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

RecruitingPhase 3Ages 18 Years - 80 YearsAllBiogen
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In plain words

What the trial is, and whether it could suit you

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, rese

Sign in to get the eligibility rules as simple questions to take to your doctor.

๐Ÿ“‹ Eligibility rules (as published)
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 at Screening 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 of screening tests confirming normal estimated glomerular filtration rate (eGFR), presence of nephrotic syndrome, hypoalbuminemia, positive anti-PLA2R antibody test (defined as an anti-PLA2R antibody titer โ‰ฅ 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 \[UPCR\] โ‰ฅ 3.0 gram per gram \[g/g\] from a 24-hour urine collection or proteinuria โ‰ฅ 3.5 gram per 24 hour \[g/24 h\]). * Participants must be on the maximally approved dose or maximally tolerated dose of at least one renin-angiotensin-aldosterone system (RAAS) inhibition therapy (e.g. angiotensin-converting enzyme inhibitor \[ACEI\], angiotensin receptor blocker \[ARB\], and/or mineralocorticoid receptor antagonists \[MRA\]) for at least 4 weeks prior to Screening. Participants not on the maximally approved dose of RAAS inhibition may be enrolled provided there is documented intolerance to maximal RAAS inhibition (e.g., angioedema, development of postural hypotension, lightheadedness, hyperkalemia, etc). Participants on MRA therapy alone at Screening must have documented prior intolerance of ACEI or ARB therapy. Participants who do not tolerate ACEI or ARB therapy are not required to start MRA therapy prior to Screening. * A UPCR of โ‰ฅ 3.0 g/g (as determined by a 24-hour urine collection) or total proteinuria โ‰ฅ 3.5 g/24 h (as determined by a 24-hour urine collection) at Screening after best supportive care for at least 4 weeks 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 is defined as an eGFR โ‰ค 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.
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What it tests

  • Felzartamab
  • Tacrolimus
  • Standard of Care IST
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Where

114 sites
Apogee Clinical Research, LLC
Huntsville, United States
The Nephrology Group, Inc. - Fresno
Fresno, United States
Academic Medical Research Institute
Los Angeles, United States
UCLA Health Connie Frank Kidney Transplant Center and General Nephrology
Los Angeles, United States
UCSF Medical Center
San Francisco, United States
Stanford University
Stanford, United States
Henry Ford Hospital- A-Basement Research Pharmacy
Detroit, United States
Elixia Health - Michigan Kidney Consultants, LLC - Elixia - PPDS
Pontiac, United States

โ€ฆand 106 more on ClinicalTrials.gov.

๐Ÿค Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible โ€” always decide together with your own doctor.
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