaven | Mississippi | 39601 | Recruiting |
| Midwest Nephrology Associates,Inc. | City of Saint Peters | Missouri | 63376 | Withdrawn |
| Icahn School of Medicine at Mount Sinai | New York | New York | 10029-6504 | Not yet recruiting |
| James J Peters Veterans Administration Medical Center - NAVREF - PPDS | The Bronx | New York | 10468 | Recruiting |
| Penn Renal Electrolyte and Hypertension Perelman | Philadelphia | Pennsylvania | 19104 | Not yet recruiting |
| Lifespan at Rhode Island Hospital | Providence | Rhode Island | 02903 | Recruiting |
| Knoxville Kidney Center, PLLC | Knoxville | Tennessee | 37923-3624 | Recruiting |
| Texas Kidney Institute - Dallas | Dallas | Texas | 95231 | Recruiting |
| Provecta Research Network | Houston | Texas | 77054 | Recruiting |
| R & H Clinical Research | Katy | Texas | 77974 | Recruiting |
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 232 non-U.S. sites.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT06935357, 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 Sep 1, 2026 · Synced Sep 7, 2026
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Open the official record
The complete protocol, eligibility criteria, and contact information for NCT06935357 live on ClinicalTrials.gov.