Clinical Trials List
2025-06-13 - 2030-06-30
Recruiting10
ICD-10N05.9
Unspecified nephritic syndrome with unspecified morphologic changes
ICD-9583.0
Nephritis and nephropathy, not specified as acute or chronic, with lesion of proliferative glomerulonephritis
An Open-Label, Multicenter, Randomized Phase 3 Study Evaluating the Efficacy and Safety of Felzartamab in Participants With Primary Membranous Nephropathy (PMN) [PROMINENT]
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Sponsor
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Trial scale
Multi-Regional Multi-Center
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Update
2026/04/10
Investigators and Locations
The Actual Total Number of Participants Enrolled
0 Recruiting
The Actual Total Number of Participants Enrolled
0 Recruiting
Co-Principal Investigator
- Chung-Te Liu 無
- Yuh-Mou Sue 無
- YUNG-HO HSU 無
- 楊韻紅 無
- Yueh-Lin Wu 無
- Tso-Hsiao Chen 無
The Actual Total Number of Participants Enrolled
0 Recruiting
Co-Principal Investigator
- Cheng-Chia Lee 無
- Guan-Hsing Chen 無
- 呂悅安 無
- 鄭雅蓮 無
- 陳佳晉 無
- 塗貽然 無
The Actual Total Number of Participants Enrolled
0 Recruiting
Co-Principal Investigator
- Hsi-Hsien Chen 無
- Te-Chao Fang 無
- Yen-Chung Lin 無
- Chih-Chin Kao 無
- 陳靜怡 無
The Actual Total Number of Participants Enrolled
0 Recruiting
Co-Principal Investigator
- 徐佳鈿 無
- 蔡尚峰 無
- TUNG-MIN YU 無
- Ming-Ju Wu 無
The Actual Total Number of Participants Enrolled
0 Recruiting
The Actual Total Number of Participants Enrolled
0 Recruiting
The Actual Total Number of Participants Enrolled
0 Recruiting
Co-Principal Investigator
- Chih-Jen Wu 無
- 潘吉豐 無
- 林承叡 無
- 施宏謀 無
The Actual Total Number of Participants Enrolled
0 Recruiting
The Actual Total Number of Participants Enrolled
0 Recruiting
Condition/Disease
Objectives
Test Drug
Active Ingredient
Dosage Form
Dosage
Endpoints
Inclution 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:
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 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.
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.
The Estimated Number of Participants
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Taiwan
24 participants
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Global
180 participants
