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Набира участници Фаза 3 NCT06962800

A Study to Learn More About the Effects and Safety of Felzartamab Infusions in Adults With Primary Membranous Nephropathy (PMN)

Фаза 3 – широко изпитване преди одобрение
Заболявания: Primary Membranous Nephropathy

Спонсор: Biogen

Налично на: БГ
Обобщение
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.
Описание
The primary objective of the study is to assess the efficacy of felzartamab compared to tacrolimus in participants with PMN in achieving complete remission (CR) of proteinuria. The secondary objectives of the study are to evaluate the efficacy of felzartamab through additional clinical endpoints and timepoints, to assess the impact of felzartamab on serum anti-phospholipase A2 receptor (PLA2R) antibodies and patient-reported outcomes, and to assess the safety, pharmacokinetics (PK) and immunogenicity of felzartamab.
Кой може да участва
Key Inclusion Criteria: * Diagnosed with PMN in need of IST according to the Investigator's clinical judgment. The diagnosis of PMN must be documented with the presence of nephrotic syndrome, and hypoalbuminemia, and confirmed with a kidney biopsy either during Screening or within 5 years of signing the informed consent form (ICF) \[see kidney biopsy exception below for participants positive for anti-PLA2R antibodies\]. For these participants, the biopsy report with redacted protected health information must be available to be reviewed by the Sponsor or an independent nephropathologist. If the participant requires a kidney biopsy during Screening, medical monitor approval must be obtained and all other eligibility criteria should be reviewed to ensure that the participant is otherwise eligible prior to performing the kidney biopsy. a. Kidney biopsy exception for anti-PLA2R antibody positive participants: Participants who are positive for anti-PLA2R antibodies and have not had a kidney biopsy performed within 5 years of signing the ICF, may be eligible for the study without undergoing a kidney biopsy based on medical monitor review confirming normal estimated glomerular filtration rate (eGFR), presence of nephrotic syndrome, hypoalbuminemia, positive anti-PLA2R antibody test (defined as an anti-PLA2R antibody titer \> 20 RU/mL), and documentation provided by the Investigator that the work-up for secondary causes of membranous nephropathy (MN) was negative with no identifiable secondary causes. * Meets one of the following: 1. Newly diagnosed PMN, defined as having never received IST for PMN in the past. 2. Relapsed PMN, defined as documented achievement of CR or partial remission (PR) after treatment with an IST for PMN followed by reappearance of nephrotic range proteinuria (urine protein to creatinine ratio \[UPCR\] ≥ 3.0 gram per gram \[g/g\] from a 24-hour urine collection or proteinuria ≥ 3.5 gram per 24 hour \[g/24 h\]). * Participants must be on the maximally approved dose or maximally tolerated dose of angiotensin-converting enzyme inhibitor (ACEI) or angiotensin receptor blocker (ARB) for at least 3 months prior to Screening. Participants not on the maximally approved dose of renin-angiotensin-aldosterone system (RAAS) inhibition may be enrolled provided there is documented intolerance to maximal RAAS inhibition (e.g., angioedema, development of postural hypotension, lightheadedness, hyperkalemia, etc). * A UPCR of ≥ 3.0 g/g (as determined by a 24-hour urine collection) or total proteinuria ≥ 3.5 g/24 h (as determined by a 24-hour urine collection) at Screening after best supportive care for at least 3 months prior to signing the ICF. Key Exclusion Criteria: * Secondary cause of MN (e.g., malignancies, medications, systemic lupus erythematosus \[SLE\], hepatitis B, hepatitis C, etc). * Severe renal impairment defined as an eGFR ≤ 30 mL/min/1.73m\^2 at Screening or including the need for dialysis or renal replacement therapy. Note: Other protocol-defined Inclusion/Exclusion criteria may apply.
Интервенции
Felzartamab
DRUG
Tacrolimus
DRUG
Standard of Care IST
DRUG
Места на провеждане 91
Argentina (5)
Organización Médica de Investigación
Buenos Aires
CINME S.A. - Centro de Investigaciones Metabólicas
Buenos Aires
Hospital Italiano de Buenos Aires
Buenos Aires
Centro Medico Dra. Laura Maffei- Investigacion Clinica Aplicada
Buenos Aires
Clínica Privada Vélez Sarsfield
Córdoba
Австралия (9)
Monash Health
Clayton , Victoria
Concord Hospital
Concord , New South Wales
Townsville Hospital
Douglas , Queensland
Royal Brisbane and Women s Hospital
Herston , Queensland
St George Hospital
Kogarah , New South Wales
Liverpool Hospital
Liverpool , New South Wales
Gold Coast University Hospital
Southport , Queensland
Griffith University Clinical Trial Unit
Southport , Queensland
Westmead Hospital
Westmead , New South Wales
Бразилия (6)
Santa Casa de Misericórdia de Belo Horizonte
Belo Horizonte , Minas Gerais
Hospital de Clinicas de Porto Alegre
Porto Alegre , Rio Grande do Sul
Hospital Sao Lucas Da Pontificia Universidade Catolica Do Rio Grande Do Sul (PUCRS)
Porto Alegre , Rio Grande do Sul
Hospital das Clinicas da Faculdade de Medicina de Ribeirao Preto da Universidade de Sao Paulo
Ribeirão Preto , São Paulo
Fundacao Faculdade Regional de Medicina de Sao Jose Do Rio Preto Hospital de Base - PPDS
São José do Rio Preto , São Paulo
Centro de Pesquisa Clínica de Nefrologia do Hospital das Clínicas da Faculdade de Medicina da Universidade de São Paulo
São Paulo
Китай (24)
Beijing Tsinghua Changgung Hospital
Beijing , Beijing Municipality
The Second Xiangya Hospital of Central South University
Changsha , Hunan
Daqing Oilfield General Hospital
Daqing , Heilongjiang
Fu Yang People's Hospital - South Campus
Fuyang , Anhui
Zhujiang Hospital of Southern Medical University
Guangzhou , Guangdong
The Affiliated Hospital of Guizhou Medical University
Guiyang , Guizhou
The Second Affiliated Hospital, Zhejiang University School of Medicine
Hangzhou , Zhejiang
Sir Run Run Shaw Hospital Zhejiang University School of Medicine - Qingchun Campus
Hangzhou , Zhejiang
Qilu Hospital of Shandong University
Jinan , Shandong
The Second Hospital of Shandong University
Jinan , Shandong
Gansu Provincial Hospital
Lanzhou , Gansu
Lanzhou University Second Hospital
Lanzhou , Gansu
The First Affiliated Hospital of Henan Science and Technology University - Jinghua Campus
Luoyang , Henan
The First Affiliated Hospital of Guangxi Medical University
Nanning , Guangxi
The People's Hospital of Guangxi Zhuang Autonomous Region
Nanning , Guangxi
The Affiliated Hospital of Qingdao University - Xihaian Campus
Qingdao , Shandong
Peking University Shenzhen Hospital
Shenzhen , Guangdong
The Second Hospital of Hebei Medical University - Main
Shijiazhuang , Hebei
The First Hospital of Hebei Medical University
Shijiazhuang , Hebei
The First Affiliated Hospital of Xian Jiaotong University
Xi'an , Shaanxi
Zhongshan Hospital Xiamen University
Xiamen , Fujian
Peking University First Hospital - Changqiao Campus
Xichengqu Beijing , Beijing Municipality
Yantai Yuhuangding Hospital
Yantai , Shandong
Yueyang People Hospital
Yueyang , Hunan
Индия (7)
M.S. Ramaiah Medical College and Hospital
Bangalore , Karnataka
Osmania General Hospital
Hyderabad , Andhra Pradesh
Nizams Institute of Medical Sciences
Hyderabad , Andhra Pradesh
Max Super Speciality Hospital - Saket
New Delhi , National Capital Territory of Delhi
Sir Ganga Ram Hospital
New Delhi , National Capital Territory of Delhi
Noble Hospital
Pune , Maharashtra
Galaxy Hospital - Varanasi
Varanasi , Uttar Pradesh
Япония (11)
National Hospital Organization Chiba Medical Center Chibahigashi National Hospital
Chia-shi , Chiba
Saitama Medical University Hospital
Iruma-Gun Moroyama-Machi , Saitama
Kagawa University Hospital
Kita-Gun Uchiko-Cho , Kagawa-ken
University of Miyazaki Hospital
Miyazaki , Miyazaki
Japanese Red Cross Musashino Hospital
Musashino-shi , Tokyo
Niigata University Medical & Dental Hospital
Niigata , Niigata
The Kitasato Institute Kitasato University Hospital
Sagamihara-Shi Minami-Ku , Kanagawa
Hokkaido University Hospital
Sapporo , Hokkaidô
Social Medical Corporation Yuuaikai Yuuai Medical Center
Tomigusuku-Shi , Okinawa
Juntendo University Urayasu Hospital
Urayasu-Shi , Chiba
Yokohama City University Hospital
Yokohama , Kanagawa
Malaysia (3)
Hospital Canselor Tuanku Muhriz UKM
Cheras , WilayahPersekutuan KualaLumpur
Prince Court Medical Centre
Kuala Lumpur
Hospital Raja Permaisuri Bainun
Perak , Pahang
Южна Корея (5)
Inje University Haeundae Paik Hospital
Busan
Seoul National University Hospital
Seoul , Seoul Teugbyeolsi
Hanyang University Seoul Hospital
Seoul
Chung-Ang University Hospital
Seoul
Ajou University Hospital
Suwon , Gyeonggido
Taiwan (9)
Hualien Tzu Chi Hospital
Hualien City , Hualien
Kaohsiung Medical University Chung-Ho Memorial Hospital
Kaohsiung City
China Medical University Hospital
Taichung
Taichung Veterans General Hospital
Taichung
National Cheng Kung University Hospital
Tainan
MacKay Memorial Hospital
Taipei
Taipei Medical University Hospital - PPDS
Taipei
Taipei Municipal Wanfang Hospital
Taipei
Chang Gung Memorial Hospital
Taoyuan District
САЩ (12)
Nephrotex Research Group
Dallas , Texas
Henry Ford Hospital- A-Basement Research Pharmacy
Detroit , Michigan
The Nephrology Group, Inc. - Fresno
Fresno , California
ECU Physicians Nephrology and Hypertension
Greenville , North Carolina
Apogee Clinical Research, LLC
Huntsville , Alabama
Knoxville Kidney Center, PLLC
Knoxville , Tennessee
University of Texas Medical Branch
League City , Texas
Academic Medical Research Institute
Los Angeles , California
University of Wisconsin School of Medicine and Public Health
Madison , Wisconsin
Elixia Health - Michigan Kidney Consultants, LLC - Elixia - PPDS
Pontiac , Michigan
COMPLETED
UCSF Medical Center
San Francisco , California
James J Peters Veterans Administration Medical Center - NAVREF - PPDS
The Bronx , New York
Технически детайли
Статус
Набира участници
Фаза
Фаза 3
Вид изследване
INTERVENTIONAL
Пол
Мъже и жени
Минимална възраст
18 Years
Максимална възраст
80 Years
Здрави доброволци
Не
Начална дата
22.05.2025
Крайна дата
29.03.2029
Регистрационен номер
NCT06962800
Източник
clinicaltrials.gov
Запитване за медицински туризъм

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