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NCT06064929 · ClinicalTrials.gov registry record · Phase 1
A Study to Learn More About the Safety and Effects of Felzartamab in Adults With Lupus Nephritis Aged 18 to 75 Years Old
A Phase 1 study of Lupus Nephritis, sponsored by HI-Bio, A Biogen Company.
- Active
- Registry status
- Phase 1
- Development phase
- 14
- Enrollment target
- 20
- Study locations
NCT06064929 is a Phase 1 study of Lupus Nephritis that is active but no longer recruiting, run by HI-Bio, A Biogen Company. The registered enrollment target is 14 participants, below the 310-participant average among 30 other Lupus Nephritis trials with a reported enrollment target (95% lower). The trial reports 20 study locations across 11 states.
The verdict
NCT06064929, a Phase 1 study of Lupus Nephritis, is active but no longer recruiting, sponsored by HI-Bio, A Biogen Company.
- ACTIVE NOT RECRUITING
- Registry status
- Phase 1
- Development phase
- 14 participants
- Enrollment target
- 20
- Study locations
Study Summary
In this study, researchers will learn more about the use of felzartamab in people with active lupus nephritis, also known as LN. In people with LN, antibodies build up in the glomeruli of the kidneys. Antibodies are proteins in the blood used by the immune system to fight infection. Glomeruli are small filters that remove waste and extra fluid from the blood. This buildup leads to inflammation and damage to the kidneys. Kidney damage can lead to too much protein and blood leaking into the urine. High levels of protein in the urine, called proteinuria, are common in people with LN. Symptoms of LN can include fever, swelling in the legs and body, and high blood pressure. If left untreated, LN can eventually lead to kidney failure. In this study, researchers will learn more about how a study drug called felzartamab affects people with LN. Felzartamab is a monoclonal antibody, which means it is an antibody made in a laboratory. Felzartamab can target immune cells that produce antibodies, helping to lower their buildup in the kidneys. The main goal of this study is to learn more about the safety of felzartamab and how it works in the body of people with LN who are taking standard of care. This will help researchers decide if they should do more studies with felzartamab in people with LN. Standard of care is the usual treatment or care given to patients for a disease, as prescribed by their doctor. The main question researchers want to answer in this study are: • How many participants had adverse events during the study? An adverse event is a health problem that may or may not be caused by the study drug. It can happen during a clinical study or within a certain amount of time after the study has ended. Researchers will also learn more about: * How much felzartamab affects proteinuria and the level of creatinine in the urine. Creatinine is a protein that is released into the blood from normal muscle wear and tear. Its levels can help doctors understand how well your
Conditions Studied
Interventions
- DRUG Felzartamab
Study Locations (20)
Texas
- Precision Comprehensive Clinical Research Solutions - Grapevine - Grapevine
- Prolato Clinical Research Center - Houston
- Accurate Clinical Research - Katy - Katy
- R & H Clinical Research - Katy
California
- University of California, San Diego (UCSD) - La Jolla
- University of California, San Francisco (UCSF) - San Francisco
- Stanford University Medical Center - Stanford
Georgia
- ClinCept, LLC/River City Vascular Specialists LLC - Columbus
- Georgia Nephrology - Lawrenceville - Lawrenceville
New York
- Joseph S. and Diane H. Steinberg Ambulatory Care Center - Brooklyn
- SUNY Downstate Medical Center - Brooklyn
Ohio
- University Hospitals Cleveland Medical Center - Cleveland
- The Ohio State University (OSU) - Columbus
Buenos Aires F.D.
- Hospital Britanico de Buenos Aires - Caba
- CEMIC - CABA
Michigan
- University of Michigan - Ann Arbor
Córdoba Province
- Clinica Priv Velez Sarsfield - Córdoba
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 14 participants |
| Start Date | 2023-11-01 |
| Est. Completion | 2026-06-30 |
| Phase | Phase 1 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT06064929
The ClinicalTrials.gov registry entry for NCT06064929 describes a study currently listed as active not recruiting, categorized as Phase 1. The registered enrollment target is 14 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 310-participant average among 30 other Lupus Nephritis trials with a reported enrollment target (95% lower). The listed sponsor is HI-Bio, A Biogen Company, which has 4 total studies on file at ClinicalTrials.gov.
The record links to 1 condition, with Lupus Nephritis appearing as the primary indexed condition, and to 1 intervention - of which Felzartamab is the first listed.
NCT06064929 reports 20 study locations spanning 11 distinct geographic areas - top geographies include Texas, California, Georgia.
Frequently Asked Questions
What is clinical trial NCT06064929 about?
NCT06064929 is a clinical study titled "A Study to Learn More About the Safety and Effects of Felzartamab in Adults With Lupus Nephritis Aged 18 to 75 Years Old". In this study, researchers will learn more about the use of felzartamab in people with active lupus nephritis, also known as LN. In people with LN, antibodies build up in the glomeruli of the kidneys. Antibodies are proteins in the blood used by the immune system to fight infection. Glomeruli are sm...
What is the current status of trial NCT06064929?
This trial is currently active not recruiting. It is a Phase 1 study. The enrollment target is 14 participants. The study started on 2023-11-01. Estimated completion is 2026-06-30.
What conditions does trial NCT06064929 study?
This clinical trial studies the following conditions: Lupus Nephritis.
What interventions are being tested in trial NCT06064929?
The interventions under investigation include: Felzartamab (DRUG).
Who is sponsoring clinical trial NCT06064929?
This trial is sponsored by HI-Bio, A Biogen Company, which has 4 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT06064929 being conducted?
This trial has 20 study locations across California, Georgia, Michigan, New York, Ohio. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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