[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"primary-membranous-nephropathy\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:primary-membranous-nephropathy":28},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,20,0,[8,42,66,98,123,145,181,203,223,246,273,304,326,346,367,387,412,433,453,474],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":15,"eligibilityCriteria":16,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":19,"enrollmentInfo":20,"targetDuration":4,"studyType":23,"phases":24,"briefSummary":26,"conditions":27,"keywords":4,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":30,"lastUpdatePostDateStruct":31,"startDateStruct":34,"completionDateStruct":36,"leadSponsor":38,"locationsCount":41},"100636904","phase-2-a-study-to-assess-the-effect-of-surovatamig-in-adult-participants-with-antibody-mediated-kidney-disease-100636904",false,"NCT07571746","A Study to Assess the Effect of Surovatamig in Adult Participants With Antibody-mediated Kidney Disease","A Phase 2, Open-label Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Efficacy of Surovatamig in Adults With Antibody-mediated Kidney Disease","CLEAR-AbKD","Inclusion Criteria:\n\n1. Participant must be 18 (or the legal age of consent in the jurisdiction in which the study is taking place) to 75 years of age inclusive, at the time of signing the informed consent.\n2. Diagnosis of anti-PLA2R antibody-positive pMN.\n3. All participants must have received SoC therapy with angiotensin-converting enzyme inhibitors or angiotensin receptor blockers for ≥ 4 weeks, with exceptions in case of intolerance, contraindications, or low blood pressure, before the screening period.\n4. Positive for anti-PLA2R.\n5. Up to date with required vaccinations as per institutional guidelines (eg, influenza, pneumococcal, and severe acute respiratory syndrome coronavirus 2) prior to study entry.\n6. Male and\u002For female assigned at birth, inclusive of all gender identities. Contraceptive use by participants or participant partners should be consistent with local regulations regarding the methods of contraception for those participating in clinical studies.\n7. Capable of giving signed informed consent\n\nExclusion Criteria:\n\n1. Receipt of B cell-depleting therapy including CD19- or CD20-directed monoclonal antibodies \\\u003C 9 months before screening.\n2. Immunomodulatory therapy \\\u003C3 months before screening.\n3. Secondary causes of membranous nephropathy\n4. Diabetes mellitus with haemoglobin A1C \\> 8.5% tested at screening visit.\n5. Malignancies\n6. History of HLH\u002FMAS. 7 Significant CNS co-morbidity\n\n8\\. History of chronic significant respiratory disease. 9. Significant opportunistic infection in the medical history deemed relevant by the Investigator.\n\n10\\. Abnormal vital sign after 10 minutes sitting at rest. 11. Administration of corticosteroids such as prednisolone at doses exceeding 20 mg or an equivalent agent \\\u003C 2 months before screening.","ALL","18 Years","75 Years",{"count":21,"type":22},43,"ESTIMATED","INTERVENTIONAL",[25],"PHASE2","The purpose of this study is to assess the safety, tolerability, pharmacokinetic, and efficacy of surovatamig administered by subcutaneous injection in adult participants with primary membranous nephropathy.",[28],"Primary Membranous Nephropathy","RECRUITING","2026-06-30",{"date":32,"type":33},"2026-07-01","ACTUAL",{"date":35,"type":33},"2026-03-28",{"date":37,"type":22},"2029-10-15",{"name":39,"class":40},"AstraZeneca","INDUSTRY",22,{"id":43,"slug":44,"hasResults":11,"nctId":45,"briefTitle":46,"officialTitle":47,"acronym":48,"eligibilityCriteria":49,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":19,"enrollmentInfo":50,"targetDuration":4,"studyType":23,"phases":52,"briefSummary":54,"conditions":55,"keywords":4,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":56,"lastUpdatePostDateStruct":57,"startDateStruct":59,"completionDateStruct":61,"leadSponsor":63,"locationsCount":65},"100608647","phase-2-evaluation-of-efficacy-safety-and-tolerability-of-povetacicept-in-participants-with-primary-membranous-nephropathy-pmn-100608647","NCT07204275","Evaluation of Efficacy, Safety, and Tolerability of Povetacicept in Participants With Primary Membranous Nephropathy (pMN)","A Phase 2b\u002F3 Adaptive, Randomized, Active-controlled Study Evaluating the Efficacy, Safety, and Tolerability of Povetacicept Versus Calcineurin Inhibitor in the Treatment of Primary Membranous Nephropathy","OLYMPUS","Key Inclusion Criteria:\n\n• Diagnosed with pMN with confirmatory historical biopsy. If no historical biopsy was performed that confirmed pMN, a biopsy can be performed during Screening to confirm eligibility\n\nKey Exclusion Criteria:\n\n• Hypersensitivity to investigational medicinal product or to any of its excipients\n\nOther protocol defined Inclusion\u002FExclusion criteria will apply",{"count":51,"type":22},176,[25,53],"PHASE3","The purpose of this study is to evaluate the efficacy, safety, and tolerability of povetacicept in participants with primary membranous nephropathy (pMN).",[28],"2026-06-26",{"date":58,"type":33},"2026-06-29",{"date":60,"type":33},"2025-09-30",{"date":62,"type":22},"2028-12-29",{"name":64,"class":40},"Vertex Pharmaceuticals Incorporated",102,{"id":67,"slug":68,"hasResults":11,"nctId":69,"briefTitle":70,"officialTitle":71,"acronym":4,"eligibilityCriteria":72,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":73,"targetDuration":4,"studyType":23,"phases":75,"briefSummary":76,"conditions":77,"keywords":78,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":88,"lastUpdatePostDateStruct":89,"startDateStruct":91,"completionDateStruct":93,"leadSponsor":95,"locationsCount":97},"100492781","phase-3-a-study-of-snp-acth-1-39-gel-in-patients-with-primary-membranous-nephropathy-100492781","NCT05696613","A Study of SNP-ACTH (1-39) Gel in Patients With Primary Membranous Nephropathy","A Phase 3 Superiority Study Comparing the Safety and Efficacy of SNP-ACTH (1-39) Gel Compared to Rituximab and FDA Approved Biosimilars in Adults With Primary Membranous Nephropathy (PMN) in a Two-Phase Adaptive Trial Design","Inclusion Criteria:\n\n* Biopsy-proven membranous glomerulonephritis or a diagnosis of MN in patients with Nephrotic Syndrome and a positive anti PLA2R antibody test.\n* Patients classified to be at a High Risk for progressive loss of kidney function, as defined by Kidney Disease Improving Global Outcomes (KDIGO) 2021-Glomerular Diseases Guideline.\n* eGFR by Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI) formula ≥40 mL\u002Fmin\u002F1.73 m\\^2\n* Patients who have had CR or PR in response to immunosuppressive therapy, but then relapsed can participate in the study if it has been more than 3 months since their last dose of high dose glucocorticoids, calcineurin inhibitors or mycophenolate mofetil\n* Patients who have had CR or PR in response to IS therapy, but then relapsed can participate in the study if it has been more than 6 months since their last dose of chlorambucil or cyclophosphamide\n* Patients who have had CR or PR in response to immunosuppressive therapy, but then relapsed can participate in the study if it has been more than 12 months since their last dose of rituximab.\n* Life expectancy \\> 24 months.\n* Other inclusion criteria may apply.\n\nExclusion Criteria:\n\n* Secondary membranous nephropathy as defined by history, physical exam, kidney biopsy results or serologies.\n* Patients who have had a ≥ 50% reduction in serum titers of PLA2R auto-antibody within 1 year before screening.\n* Type 1 or 2 diabetes mellitus\n* Patients who must be initiated on drugs likely to affect renal function if not properly dosed.\n* Surgery within 1 month of study entry\n* History of sensitivity to proteins of porcine origin.\n* Other exclusion criteria may apply.",{"count":74,"type":22},148,[53],"The goal of the Phase 3a part of this clinical trial is to determine the optimal dose that will be used in the Phase 3b part of this clinical trial. The goal of the Phase 3b part is to assess the efficacy of SNP-ACTH (1-39) Gel relative to rituximab in patients with primary membranous nephropathy (PMN) at month 24.",[28],[79,80,81,82,83,84,85,86,87],"Kidney disease","Rituximab","Nephritis","Melanocortin","Hormones","Glucocorticoids","Glomerular Disease","ACTH","PMN","2026-06-22",{"date":90,"type":33},"2026-06-25",{"date":92,"type":33},"2023-03-13",{"date":94,"type":22},"2027-12-31",{"name":96,"class":40},"Cerium Pharmaceuticals, Inc.",31,{"id":99,"slug":100,"hasResults":11,"nctId":101,"briefTitle":102,"officialTitle":103,"acronym":104,"eligibilityCriteria":105,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":19,"enrollmentInfo":106,"targetDuration":4,"studyType":23,"phases":108,"briefSummary":109,"conditions":110,"keywords":111,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":113,"lastUpdatePostDateStruct":114,"startDateStruct":116,"completionDateStruct":118,"leadSponsor":120,"locationsCount":122},"100605074","phase-2-study-of-alxn1920-in-adult-participants-with-primary-membranous-nephropathy-pmn-100605074","NCT07157787","Study of ALXN1920 in Adult Participants With Primary Membranous Nephropathy (PMN)","A Phase 2a, Randomized, Double-blind, Placebo-controlled, Parallel-Group, Multicenter Study to Evaluate the Efficacy, Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, and Immunogenicity of ALXN1920 in Adult Participants With PMN (Primary Membranous Nephropathy) Who Are at a High Risk for Disease Progression","AUTUMN","Inclusion Criteria:\n\n* Participants who have a documented diagnosis of PMN, established by positive antiPLA2R antibody level (\\> 20 RU\u002FmL) at Screening, which must be confirmed by a central laboratory\n* Participants are willing to receive the background Standard of Care (SoC)\n* Participants at high risk for disease progression, defined as:\n\n  1. Receiving ACE inhibitor or ARB for a minimum of 8 weeks prior to Screening, with the dose titrated to the maximally tolerated level. Participants with less than 8 weeks on ACE inhibitor or ARB before Screening or who have not yet reached maximally tolerated dose will enter the Run-in Period.\n  2. Participants who are on ACE inhibitor or ARB for a minimum of 8 weeks with Systolic Blood Pressure \\\u003C 140 mmHg in ≥ 75% of the readings within last 8 weeks.\n  3. Having two proteinuria measurements with each \\> 3.5 g\u002Fday, the second measurement showing ≤50% decrease from the first measurement.\n* eGFR60 mL\u002Fmin\u002F1.73 m2 during Screening calculated by CKD-EPI 2021 creatinine formula\n* All participants must receive prophylactic treatment with appropriate antibiotics while receiving Rituximab (RTX), and be willing to be vaccinated against Neisseria meningitidis\n\nExclusion Criteria:\n\n* Documented rapid deterioration of kidney function\n* History of life-threatening Nephrotic Syndrome within 1 year before Screening\n* Diagnosis of anti- phospholipase A2 receptor (PLA2R) negative membranous nephropathy (MN) or anti-PLA2R positive MN but Screening serum anti-PLA2R \\\u003C 20 RU\u002FmL or kidney disease other than PMN\n* History of kidney transplant or planned kidney transplant or dialysis during the Treatment Period\n* History of other solid organ (heart, lung, small bowel, pancreas, or liver) or bone marrow transplant; or planned transplant during the Treatment Period\n* History or presence of any clinically relevant co-morbidities\n* History of intolerance or hypersensitivity to ACEi or ARB\n* Initiation or dose adjustment of SGLT2i within 12 weeks prior to randomization or planned adjustment of GSLT2i dose throughout the treatment period.\n* Use of traditional Chinese medicines or Chinese proprietary medicines with systemic immunosuppressive properties within 6 months prior to screening.\n* Use of MRA, or ERA within 12 weeks prior to randomization and throughout the study period\n\nNote: Additional inclusion\u002Fexclusion criteria may apply, per protocol.",{"count":107,"type":22},30,[25],"The primary objective of this study is to evaluate the efficacy of ALXN1920 compared with placebo in participants with PMN who are at a high risk for disease progression using 24-hour urine protein creatinine ratio (UPCR).",[28],[28,87,112],"ALXN1920","2026-06-17",{"date":115,"type":33},"2026-06-18",{"date":117,"type":33},"2025-09-19",{"date":119,"type":22},"2027-07-09",{"name":121,"class":40},"Alexion Pharmaceuticals, Inc.",40,{"id":124,"slug":125,"hasResults":11,"nctId":126,"briefTitle":127,"officialTitle":128,"acronym":129,"eligibilityCriteria":130,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":131,"enrollmentInfo":132,"targetDuration":4,"studyType":23,"phases":134,"briefSummary":135,"conditions":136,"keywords":4,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":113,"lastUpdatePostDateStruct":137,"startDateStruct":138,"completionDateStruct":140,"leadSponsor":142,"locationsCount":144},"100590083","phase-3-a-study-to-learn-more-about-the-effects-and-safety-of-felzartamab-infusions-in-adults-with-primary-membranous-nephropathy-pmn-100590083","NCT06962800","A Study to Learn More About the Effects and Safety of Felzartamab Infusions in Adults With Primary Membranous Nephropathy (PMN)","An Open-Label, Multicenter, Randomized Phase 3 Study Evaluating the Efficacy and Safety of Felzartamab in Participants With Primary Membranous Nephropathy (PMN) [PROMINENT]","PROMINENT","Key Inclusion Criteria:\n\n* 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.\n\n  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\u002FmL), and documentation provided by the Investigator that the work-up for secondary causes of membranous nephropathy (MN) was negative with no identifiable secondary causes.\n* Meets one of the following:\n\n  1. Newly diagnosed PMN, defined as having never received IST for PMN in the past.\n  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\u002Fg\\] from a 24-hour urine collection or proteinuria ≥ 3.5 gram per 24 hour \\[g\u002F24 h\\]).\n* 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).\n* A UPCR of ≥ 3.0 g\u002Fg (as determined by a 24-hour urine collection) or total proteinuria ≥ 3.5 g\u002F24 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.\n\nKey Exclusion Criteria:\n\n* Secondary cause of MN (e.g., malignancies, medications, systemic lupus erythematosus \\[SLE\\], hepatitis B, hepatitis C, etc).\n* Severe renal impairment defined as an eGFR ≤ 30 mL\u002Fmin\u002F1.73m\\^2 at Screening or including the need for dialysis or renal replacement therapy.\n\nNote: Other protocol-defined Inclusion\u002FExclusion criteria may apply.","80 Years",{"count":133,"type":22},180,[53],"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.\n\nKidney 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.\n\nIn 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.\n\nThe main question that researchers want to answer is:\n\n* How many participants achieve a complete response after 104 weeks of treatment?\n* A complete response means that their urine protein levels decrease to a low level and their kidney function remains stable.\n\nResearchers will also learn about:\n\n* How long it takes before the participants' disease gets worse\n* How long the participants' urine protein levels stay low\n* How many participants develop antibodies against felzartamab in the blood?\n* How many participants achieve a complete response after 76 weeks of treatment\n* How many participants have medical problems during the study\n* How felzartamab is processed by the body\n* How felzartamab affects participants' tiredness and overall physical health\n\nThe study will be done as follows:\n\n* Participants will be screened to check if they can join the study. This may take up to 42 days.\n* Participants will be randomized to receive either felzartamab as intravenous (IV) infusions or tacrolimus, taken orally as tablets.\n* 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.\n* If a participant stops treatment early, there will be follow-up visits every 12 weeks until they reach Week 104.\n* 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.",[28],{"date":115,"type":33},{"date":139,"type":33},"2025-05-22",{"date":141,"type":22},"2029-03-29",{"name":143,"class":40},"Biogen",103,{"id":146,"slug":147,"hasResults":11,"nctId":148,"briefTitle":149,"officialTitle":150,"acronym":4,"eligibilityCriteria":151,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":19,"enrollmentInfo":152,"targetDuration":4,"studyType":23,"phases":154,"briefSummary":156,"conditions":157,"keywords":159,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":171,"lastUpdatePostDateStruct":172,"startDateStruct":174,"completionDateStruct":176,"leadSponsor":178,"locationsCount":180},"100558910","phase-1-a-phase-12-study-of-nkx019-in-subjects-with-autoimmune-disease-ntrust-1-100558910","NCT06557265","A Phase 1\u002F2 Study of NKX019 in Subjects With Autoimmune Disease (Ntrust-1)","A Phase 1\u002F2 Study of NKX019, a CD19 Chimeric Antigen Receptor Natural Killer (CAR NK) Cell Therapy, in Subjects With Autoimmune Disease","General Inclusion Criteria:\n\n1. Age ≥18 and ≤75\n2. Signed informed consent form and ability to adhere to the study visit schedule and comply with other protocol requirements\n3. Women of childbearing potential must have negative pregnancy tests at screening and baseline, and agree to abstinence or acceptable birth control from 2 weeks prior to the first dose through 1 year after the last dose\n4. Progression despite maximal tolerated doses of renin-angiotensin system (RAS) blockade agents\n5. . For participants taking chronic corticosteroids for management of the disease under study, the prednisone (or equivalent) dose must be ≤20 mg\u002Fday at 2 weeks prior to Screening and stable for ≥ 14 days before start of Screening\n6. For participants on immunosuppressives or immunomodulators (other than corticosteroids), all doses must be stable for ≥ 4 weeks prior to Screening\n\nLN-specific Inclusion Criteria:\n\n1. Score of 10 or more points on the American College of Rheumatology (ACR) 2019 classification criteria for SLE\n2. Active biopsy proven lupus nephritis Class III or Class IV without Class V overlap using the 2018 International Society of Nephrology and Renal Pathology Society (ISN\u002FRPS) criteria as evidenced on kidney biopsy during consent or within 6 months before screening. The biopsy must have at least mild to moderate activity score and no more than moderate chronicity index per NIH indices\n3. Active renal disease as defined by urinary protein:creatinine ratio (UPCR) ≥ 1.5 g\u002Fg or proteinuria ≥1.5 g\u002Fday on a 24-hour collection and ≤ 7 g\u002Fday by either measure\n4. One or more of the following: positive antinuclear antibodies (ANA) ≥ 1:80 at screening OR positive anti-dsDNA OR positive anti-Smith (anti-Sm)\n5. Refractory LN defined as having received ≥ 2 prior therapies for LN (immunosuppressant and corticosteroid\u002For immunomodulatory agent, and corticosteroid at therapeutic range for at least 90 days), and had an inadequate response to therapy despite being on a therapeutic dose for ≥ 90 days\n\npMN-specific Inclusion Criteria:\n\n1. Evidence of pMN by renal biopsy during screening or within 6 months before screening\n2. Active renal disease at screening defined by spot UPCR ≥ 3.5 g\u002Fg or proteinuria ≥ 3.5 g\u002Fday on a 24-hour collection\n3. Presence of primary membranous nephropathy autoantibodies\n4. Refractory or intolerant to at least 1 induction therapy for pMN (immunosuppressant and corticosteroid or immunomodulatory agent and\u002Fcorticosteroid) and defined as not achieving a complete remission after 180 days, or partial remission after 90 days\n\nGeneral Exclusion Criteria:\n\n1. eGFR \\\u003C 45 ml\u002Fmin\u002F1.73 m\\^2\n2. Currently requiring renal dialysis or expected to require dialysis during the study period\n3. Previous solid organ or hematopoietic cell transplant or planned transplant within study treatment period\n4. Congenital or acquired immunodeficiency resulting in severe infection or those receiving chronic immunoglobulin replacement therapy\n5. Liver disease or dysfunction, including cirrhosis and\u002For aspartate aminotransferase, alanine aminotransferase, or bilirubin ≥ 3 times the upper limit of normal\n6. Pulmonary comorbidity including chronic obstructive pulmonary disease or asthma requiring daily oral steroids, resting hypoxemia (\\\u003C92% oxygen saturation via pulse oximetry) on room air, or significant smoking history (i.e. \\>10 pack\u002Fyear) with active pulmonary disease\n7. Bone marrow insufficiency unrelated to active underlying autoimmune disease with white blood cell count \\\u003C 3,000\u002Fmm\\^3; hemoglobin levels \\\u003C 9 gm\u002FdL absolute neutrophil count \\\u003C 1500\u002Fmm\\^3; platelet count \\\u003C 100,000\u002Fmm\\^3\n8. Major cardiac disease, abnormalities, or interventions as defined by, but not limited to:\n\n   1. Uncontrolled angina or unstable life-threatening arrhythmias\n   2. History of myocardial infarction within 12 weeks prior to the first dose of NKX019\n   3. Any prior coronary artery bypass graft surgery\n   4. ≥ Class III New York Heart Association (NYHA) congestive heart failure (CHF), significantly decreased ejection fraction (EF ≤ 40%), or severe cardiac insufficiency.\n   5. Prolongation of the QT interval corrected for heart rate (QTc) (Fridericia) interval of \\> 480 msec\n   6. Peripheral artery bypass graft surgery, pulmonary embolism, or other ≥ Grade 2 thrombotic or embolic events within 12 weeks prior to the first dose of NKX019\n   7. Uncontrolled hypertension (systolic BP \\> 160mmHg and\u002For diastolic BP \\> 90mmHg) despite therapy\n9. Active bleeding disorders\n10. Any overlapping autoimmune condition for which the condition or the treatment of the condition may affect the study assessments or outcomes (eg, anti-GBM antibody glomerulonephritis or any condition for additional immunosuppression is indicated); clinically significant conditions that could cause a secondary nephropathy (eg, infections, liver disease, tumors or drugs); or kidney biopsy-confirmed significant renal disease other than disease under study (eg, diabetic nephropathy, hypertensive nephropathy). Overlapping conditions for which the condition or treatment is not expected to affect assessments or outcomes (eg, Sjögren's syndrome, rheumatoid arthritis) are not excluded\n11. Pregnancy, breast feeding or, if of childbearing potential, not using adequate contraceptive precautions\n12. Current infection requiring active systemic anti-infective therapy or recent acute infection requiring systemic therapy within 30 days of planned LD\n13. History of positive HIV antibody or test positive at screening, Hepatitis B or C positive at screening, active tuberculosis (TB) or latent TB requiring suppressive therapy\n14. Major surgery within 28 days prior to the first dose of NKX019 or any surgery from which the participant has not recovered or has ongoing complications\n15. Malignancy within 5 years of screening, with the exception of basal and squamous cell carcinomas treated by complete excision. Participants with cervical dysplasia that is cervical intraepithelial neoplasia but have been treated with conization or loop electrosurgical excision procedure and have had a normal repeat Papanicolaou test are allowed\n16. Prior cellular therapy including mesenchymal, CAR-T or CAR-NK cells\n17. Central nervous system (CNS) comorbidity or any autoimmune disease with CNS involvement within 90 days prior to the first dose of NKX019 as well as active CNS lupus within 1 year prior to screening\n18. Any other acute or chronic medical or psychiatric condition, or known laboratory abnormality that, in the Investigator's opinion, is expected to interfere or impact study participation\n19. Current participation in another interventional clinical trial\n\n    a. Potential participants can be considered for enrollment after investigational product washout period of 5 half-lives or 30 days, whichever is longer\n20. Currently taking or known need for any of the medications prohibited in the study protocol\n21. Known hypersensitivity or contraindications to the study treatment including LD; or other components such as human serum albumin or dimethyl sulfoxide\n\nLN-specific Exclusion Criteria:\n\n1\\. Known clinically active antiphospholipid antibody syndrome (APS); or high-risk profile",{"count":153,"type":22},120,[155,25],"PHASE1","This is a Phase 1\u002F2, open-label, multi-center, multi-cohort, non-randomized dose escalation and dose expansion basket study to determine the safety and tolerability of NKX019 (allogeneic CAR NK cells targeting CD19) in participants with autoimmune diseases.",[158,28],"Lupus Nephritis",[160,161,162,163,164,165,166,167,158,168,169,28,170],"CD19","CAR","Allogeneic","NKX019","Interleukin 15","Cell Therapy","Immunotherapy","Adoptive cell therapy","Ntrust-1","LN","pMN","2026-06-02",{"date":173,"type":33},"2026-06-04",{"date":175,"type":33},"2024-06-13",{"date":177,"type":22},"2027-04",{"name":179,"class":40},"Nkarta, Inc.",19,{"id":182,"slug":183,"hasResults":11,"nctId":184,"briefTitle":185,"officialTitle":186,"acronym":4,"eligibilityCriteria":187,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":131,"enrollmentInfo":188,"targetDuration":4,"studyType":23,"phases":190,"briefSummary":191,"conditions":192,"keywords":4,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":193,"lastUpdatePostDateStruct":194,"startDateStruct":196,"completionDateStruct":198,"leadSponsor":200,"locationsCount":202},"100552215","phase-2-a-clinical-study-of-b007-in-the-treatment-of-primary-membranous-nephropathy-100552215","NCT06470191","A Clinical Study of B007 in the Treatment of Primary Membranous Nephropathy.","A Multicenter, Randomized, Controlled, Open Phase II\u002FIII Clinical Study to Evaluate the Efficacy and Safety of B007 Versus Cyclosporine in the Treatment of Primary Membranous Nephropathy.","Inclusion Criteria:\n\n1. Subjects with primary membranous nephropathy pathologically confirmed by renal biopsy;\n2. Subjects with glomerular filtration rate（eGFR） ≥ 45 mL\u002Fmin\u002F1.73 m2.\n3. If taking Angiotensin converting enzyme inhibitors\u002Fangiotensin II receptor antagonists\u002Fsodium-glucose cotransporter 2 inhibitors\u002Fendothelin inhibitors, a stable dose within 4 weeks before randomization;\n4. Subjects with 24-hour elevated urinary protein in accordance with the prescribed conditions;\n5. Subjects whose laboratory test results meet the prescribed standards during the screening period;\n6. Subjects who have fully understood this study and voluntarily signed the informed consent form；\n7. Subjects who are able to follow the study protocol as judged by the investigator.\n\nExclusion Criteria:\n\n1. Subjects with secondary membranous nephropathy or primary membranous nephropathy whose pathological reports suggest concomitant crescent bodies;\n2. Subjects identified by the investigator as previously resistant to CD20 monoclonal antibody or cyclosporine;\n3. Subjects who have received medication prescribed for membranous nephropathy;\n4. Subjects with concomitant prescribed diseases;\n5. Subjects with a known history of severe allergic reactions to humanized monoclonal antibodies, or known allergies to any component of cyclosporine or B007;\n6. Subjects who received live vaccination, major surgery, or participated in other clinical trials within 28 days before receiving the study drug;\n7. Subjects with positive hepatitis B surface antigen; those with positive hepatitis C virus antibody; those with a history of immunodeficiency or suffer from other acquired or congenital immunodeficiency diseases;\n8. Subjects who have a clear history of tuberculosis or have received anti-tuberculosis treatment;\n9. Subjects with CD4+ T lymphocyte count \\\u003C 400 cells\u002FμL;\n10. Pregnant or lactating women; women of childbearing potential who have not been sterilized do not agree to use appropriate contraceptive measures during treatment and for at least 12 months after the last dose of the study drug;\n11. For male subjects who have not been sterilized: those who do not consent to the use of barrier contraception during the study period and for at least 12 months after the last administration of the study drug, and who do not consent to the use of other contraceptive methods by their spouses;\n12. Other conditions unsuitable for participation in this study determined by the Investigator.",{"count":189,"type":22},216,[25,53],"To evaluate the efficacy and safety of B007 in the Treatment of Primary Membranous Nephropathy",[28],"2026-04-29",{"date":195,"type":33},"2026-05-05",{"date":197,"type":33},"2024-07-30",{"date":199,"type":22},"2026-12-31",{"name":201,"class":40},"Shanghai Jiaolian Drug Research and Development Co., Ltd",21,{"id":204,"slug":205,"hasResults":11,"nctId":206,"briefTitle":207,"officialTitle":208,"acronym":4,"eligibilityCriteria":209,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":19,"enrollmentInfo":210,"targetDuration":4,"studyType":23,"phases":212,"briefSummary":213,"conditions":214,"keywords":4,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":193,"lastUpdatePostDateStruct":215,"startDateStruct":217,"completionDateStruct":219,"leadSponsor":221,"locationsCount":222},"100490613","phase-1-a-phase-i-clinical-study-of-recombinant-humanized-anti-cd20b-lymphocyte-antigen-cd20-monoclonal-antibody-subcutaneous-injection-in-the-treatment-of-primary-membranous-nephropathy-100490613","NCT05668403","A Phase I Clinical Study of Recombinant Humanized Anti-CD20(B-lymphocyte Antigen CD20) Monoclonal Antibody Subcutaneous Injection in the Treatment of Primary Membranous Nephropathy","A Phase I Clinical Study to Evaluate the Safety, Tolerability, Pharmacokinetic and Pharmacodynamic Profiles and Preliminary Efficacy of Subcutaneous Injection of Recombinant Humanized Anti-CD20 Monoclonal Antibody in the Treatment of Primary Membranous Nephropathy","Inclusion Criteria:\n\n1. Subjects who have fully understood this study and voluntarily signed the informed consent form;\n2. Male or female subjects, aged between 18 and 75 years;\n3. Subjects with primary membranous nephropathy pathologically confirmed by renal biopsy;\n4. Subjects with systolic blood pressure ≤ 140 mmHg and diastolic blood pressure ≤ 90 mmHg at screening;\n5. If taking ACEI(Angiotensin converting enzyme inhibitors), ARB(Angiotensin receptor blocker), a stable dose within 4 weeks before screening is required;\n6. Subjects who are able to follow the study protocol as judged by the investigator.\n\nExclusion Criteria:\n\n1. Subjects with secondary membranous nephropathy;\n2. Subjects with uncontrolled blood pressure as judged by the investigator within 3 months before screening;\n3. Subjects with decreases in urine protein ≥ 50% within 6 months before screening;\n4. Subjects who have received or are receiving renal replacement therapy;\n5. Subjects with type 1 diabetes mellitus, or those with type 2 diabetes mellitus who are diagnosed as diabetic nephropathy by percutaneous renal biopsy;\n6. Subjects who have a clear history of tuberculosis or have received anti-tuberculosis treatment;\n7. Subjects with active bacterial, viral, fungal, mycobacterial, parasitic or other infections requiring systemic antibiotics or antiviral therapy;\n8. Subjects with known history of severe allergic reactions to humanized monoclonal antibodies；\n9. Subjects who received live vaccination, major surgery, or participated in other clinical trials within 28 days before receiving the study drug;\n10. Pregnant or lactating women; women of childbearing potential who have not been sterilized do not agree to use appropriate contraceptive measures during treatment and for at least 12 months after the last dose of the study drug;\n11. Subjects with serious, progressive, or uncontrolled disease that may increase risks during the participation in the study as assessed by the investigator;\n12. Subjects with a history of alcoholism or drug abuse within 12 months;\n13. Subjects with positive hepatitis B surface antigen; those with positive hepatitis C virus antibody; those with a history of immunodeficiency;\n14. Subjects with CD4+ T lymphocyte count \\\u003C 300 cells\u002FμL;\n15. Other conditions unsuitable for participation in this study determined by the Investigator.",{"count":211,"type":22},52,[155],"This Phase I Clinical Study assessed the Safety, Tolerability, Pharmacokinetic and Pharmacodynamic Profiles and Preliminary Efficacy of Subcutaneous Injection of Recombinant Humanized Anti-CD20 Monoclonal Antibody in the Treatment of Primary Membranous Nephropathy",[28],{"date":216,"type":33},"2026-04-30",{"date":218,"type":33},"2023-03-02",{"date":220,"type":22},"2027-12-30",{"name":201,"class":40},6,{"id":224,"slug":225,"hasResults":11,"nctId":226,"briefTitle":227,"officialTitle":228,"acronym":229,"eligibilityCriteria":230,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":19,"enrollmentInfo":231,"targetDuration":4,"studyType":23,"phases":233,"briefSummary":234,"conditions":235,"keywords":236,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":238,"lastUpdatePostDateStruct":239,"startDateStruct":240,"completionDateStruct":242,"leadSponsor":244,"locationsCount":232},"100600388","phase-2-a-phase-2-study-of-budoprutug-in-subjects-with-primary-membranous-nephropathy-100600388","NCT07096843","A Phase 2 Study of Budoprutug in Subjects With Primary Membranous Nephropathy","A Phase 2, Open-Label Study to Evaluate the Safety and Efficacy of Budoprutug (TNT119) in Subjects With Primary Membranous Nephropathy (PMN)","PrisMN","Inclusion Criteria:\n\n* Confirmed diagnosis of PMN with positive anti-PLA2R antibodies\n* CD19+ B cell count ≥40 cells\u002FμL\n* UPCR ≥2.0 g\u002Fg\n* eGFR ≥35 mL\u002Fmin\u002F1.73 m²\n* Stable RAAS inhibitor therapy\n* Blood pressure \\\u003C150\u002F90 mmHg at baseline\n* Adequate hematologic, hepatic, and renal function\n* Willing to use effective contraception (both sexes)\n* Other inclusion criteria may apply\n\nExclusion Criteria:\n\n* Secondary Membranous Nephropathy\n* Rapidly progressive glomerulonephritis or other glomerulopathies\n* Prior B cell-depleting therapy within 24 weeks\n* Recent use of immunosuppressants\n* Active or high-risk infections\n* History of malignancy\n* Pregnancy or breastfeeding\n* Recent major surgery or hospitalization\n* Other exclusion criteria may apply",{"count":232,"type":22},45,[25],"To evaluate the safety and tolerability of three dose regimens of budoprutug in subjects with PMN",[28],[87,237,229],"Anti-CD19","2026-04-28",{"date":216,"type":33},{"date":241,"type":33},"2025-08-25",{"date":243,"type":22},"2027-10",{"name":245,"class":40},"Climb Bio, Inc.",{"id":247,"slug":248,"hasResults":11,"nctId":249,"briefTitle":250,"officialTitle":251,"acronym":4,"eligibilityCriteria":252,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":253,"targetDuration":4,"studyType":23,"phases":255,"briefSummary":257,"conditions":258,"keywords":259,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":262,"lastUpdatePostDateStruct":263,"startDateStruct":265,"completionDateStruct":267,"leadSponsor":269,"locationsCount":272},"100560151","phase-4-efficacy-and-safety-of-finerenone-in-patients-with-primary-membranous-nephropathy-100560151","NCT06573411","Efficacy and Safety of Finerenone in Patients With Primary Membranous Nephropathy","Efficacy and Safety of Finerenone in Patients With Primary Membranous Nephropathy: A Prospective, Randomized, Controlled, Multicenter Clinical Study","Inclusion Criteria:\n\n* Adults (age≥18,and ≤75) with primary MN.\n* Administration of the maximum tolerable dose of ACEI\u002FARB for ≥4 weeks.\n* BP ≤140\u002F90 mmHg.\n* Urine protein content of 1.0-5.0 g\u002Fd.\n* eGFR ≥60 (CKD-EPI).\n* Postmenopausal or postoperatively infertile status or on medical contraception (considering the potential risk of thromboembolism in patients with kidney disease) in women.\n* Voluntary signing of informed consent.\n\nExclusion Criteria:\n\n* Type 1 or type 2 diabetes. Patients with a recent history of steroid-induced diabetes were eligible with renal biopsy showing no evidence of secondary diabetic nephropathy within 6 months before the screening period.\n* Patients with secondary membranous nephropathy (e.g., due to hepatitis B and C, systemic lupus erythematosus, drug therapy, malignant tumors and other secondary causes).\n* Uncontrolled arterial hypertension.\n* Treatment with glucocorticoids, immunosuppressants and\u002For biological agents in the past 6 months.\n* Treatment with any other study drug within the last month.\n* Females with a positive pregnancy screening test, lactating or planning to become pregnant in the next 24 months. Female or male patients unwilling to use contraceptive methods throughout the study.\n* A history of mental illness.\n* Laboratory tests meeting the following criteria:\n\n  1. Hemoglobin levels \\\u003C80 g\u002FL;\n  2. Platelet count \\\u003C80×109\u002FL;\n  3. Neutrophil count \\\u003C1.0×109\u002FL;\n  4. Aspartate aminotransferase (AST) or amino aminotransferase (ALT) \\>2.5 times the upper limit of normal, except in relation to the primary disease.\n* Very high-risk cases (life-threatening nephrotic syndrome or unexplained rapid deterioration of renal function).\n* Unsuitability for inclusion in the trial as judged by the investigator.",{"count":254,"type":22},116,[256],"PHASE4","This is a prospective, randomized, multicenter, controlled trial. One hundred sixteen patients with primary membranous nephropathy (PMN) will be randomly divided into the intervention and control groups. The intervention group will be administered maximum tolerable dose of ACEI\u002FARB and finerenone 20 mg QD. Control patients will be administered maximum tolerable dose of ACEI\u002FARB. The primary endpoint is the relative change in urinary protein content from baseline to 6 months.",[28],[260,261],"finerenone","urinary protein","2026-04-03",{"date":264,"type":33},"2026-04-08",{"date":266,"type":33},"2024-09-30",{"date":268,"type":22},"2026-10-30",{"name":270,"class":271},"First Affiliated Hospital, Sun Yat-Sen University","OTHER",1,{"id":274,"slug":275,"hasResults":11,"nctId":276,"briefTitle":277,"officialTitle":278,"acronym":4,"eligibilityCriteria":279,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":19,"enrollmentInfo":280,"targetDuration":4,"studyType":23,"phases":282,"briefSummary":283,"conditions":284,"keywords":289,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":294,"lastUpdatePostDateStruct":295,"startDateStruct":297,"completionDateStruct":299,"leadSponsor":301,"locationsCount":303},"100551903","phase-2-study-of-wal0921-in-patients-with-glomerular-kidney-diseases-100551903","NCT06466135","Study of WAL0921 in Patients With Glomerular Kidney Diseases","Safety, Efficacy, Pharmacokinetics, and Pharmacodynamics of WAL0921 in Patients With Glomerular Kidney Diseases and Proteinuria","Inclusion Criteria:\n\n* Adults, age 18-75 years\n* Diagnosis of one of the following glomerular kidney diseases: diabetic nephropathy; primary focal segmental glomerulosclerosis; treatment resistant-minimal change disease; primary IgA nephropathy; primary membranous nephropathy\n* eGFR greater than or equal to 30 mL\u002Fmin\u002F1.73 m2\n\nExclusion Criteria:\n\n* Currently pregnant or planning to become pregnant\n* History of organ transplantation\n* History of alcohol or substance use disorder\n* Acute dialysis or acute kidney injury within 6 months of Screening\n* Any prior or current medical condition that, in the judgment of the Investigator, would prevent the subject from safely participating in and\u002For completing all study requirements",{"count":281,"type":22},96,[25],"This is an adaptive prospective, multi-center, randomized, double-blind, placebo-controlled study to evaluate the safety, efficacy, pharmacokinetics, and pharmacodynamics of WAL0921 in subjects with glomerular kidney disease and proteinuria, including diabetic nephropathy and rare glomerular kidney diseases (primary focal segmental glomerulosclerosis \\[FSGS\\], treatment-resistant minimal change disease \\[TR MCD\\], primary immunoglobulin A nephropathy \\[IgAN\\], and primary membranous nephropathy \\[PMN\\]). Subjects in this study will be randomized to receive the investigational drug WAL0921 or placebo as an intravenous infusion once every 2 weeks for 7 total infusions. All subjects will be followed for 24 weeks after their last infusion.",[285,286,287,288,28],"Diabetic Nephropathies","Primary Focal Segmental Glomerulosclerosis","Minimal Change Disease","Primary Immunoglobulin A Nephropathy",[290,291,292,293,87],"DN","FSGS","TR-MCD","IgAN","2026-03-27",{"date":296,"type":33},"2026-04-02",{"date":298,"type":33},"2024-07-02",{"date":300,"type":22},"2027-06",{"name":302,"class":40},"Walden Biosciences",50,{"id":305,"slug":306,"hasResults":11,"nctId":307,"briefTitle":308,"officialTitle":309,"acronym":4,"eligibilityCriteria":310,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":131,"enrollmentInfo":311,"targetDuration":4,"studyType":23,"phases":313,"briefSummary":314,"conditions":315,"keywords":4,"overallStatus":316,"whyStopped":4,"lastUpdateSubmitDate":317,"lastUpdatePostDateStruct":318,"startDateStruct":320,"completionDateStruct":322,"leadSponsor":324,"locationsCount":4},"100610968","phase-1-a-phase-i-study-of-yk012-in-primary-membranous-nephropathy-100610968","NCT07234474","A Phase I Study of YK012 in Primary Membranous Nephropathy","A Phase I Study of YK012, a Humanized CD19 × CD3 Bispecific Antibody, in Participants With Very High-Risk, Refractory Primary Membranous Nephropathy","Inclusion Criteria:\n\n* Age 18-80 (inclusive), both gender.\n* Diagnosed with primary (idiopathic) membranous nephropathy by renal biopsy within 10 years.\n* Participants who meet the criteria of very high-risk primary (idiopathic) membranous nephropathy based on 2021 Kidney Disease: Improving Global Outcomes (KDIGO) Clinical Practice Guideline for the Management of Glomerular Diseases and who have failed available therapies for the treatment of pMN.\n* eGFR estimated using the Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI) formula is ≥45 mL\u002Fmin\u002F1.73 m².\n* If taking angiotensin-converting enzyme inhibitor (ACEI), angiotensin II receptor blocker (ARB), or Sodium-Glucose Co-Transporter 2 (SGLT-2) inhibitor, the medication dosage must have been stable (≤50% change in dose) for at least 4 weeks prior to screening and continue being stable prior to the initiation of the investigational product.\n* Laboratory tests within 7 days prior to enrollment meet the pre-defined criteria.\n* Be able to understand and voluntarily participate in this clinical trial with written signed informed consent and available for scheduled visits, treatments, examinations, and other study procedures.\n\nExclusion Criteria:\n\n* Diagnosed with secondary membranous nephropathy.\n* Any prior receipt of protocol-specified pharmacological treatment for membranous nephropathy.\n* History of malignant tumor within 5 years prior to screening.\n* Poorly controlled hypertension.\n* Participants with severe renal insufficiency who have received or require dialysis or kidney transplantation within 6 months prior to the initiation of the investigational product.\n* History of diabetic nephropathy confirmed by renal biopsy.\n* History of severe or chronic infections within 6 months prior to screening or currently infection requiring systemic antibiotic or antiviral therapy.\n* History of cardiovascular event leading to hospitalization within 6 months prior to screening.\n* Other severe or poorly controlled diseases that may affect the protocol compliance or efficacy assessments.\n* Have active tuberculosis with clear evidence of infection.\n* History of substantial organ or bone marrow transplantation.\n* Received live vaccination, underwent major surgery, or participated in other clinical trials and applied any other study drugs within 28 days prior to the initiation of the investigational product.\n* Hepatitis B surface antigen (HBsAg) positive, or hepatitis B core antibody (HBcAb) positive with hepatitis B virus (HBV) DNA quantification ≥ 1×103 copies\u002FL or ≥ 50 IU\u002FL (HBcAb positive participants require regular HBV DNA testing); Hepatitis C virus (HCV) antibody positive; Human immunodeficiency virus (HIV) seropositive; Syphilis helical antibody positive.\n* Peripheral blood CD4+ T-lymphocyte count \\\u003C 200 cells\u002FμL.\n* The peripheral blood B-cell count is below the lower limit of normal.\n* Known hypersensitivity to any of the ingredients of YK012.\n* Female participants who are pregnant or breastfeeding, or women of childbearing potential (WOCBP) who have a positive pregnancy test result at screening; or those who plan to have children during the trial period and for 12 months after the end of the trial, and those who are unwilling to use one or more physical contraceptive methods during the trial period and for 12 months after the end of the trial.\n* Other conditions that the investigator considers inappropriate for participation in this trial.",{"count":312,"type":22},66,[155],"The goal of this clinical trial is to evaluate the safety, tolerability, pharmacokinetics(PK), pharmacodynamics (PD), immunogenicity, and preliminary efficacy of YK012 in participants with primary membranous nephropathy (pMN).",[28],"NOT_YET_RECRUITING","2026-02-04",{"date":319,"type":33},"2026-02-05",{"date":321,"type":22},"2026-10",{"date":323,"type":22},"2028-02",{"name":325,"class":40},"Excyte Biopharma Ltd",{"id":327,"slug":328,"hasResults":11,"nctId":329,"briefTitle":330,"officialTitle":330,"acronym":4,"eligibilityCriteria":331,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":19,"enrollmentInfo":332,"targetDuration":4,"studyType":23,"phases":334,"briefSummary":335,"conditions":336,"keywords":4,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":337,"lastUpdatePostDateStruct":338,"startDateStruct":340,"completionDateStruct":342,"leadSponsor":344,"locationsCount":272},"100615219","phase-2-phase-ii-randomized-open-label-multicenter-clinical-study-evaluating-the-safety-efficacy-pharmacokinetics-and-pharmacodynamics-of-shr-2173-injection-in-patients-with-primary-membranous-nephropathy-100615219","NCT07289763","Phase II Randomized, Open-label, Multicenter Clinical Study Evaluating the Safety, Efficacy, Pharmacokinetics, and Pharmacodynamics of SHR-2173 Injection in Patients With Primary Membranous Nephropathy","Inclusion Criteria:\n\n1. Age 18-75 years, regardless of gender;\n2. Weight ≥40.0 kg at screening;\n3. Diagnosed as primary membranous nephropathy through kidney biopsy.\n\nExclusion Criteria:\n\n1. Secondary membranous nephropathy.\n2. Subjects developed rapidly progressive glomerulonephritis or required kidney transplantation.\n3. Subjects who have undergone kidney dialysis in the previous 12 months or are expected to require dialysis during the study period.\n4. Subjects who have a malignant tumor or a history of malignant tumor\n5. Subjects who have undergone major surgery within the previous 3 months, or plan to undergo major surgery during the study period.",{"count":333,"type":22},75,[25],"To investigate the safety, efficacy, pharmacokinetics, and pharmacodynamics of SHR-2173 injection in patients with primary membranous nephropathy",[28],"2026-01-22",{"date":339,"type":33},"2026-01-26",{"date":341,"type":33},"2025-12-31",{"date":343,"type":22},"2027-09",{"name":345,"class":40},"Guangdong Hengrui Pharmaceutical Co., Ltd",{"id":347,"slug":348,"hasResults":11,"nctId":349,"briefTitle":350,"officialTitle":351,"acronym":4,"eligibilityCriteria":352,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":19,"enrollmentInfo":353,"targetDuration":4,"studyType":23,"phases":355,"briefSummary":356,"conditions":357,"keywords":4,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":358,"lastUpdatePostDateStruct":359,"startDateStruct":361,"completionDateStruct":363,"leadSponsor":365,"locationsCount":272},"100576180","phase-3-obinotuzumab-versus-cyclophosphamide--glucocorticoids-in-primary-membranous-nephropathyblossom-study-100576180","NCT06781944","OBINOTUZUMAB Versus Cyclophosphamide + Glucocorticoids in Primary Membranous Nephropathy(Blossom Study)","A Multicenter, Open- Label, Randomized, Clinical Trial to Investigate the Efficacy and Safety of OBINOTUZUMAB Versus Cyclophosphamide Combined With Glucocorticoids in Patients With Primary Membranous Nephropathy (Blossom Study)","Inclusion Criteria:\n\n* Aged 18～75 years (including 18 and 75)old at the time of signing Informed Consent Form\n* pMN patients diagnosed according to renal biopsy (original biopsy needs to include light, immunofluorescence, and electron microscopy) within 5 years or serum anti-PLA2R antibody (≥14 RU\u002Fml )\n* 24-hour UPCR ≥ 4 g\u002Fg and serum albumin (sALB) \\\u003C 30 g\u002FL,despite being treated with ACEi and\u002For ARB for ≥ 6 months prior to screening, or 24-hour UPCR ≥ 5 g\u002Fg and sALB \\\u003C 30 g\u002FL , despite being treated with ACEi and\u002For ARB for ≥ 3 months prior to screening; or 24-hour UPCR ≥ 8 g\u002Fg and sALB \\\u003C 25 g\u002FL, despite being treated with ACEi and\u002For ARB for ≥ 1 month prior to screening,.\n* eGFR ≥40 mL\u002Fmin\u002F1.73m2 (CKD-EPI), a renal biopsy is required to exclude renal damage due to other co-morbidities if eGFR \\\u003C60mL\u002Fmin\u002F1.73 m2.\n* Ability to comply with the study protocol, in the investigator's judgment\n\nExclusion Criteria:\n\n* Patients with a secondary cause of MN (e.g. hepatitis B, systemic lupus erythematosus, medications, malignancies)\n* Type 1 or 2 diabetes mellitus\n* eGFR \\\u003C40 mL\u002Fmin\u002F1.73m2 (CKD-EPI) or dialysis or kidney transplantation\n* Evidence of 50% reduction in proteinuria or serum anti-PLA2R antibody within 6 months prior to screening",{"count":354,"type":22},144,[53],"This is a randomized, parallel group, active-controlled, open-label, Phase III study comparing the efficacy and safety of obinutuzumab versus cyclophosphamide combined with glucocorticoids in patients with primary membranous nephropathy (pMN). Approximately 144 patients with pMN who have been diagnosed by biopsy or serum anti-PLA2R antibody will be enrolled.\n\nIntervention: Intravenous infusion of 1,000 mg obinutuzumab at weeks 0, 2, 24 and 26 Comparator: Cyclical cyclophosphamide and glucocorticoids Methylprednisolone 500 mg iv will be given for 3 consecutive days at the start of month 1,3,5 and followed by prednisone 0.5mg\u002Fkg\u002Fd (max 40 mg\u002Fd) for 27 days.\n\nOral cyclophosphamide will be given for 30 days in month 2, 4, 6.",[28],"2026-01-16",{"date":360,"type":33},"2026-01-21",{"date":362,"type":33},"2024-10-23",{"date":364,"type":22},"2028-05-31",{"name":366,"class":271},"Huashan Hospital",{"id":368,"slug":369,"hasResults":11,"nctId":370,"briefTitle":371,"officialTitle":372,"acronym":4,"eligibilityCriteria":373,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":131,"enrollmentInfo":374,"targetDuration":4,"studyType":23,"phases":376,"briefSummary":377,"conditions":378,"keywords":4,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":379,"lastUpdatePostDateStruct":380,"startDateStruct":382,"completionDateStruct":384,"leadSponsor":386,"locationsCount":272},"100591615","phase-1-study-of-yk012-in-primary-membranous-nephropathy-100591615","NCT06982729","Study of YK012 in Primary Membranous Nephropathy","A Phase I Clinical Study to Evaluate the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, and Preliminary Efficacy of YK012 in the Treatment of Primary Membranous Nephropathy","Inclusion Criteria:\n\n* Aged 18 to 80 years (inclusive), regardless of gender.\n* Kidney biopsy-confirmed diagnosis of primary (idiopathic) membranous nephropathy within the past 10 years.\n* Elevated 24-hour urine protein, meeting the pre-defined criteria.\n* Estimated glomerular filtration rate (eGFR) ≥60 mL\u002Fmin\u002F1.73m² as calculated by the CKD-EPI equation.\n* If currently taking an angiotensin-converting enzyme inhibitor (ACEi), angiotensin II receptor blocker (ARB), or sodium-glucose cotransporter-2 (SGLT-2) inhibitor, the dose must have been stable for at least 4 weeks prior to enrollment or since initiation of therapy.\n* Laboratory test results must meet the predefined criteria within 7 days prior to enrollment.\n* Capable of understanding and voluntarily participating in this clinical trial, having provided written informed consent, and able to comply with scheduled visits, treatments, examinations, and other study procedures as required.\n\nExclusion Criteria:\n\n* Diagnosis of secondary membranous nephropathy.\n* Any prior receipt of protocol-specified pharmacological treatment for membranous nephropathy.\n* History of malignancy within 5 years prior to enrollment.\n* Poorly controlled hypertension at enrollment.\n* Severe renal dysfunction with prior dialysis or kidney transplantation within 6 months prior to enrollment.\n* Prior kidney biopsy-confirmed diagnosis of diabetic nephropathy.\n* History of severe or chronic infections within the 6 months before enrollment or current need for systemic antibiotic or antiviral therapy.\n* Cardiovascular or cerebrovascular events requiring hospitalization within 6 months prior to enrollment.\n* Severe or poorly controlled comorbidities that may affect protocol compliance or efficacy evaluation.\n* Active Tuberculosis (TB) with documented evidence of infection.\n* History of solid organ or bone marrow transplantation.\n* Live vaccination, major surgery, or participated in other clinical trials with investigational drug use within 28 days prior to enrollment.\n* HBsAg-positive, or HBcAb-positive with detectable HBV DNA above the normal range; HCV antibody-positive; HIV seropositive; Treponema pallidum antibody-positive.\n* CD4+ T lymphocyte count \\\u003C200 cells\u002FμL\n* Known hypersensitivity to any component of YK012.\n* Pregnancy, breastfeeding, or positive pregnancy test at screening; or plans to become pregnant during the trial or within 12 months after study completion, or unwillingness to use physical contraceptive methods during the study and for 12 months thereafter.\n* Other conditions deemed by the investigator to make the subject unsuitable for participation in this study.",{"count":375,"type":22},72,[155],"The goal of this clinical trial is to evaluate the safety, tolerability, pharmacokinetics (PK), pharmacodynamics (PD), immunogenicity, and preliminary efficacy of YK012 in participants with primary membranous nephropathy (PMN).",[28],"2025-11-14",{"date":381,"type":33},"2025-11-17",{"date":383,"type":33},"2025-03-08",{"date":385,"type":22},"2027-12",{"name":325,"class":40},{"id":388,"slug":389,"hasResults":11,"nctId":390,"briefTitle":391,"officialTitle":392,"acronym":393,"eligibilityCriteria":394,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":395,"targetDuration":397,"studyType":398,"phases":4,"briefSummary":399,"conditions":400,"keywords":401,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":403,"lastUpdatePostDateStruct":404,"startDateStruct":406,"completionDateStruct":408,"leadSponsor":410,"locationsCount":272},"100584743","a-real-world-study-about-pmn-100584743","NCT06893328","A Real World Study About PMN","PMNTRWS: A Non-interventional Study on Treatment and Therapeutic Efficacy in Chinese Patients With Primary Membranous Nephropathy (PMNTRWS)\"","PMNTRWS","Inclusion Criteria:\n\n1\\. Diagnosed as primary membranous nephropathy (PMN) by renal biopsy; 2. Aged over 18 years; 3. An average 24-hour urine protein ≥ 3.5g twice a week after treatment with ACE inhibitors or ARBs for at least 3 months.\n\n\\-\n\nExclusion Criteria:\n\n1. With secondary membranous nephropathy (such as hepatitis B and C, systemic lupus erythematosus, drug therapy, malignant tumors and other secondary causes);\n2. Active infection, such as active hepatitis B or hepatitis C, tuberculosis (evidence of active tuberculosis infection within 1 year), or human immunodeficiency virus HIV infection (positive for anti-HIV antibodies), etc.\n3. A history of immunodeficiency, including other acquired or congenital immunodeficiency diseases, or organ transplantation.\n\n   \\-",{"count":396,"type":22},200,"2 Years","OBSERVATIONAL","The investigators designed a randomized, controlled, multicenter clinical study to compare the efficacy and safety of rituximab combined with hormones versus rituximab monotherapy in the treatment of primary membranous nephropathy. At the same time, the investigators conducted a real-world study on patients who did not meet the inclusion and exclusion criteria or were unwilling to enter the RCT cohort, to further observe the trial results in a broader population.",[28],[402],"Real-world Study","2025-08-18",{"date":405,"type":33},"2025-08-22",{"date":407,"type":33},"2024-11-11",{"date":409,"type":22},"2027-11-11",{"name":411,"class":271},"Wei Chen",{"id":413,"slug":414,"hasResults":11,"nctId":415,"briefTitle":416,"officialTitle":417,"acronym":4,"eligibilityCriteria":418,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":131,"enrollmentInfo":419,"targetDuration":4,"studyType":23,"phases":421,"briefSummary":422,"conditions":423,"keywords":4,"overallStatus":316,"whyStopped":4,"lastUpdateSubmitDate":424,"lastUpdatePostDateStruct":425,"startDateStruct":427,"completionDateStruct":429,"leadSponsor":431,"locationsCount":4},"100595183","phase-2-a-study-to-learn-more-about-the-effects-and-safety-of-jmt601-in-adults-with-primary-membranous-nephropathy-100595183","NCT07029139","A Study to Learn More About the Effects and Safety of JMT601 in Adults With Primary Membranous Nephropathy","A Multicenter, Randomized, Controlled, Open-label Phase II Clinical Study Evaluating the Efficacy and Safety of JMT601 Injection in Participants With Primary Membranous Nephropathy","Inclusion Criteria:\n\n1. The age range is between 18 and 80 years old, regardless of gender.\n2. Diagnosed with primary membranous nephropathy by renal biopsy during the screening\u002Finduction period or within 24 months before screening. Pathological reports must be reviewed by the investigator prior to study drug administration.\n3. The glomerular filtration rate (eGFR) estimated by CKD-EPI formula is ≥ 40ml\u002Fmin\u002F1.73m\\^2, or the endogenous creatinine clearance rate (CrCl) based on 24-hour urine examination is ≥ 40ml\u002Fmin.\n4. Participants taking angiotensin converting enzyme inhibitors\u002Fangiotensin II receptor antagonists must maintain a stable dose for at least 4 weeks before screening;\n5. Participants with systolic blood pressure ≤140 mmHg and diastolic blood pressure ≤ 90 mmHg at screening.\n6. During the screening period and the baseline visit, the 24-hour urine protein is \\> 3.5g.\n7. Have never received immunosuppressive therapy for PMN (cyclophosphamide, calcineurin inhibitors, such as cyclosporine and tacrolimus) and B cell exhaustion therapy (such as rituximab); or relapsed after receiving the above treatment to achieve complete remission or partial remission (comprehensively judged and recorded by the researcher), and have not received the above treatment after recurrence (excluding those who are ineffective or resistant to B cell depletion drugs).\n8. Have fully understood this study and voluntarily signed the informed consent form.\n\nExclusion Criteria:\n\n1. Secondary membranous nephropathy.\n2. Diagnostic renal biopsy shows evidence of glomerular crescent formation, which suggests the diagnosis of other renal diseases or renal biopsy evidence of interstitial fibrosis\u002Ftubular atrophy in cortical area \\> 50%.\n3. Uncontrolled blood pressure as judged by the investigator within the 3 months prior to screening.\n4. Individuals with evidence of a ≥50% decrease in urine protein within the first 6 months before screening.\n5. Currently undergoing or planning to undergo renal replacement therapy during the study period.\n6. Type 1 diabetes or type 2 diabetes with diabetic nephropathy (confirmed by renal biopsy report) or without biopsy-confirmed diabetic nephropathy but with a diabetes duration ≥5 years.\n7. Presence of severe, progressive, or uncontrolled comorbidities.\n8. Individuals who have had or currently have malignant tumors.\n9. Participants with autoimmune diseases requiring systemic immunosuppression therapy, or those judged by researchers to have autoimmune diseases that interfere with the clinical evaluation of primary membranous nephropathy or are not suitable for clinical trials.\n10. A history of previous or current hemolytic anemia, Evans syndrome, arteritis.\n11. Participants with suspected active or latent tuberculosis patients based on medical history or tuberculosis screening.\n12. Severe active bacterial, viral, fungal, mycobacterial, parasitic, or other infections requiring systemic antibiotics or antiviral treatment within 1 month before screening.\n13. Have received prescribed treatment for membranous nephropathy before screening.\n14. Participants using of complementary therapies that may interfere with the investigator's assessment of participant efficacy and safety within 4 weeks prior to randomization.\n15. Live vaccines or major surgery within 28 days before the investigational drug administration or undergoing major surgery.\n16. Participants who have participated in clinical trials of other drugs with a screening time less than 30 days from the last administration or the five half-lives of the original drug (whichever is longer), or those who plan to participate in clinical trials of another drug during the study period.\n17. Participants who have received targeted CD47 or signal regulatory protein α (SIRPα) therapy.\n18. A history of alcoholism or drug abuse within 12 months.\n19. Virology test results at screening meet the criteria:\n\n    HBsAg positivity; If HBsAg is negative and HBcAb is positive, HBV DNA should be exceeding the upper limit of the local laboratory reference range; Positive hepatitis C virus (HCV) antibody with detectable HCV RNA; Positive serology for human immunodeficiency virus (HIV).\n20. Any of the following abnormal laboratory test results during screening: hemoglobin\\\u003C80g\u002FL, platelet count\\\u003C100× 10\\^9\u002FL , absolute neutrophil count\\\u003C1.5× 10\\^9\u002FL , AST or ALT values\\>2× upper limit of normal (ULN), CD4+ T lymphocyte count \\\u003C 300 cells\u002FμL, QTcF\\>450 ms for males and \\>460 ms for females.\n21. Participants who have previously shown resistance to CD20 inhibitors or cyclosporine.\n22. Known history of severe hypersensitivity reactions to humanized monoclonal antibodies or documented allergy to any component of rituximab (dose-escalation part only), JMT601 injection, or cyclosporine (dose-expansion part only).\n23. Pregnant or lactating women; Women of childbearing potential not undergoing sterilization who are unwilling to use adequate contraception during treatment and for at least 6 months after the last dose of the investigational drug.\n24. Men not undergoing sterilization who are unwilling to use barrier contraception during the study and for at least 6 months after the last dose of the investigational drug, and who refuse to ensure their partners use additional contraceptive methods (e.g., oral contraceptives, intrauterine devices, barrier methods, or spermicides).\n25. Other conditions that the investigator deems render the subject unsuitable for study participation.",{"count":420,"type":22},156,[25],"This study is a multicenter, randomized, controlled, open-label, Phase Ⅱ clinical study to evaluate the efficacy, safety, Pharmacokinetics characteristics, Pharmacodynamics effects, and immunogenicity of JMT601 in participants with primary membranous nephropathy.\n\nThe study has two parts. Part one is dose escalation part, and Part two is dose expansion part.",[28],"2025-06-11",{"date":426,"type":33},"2025-06-19",{"date":428,"type":22},"2025-06-30",{"date":430,"type":22},"2029-03-01",{"name":432,"class":40},"Shanghai JMT-Bio Inc.",{"id":434,"slug":435,"hasResults":11,"nctId":436,"briefTitle":437,"officialTitle":438,"acronym":4,"eligibilityCriteria":439,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":19,"enrollmentInfo":440,"targetDuration":4,"studyType":23,"phases":441,"briefSummary":442,"conditions":443,"keywords":4,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":444,"lastUpdatePostDateStruct":445,"startDateStruct":447,"completionDateStruct":449,"leadSponsor":451,"locationsCount":180},"100500793","phase-1-evaluate-the-efficacy-safety-pharmacokinetics-and-pharmacodynamics-of-ever001-100500793","NCT05800873","Evaluate The Efficacy, Safety, Pharmacokinetics And Pharmacodynamics Of EVER001","A Phase 1b\u002F2 Study To Evaluate The Efficacy, Safety, Pharmacokinetics And Pharmacodynamics Of EVER001 In Participants With Selected Proteinuric Glomerular Diseases","Inclusion Criteria:\n\n1. Having clinical diagnosis of primary membranous nephropathy, as verified by biopsy.\n2. Have positive anti-PLA2R autoantibody test results \\> 20 relative units (RU)\u002Fml.\n3. During screening at least one testing of proteinuria must be \\>3.5 g\u002F24h.\n4. Have nephrotic range proteinuria for at least 8 weeks prior to Day 1 and no improvement (\\\u003C50% reduction) despite supportive therapy of ACE inhibitor or ARB unless contraindicated, for patients who have two tests of proteinuria during screening ≥8.0g\u002F24h, the duration of nephrotic range proteinuria for at least 8 weeks is not required.\n\nExclusion Criteria:\n\n1. Non-primary membranous nephropathy or other condition affecting the kidney.\n2. eGFR at screening \\\u003C 45 mL\u002Fmin\u002F1.73m2 or kidney function not stable .\n3. Uncontrolled hypertension .\n4. Serum albumin level at screening # 25g\u002Fl.\n5. Have received: B-cell targeted therapy except rituximab at any time;Rituximab and the biosimilars within 2 years (participants with rituximab treatment between 1 and 2 years prior to Day 1 are eligible if there is documented evidence of B-cell repopulation to \\>90% of Lower Limits of Normal Range.); Cyclophosphamide or Chlorambucil within 180 days;other immunosuppressive\u002Fimmunomodulatory agents within 90 days;greater than 30mg\u002Fday prednisone or equivalence within 30 days.\n6. Acute or chronic infection,including positivity of tuberculosis infection test.\n7. Positive serology for TP,HIV, HBV, or HCV.\n8. Lab testing abnormality as: WBC\\\u003C 3000\u002Fmm³, Lymphocyte \\\u003C 1000\u002F mm³, neutrophil \\\u003C1500\u002Fmm³, Hb \\\u003C 80g\u002FL, Platelet count \\\u003C100×10e9\u002F L, Prothrombin time\\>1.5×ULN, Activated partial thromboplastin time ≥1.5×ULN, Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≥ 1.5×ULN, alkaline phosphatase and bilirubin \\>1.5×ULN.\n9. Judged by the investigator that the participant is unlikely to comply with study procedures, restrictions, and requirements.",{"count":107,"type":22},[155],"EVER001 is a highly selective, oral, reversable, covalent Bruton tyrosine kinase (BTK) inhibitor with high selectivity over other kinases, which is being developed to treat proteinuric glomerular diseases.\n\nThe overall aim of the study is to evaluate the efficacy, safety, pharmacokinetics and pharmacodynamics of EVER001 in subjects with selected proteinuric glomerular diseases. The first targeted disease is primary membranous nephropathy.",[28],"2025-05-26",{"date":446,"type":33},"2025-05-31",{"date":448,"type":33},"2023-05-15",{"date":450,"type":22},"2026-09-15",{"name":452,"class":40},"Everest Medicines (China) Co.,Ltd.",{"id":454,"slug":455,"hasResults":11,"nctId":456,"briefTitle":457,"officialTitle":457,"acronym":458,"eligibilityCriteria":459,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":460,"targetDuration":4,"studyType":23,"phases":462,"briefSummary":463,"conditions":464,"keywords":4,"overallStatus":316,"whyStopped":4,"lastUpdateSubmitDate":465,"lastUpdatePostDateStruct":466,"startDateStruct":468,"completionDateStruct":470,"leadSponsor":472,"locationsCount":272},"100563347","phase-2-the-efficacy-and-safety-of-treatment-with-telitacicept-in-primary-membranous-nephropathy-100563347","NCT06614985","The Efficacy and Safety of Treatment With Telitacicept in Primary Membranous Nephropathy","TEST-T-PMN","Inclusion Criteria:\n\n1. Patients must have a confirmed diagnosis of primary membranous nephropathy through renal biopsy to be eligible for inclusion in the study.\n2. Adult patients aged 18 years or older of any gender are eligible for inclusion in the study.\n3. Patients who meet the diagnostic criteria for nephrotic syndrome, which includes quantitative urine protein levels greater than 3.5 g\u002F24 h and serum albumin levels less than 30 g\u002FL, are eligible for inclusion in the study.\n4. Patients who meet the high-risk criteria for progression of membranous nephropathy based on the KDIGO (Kidney Disease: Improving Global Outcomes) guidelines are eligible for inclusion in the study. High-risk criteria include eGFR less than 60 mL\u002Fmin\u002F1.73 m2 and\u002For urine protein excretion greater than 8 g\u002Fday for at least 6 months, or normal eGFR with urine protein excretion greater than 3.5 g\u002Fday and urine protein reduction less than 50% after 6 months of ACEI\u002FARB treatment, with any of the following criteria: serum albumin less than 25 g\u002FL, anti-PLA2R antibody greater than 50 RU\u002FmL, urine α1-microglobulin greater than 40 μg\u002Fmin, urine IgG1 greater than 1 μg\u002Fmin, urine β2-microglobulin greater than 250 mg\u002Fday, and SI greater than 0.2.\n5. Participants are required to consent to use effective contraception methods with their partners throughout the entire duration of the study. Participants must have a thorough understanding of the nature, significance, potential benefits, inconveniences, and potential risks of the study and voluntarily sign an informed consent form.\n\nExclusion Criteria:\n\n1. Secondary membranous nephropathy patients (caused by autoimmune or infectious diseases, tumors, etc.);\n2. Patients with HIV infection, viral hepatitis, active liver disease (with ALT\u002FAST\u002Fbilirubin levels exceeding 3 times the upper limit of normal), or other severe infections;\n3. Patients with a rapid decline in eGFR (\\>15 mL\u002Fmin) during the screening period are excluded;\n4. Patients who have undergone kidney transplantation or other organ transplantation;\n5. Patients with a known allergy or hypersensitivity to the active ingredient of the investigational drug or any of the listed excipients;\n6. Patients with acute or critical cardiovascular or cerebrovascular diseases;\n7. Patients with immunodeficiency, hypoalbuminemia (IgG \\\u003C 400 mg\u002Fdl), or IgA deficiency (IgA \\\u003C 10 mg\u002FdL);\n8. Pregnant or lactating women;\n9. Patients diagnosed with malignant tumors within the past 5 years;\n10. Laboratory findings of severe abnormalities (Hb \\\u003C 80 g\u002FL, PLT \\\u003C 50,000\u002Fmm3, neutrophil count \\\u003C 1,000\u002Fmm3, etc.);\n11. Patients who have used steroids or immunosuppressive agents (including but not limited to corticosteroids, adrenocorticotropic hormones, azathioprine, mycophenolate mofetil, cyclophosphamide, methotrexate, leflunomide, tacrolimus, cyclosporine, biologic agents such as rituximab, etc.), cyclophosphamide, bortezomib, dexamethasone, Chinese medicines or preparations containing Tripterygium wilfordii, intravenous immunoglobulin, plasma exchange, leukapheresis, live vaccines, or other investigational drugs, etc., within 3 months prior to screening;\n12. Patients with other diseases or conditions that, in the opinion of the investigator, would render the patient unsuitable for participation in this study;",{"count":461,"type":22},172,[25],"This is a multiple-center, prospective, open-label, positive drug controlled, randomized, clinical study to evaluate the safety and efficacy of Telitacicept in the treatment of primary membranous nephropathy.",[28],"2024-09-23",{"date":467,"type":33},"2024-09-26",{"date":469,"type":22},"2024-10-20",{"date":471,"type":22},"2027-10-01",{"name":473,"class":271},"Renmin Hospital of Wuhan University",{"id":475,"slug":476,"hasResults":11,"nctId":477,"briefTitle":478,"officialTitle":479,"acronym":4,"eligibilityCriteria":480,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":19,"enrollmentInfo":481,"targetDuration":4,"studyType":23,"phases":483,"briefSummary":484,"conditions":485,"keywords":486,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":492,"lastUpdatePostDateStruct":493,"startDateStruct":495,"completionDateStruct":497,"leadSponsor":498,"locationsCount":272},"100478749","phase-4-clinical-study-of-rituximab-combined-with-corticosteroids-or-rituximab-monotherapy-in-the-treatment-of-primary-membranous-nephropathy-100478749","NCT05514015","Clinical Study of Rituximab Combined With Corticosteroids or Rituximab Monotherapy in the Treatment of Primary Membranous Nephropathy","A Prospective, Randomized, Multicenter Clinical Trial Comparing the Efficacy and Safety of Rituximab Combined With Corticosteroids or Rituximab Monotherapy in Primary Membranous Nephropathy","Inclusion Criteria\n\n1. Men and women aged 18-75 years;\n2. Patients diagnosed as primary membranous nephropathy (PMN) by renal biopsy;\n3. After treatment with ACE inhibitors or ARBs for at least 3 months, the following two points were met (unless intolerance to ACE inhibitors or ARBs, contraindications, hypotension that may cause side effects, or the investigator judged that the patient was not suitable for RAS inhibitors):\n\n(1) Those who have an average 24-hour urine protein ≥ 3.5g twice a week, or an average 24-hour urine protein ≥ 5g twice in 14 days, the requirement of RASi for at least 3 months is not required (2) Blood pressure≤ 130\u002F80mmHg, 4. Glomerular filtration rate (eGFR) ≥30mL\u002Fmin\u002F1.73m2 (calculated according to the CKD-EPI formula) 5. If female, must be postmenopausal or postoperatively infertile or on medical contraception (considering the potential risk of thromboembolism in patients with kidney disease); 6. Subjects voluntarily signed the informed consent form;\n\nExclusion Criteria:\n\n1. Patients with type 1 diabetes mellitus or type 2 diabetes mellitus complicated with diabetic nephropathy. Patients with a recent history of steroid-induced diabetes were eligible if renal biopsies show no evidence of secondary diabetic nephropathy within 6 months before the screening period\n2. Patients with secondary membranous nephropathy (such as hepatitis B and C, systemic lupus erythematosus, drug therapy, malignant tumors and other secondary causes);\n3. Previous treatment with rituximab, steroids, alkylating agents, calcineurin inhibitors, synthetic ACTH, mycophenolate (MMF), and azathioprine;\n4. Receipt of any other study medication (within the last month);\n5. Suspected or known allergy or immune reaction to rituximab, corticosteroids or any of their components (including excipients);\n6. Active infection, such as active hepatitis B or hepatitis C, tuberculosis (evidence of active tuberculosis infection within 1 year), or human immunodeficiency virus HIV infection (positive for anti-HIV antibodies), etc.\n7. A history of immunodeficiency, including other acquired or congenital immunodeficiency diseases, or organ transplantation;\n8. Females with a positive pregnancy screening test or lactating or planning to become pregnant in the next 24 months. Female or male patients who were unwilling to use contraceptive methods throughout the study;\n9. A history of mental illness;\n10. Laboratory tests that meet the following criteria need to be excluded:\n\n(1) Hemoglobin\\\u003C80g\u002FL; (2) Platelet \\\u003C 80×109\u002FL; (3) Neutrophil \\\u003C1.0×109\u002FL; (4) Aspartate aminotransferase (AST) or amino aminotransferase (ALT) \\> 2.5× upper limit of normal except in relation to the primary disease; 11. Very high-risk patients: presenting with life-threatening nephrotic syndrome, or unexplained rapid deterioration of renal function 12. Any patient judged by the investigator to be unsuitable for inclusion in the trial.",{"count":482,"type":22},78,[256],"This was a prospective, randomized, multicenter clinical trial. Seventy-eight patients with primary membranous nephropathy (PMN) were randomly divided into intervention or control group. Intervention group was given rituximab combined with corticosteroids in induction therapy and the control group was given rituximab monotherapy. After 6 months, patients who had decreased 24h urinary protein by \\> 25% but did not achieve CR were given rituximab maintenance therapy. The complete response rate at 12 months was measured.",[28],[487,488,489,490,491],"rituximab","Primary membranous nephropathy","rituximab combined with corticosteroids","safety","remission","2024-04-01",{"date":494,"type":33},"2024-04-02",{"date":496,"type":22},"2024-03-29",{"date":199,"type":22},{"name":270,"class":271}]