[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"minimal-change-disease-mcd\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:minimal-change-disease-mcd":27},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,4,0,[8,41,67,105],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":15,"eligibilityCriteria":16,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":19,"targetDuration":4,"studyType":22,"phases":23,"briefSummary":25,"conditions":26,"keywords":4,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":29,"lastUpdatePostDateStruct":30,"startDateStruct":33,"completionDateStruct":35,"leadSponsor":37,"locationsCount":40},"100647538","phase-2-a-trial-to-assess-the-efficacy-and-safety-of-obinutuzumab-in-treating-adults-with-minimal-change-disease-mcd-100647538",false,"NCT07710157","A Trial to Assess the Efficacy and Safety of Obinutuzumab in Treating Adults With Minimal Change Disease (MCD)","A Randomized Controlled, Two-arm (1:1 Ratio) Phase IIa Trial to Assess the Efficacy and Safety of Obinutuzumab in Treating Adults With de Novo Minimal Change Disease","OBELIX-NS","Inclusion Criteria:\n\n1. Understands and agrees to comply with the study procedures and provides informed consent as documented by signature\n2. Male or female patients aged 18 years or older at the time of consent\n3. Confirmed first episode of nephrotic syndrome at trial enrolment (serum albumin \\\u003C30g\u002Fl and UPCR \\>3g\u002Fg creatinine (\\>300 mg\u002Fmmol) secondary to de novo MCD\n4. Histologically confirmed MCD (latest before randomization to Arm A or B)\n5. Only applies to women of childbearing potential (WOCBP):\n\n   1. Has a high sensitivity negative urine\u002Fserum pregnancy test at screening\n   2. Agrees to follow contraceptive guidance until 18 months after 2nd obinutuzumab treatment (if randomized to Arm B)\n6. Only applies to trial sites in France: Patients affiliated with the French health care system\n\nExclusion Criteria:\n\n1. MCD due to secondary causes, including malignancy of a type likely to be associated with MCD (i.e., lymphoproliferative disorders), or potentially related to treatment known to be associated with MCD occurrence (lithium, interferon, non-steroidal anti-inflammatory drugs)\n2. Family history of MCD or in a first degree relative unless previously shown to be steroid-responsive\n3. Previous B cell depletion, independent of the agent and treatment target (i.e., CD20, CD38, etc.), within 18 months preceding baseline of the trial, or 12 months if there is evidence of B cell return in peripheral lymphocyte subsets\n4. Previous cyclophosphamide within 6 months preceding baseline of the trial\n5. Treatment with Predniso(lo)ne within screening phase (before randomization)\n6. Evidence of current or past infection with Hepatitis B, C or Human Immunodeficiency Virus (HIV) (unless appropriate prophylaxis is given and no replicating virus is detected)\n7. Evidence of active severe infection requiring systemic antibacterial, antifungal or antiviral therapy within 14 days prior to first dose of study drug\n8. Severe heart failure or severe, uncontrolled cardiac disease (NYHA class III or IV)\n9. Patient with a history of prior malignancy within 5 years before the first dose of study drug. Exceptions may apply for the following: malignancies with a negligible risk of metastasis or death such as adequately treated carcinoma in situ of the cervix, nonmelanoma skin carcinoma, ductal carcinoma in situ, or Stage I uterine cancer\n10. Pregnant or breast-feeding women\n11. Live vaccine administration in the four weeks prior to screening and during the study duration of 52 weeks\n12. Previous\u002Fknown hypersensitivity to predniso(lo)ne or obinutuzumab or to any of the excipients to be in accordance with the SmPC of Gazyvaro\n13. Co-enrolment in another clinical trial of an investigational medicinal product\n14. Any other reason which, in the opinion of the Principal Investigator (PI), renders the patient unsuitable for the trial.","ALL","18 Years",{"count":20,"type":21},48,"ESTIMATED","INTERVENTIONAL",[24],"PHASE2","OBELIX-NEPHROSIS (NS)\n\nThe goal of this clinical trial is to learn if obinutuzumab works to treat minimal change disease in adults. It will also learn about the safety of drug obinutuzumab. The main questions it aims to answer are:\n\nIs obinutuzumab non-inferior to glucocorticoids at inducing remission? Does obinutuzumab provide superiority in terms of relapse-free survival after 52 weeks? What medical problems do participants have when receiving obinutuzumab? Researchers will compare drug obinutuzumab to glucocorticoids and aim to phenotype participants with minimal change disease.\n\nParticipants will:\n\nTake the drug obinutuzumab (2 doses) or glucocorticoids Visit the clinic for 8 visits over a period of 52 weeks, plus additional controls when disease relapses occur",[27],"Minimal Change Disease (MCD)","RECRUITING","2026-08-13",{"date":31,"type":32},"2026-08-17","ACTUAL",{"date":34,"type":32},"2026-07-13",{"date":36,"type":21},"2029-06-30",{"name":38,"class":39},"Medical University Innsbruck","OTHER",6,{"id":42,"slug":43,"hasResults":11,"nctId":44,"briefTitle":45,"officialTitle":46,"acronym":4,"eligibilityCriteria":47,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":48,"enrollmentInfo":49,"targetDuration":4,"studyType":22,"phases":51,"briefSummary":52,"conditions":53,"keywords":4,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":56,"lastUpdatePostDateStruct":57,"startDateStruct":59,"completionDateStruct":61,"leadSponsor":63,"locationsCount":66},"100640089","phase-2-evaluate-the-efficacy-safety-pharmacokinetics-and-pharmacodynamics-of-ever001-in-participants-with-selected-proteinuric-glomerular-diseases-100640089","NCT07614477","Evaluate the Efficacy, Safety, Pharmacokinetics, and Pharmacodynamics of EVER001 in Participants With Selected Proteinuric Glomerular Diseases","The Sub-Study 3 of A Phase 1b\u002F2 Study to Evaluate the Efficacy, Safety, Pharmacokinetics, and Pharmacodynamics of EVER001 in Participants With Selected Proteinuric Glomerular Diseases (ES108001)","Inclusion Criteria:\n\n* Primary FSGS or MCD\u002FIgAN confirmed by renal biopsy\n* eGFR ≥ 45 mL\u002Fmin\u002F1.73 m²\n* For participants with FSGS or MCD: must have a 24-hour urine protein-to-creatinine ratio (UPCR) \\> 3.5 g\u002Fg and serum albumin \\\u003C 30 g\u002FL during the screening period\n* For participants in the IgAN group: 24-hour UPCR ≥ 0.8 g\u002Fg; ARB or ACEI stable for ≥ 12 weeks prior to Day 1\n* Patients with FSGS or MCD who have not been treated with immunosuppressants or are sensitive to prior immunosuppressant treatment\n\nExclusion Criteria:\n\n* Hereditary or secondary FSGS\u002FMCD; collapsing FSGS\n* BMI ≥ 35 kg\u002Fm² in participants with FSGS\u002FMCD\n* Evidence of diabetes mellitus or a history of diabetes mellitus\n* Acute or chronic infection requiring treatment\n* Patients infected with HIV, hepatitis C, syphilis, or hepatitis B\n* Patients with current or prior inadequately treated active tuberculosis (TB), latent TB, or evidence of current household contact with active TB\n* At risk of bleeding\n* Baseline 24-hour UPCR \\> 3 g\u002Fg and serum albumin \\\u003C 30 g\u002FL in participants with IgAN","75 Years",{"count":50,"type":21},45,[24],"This is a Phase 1b\u002F2, open-label, multi-center study evaluating the therapeutic potential and safety of the investigational drug EVER001 in adults with FSGS, MCD, or IgAN. EVER001 acts on multiple immune pathways without directly affecting T cells or depleting B cells (both are lymphocytes). The study will be conducted at \\~30 centers in China, enrolling 45 participants aged 18-75 years (15 per indication). The IMP is a 100 mg oral capsule, dosed at 200 mg twice daily (2 capsules per dose, 4 daily) for 52 weeks.",[27,54,55],"IgA Nephropathy (IgAN)","Focal Segmental Glomerulosclerosis (FSGS)","2026-08-03",{"date":58,"type":32},"2026-08-05",{"date":60,"type":32},"2026-05-20",{"date":62,"type":21},"2029-03-31",{"name":64,"class":65},"Everest Medicines (China) Co.,Ltd.","INDUSTRY",2,{"id":68,"slug":69,"hasResults":11,"nctId":70,"briefTitle":71,"officialTitle":72,"acronym":73,"eligibilityCriteria":74,"healthyVolunteers":11,"sex":17,"minAge":4,"maxAge":75,"enrollmentInfo":76,"targetDuration":4,"studyType":78,"phases":4,"briefSummary":79,"conditions":80,"keywords":83,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":95,"lastUpdatePostDateStruct":96,"startDateStruct":98,"completionDateStruct":100,"leadSponsor":102,"locationsCount":104},"100148840","nephrotic-syndrome-study-network-100148840","NCT01209000","Nephrotic Syndrome Study Network","Nephrotic Syndrome Study Network Under the Rare Diseases Clinical Research Network","NEPTUNE","Cohort A (biopsy cohort) Inclusion Criteria:\n\nPatients presenting with an incipient clinical diagnosis for FSGS\u002FMCD or MN or pediatric participants not previously biopsied, with a clinical diagnosis for FSGS\u002FMCD or MN meeting the following inclusion criteria:\n\n* Documented urinary protein excretion ≥1500 mg\u002F24 hours or spot protein: creatinine ratio equivalent at the time of diagnosis or within 3 months of the screening\u002Feligibility visit.\n* Scheduled renal biopsy\n\nCohort B (non-biopsy, cNEPTUNE) Inclusion Criteria:\n\n* Age \\\u003C19 years of age\n* Initial presentation with \\\u003C30 days immunosuppression therapy\n* Proteinuria\u002Fnephrotic\n\n  * UA\\>2+ and edema OR\n  * UA\\>2+ and serum albumin \\\u003C3 OR\n  * UPC \\> 2g\u002Fg and serum albumin \\\u003C3\n\nExclusion Criteria (Cohort A\\&B):\n\n* Prior solid organ transplant\n* A clinical diagnosis of glomerulopathy without diagnostic renal biopsy\n* Clinical, serological or histological evidence of systemic lupus erythematosus (SLE) as defined by the ARA criteria. Patients with membranous in combination with SLE will be excluded because this entity is well defined within the International Society of Nephrology\u002FRenal Pathology Society categories of lupus nephritis, and frequently overlaps with other classification categories of SLE nephritis (68)\n* Clinical or histological evidence of other renal diseases (Alport, Nail Patella, Diabetic Nephropathy, IgA-nephritis, monoclonal gammopathy (multiple myelomas), genito-urinary malformations with vesico-urethral reflux or renal dysplasia)\n* Known systemic disease diagnosis at time of enrollment with a life expectancy less than 6 months\n* Unwillingness or inability to give a comprehensive informed consent\n* Unwillingness to comply with study procedures and visit schedule\n* Institutionalized individuals (e.g., prisoners)","80 Years",{"count":77,"type":21},1200,"OBSERVATIONAL","Minimal change disease (MCD), focal segmental glomerulosclerosis (FSGS), and Membranous nephropathy (MN), generate an enormous individual and societal financial burden, accounting for approximately 12% of prevalent end stage renal disease (ESRD) cases (2005) at an annual cost in the US of more than $3 billion. However, the clinical classification of these diseases is widely believed to be inadequate by the scientific community. Given the poor understanding of MCD\u002FFSGS and MN biology, it is not surprising that the available therapies are imperfect. The therapies lack a clear biological basis, and as many families have experienced, they are often not beneficial, and in fact may be significantly toxic. Given these observations, it is essential that research be conducted that address these serious obstacles to effectively caring for patients.\n\nIn response to a request for applications by the National Institutes of Health, Office of Rare Diseases (NIH, ORD) for the creation of Rare Disease Clinical Research Consortia, a number of affiliated universities joined together with The NephCure Foundation the NIDDK, the ORDR, and the University of Michigan in collaboration towards the establishment of a Nephrotic Syndrome (NS) Rare Diseases Clinical Research Consortium.\n\nThrough this consortium the investigators hope to understand the fundamental biology of these rare diseases and aim to bank long-term observational data and corresponding biological specimens for researchers to access and further enrich.",[27,81,82],"Membranous Nephropathy","Glomerulosclerosis, Focal Segmental",[84,85,86,87,88,89,81,90,91,92,73,93,94],"Focal and Segmental Glomerulosclerosis","Focal & Segmental Glomerulosclerosis","Focal Segmental Glomerulosclerosis","FSGS","Minimal change disease","MCD","MN","Nephrotic Syndrome","Neph Syndrome","NephCure","Halpin","2026-06-08",{"date":97,"type":32},"2026-06-10",{"date":99,"type":32},"2010-04",{"date":101,"type":21},"2030-12-31",{"name":103,"class":39},"University of Michigan",44,{"id":106,"slug":107,"hasResults":11,"nctId":108,"briefTitle":109,"officialTitle":110,"acronym":4,"eligibilityCriteria":111,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":48,"enrollmentInfo":112,"targetDuration":4,"studyType":22,"phases":114,"briefSummary":116,"conditions":117,"keywords":4,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":118,"lastUpdatePostDateStruct":119,"startDateStruct":121,"completionDateStruct":123,"leadSponsor":125,"locationsCount":127},"100631363","phase-2-a-clinical-study-of-bat4406f-injection-in-patients-with-minimal-change-diseasefocal-segmental-glomerulosclerosis-100631363","NCT07499700","A Clinical Study of BAT4406F Injection in Patients With Minimal Change Disease\u002FFocal Segmental Glomerulosclerosis","A Phase II\u002FIII Clinical Study Evaluating the Efficacy and Safety of BAT4406F Injection in Patients With Minimal Change Disease\u002FFocal Segmental Glomerulosclerosis","Inclusion Criteria:\n\n1. Clinically diagnosed with NS, with a pathological diagnosis of Minimal change disease\u002FFocal segmental glomerulosclerosis confirmed by renal biopsy within 7 years (Minimal change disease) or 10 years (Focal segmental glomerulosclerosis) prior to screening, and who are responsive to corticosteroid therapy\n2. The time since achieving complete remission following corticosteroid therapy for the most recent active or relapsed disease is within 8 weeks of baseline\n\nExclusion Criteria:\n\n1. Secondary Nephrotic Syndrome\n2. Known genetic defects associated with Nephrotic Syndrome or a family history of Nephrotic Syndrome\n3. Receipt of any B-cell depletion or B-cell-modifying therapy within 6 months prior to baseline\n4. History of allergy to monoclonal antibodies; or a predisposition to allergies\n5. Received treatment with immunosuppressants within 60 days prior to baseline\n6. Received immunoglobulin within 90 days prior to baseline; or received immunomodulators such as thymosin within 4 weeks prior to baseline\n7. Participation in a clinical trial of another investigational drug within 90 days prior to baseline or within 5 half-lives of the drug (whichever is longer), or plans to participate in a clinical trial of another drug during the study period\n8. Marked abnormalities in liver or kidney function\n9. Positive for hepatitis B surface antigen (HBsAg); or positive for hepatitis C virus (HCV) antibodies; or positive for Treponema pallidum antibodies; or history of Human Immunodeficiency Virus or positive for Human Immunodeficiency Virus antibodies",{"count":113,"type":21},192,[24,115],"PHASE3","This is a phase II\u002FIII multicenter, randomized, double-blind, placebo-controlled study to investigate the efficacy and safety of BAT4406F injection in patients with Minimal Change Disease\u002FFocal Segmental Glomerulosclerosis",[27,55],"2026-03-29",{"date":120,"type":32},"2026-04-03",{"date":122,"type":32},"2025-10-26",{"date":124,"type":21},"2030-11-26",{"name":126,"class":65},"Bio-Thera Solutions",1]