Felzartamab: Administered intravenously
Tacrolimus: Administered orally
Standard of Care IST: Administered intravenously and orally
In this study, researchers will learn more about the use of felzartamab in participants with primary membranous nephropathy, also known as PMN. In people with PMN, autoantibodies build up in the glomeruli of the kidney. Antibodies are proteins that help the body fight off infection. An autoantibody is a type of antibody that mistakenly targets and attacks the body's own tissues. Glomeruli are the filters of the kidney that remove waste and extra fluid from the body. In PMN, the build-up of autoantibodies in the glomeruli causes 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 PMN. Symptoms of PMN can include swelling in the legs and body, tiredness, and high blood pressure. If left untreated, PMN can eventually lead to kidney failure.
In this study, researchers will learn more about how a study drug called felzartamab affects people with PMN. Felzartamab is a monoclonal antibody, which means it is an antibody made in a laboratory. Felzartamab can target immune cells that produce autoantibodies, helping to lower their buildup in the kidneys. The main goal of this study is to compare how felzartamab works compared to a drug called tacrolimus. Tacrolimus is another drug given to people with PMN and kidney disease.
The main question that researchers want to answer is:
* How many participants achieve a complete response after 104 weeks of treatment?
* A complete response means that their urine protein levels decrease to a low level and their kidney function remains stable.
Researchers will also learn about:
* How long it takes before the participants' disease gets worse
* How long the participants' urine protein levels stay low
* How many participants develop antibodies against felzartamab in the blood?
* How many participants achieve a complete response after 76 weeks of treatment
* How many participants have medical problems during the study
* How felzartamab is processed by the body
* How felzartamab affects participants' tiredness and overall physical health
The study will be done as follows:
* Participants will be screened to check if they can join the study. This may take up to 42 days.
* Participants will be randomized to receive either felzartamab as intravenous (IV) infusions or tacrolimus, taken orally as tablets.
* If participants have worsening kidney function or worsening proteinuria, or if their PMN relapses, or if they show no signs of improvement in their PMN, they will have a chance to receive rescue treatment.
* If a participant stops treatment early, there will be follow-up visits every 12 weeks until they reach Week 104.
* In total, participants will have up to 23 study visits. Participants who do not need rescue treatment will stay in the study for up to 104 weeks. Participants who need rescue treatment will stay in the study for up to 156 weeks.
| Facility | City | Region | Status |
|---|---|---|---|
| Apogee Clinical Research, LLC | Huntsville | Alabama | Recruiting |
| The Nephrology Group, Inc. - Fresno | Fresno | California | Recruiting |
| Academic Medical Research Institute | Los Angeles | California | Recruiting |
| UCLA Health Connie Frank Kidney Transplant Center and General Nephrology | Los Angeles | California | Recruiting |
| UCSF Medical Center | San Francisco | California | Recruiting |
| Stanford University | Stanford | California | Recruiting |
| Henry Ford Hospital- A-Basement Research Pharmacy | Detroit | Michigan | Recruiting |
| Elixia Health - Michigan Kidney Consultants, LLC - Elixia - PPDS | Pontiac | Michigan | Completed |
| James J Peters Veterans Administration Medical Center - NAVREF - PPDS | The Bronx | New York | Recruiting |
| ECU Physicians Nephrology and Hypertension | Greenville | North Carolina | Recruiting |
| University Hospitals Cleveland Medical Center | Cleveland | Ohio | Recruiting |
| Knoxville Kidney Center, PLLC | Knoxville | Tennessee | Recruiting |
| Vanderbilt University Medical Center | Nashville | Tennessee | Recruiting |
| Nephrotex Research Group | Dallas | Texas | Recruiting |
| University of Texas Medical Branch | League City | Texas | Recruiting |
| University of Wisconsin School of Medicine and Public Health | Madison | Wisconsin | Recruiting |
| Organización Médica de Investigación | Buenos Aires | Argentina | Recruiting |
| CINME S.A. - Centro de Investigaciones Metabólicas | Buenos Aires | Argentina | Recruiting |
| Hospital Italiano de Buenos Aires | Buenos Aires | Argentina | Recruiting |
| Centro Medico Dra. Laura Maffei- Investigacion Clinica Aplicada | Buenos Aires | Argentina | Recruiting |
| Clínica Privada Vélez Sarsfield | Córdoba | Argentina | Recruiting |
| Concord Hospital | Concord | New South Wales | Recruiting |
| St George Hospital | Kogarah | New South Wales | Recruiting |
| Liverpool Hospital | Liverpool | New South Wales | Recruiting |
| Westmead Hospital | Westmead | New South Wales | Recruiting |
| Townsville Hospital | Douglas | Queensland | Recruiting |
| Royal Brisbane and Women s Hospital | Herston | Queensland | Recruiting |
| Gold Coast University Hospital | Southport | Queensland | Recruiting |
| Griffith University Clinical Trial Unit | Southport | Queensland | Recruiting |
| Monash Health | Clayton | Victoria | Recruiting |
| Sunshine Hospital - Australia | St Albans | Victoria | Recruiting |
| Santa Casa de Misericórdia de Belo Horizonte | Belo Horizonte | Minas Gerais | Recruiting |
| Hospital de Clinicas de Porto Alegre | Porto Alegre | Rio Grande do Sul | Recruiting |
| Hospital Sao Lucas Da Pontificia Universidade Catolica Do Rio Grande Do Sul (PUCRS) | Porto Alegre | Rio Grande do Sul | Recruiting |
| Hospital das Clinicas da Faculdade de Medicina de Ribeirao Preto da Universidade de Sao Paulo | Ribeirão Preto | São Paulo | Recruiting |
| Fundacao Faculdade Regional de Medicina de Sao Jose Do Rio Preto Hospital de Base - PPDS | São José do Rio Preto | São Paulo | Recruiting |
| Hospital Alemao Oswaldo Cruz (HAOC) | São Paulo | Brazil | Recruiting |
| Centro de Pesquisa Clínica de Nefrologia do Hospital das Clínicas da Faculdade de Medicina da Universidade de São Paulo | São Paulo | Brazil | Recruiting |
| Vancouver Coastal Health Research Institute | Vancouver | British Columbia | Recruiting |
| London Health Sciences Centre - Victoria Hospital | London | Ontario | Recruiting |
+ 72 more sites — see the full list on the official registry below.
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
View NCT06962800 on ClinicalTrials.gov ↗ ← All trials in India