[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"glomerular-disease\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:glomerular-disease":29},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,6,0,[8,48,93,122,160,186],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":13,"acronym":4,"eligibilityCriteria":14,"healthyVolunteers":11,"sex":15,"minAge":16,"maxAge":17,"enrollmentInfo":18,"targetDuration":4,"studyType":21,"phases":22,"briefSummary":24,"conditions":25,"keywords":31,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":36,"lastUpdatePostDateStruct":37,"startDateStruct":40,"completionDateStruct":42,"leadSponsor":44,"locationsCount":47},"100131289","phase-2-rituximab-plus-cyclosporine-in-idiopathic-membranous-nephropathy-100131289",false,"NCT00977977","Rituximab Plus Cyclosporine in Idiopathic Membranous Nephropathy","* INCLUSION CRITERIA:\n\nIn order to be eligible to participate in this study, an individual must meet all of the following criteria:\n\n1. Stated willingness to comply with all study procedures and availability for the duration of the study\n2. Male or female, \\>= 18 years of age\n3. Nephrotic range proteinuria that persists for at least 6 months post diagnosis of membranous nephropathy greater than 3.5 grams \u002F24 hours (based on 24-hour urine collection).\n\n   a. If the subject s renal function rapidly declines in less than 6 months could proceed with immunosuppression therapy sooner such as complications of the nephrotic syndrome that are not controlled with supportive therapy or evidence of decline in glomerular filtration rate or proteinuria \\>8 grams\u002Fday. Subjects with declining renal function and\u002For high-grade proteinuria due to MN are considered \"high risk\" subjects and have a higher probability of progression to end stage kidney disease.\n4. Nephrotic range proteinuria (\\>3.5 g\u002F24 hours) that persists despite angiotensin antagonist therapy (ACE inhibitor or ARB) for at least 2 months unless intolerant.\n\n   a. The rationale is that blockade of the renin angiotensin system (RAAS) is widely considered to be part of the standard of care treatment for subjects with the nephrotic syndrome. Nephrotic range proteinuria will be defined as an estimated average proteinuria \\>3.5 g\u002F24 hours in adults based on at least two 24-hour urine protein excretions obtained prior to initiating therapy. Incomplete urine\n\n   collections (based on inadequate creatinine excretion) will be excluded.\n5. Renal biopsy within the past 24 months must reveal typical changes of membranous nephropathy by light and electron microscopy or a positive anti-PLA2R antibody test in the serum. There has been a change in the management strategies for MN such that a renal biopsy is not absolutely required for diagnosis if patient has positive circulating anti-PLA2R antibody.\n\n   a. Based on published KDIGO 2021 Clinical Practice Guidelines 3.1.1 patients with MN who are positive for anti-PLA2R do not require renal biopsy as long as renal function is normal (eGFR \\>60) and has not had immunosuppression as it has been demonstrated that results of the biopsy have not altered clinical approach and management. If not PLA2R positive, renal biopsy within 24 months is still required.\n6. Blood pressure \\\u003C=140\u002F90 on \\>75% of measurement while on anti-hypertensive treatment for at least 1-2 months.\n7. There is no evidence to suggest secondary forms of membranous nephropathy.\n8. Ability to take oral medication and be willing to adhere to the cyclosporine regimen\n9. For females of reproductive potential: use of highly effective contraception for at least 1 month prior to screening and agreement to use such a method during study participation and for 12 months after the last Rituximab infusion.\n10. For males of reproductive potential: use of condoms or other methods to ensure effective contraception with partner.\n11. Ability of subject to understand and the willingness to sign a written informed consent document.\n\nEXCLUSION CRITERIA:\n\nAn individual who meets any of the following criteria will be excluded from participation in this study:\n\n1. Estimated GFR\\\u003C40 ml\u002Fmin\u002F1.73 m\\^2 from the preceding 2 months prior to enrollment while on ACEI\u002FARB therapy.\n2. Immunosuppressive medications or experimental medications of any type during the three-month period prior to initiating Rituximab and cyclosporine.\n3. Prior exposure to cyclosporine or tacrolimus for more than 6 months and\u002For evidence of intolerance or toxicity associated with cyclosporine treatment of any duration including irreversible azotemia, liver dysfunction or hypertension\n4. Rituximab use within the previous 12 months.\n5. Clinically significant medical conditions (i.e., severe heart failure NYHA class IV, uncontrolled coronary artery disease\u002Funstable angina), which in the opinion of the investigator, could increase the subject s risk of participating in the study or could confound the interpretation of the results of the study.\n6. Positive HIV serology\n7. Positive HCV serology\n8. Active acute or chronic infection requiring antimicrobial therapy or serious viral infection cytomegalovirus, herpes simplex, varicella zoster virus (chicken pox or shingles), Parvovirus B19 (can be based on previous medical records within the past 24-months)\n9. Live viral vaccines within one month prior to Rituximab.\n10. Pregnancy or lactation\n11. Cancer diagnosis or cancer recurrence within the preceding 5 years, excluding basal cell carcinoma of the skin. The rationale is that immunosuppression may accelerate cancer progression.\n12. Clinical evidence of cirrhosis or chronic active liver disease sufficiently severe to impair cyclosporine metabolism; this would include a prolonged prothrombin time.\n13. Cytopenia (neutrophils \\\u003C1500\u002Fmm\\^3 and\u002For thrombocytopenia \\\u003C75,000) and\u002For CD4 T cell count \\\u003C200\u002Fmm\\^3). The rationale is that Rituximab therapy may be followed by cytopenia with the granulocyte lineage being at greatest risk. Patients with low CD4 T cell counts are prone to infection which can be exacerbated by Rituximab.\n14. Diabetes mellitus. The rationale is that diabetes may lead to worsening of proteinuria that would not respond to immunosuppression and would confound the results.","ALL","18 Years","90 Years",{"count":19,"type":20},30,"ESTIMATED","INTERVENTIONAL",[23],"PHASE2","Background:\n\n* Membranous nephropathy is associated with damage to the walls of the glomeruli, the small blood vessels in the kidneys that filter waste products from the blood. This damage causes leakage of blood proteins into the urine and is associated with low blood protein levels, high blood cholesterol values, and swelling of the legs. These problems can decrease or go away without treatment in about 25 percent of patients, but if they persist, some patients may experience impaired (or loss of) kidney function, blood vessel and heart disease, and a risk of forming blood clots in veins.\n* Kidney biopsies that show that antibodies have been deposited along the glomeruli suggest that specialized cells of the immune system, called B and T cells, are causing damage to the kidneys through their increased activity. To suppress the action of B and T cells and to decrease the harmful deposits in the kidneys, drug treatments are required.\n* Patients with membranous nephropathy are often treated with immunosuppressive drugs such as cyclosporine or cytoxan plus steroids that attempt to reduce or suppress the activity of the immune system, decrease antibody production, and reduce antibody deposits in the kidney. However, not everyone responds to these medications and the kidney disease can return in some patients when the drugs are stopped. Also, there are side effects associated with long term usage of these medications. Rituximab, a different immunosuppressant, has also been used for this purpose. Although cyclosporine and Rituximab have been used separately, they have not been tried in combination as a possible treatment for membranous nephropathy.\n\nObjectives:\n\n\\- To determine the safety and effectiveness of combining rituximab and cyclosporine to treat membranous nephropathy.\n\nEligibility:\n\n\\- Individuals 18 years of age and older who have been diagnosed with membranous nephropathy based on a kidney biopsy done within the preceding 24 months, and who have had excess levels of protein in the urine for at least 6 months based on urine and blood tests.\n\nDesign:\n\n* Potential participants will be screened with an initial clinic evaluation and full medical history.\n* Before the treatment, there will be a run-in period that will last up to 2 months. During this time, participants will be placed on a blood pressure lowering medication and will not take any other immunosuppressant medications.\n* Participants will visit the NIH clinical center for a baseline evaluation, four intravenous infusions of rituximab, and also at 1- to 6-month intervals throughout the study.\n* Active treatment period will involve a 6-month course of cyclosporine and a total of four doses of rituximab. Participants will take cyclosporine tablets twice daily, and have two infusions of rituximab given 2 weeks apart, After 6 months, the cyclosporine dose will slowly be decreased over several weeks and then completely discontinued. Participants will then receive another course (two doses 2 weeks apart) of rituximab, depending on results of blood work.\n* Participants will have frequent blood and urine tests performed to monitor the results of treatment and reduce the chance of side effects.",[26,27,28,29,30],"Nephrotic Syndrome","Proteinuria","Autoimmune Disease","Glomerular Disease","Membranous Glomerulonephritis",[32,26,33,34,27],"Kidney Disease","Autoimmune Diseases","Clinical Trial","RECRUITING","2026-06-11",{"date":38,"type":39},"2026-06-12","ACTUAL",{"date":41,"type":39},"2010-12-22",{"date":43,"type":20},"2027-12-31",{"name":45,"class":46},"National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)","NIH",2,{"id":49,"slug":50,"hasResults":11,"nctId":51,"briefTitle":52,"officialTitle":53,"acronym":4,"eligibilityCriteria":54,"healthyVolunteers":11,"sex":15,"minAge":16,"maxAge":55,"enrollmentInfo":56,"targetDuration":4,"studyType":21,"phases":58,"briefSummary":60,"conditions":61,"keywords":69,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":82,"lastUpdatePostDateStruct":83,"startDateStruct":85,"completionDateStruct":87,"leadSponsor":89,"locationsCount":92},"100582054","phase-3-open-label-extension-study-of-zigakibart-in-adults-with-iga-nephropathy-100582054","NCT06858319","Open-label Extension Study of Zigakibart in Adults With IgA Nephropathy.","A Multicenter Open-label Extension Study to Evaluate the Long-term Safety and Tolerability of Zigakibart in Adults With Primary IgA Nephropathy.","Inclusion Criteria:\n\n1. Signed informed consent must be obtained prior to participation in the OLE study.\n2. Completion of the parent study (both participants assigned to receive the investigational product and placebo) as defined by the respective protocol.\n3. Per Investigator's clinical judgment, the participant may benefit from receiving open-label treatment of zigakibart 600 mg s.c. Q2W.\n\nExclusion Criteria:\n\n1. Participants who prematurely withdrew from zigakibart parent studies in IgAN for any reason.\n2. Participants who at the time of first study treatment administration in the OLE are receiving chronic dialysis (≥30 days) or who require kidney transplantation.\n3. Acute kidney injury (AKI), defined by AKIN criteria (Mehta et al 2007) within 4 weeks of first study treatment administration in the OLE study.\n4. Clinical suspicion or diagnosis of rapidly progressive glomerulonephritis (RPGN), defined by KDIGO guidelines, or another glomerulopathy at the time of first study treatment administration in the OLE study.\n5. Received a live vaccination within 12 weeks prior to first study treatment administration in the OLE study or plan to have a live vaccination within 6 months after the last dose of study treatment.\n6. Use of systemic corticosteroid therapy (including budesonide) or other immunosuppressive therapy such as but not limited to mycophenolate, azathioprine, cyclosporine, tacrolimus, cyclophosphamide, etc., and herbs such as Tripterygium Wilfordii Hook F, Caulis sinomenii, and Sinomenium acutum for \\> 2 weeks in the 12 weeks prior to first study treatment administration in the OLE study; use of rituximab within 180-days of first study treatment administration in the OLE study.\n7. Current severe infection at the time of first study treatment in the OLE study or history of recurrent, severe, infections as determined by the Investigator.\n8. Newly diagnosed positive serology for hepatitis A virus IgM antibodies (anti-HAV IgM), hepatitis B surface antigen (HBsAg), detectable hepatitis B virus (HBV) DNA, hepatitis C virus (HCV) antibodies (participants who completed treatment and are persistently antibody positive but have documentation of negative HCV polymerase chain reaction \\[PCR\\] will be allowed), or antibodies to HIV-1 and\u002For HIV-2.\n9. Newly diagnosed malignancy (participants with basal cell carcinoma that was completely resected or curatively treated cervical carcinoma in situ or low-risk prostate cancer (i.e., Gleason score \\\u003C 7 and prostate specific antigen \\\u003C 10 ng\u002FmL) are eligible for the study).\n10. Pregnancy or breastfeeding or intent to become pregnant or to donate sperm during the study period and until 24 weeks after last dose.\n11. History or evidence of any other clinically significant medical or psychiatric disorder, condition, disease, or laboratory finding that, in the discretion of the Investigator, constitutes an uncertain or unfavorable benefit-risk for continued long-term therapy with zigakibart.\n12. Confirmed IgG levels \\\u003C 3 g\u002FL prior to first study treatment administration in the OLE study.\n13. Women of child-bearing potential, defined as all women physiologically capable of becoming pregnant, from menarche until becoming post-menopausal unless they are using highly effective methods of contraception (failure rate \\\u003C 1% per year) while taking study treatment and for 24 weeks after stopping study treatment. Women are considered post-menopausal if they have had 12 months of natural (spontaneous) amenorrhea with an appropriate clinical profile (e.g., hormonal profile confirming menopause and\u002For age-appropriate history of vasomotor symptoms).\n14. Sexually active males unwilling to use a highly effective methods of contraception during intercourse while taking study treatment and for 24 weeks after stopping study treatment. In addition, male participants must not donate sperm for the time period specified above.\n\nHighly effective contraception methods for both women and men include:\n\n* Total abstinence (when this is in line with the preferred and usual lifestyle of the participant). Note that periodic abstinence (e.g., calendar, ovulation, symptothermal, post-ovulation methods) and withdrawal are not acceptable methods of contraception.\n* Bilateral oophorectomy with or without hysterectomy, total hysterectomy or bilateral salpingectomy at least six weeks before taking study treatment. In case of oophorectomy alone, only when the reproductive status of the woman has been confirmed by follow up hormone level assessment are they considered to be not of childbearing potential.\n* Bilateral tubal occlusion, bilateral tubal ligation (at least six weeks before taking study treatment).\n* Sterilization (vasectomy) of male partner(s) of the female participant at least 6 months prior to first study treatment provided partner(s) has(have) received medical confirmation of surgical success.\n* Use of hormonal contraception methods:\n* Combined (estrogen and progestogen containing) hormonal contraception associated with inhibition of ovulation; oral, intravaginal or transdermal.\n* Progestogen-only hormonal contraception (where inhibition of ovulation is not the primary or only mode of action): oral, injectable or implantable.\n* Intrauterine device (IUD) or intrauterine hormone-releasing system (IUS). In case of use of hormonal contraception, women should have been stable on the same method for a minimum of 3 months before taking study treatment.","100 Years",{"count":57,"type":20},220,[59],"PHASE3","The purpose of this study is to determine if zigakibart is safe and effective for long-term use in patients with immunoglobulin A nephropathy (IgAN). This is an extension study for patients who have already completed an another zigakibart study.",[62,63,64,65,29,66,67,68],"Kidney Diseases","Kidney Diseases, Chronic","Urological Diseases","Glomerulonephritis","Glomerulonephritis, IGA","Glomerulopathy","Immunoglobulin Disease",[70,71,72,73,74,65,75,33,76,62,66,77,78,79,80,81],"Urologic Diseases","Female Urogenital Diseases","Female Urogenital Diseases and Pregnancy Complications","Urogenital Diseases","Male Urogenital Diseases","Nephritis","Immune System Diseases","Primary IgA \u002F Immunoglobulin A nephropathy","eGFR","UPCR","UACR","FUB523","2026-05-28",{"date":84,"type":39},"2026-06-01",{"date":86,"type":39},"2025-07-28",{"date":88,"type":20},"2031-06-25",{"name":90,"class":91},"Novartis Pharmaceuticals","INDUSTRY",18,{"id":94,"slug":95,"hasResults":11,"nctId":96,"briefTitle":97,"officialTitle":98,"acronym":99,"eligibilityCriteria":100,"healthyVolunteers":11,"sex":15,"minAge":16,"maxAge":101,"enrollmentInfo":102,"targetDuration":4,"studyType":21,"phases":104,"briefSummary":105,"conditions":106,"keywords":109,"overallStatus":111,"whyStopped":4,"lastUpdateSubmitDate":112,"lastUpdatePostDateStruct":113,"startDateStruct":115,"completionDateStruct":117,"leadSponsor":119,"locationsCount":121},"100629435","phase-2-efficacy-and-safety-study-of-hs-10542-for-iga-nephropathy-100629435","NCT07474636","Efficacy and Safety Study of HS-10542 for IgA Nephropathy","A Randomized, Double-Blind, Placebo-Controlled, Phase 2 Dose-Ranging Study to Evaluate the Efficacy and Safety of HS-10542 Capsules in Primary Immunoglobulin A (IgA) Nephropathy","HS-10542","Inclusion Criteria:\n\n1. Participant is a male or female≥18 years and≤74 years of age at the time of signing the informed consent.\n2. Body weight≥35kg, BMI\\\u003C37.5kg\u002Fm2.\n3. Primary IgA nephropathy was confirmed by renal biopsy within 8 years.\n4. 24-hour urine protein excretion≥1.0g\u002F24h, or UPCR≥0.8g\u002Fg at screening and prior to randomization.\n5. eGFR≥30 ml\u002Fmin\u002F1.73m2 at screening and prior to randomization；\n6. A fertile female participant or a male participant whose partner is a fertile female, who has not had a fertility, sperm\u002Fegg donation plan and voluntarily takes highly effective contraceptive measures (including the partner).\n7. All participants received RAS blocker treatment at least for 12 weeks, or demonstrated intolerance to RAS blockers, but has received SGLT2 inhibitors, endothelin receptor antagonists, or a mineralocorticoid receptor antagonist for at least 12 weeks, and have achieved the maximum recommended dose according to the product label or the maximum tolerated dose with stable dosing for at least 4 weeks prior to randomization.\n8. Participants should be able to complete vaccinations against Neisseria meningitidis (types A, C, Y, and W-135) and streptococcus pneumoniae at least 2 weeks prior to the first dose.\n9. Understand the research procedures and methods, voluntarily participate in this trial, and sign the informed consent form in person.\n\nExclusion Criteria:\n\n1. Participants with a history of severe allergies to drugs, food or the environment, or allergic to any RAS blockers, investigational products, or components as evaluated by the investigator;\n2. Participant has secondary forms of IgAN as defined by investigator (eg, IgA vasculitis nephritis, SLE) or participant has nephrotic syndrome (defined as proteinuria\\>3.5 g\u002Fday and serum albumin\\\u003C3.0 g\u002FdL, with or without edema);\n3. IgA nephropathy with rapid decline of renal function; Kidney pathology indicated that more than 50% of the glomerulus had large crescent body formation, which may affect the study results; Tubule atrophy - interstitial fibrosis of more than 50%;\n4. Patients with concomitant immunodeficiency disorders; or those with other systemic diseases assessed by the investigator as potentially causing proteinuria (e.g., diabetic nephropathy, autoimmune diseases, ANCA-associated vasculitis, etc.);\n5. Any organ transplant recipient, including those who have undergone solid organ transplants, bone marrow transplants and haematopoietic stem cell transplants.\n6. Participants with a medical history of invasive infections caused by capsulated bacteria, including Neisseria meningitidis and Streptococcus pneumoniae;\n7. Participants with chronic recurrent infections within 1 year prior to screening, such as liver abscess and pyelonephritis; Or participants with active infection who requiring intravenous antibiotic therapy within 2 weeks prior to randomization;\n8. Participants have a history of malignancy (except of radical excision of basal cell or squamous cell skin cancer, or cervical carcinoma in situ.), Participants with prior malignancy who have been documented to be cancer-free for≥5 years may be enrolled;\n9. Participants with a history of severe trauma or major surgery within 12 weeks prior to screening, or who plan to undergo surgery during the study period;\n10. Participants with a history of blood donation or a history of severe blood loss (≥400 mL blood loss) within 12 weeks prior to screening, or who have received blood transfusions within 12 weeks prior to screening;\n11. Participants had received systemic glucocorticoid therapy, immunosuppressive agents (e.g. mycophenolate mofetil or calcineurin inhibitors), Chinese patent medicines with immunosuppressive properties (e.g. Tripterygium wilfordii tablets), or renin inhibitors within 12 weeks of randomisation. Alternatively, they were assessed by the investigator as potentially requiring such treatments during the study period.\n12. Participants had received treatment with biologics (e.g. telitacicept, atacicept, povetacicept, sibeprenlimab, CD38 monoclonal antibodies), or with budesonide enteric capsules (NEFECON) or cytokine inhibitors, as well as other products related to the complement pathway (e.g. eculizumab, ravulizumab and avacopan), which were not included in the investigational drug of this study within 6 months prior to randomisation, or participants had received iptacopan within 12 weeks prior to randomization;\n13. Participants have a history of gastrointestinal surgery that may significantly affect the absorption, distribution, metabolism or excretion of drugs. Or have a history of severe gastrointestinal disease, or be experiencing symptoms of dysphagia or recurrent vomiting that cause difficulty eating or taking medication.\n14. Participants with poorly controlled severe systemic diseases at screening, including, but not limited to, severe hypertension (SBP≥180 mmHg and\u002For DBP110 mmHg), severe cardiac disease, pulmonary disease, hepatic disease or haematological disorders, which significantly increase the participant's safety risk as assessed by the investigator;\n15. Participants with a history of tuberculosis, or who have current symptoms, signs, imaging or laboratory evidence of active tuberculosis, or who have a positive IGRA tuberculosis infection screening test result (except the participants who have medical documented evidence of having received standardized preventive anti-tuberculosis treatment within the 5 years prior to screening);\n16. ALT or AST or total bilirubin levels\\>3×ULN at screening;\n17. Hb\\\u003C90 g\u002FL or PLT\\\u003C80×109\u002FL at screening;\n18. HBsAg positive; or HBsAg negative but HBcAb positive with HBV-DNA quantitative results exceeding the ULN defined by the local lab; HCV antibody positive with HCV-RNA quantitative results exceeding the ULN defined by the local lab; HIV antibody positive;\n19. HBA1C≥9.0% at screening;\n20. Participants who have participated in a clinical trial of any drug or medical device within 12 weeks prior to randomization and are expected to have residual effects of the investigational treatment (as determined by the investigator), or in any drug clinical trial within 30 days (or 5 half-lives of the investigational drug, whichever is longer) prior to screening, or who participated in a clinical trial of oligonucleotide drugs within 1 year prior to randomization;\n21. Women who are pregnant or breastfeeding prior to randomization;\n22. Drug or alcohol abuse within 6 months prior to randomization;\n23. Any illness or condition that the investigator deems likely to increase the risk of the trial, affect participants adherence to the protocol or prevent them from completing it.","74 Years",{"count":103,"type":20},90,[23],"This is a multicenter, randomized, double-blind, parallel, placebo-controlled study and is being conducted to evaluate the efficacy and safety of HS-10542 capsules for primary IgA nephropathy.",[107,108,29],"IgAN","Immunoglobulin A Nephropathy (IgAN)",[107,110,99],"Immunoglobulin A Nephropathy","NOT_YET_RECRUITING","2026-03-11",{"date":114,"type":39},"2026-03-16",{"date":116,"type":20},"2026-03-17",{"date":118,"type":20},"2028-01-30",{"name":120,"class":91},"Jiangsu Hansoh Pharmaceutical Co., Ltd.",1,{"id":123,"slug":124,"hasResults":11,"nctId":125,"briefTitle":126,"officialTitle":127,"acronym":128,"eligibilityCriteria":129,"healthyVolunteers":11,"sex":15,"minAge":130,"maxAge":4,"enrollmentInfo":131,"targetDuration":4,"studyType":133,"phases":4,"briefSummary":134,"conditions":135,"keywords":147,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":150,"lastUpdatePostDateStruct":151,"startDateStruct":153,"completionDateStruct":155,"leadSponsor":157,"locationsCount":121},"100478094","interview-study-of-adult-and-child-patients-and-parents-of-children-with-swelling-due-to-nephrotic-syndrome-100478094","NCT05505500","Interview Study of Adult and Child Patients and Parents of Children With Swelling Due to Nephrotic Syndrome.","Preparing a Clinical Outcomes Assessment Set for Nephrotic Syndrome","Prepare-NS","Criteria for the Observer Reported Outcomes (ObsRO) cohort of the study:\n\nInclusion Criteria:\n\n1. Parents\u002Fguardians must be able to read and understand English;\n2. Parents\u002Fguardians must be caring for a child (ages 2-11.999) with a medically documented diagnosis of idiopathic (primary) Nephrotic Syndrome (NS) or primary or monogenic NS associated kidney disease. Populations with Primary NS Conditions: Focal segmental glomerulosclerosis (FSGS), Minimal Change Disease (MCD), Immunoglobulin M (IgM) Nephropathy, Membranous Nephropathy (MN), and childhood - onset nephrotic syndrome not biopsied;\n3. The child must have a current NS-associated edema\n4. The child must have native kidney function\n5. Parents\u002Fguardians must provide informed consent.\n\nExclusion Criteria:\n\n1\\. Index case with dialysis dependence throughout the 3-month pre-enrollment period\n\nCriteria for the Patient Reported Outcomes (PRO) cohort of the study:\n\nInclusion Criteria:\n\n1. ≥8 years of age\n2. Able to read and understand English\n3. Primary (idiopathic) kidney disease that causes NS or monogenic NS associated kidney disease.\n\n   i. Populations with Primary Nephrotic Syndrome (NS) Conditions include: FSGS, MCD, IgM nephropathy, MN, and childhood - onset nephrotic syndrome not biopsied\n4. Current NS-associated edema\n5. Kidney function with most recent estimated Glomerular Filtration Rate (eGFR) \\> 25 ml\u002Fmin\u002F1.73m2\n6. Informed Consent: For patients ≥8 to \\\u003C18 years of age: a parent or legal guardian provide informed consent and the patient must provide assent. Patients ≥18 years of age must provide informed consent.\n\nExclusion Criteria:\n\n1. Native kidney disease participant with dialysis dependence during the 3-month pre-enrollment period\n2. Co-existing significant chronic or severe acute health condition that has the potential to influence how the participant feels or functions as related to fluid overload in NS","2 Years",{"count":132,"type":20},150,"OBSERVATIONAL","Researchers from the University of Michigan and Northwestern University are studying people's experiences with swelling caused by Nephrotic Syndrome. Interviews with patients (child and adult) and parents of young children will be conducted. The information collected from the interviews will be used to develop a survey to use when testing new medications for Nephrotic Syndrome.\n\nPlease consider participating in a 1-hour long interview with the Prepare-NS research study to discuss children and adults experiences with swelling.",[136,137,138,139,140,141,142,26,29,143,144,145,146],"Fluid Overload","Glomerulosclerosis, Focal Segmental","Edema","Membranous Nephropathy","Minimal Change Disease","Minimal Change Nephrotic Syndrome","IgM Nephropathy","Nephrotic Syndrome, Minimal Change","Nephrotic Syndrome in Children","Nephrotic Syndrome With Edema (Diagnosis)","FSGS",[26,148,149,136,138,146,140,139,142],"Child","Adult","2025-12-15",{"date":152,"type":39},"2025-12-22",{"date":154,"type":39},"2022-04-18",{"date":156,"type":20},"2026-04-30",{"name":158,"class":159},"University of Michigan","OTHER",{"id":161,"slug":162,"hasResults":11,"nctId":163,"briefTitle":164,"officialTitle":164,"acronym":165,"eligibilityCriteria":166,"healthyVolunteers":167,"sex":15,"minAge":168,"maxAge":169,"enrollmentInfo":170,"targetDuration":4,"studyType":133,"phases":4,"briefSummary":172,"conditions":173,"keywords":176,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":177,"lastUpdatePostDateStruct":178,"startDateStruct":180,"completionDateStruct":182,"leadSponsor":184,"locationsCount":47},"100403065","the-impact-of-glomerular-disorders-on-bone-quality-and-strength-100403065","NCT04528446","The Impact of Glomerular Disorders on Bone Quality and Strength","BoneGN","Inclusion Criteria for participants with glomerular disease:\n\n1. CureGN participant or CureGN Eligible\n\n   CureGN eligible is defined as having a diagnosis of Glomerulonephropathy (GN). Patients would otherwise be enrolled in be in CureGN study, except for lacking a minor entry criteria, such as:\n   1. First diagnostic kidney biopsy within 5 years of CureGN study enrollment\n   2. Access to first kidney biopsy report and\u002For slides or not being interested in study participation.\n2. Males or females 5 to 55 years (premenopausal for women)\n3. Females must have a negative urine\u002Fserum pregnancy test\n4. Stable doses of nutritional vitamin D or active vitamin D therapy for at least 3 months before enrollment ((if on either form of Vitamin D)\n5. Consent\u002FParental\u002Fguardian permission (informed consent) and if appropriate, child assent\n\nExclusion Criteria for all participants\n\n1. Chronic Dialysis\n2. Solid organ transplantation\n3. Lower extremity amputations or non-ambulatory\n4. Malignancy requiring chemotherapy or metastatic to bone\n5. Metabolic bone disease (e.g., Paget's disease, primary hyperparathyroidism)\n6. Endocrinopathy (current hyperthyroidism or untreated hypothyroidism, Cushing's syndrome)\n7. Medical diseases (end stage liver disease, heart or lung disease, intestinal malabsorption)\n8. Those treated with bisphosphonates, teriparatide, calcitonin, selective estrogen receptor modulators, estrogen, or phenytoin in the past 12 months\n9. Previous bilateral wrist and tibia fractures\n10. Pregnant or lactating females\n11. Parents\u002Fguardians or participants who, in the opinion of the Investigator, may be non-compliant with study schedules or procedures.",true,"5 Years","55 Years",{"count":171,"type":20},270,"The primary objectives of this study are to: (1) determine the impact of glomerular disease on bone strength and (2) investigate the pathophysiologic underpinnings of impaired bone strength in glomerular disease.",[29,174,175],"Bone Diseases, Metabolic","Bone Fracture",[32,175],"2024-06-28",{"date":179,"type":39},"2024-07-01",{"date":181,"type":39},"2019-06-14",{"date":183,"type":20},"2024-12",{"name":185,"class":159},"Columbia University",{"id":187,"slug":188,"hasResults":11,"nctId":189,"briefTitle":190,"officialTitle":191,"acronym":192,"eligibilityCriteria":193,"healthyVolunteers":11,"sex":15,"minAge":4,"maxAge":4,"enrollmentInfo":194,"targetDuration":196,"studyType":133,"phases":4,"briefSummary":197,"conditions":198,"keywords":203,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":209,"lastUpdatePostDateStruct":210,"startDateStruct":212,"completionDateStruct":214,"leadSponsor":216,"locationsCount":5},"100357120","korea-renal-biobank-network-system-toward-next-generation-analysis-100357120","NCT03929887","KOrea Renal Biobank NEtwoRk System TOward NExt-generation Analysis","Multicenter Prospective Cohort of Kidney Biopsy for Glomerular Disease Research","KORNERSTONE","1. Inclusion criteria\n\n   * Patient suspected of glomerular disease who received kidney biopsy in participating university medical centers\n   * Children (age\\\u003C18 years) also included\n2. Exclusion criteria - Patients who previously received a kidney transplant",{"count":195,"type":20},3000,"20 Years","Glomerulonephritis (GN) generates an enormous individual and social economic burden. However, the therapeutic options are largely based on clinical and pathological parameters and the individual response to therapy or prognosis is uncertain.\n\nRecently, along with advances in molecular analysis and computational bioinformatics, genomic data from human renal biopsies could provide a strong foundation for the future of precision medicine in nephrology.\n\nIn response to a request for applications by the Ministry of Health and Welfare of Korea for the creation of Clinical Research Registry, multi-center N network has been established for prospective cohort with kidney biopsy samples (KORNERSTONE).\n\nThrough this Network the investigators hope to understand the fundamental biology of glomerulonephritis and aim to bank long-term observational data and corresponding biological data including genomic data from kidney tissues, and kidney pathologic data which is digitalized This database is archived to a web-based platform to access easily and further enrich for researchers.",[29,140,199,139,200,201,202],"IgA Nephropathy","Focal Segmental Glomerulosclerosis","Lupus Nephritis","Crescentic Glomerulonephritis",[204,205,206,207,208],"Glomerular disease","sample repository","clinical data","digital pathology repository","web-based database","2020-02-10",{"date":211,"type":39},"2020-02-12",{"date":213,"type":39},"2019-05-01",{"date":215,"type":20},"2028-12-31",{"name":217,"class":159},"Seoul National University Hospital"]