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Tests treatment safety and results for Primary Membranous Nephropathy
Official title A Study to Learn More About the Effects and Safety of Felzartamab Infusions in Adults With Primary Membranous Nephropathy (PMN)
ClinicalTrials.gov ID: NCT06962800
What this study is testing
What is Felzartamab?
Felzartamab is an investigational medicine, given as an infusion into a vein, being studied as a potential treatment for primary membranous nephropathy.
Also referred to as MOR202, MOR03087, TJ202, BIIB148, HIB202.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 3: a large, late-stage study
- Time commitment: about 156 weeks
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 80
You may be able to join if
- 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...
- Meets one of the following:
- Newly diagnosed PMN, defined as having never received IST for PMN in the past.
- Relapsed PMN, defined as documented achievement of CR or partial remission (PR) after treatment with an IST for PMN followed by reappearance of...
- Participants must be on the maximally approved dose or maximally tolerated dose of angiotensin-converting enzyme inhibitor (ACEI) or angiotensin...
You likely can't join if
- 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...
See the full eligibility 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...
- Meets one of the following:
- Newly diagnosed PMN, defined as having never received IST for PMN in the past.
- 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...
- 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...
- 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...
- 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.
The study team makes the final eligibility decision.
Where it's taking place
- Huntsville, Alabama, United States
- Fresno, California, United States
- Los Angeles, California, United States
- San Francisco, California, United States
- Stanford, California, United States
- Detroit, Michigan, United States
- Pontiac, Michigan, United States
- The Bronx, New York, United States
- Greenville, North Carolina, United States
- Cleveland, Ohio, United States
- Knoxville, Tennessee, United States
- Nashville, Tennessee, United States
- Dallas, Texas, United States
- League City, Texas, United States
- Madison, Wisconsin, United States
- Buenos Aires, Argentina
- Córdoba, Argentina
- Concord, New South Wales, Australia
- Kogarah, New South Wales, Australia
- Liverpool, New South Wales, Australia
+ 64 more site(s).
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The study runs about 156 weeks per participant, based on its public description. The team confirms the exact schedule and number of visits before you enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 80 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Huntsville, Alabama, United States; Fresno, California, United States; Los Angeles, California, United States; San Francisco, California, United States; Stanford, California, United States; Detroit, Michigan, United States and 78 more location(s). Enter your location above to see the nearest site and check your eligibility.
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BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.