[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"c3-glomerulopathy\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:c3-glomerulopathy":26},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,9,0,[8,48,85,110,134,159,186,212,235],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":4,"eligibilityCriteria":15,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":18,"enrollmentInfo":19,"targetDuration":4,"studyType":22,"phases":4,"briefSummary":23,"conditions":24,"keywords":27,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":36,"lastUpdatePostDateStruct":37,"startDateStruct":40,"completionDateStruct":42,"leadSponsor":44,"locationsCount":47},"100624940","a-study-of-iptacopan-in-korean-patients-with-paroxysmal-nocturnal-hemoglobinuria-or-c3-glomerulopathy-100624940",false,"NCT07416162","A Study of Iptacopan in Korean Patients With Paroxysmal Nocturnal Hemoglobinuria or C3 Glomerulopathy","A Post-marketing Surveillance of Fabhalta® (Iptacopan) in Korean Patients With Paroxysmal Nocturnal Hemoglobinuria (PNH) or C3 Glomerulopathy (C3G)","Inclusion criteria:\n\n1. Patients aged 18 years or older who have been diagnosed with PNH or C3G.\n2. Patients who have received vaccination in accordance with the approved Korean labeling prior to initiating treatment with iptacopan.\n3. Patients who are being treated or will be treated with iptacopan in accordance with the approved Korean labeling.\n4. Patients who have voluntarily provided consent for study participation (written informed consent).\n\nExclusion criteria:\n\n1. Patients who fall under the contraindications for iptacopan administration according to approved Korean labeling.\n2. Patients for whom iptacopan administration is deemed inappropriate based on the investigator's judgment.","ALL","18 Years","99 Years",{"count":20,"type":21},21,"ESTIMATED","OBSERVATIONAL","This is a post-marketing surveillance study conducted as part of the Risk Management Plan (RMP) for South Korea, to evaluate the safety and effectiveness of iptacopan in real-world clinical settings for the treatment of either PNH or C3G in Korean patients. Prospective data will be collected from patient medical records to address the objectives for all eligible populations.",[25,26],"Paroxysmal Nocturnal Hemoglobinuria","C3 Glomerulopathy",[28,29,30,31,32,33,34,25,26],"Iptacopan","Factor B inhibitor","Post-Marketing Surveillance","Complement inhibition","Hemolysis","Proteinuria","Dense Deposit Disease","RECRUITING","2026-06-25",{"date":38,"type":39},"2026-06-26","ACTUAL",{"date":41,"type":39},"2026-06-15",{"date":43,"type":21},"2029-02-01",{"name":45,"class":46},"Novartis Pharmaceuticals","INDUSTRY",3,{"id":49,"slug":50,"hasResults":11,"nctId":51,"briefTitle":52,"officialTitle":53,"acronym":4,"eligibilityCriteria":54,"healthyVolunteers":11,"sex":16,"minAge":55,"maxAge":56,"enrollmentInfo":57,"targetDuration":4,"studyType":59,"phases":60,"briefSummary":62,"conditions":63,"keywords":65,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":76,"lastUpdatePostDateStruct":77,"startDateStruct":79,"completionDateStruct":81,"leadSponsor":83,"locationsCount":84},"100359082","phase-3-long-term-efficacy-safety-and-tolerability-of-iptacopan-in-c3g-or-ic-mpgn-100359082","NCT03955445","Long-term Efficacy, Safety and Tolerability of Iptacopan in C3G or IC-MPGN","An Open-label, Non-randomized Extension Study to Evaluate the Long-term Efficacy, Safety and Tolerability of Iptacopan (LNP023) in C3 Glomerulopathy or Idiopathic Immune-complex-membranoproliferative Glomerulonephritis","Inclusion Criteria:\n\n\\- Patients must have completed the treatment period of the CLNP023X2202, CLNP023B12301 or CLNP023B12302 study on study drug\n\nExclusion Criteria:\n\n* Severe concurrent co-morbidities, e.g. advanced cardiac disease (NYHA class IV), severe pulmonary arterial hypertension (WHO class IV), or any illness or medical condition that in the opinion of the investigator and sponsor is likely to prevent the patient from safely tolerating LNP023 or complying with the requirements of the study\n* Participants with an active systemic bacterial, viral or fungal infection within 14 days prior to screening, or the presence of fever ≥ 38oC (100.4oF) within 7 days prior to screening.\n* History or current diagnosis of ECG abnormalities indicating significant risk of safety for subjects\n* History of HIV or any other immunodeficiency disease\n\nOther protocol-defined inclusion\u002Fexclusion criteria may apply","12 Years","100 Years",{"count":58,"type":21},225,"INTERVENTIONAL",[61],"PHASE3","This is an open-label extension study to evaluate the long-term efficacy, safety and tolerability of iptacopan in subjects with C3 glomerulopathy or idiopathic immune-complex-membranoproliferative glomerulonephritis",[26,64],"Immune-complex-membranoproliferative Glomerulonephritis",[66,67,68,69,70,71,72,73,74,75],"C3G","C3 glomerulopathy","C3GN","C3 glomerulonephritis","DDD","dense deposit disease","iptacopan","LNP023","IC-MPGN","idiopathic immune-complex- membranoproliferative glomerulonephritis","2026-04-09",{"date":78,"type":39},"2026-04-14",{"date":80,"type":39},"2019-10-03",{"date":82,"type":21},"2036-05-30",{"name":45,"class":46},50,{"id":86,"slug":87,"hasResults":11,"nctId":88,"briefTitle":89,"officialTitle":90,"acronym":4,"eligibilityCriteria":91,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":92,"enrollmentInfo":93,"targetDuration":4,"studyType":59,"phases":95,"briefSummary":98,"conditions":99,"keywords":4,"overallStatus":100,"whyStopped":4,"lastUpdateSubmitDate":101,"lastUpdatePostDateStruct":102,"startDateStruct":104,"completionDateStruct":106,"leadSponsor":108,"locationsCount":4},"100489030","phase-1-study-of-nm8074-in-adult-c3-glomerulopathy-patients-100489030","NCT05647811","Study of NM8074 in Adult C3 Glomerulopathy Patients","A Phase Ib, Open Label, Dose Escalation Study of NM8074 in Subjects With C3 Glomerulopathy (C3G)","Inclusion Criteria:\n\n* Patients ≥ 18 and ≤ 65 years at the time of consent\n* Diagnosis of C3 Glomerulopathy as confirmed by C3 nephropathy in biopsy within 12 months prior to enrollment\n* Reduced serum C3 levels (defined as less than 0.85 x lower limit of the central laboratory normal range) at Screening\n* Patients with confirmed proteinuria\n* Willing and able to understand and complete informed consent procedures, including signing and dating the informed consent form (ICF), and comply with the study visit schedule\n* Women of child-bearing potential (WOCBP), defined as all women physiologically capable of becoming pregnant, must have a negative pregnancy test at screening and must agree to use highly effective methods of contraception during dosing and for 1 week after stopping of investigational drug\n* Males must agree to use contraceptives and refrain from donating sperm for the duration of the study\n* Patients must have documentation of previous vaccination or be willing to be vaccinated prior to dosing with NM8074. All patients will be vaccinated against Neisseria meningitidis, Streptococcus pneumoniae and Haemophilus influenzae according to the most current Advisory Committee on Immunization Practices (ACIP) recommendations.\n* Estimated glomerular filtration (eGFR) rate of ≤ 60 ml\u002Fmin but ≥ 20 ml\u002Fmin\n\nExclusion Criteria:\n\n* Use of other investigational drugs at the time of enrollment\n* Patients with other renal diseases that would interfere with interpretation of the study\n* Estimated glomerular filtration rate of ≤ 20 mL\u002Fmin\u002F1.73m2 based on Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI) at Screening\n* Has alanine aminotransferase (ALT) or aspartate aminotransferase (AST) \\> 5 times the upper limit of normal (xULN)\n* Has a known history of meningococcal disease or N. meningitidis\n* Currently active systemic infection or suspicion of active bacterial, viral, or fungal infection that requires antibiotic, antifungal, antiparasitic, or antiviral mediations\n* Temperature \\> 38°C for more than two weeks prior to screening\n* History of renal organ transplantation\n* Pregnant, planning to become pregnant, or nursing female subjects\n* C3G patients currently under complement blocker treatments\n* Participation in any experimental small molecule or non-antibody therapy within 60 days prior to dosing on Day 1 (participation in observational studies and\u002For registry studies is permitted)","65 Years",{"count":94,"type":21},18,[96,97],"PHASE1","PHASE2","This is a Phase Ib, open-label, dose-escalation study designed to evaluate the safety, efficacy, and immunogenicity of NM8074 administered intravenously to patients with C3 Glomerulopathy.",[26],"NOT_YET_RECRUITING","2026-04-07",{"date":103,"type":39},"2026-04-13",{"date":105,"type":21},"2027-05",{"date":107,"type":21},"2030-07",{"name":109,"class":46},"NovelMed Therapeutics",{"id":111,"slug":112,"hasResults":11,"nctId":113,"briefTitle":114,"officialTitle":115,"acronym":4,"eligibilityCriteria":116,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":56,"enrollmentInfo":117,"targetDuration":4,"studyType":22,"phases":4,"briefSummary":119,"conditions":120,"keywords":122,"overallStatus":100,"whyStopped":4,"lastUpdateSubmitDate":126,"lastUpdatePostDateStruct":127,"startDateStruct":129,"completionDateStruct":131,"leadSponsor":133,"locationsCount":4},"100618410","chart-c3gclnp023b12011-100618410","NCT07331259","CHART-C3G\u002FCLNP023B12011","C3 Glomerulopathy Patient Characteristics and Treatment Response to Iptacopan in Routine Care: Analysis of Medical Charts (CHART-C3G)","Inclusion Criteria:\n\n* Clinical diagnosis of C3G (confirmed by biopsy, only if available)\n* Aged ≥18 years at time of index date.\n* At least 6 months of baseline period preceding index date.\n* Users of iptacopan treatment including those who have discontinued iptacopan within the last twelve weeks.\n\nExclusion Criteria:\n\n* Interventional C3G clinical trial participation",{"count":118,"type":21},83,"This is a non-interventional chart abstraction cohort study with longitudinal follow up. Patients with C3G treated with iptacopan will be enrolled and characterized (i.e., systematically describe and summarize) regarding their medical history and iptacopan use and evaluated for clinical events, outcomes, and laboratory measurements upon and after iptacopan treatment initiation. Medical charts will be used to obtain secondary pseudonymized patient-level data with reference to 2 time anchors: at index date (date of iptacopan treatment initiation) with baseline covering 12 months prior to index date, and at 12-month follow-up (twelve months after the index date).The observation period includes baseline plus follow-up.\n\nIptacopan will be used as prescribed by the clinician in accordance with the terms of the marketing authorization. This Novartis-sponsored study, mainly executed by a contract research organization (CRO), will use secondary data from EHR obtained through reference centers\u002F centers of excellence in glomerular diseases in Germany.\n\nThe primary objective of this study is to characterize the demographic and clinical profiles of adult patients diagnosed with C3G upon iptacopan treatment initiation.",[26,121,33],"Complement-mediated Kidney Disease",[123,124,66,28,125],"NIS-PDC","Germany","estimated Glomerular Filtration Rate","2025-12-29",{"date":128,"type":39},"2026-01-09",{"date":130,"type":21},"2026-01-01",{"date":132,"type":21},"2027-03-01",{"name":45,"class":46},{"id":135,"slug":136,"hasResults":11,"nctId":137,"briefTitle":138,"officialTitle":139,"acronym":4,"eligibilityCriteria":140,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":18,"enrollmentInfo":141,"targetDuration":4,"studyType":59,"phases":143,"briefSummary":144,"conditions":145,"keywords":147,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":149,"lastUpdatePostDateStruct":150,"startDateStruct":152,"completionDateStruct":154,"leadSponsor":156,"locationsCount":158},"100532202","phase-2-safety-and-efficacy-study-of-oms906-in-patients-with-c3g-and-icgn-100532202","NCT06209736","Safety and Efficacy Study of OMS906 in Patients With C3G and ICGN","A Phase 2 Proof of Concept Study to Evaluate the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, and Preliminary Efficacy of OMS906 in Patients With C3 Glomerulopathy (C3G) and Idiopathic Immune Complex-Mediated Glomerulonephritis (ICGN)","Inclusion Criteria:\n\n1. Male or female adults 18 years and older.\n2. Competent to provide informed consent and has completed informed consent procedures.\n3. Diagnosis of C3G, including dense deposit disease, or ICGN confirmed by biopsy within 36 months of screening.\n4. Two 24-hour UPCR ≥ 0.8 gm\u002Fgm with the 2 collections separated by 14 - 28 days.\n5. GFR estimated by the CKD-EPI equation ≥ 45 mL\u002Fmin\u002F1.73 m2.\n6. Serum C3 concentration less than the lower limit of laboratory normal during screening.\n7. Must be on stable maximally tolerated or allowed dose of ACE inhibitor or ARB for at least 90 days.\n8. If receiving a sodium-glucose co-transporter-2 (SGLT-2) inhibitor, must be on a stable dose for at least 90 days.\n9. If receiving mycophenolate mofetil, a mineralocorticoid receptor antagonist, or a corticosteroid, must be on stable dose for at least 90 days.\n10. Have current vaccination status for Neisseria meningitidis, Streptococcus pneumonia and Haemophilus influenza (where available) and agree to maintain vaccination throughout the study.\n\n    Patients who have not received these vaccinations at the time of screening may be vaccinated at any time prior to 2 weeks before the first study drug administration. Vaccine serotypes will be chosen by the local standard of care and serotype prevalence.\n11. Female patients of child-bearing potential must have a negative highly sensitive pregnancy test at screening and prior to each dose of OMS906.\n12. Females must use highly effective birth control\\* to prevent pregnancy during the clinical trial and for 20 weeks (140 days) following their last dose of study drug.\n13. Males must use highly effective birth control\\* with a female partner to prevent pregnancy during the clinical trial and for 20 weeks (140 days) following their last dose of study drug.\n\nExclusion Criteria:\n\n1. History of major organ transplant or hematopoietic stem cell\u002Fmarrow transplant.\n2. Have known congenital deficiency of any of complement factors C1q, C1r, C1s, C2 or C4.\n3. Have rapidly progressing glomerulonephritis defined as a 50% or greater decline in the eGFR within 3 months with renal biopsy findings of glomerular crescent formation seen in at least 50% of glomeruli.\n4. Have renal biopsy findings showing interstitial fibrosis\u002Ftubular atrophy of more than 50%.\n5. Immunodeficiency or treatment with immunosuppressive agents (except mycophenolate mofetil or corticosteroids at the prednisone equivalent of ≤ 7.5 mg\u002Fday in patients with C3G only) within 90 days of screening.\n6. Treatment with rituximab within 6 months of screening.\n7. Resting blood pressure \\> 140\u002F90 mmHg during screening.\n8. History of any active malignancy within 5 years of screening except non-melanoma skin cancers.\n9. History of monoclonal gammopathy of unknown significance or any autoimmune disorder.\n10. Elevation of liver function tests, defined as total bilirubin \\> 2 × upper limit of normal (ULN), direct bilirubin \\> 1.5 × ULN, and elevated transaminases, alanine aminotransferase (ALT) or aspartate aminotransferase (AST) \\> 2 × ULN.\n11. History of any severe hypersensitivity reactions to other monoclonal antibodies or excipients included in the OMS906 preparation.\n12. Significant active bacterial or viral infection within the 2 weeks prior to screening including Covid-19 infection.\n13. Use of any other complement inhibitor within 6 months prior to the screening visit.\n14. Have human immunodeficiency virus, hepatitis B, or untreated hepatitis C infection.\n15. Pregnant, planning to become pregnant, or nursing female patient.\n16. Recent surgery requiring general anesthesia within the 2 weeks prior to screening or expected to have surgery requiring general anesthesia during the treatment period.\n17. History of any significant medical, neurologic, or psychiatric disorder that in the opinion of the investigator would make the patient unsuitable for participation in the study.\n18. Treatment with any investigational medicinal product or investigational device within 30 days (or within 5 × its half-life in days, whichever is the longer period) prior to screening, or participation in another concurrent clinical trial involving a therapeutic intervention. Participation in observational and\u002For registry studies is permitted.\n19. Unable or unwilling to comply with the requirements of the study.",{"count":142,"type":21},20,[97],"The purpose of this study is to assess the safety, tolerability, pharmacokinetics, pharmacodynamics, and preliminary efficacy of OMS906 in patients with C3 Glomerulopathy (C3G) and Idiopathic Immune Complex-Mediated Glomerulonephritis (ICGN)",[26,146],"Idiopathic Immune Complex-Mediated Glomerulonephritis",[66,148],"ICGN","2025-07-10",{"date":151,"type":39},"2025-07-15",{"date":153,"type":39},"2024-03-01",{"date":155,"type":21},"2026-04",{"name":157,"class":46},"Omeros Corporation",6,{"id":160,"slug":161,"hasResults":11,"nctId":162,"briefTitle":163,"officialTitle":164,"acronym":4,"eligibilityCriteria":165,"healthyVolunteers":11,"sex":16,"minAge":166,"maxAge":4,"enrollmentInfo":167,"targetDuration":4,"studyType":59,"phases":169,"briefSummary":170,"conditions":171,"keywords":4,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":175,"lastUpdatePostDateStruct":176,"startDateStruct":178,"completionDateStruct":180,"leadSponsor":182,"locationsCount":185},"100376559","phase-2-evaluation-of-a-renin-inhibitor-aliskiren-compared-to-enalapril-in-c3-glomerulopathy-100376559","NCT04183101","Evaluation of a Renin Inhibitor, Aliskiren, Compared to Enalapril, in C3 Glomerulopathy","Phase 2, Multicenter, Randomized, Open-label, Controlled, 2-arm Cross-over Study to Evaluate the Clinical Efficacy of a Renin Inhibitor, Aliskiren, Compared to an Angiotensin Converting Enzyme Inhibitor, Enalapril, in C3 Glomerulopathy","Inclusion Criteria:\n\n1. Children ≥ 6 years and adults.\n2. Initial diagnosis of Dense Deposit Disease and C3 glomerulonephritis confirmed by kidney biopsy obtained not more than 2 years before the first dose of the study drug.\n3. Either absence of treatment at the study start or ongoing treatment with aliskiren, angiotensin converting enzyme inhibitors, angiotensin receptor blockers or immune suppressive medications (such as mycophenolate mofetil\u002FMMF or corticosteroids)\n4. Written informed consent has been given by:\n\n   1. the patient's legal guardians if the patient is less than 15 years old\n   2. the patient and his\u002Fher legal guardians if the patient is ≥ 15 but \\\u003C 18 years old\n   3. the patient, if the patient is ≥ 18 years old\n5. Female subjects of childbearing potential must:\n\n   1. Understand that the study medication is expected to have a teratogenic risk\n   2. Agree to use a highly effective contraceptive during study drug therapy. This applies unless the subject is less than 18 years of age, has not had sexual debut and commits to sexual abstinence confirmed by a pregnancy test on every study visit. Either of the following methods of contraception may be used:\n\n      * Combined (estrogen and progesterone) hormonal contraception associated with inhibition of ovulation: oral, intravaginal or transdermal\n      * Progestogen-only hormonal contraception associated with inhibition of ovulation: oral, injectable or implantable\n      * Intrauterine device\n      * Intrauterine hormone-releasing system\n      * Bilateral tubal occlusion\n      * Vasectomized partner\n      * Sexual abstinence\n      * Male or female condom with or without spermicide\n      * Cap, diaphragm or sponge with spermicide\n   3. Agree to have a pregnancy test before the start of study medication. This requirement also applies to women of childbearing age who practice complete and continued abstinence and adolescent girls after menarche.\n   4. Agree to have a pregnancy test every 3rd month including at the end of study treatment, except in the case of confirmed tubal sterilization. This requirement also applies to women of childbearing age who practice complete and continued abstinence and adolescent girls after menarche.\n\nExclusion Criteria:\n\n1. Known allergy to aliskiren, ACEi or substances contained in these preparations.\n2. Angioedema caused by aliskiren or enalapril\n3. Weight \\\u003C 25 kg\n4. Glomerular filtration rate ≤ 50 ml\u002Fmin\u002F1.73 m2 (measured by iohexol clearance) in children and ≤ 30 ml\u002Fmin\u002F1.73 m2 in adults.\n5. Rapid deterioration of kidney function during the latest year of the disease\n6. Patients with a renal transplant\n7. Immune complex-mediated membranoproliferative glomerulonephritis (such as in HIV infection, hepatitis, SLE)\n8. Females who breastfeed, are pregnant or planning to become pregnant during the study.\n9. Co-morbidity such as malignancy, congestive heart failure, recent myocardial infarction.\n10. Mental incapacity or language barriers to understand the contents of the study design.\n11. Simultaneous use of another complement-antagonist (such as eculizumab). Eculizumab must be discontinued and complement activity normalized before the start of study drug.\n12. Simultaneous use of aliskiren or enalapril with cyclosporine or nonsteroidal anti-inflammatory drugs (NSAID).","6 Years",{"count":168,"type":21},30,[97],"The aim of this cross-over trial is to assess aliskiren, a direct renin inhibitor, as a novel treatment to block complement activation in the kidneys and thereby attenuate renal disease and stabilize or improve kidney function and compare it to the currently used treatment with the angiotensin converting enzyme inhibitor, enalapril, in patients with the complement-mediated renal disease C3 glomerulopathy. Patients will be randomized to one or the other treatment for the first 6 months and then switch to the other treament for the following 2.5 years. Treatment will continue for altogether 3 years for each patient.",[26,172,173,34,174],"Membranoproliferative Glomerulonephritis","Complement Abnormality","C3 Glomerulonephritis","2025-06-19",{"date":177,"type":39},"2025-06-22",{"date":179,"type":39},"2020-10-01",{"date":181,"type":21},"2029-12",{"name":183,"class":184},"Region Skane","OTHER",4,{"id":187,"slug":188,"hasResults":11,"nctId":189,"briefTitle":190,"officialTitle":191,"acronym":4,"eligibilityCriteria":192,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":56,"enrollmentInfo":193,"targetDuration":4,"studyType":22,"phases":4,"briefSummary":195,"conditions":196,"keywords":197,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":204,"lastUpdatePostDateStruct":205,"startDateStruct":206,"completionDateStruct":208,"leadSponsor":210,"locationsCount":211},"100595214","home-reported-outcomes-in-c3g-study-100595214","NCT07029542","Home Reported Outcomes in C3G Study","A Mobile App-Based, Prospective, Observational Study to Evaluate Disease Burden and Treatment Patterns in C3 Glomerulopathy (C3G) in the US","Inclusion Criteria:\n\nEligible participants will meet the following basic criteria:\n\n* Clinical diagnosis of C3G, regardless of symptom, treatment, or transplant history\n* Adult aged 18 or older; adult caregiver to an adult patient aged 18 or older; or adult caregiver to a pediatric patient under 18 years of age\n* Able to provide informed consent\n* Has access to technology (i.e. mobile phone, tablet) that facilitates their participation in the app-based study\n* US-based with a proficient understanding of and ability to read the English language\n\nThe study team will aim to enroll and collect data on participants who are taking any form of treatment. Participants may be asked to recall the start date of taking their current therapy.\n\nDiagnosis of C3G will be confirmed through self-reported screening procedures, patient-supplied documentation, and\u002For successful linkage of the patient's data with their record in a Novartis data platform. Confirmation of diagnosis for each participant will be reviewed by the Folia Health study team as part of standard validation procedures.\n\nExclusion Criteria:\n\nStudy participants who do not fit all inclusion criteria listed above are unable to participate in this study. Outside of the stated inclusion criteria, there is currently no other exclusion criteria in order to meet the exploratory nature of the primary endpoint. This includes treatment regimen; there is no exclusion criteria on the basis of treatment prescription or use.",{"count":194,"type":21},100,"The study aims to longitudinally capture the full spectrum of symptoms, treatment utilization, and overall Health-related Quality of Life (HRQoL) experienced by C3 glomerulopathy (C3G) patients and their caregivers. By primarily utilizing home reported outcomes (HRO) data on symptom burden and treatment usage, supplemented with patient-reported outcome (PRO) measures (collected at baseline and monthly), the study seeks to establish a new real-world data (RWD) source to understand symptom variability and HRQoL as reported by C3G patients and caregivers, including those taking iptacopan",[26],[198,199,200,201,202,203],"Home reported outcomes (HRO),","NIS,","FACIT-F,","EQ-5D,","Symptoms,","Treatments","2025-06-11",{"date":175,"type":39},{"date":207,"type":39},"2025-04-07",{"date":209,"type":21},"2026-04-30",{"name":45,"class":46},1,{"id":213,"slug":214,"hasResults":11,"nctId":215,"briefTitle":216,"officialTitle":217,"acronym":4,"eligibilityCriteria":218,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":219,"targetDuration":4,"studyType":59,"phases":221,"briefSummary":222,"conditions":223,"keywords":4,"overallStatus":100,"whyStopped":4,"lastUpdateSubmitDate":225,"lastUpdatePostDateStruct":226,"startDateStruct":228,"completionDateStruct":230,"leadSponsor":232,"locationsCount":234},"100576518","phase-2-a-study-of-sgb-9768-in-patients-with-complement-mediated-kidney-diseases-100576518","NCT06786338","A Study of SGB-9768 in Patients with Complement-mediated Kidney Diseases","A Phase 2, Multicenter, Open-label Study to Evaluate the Efficacy and Safety of SGB-9768 in Patients with Primary IgA Nephropathy, C3 Glomerulopathy, and Immune Complex-mediated Membranoproliferative Glomerulonephritis.","Inclusion Criteria:\n\n* Aged ≥18 years\n* Weight ≥40 kg, with a body mass index (BMI) between 15 and 35 kg\u002Fm²\n* Biopsy-confirmed diagnosis of primary IgA nephropathy, C3 glomerulopathy or IC-MPGN, accompanied by C3 deposition in the glomeruli.\n* Urine protein-to-creatinine ratio (UPCR) ≥0.75 g\u002Fg\n* Estimated glomerular filtration rate (eGFR) (calculated using the CKD-EPI formula) must be ≥30 mL\u002Fmin\u002F1.73 m².\n* Must be on a stable maximum tolerated doses of ACE inhibitors (ACEI) or angiotensin receptor blockers (ARB) for at least 12 weeks\n* Participants of childbearing potential must use highly effective contraception during the study and for at least 12 weeks following the end of the study or last dose of study drug\n\nExclusion Criteria:\n\n* Kidney biopsy indicates more than 50% tubular atrophy or interstitial fibrosis.\n* Kidney biopsy shows more than 50% formation of glomerular crescents, or clinical signs suggestive of rapidly progressive glomerulonephritis.\n* IgA nephropathy, C3 glomerulopathy, or IC-MPGN secondary to other diseases\n* Presence of other systemic diseases or kidney diseases that may cause proteinuria\n* Received immunosuppressants or other immunomodulators within 90 days prior to the first administration of the investigational drug\n* Received B-cell targeted biologics or other biologics within 180 days prior to the first administration of the investigational drug\n* Used SGLT2 inhibitors or endothelin receptor antagonists, unless have been stably used for 12 weeks or more\n* Significant comorbidities\n* History of any malignant tumors of any organ system within the past 5 years\n* History of severe trauma or major surgery within 12 weeks prior to screening, or plans to undergo surgery during the study.\n* History of immunodeficiency diseases, congenital asplenia or splenectomy.\n* History of recurrent invasive infections, active systemic bacterial, viral, or fungal infections\n* Positive test results for HBV, HCV, HIV\n* Alanine aminotransferase (ALT) or aspartate aminotransferase (AST) levels \\> 2.5 times the upper limit of normal (ULN)",{"count":220,"type":21},38,[97],"This study looks at how well and safely SGB-9768 works for patients with certain kidney diseases: primary IgA nephropathy, C3 glomerulopathy, and immune complex-related membranoproliferative glomerulonephritis. It's a phase 2 trial done at several locations where both patients and doctors know what treatment is being given.",[224,26,74],"IgA Nephropathy (IgAN)","2025-01-20",{"date":227,"type":39},"2025-01-22",{"date":229,"type":21},"2025-04-01",{"date":231,"type":21},"2026-10-01",{"name":233,"class":46},"Suzhou Sanegene Bio Inc.",11,{"id":236,"slug":237,"hasResults":11,"nctId":238,"briefTitle":239,"officialTitle":240,"acronym":241,"eligibilityCriteria":242,"healthyVolunteers":11,"sex":16,"minAge":4,"maxAge":4,"enrollmentInfo":243,"targetDuration":245,"studyType":22,"phases":4,"briefSummary":246,"conditions":247,"keywords":4,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":329,"lastUpdatePostDateStruct":330,"startDateStruct":332,"completionDateStruct":334,"leadSponsor":336,"locationsCount":211},"100521150","national-registry-of-rare-kidney-diseases-100521150","NCT06065852","National Registry of Rare Kidney Diseases","National Registry of Rare Kidney Diseases (RaDaR)","RaDaR","* Kidney Rare Disease\n* Paeds and adults\n* Eligibility differs for each rare disease group\n* See: https:\u002F\u002Fukkidney.org\u002Frare-renal\u002Frecruitment",{"count":244,"type":21},35000,"30 Years","The goal of this National Registry is to is to collect information from patients with rare kidney diseases, so that it that can be used for research.\n\nThe purpose of this research is to:\n\n* Develop Clinical Guidelines for specific rare kidney diseases. These are written recommendations on how to diagnose and treat a medical condition.\n* Audit treatments and outcomes. An audit makes checks to see if what should be done is being done and asks if it could be done better.\n* Further the development of future treatments.\n\nParticipants will be invited to participate on clinical trials and other studies. The registry has the capacity to feedback relevant information to patients and in conjunction with Patient Knows Best (Home - Patients Know Best), allows patients to provide information themselves, including their own reported quality of life and outcome measures.",[248,249,250,251,252,253,254,255,256,257,258,259,260,261,26,262,263,264,265,266,34,267,268,269,270,271,272,273,274,275,276,277,278,279,280,281,282,283,284,285,286,287,288,289,290,291,292,293,294,295,296,297,298,299,300,301,302,303,172,304,305,306,307,308,309,310,311,312,313,314,315,316,317,318,319,320,321,322,323,324,325,326,327,328],"Adenine Phosphoribosyltransferase Deficiency","AH Amyloidosis","AHL Amyloidosis","AL Amyloidosis","Alport Syndrome","Atypical Hemolytic Uremic Syndrome","Autoimmune Distal Renal Tubular Acidosis","Autosomal Recessive Proximal Renal Tubular Acidosis","Autosomal Recessive Distal Renal Tubular Acidosis","Autosomal Dominant Polycystic Kidney Disease","Autosomal Recessive Polycystic Kidney Disease","Bartter Syndrome","BK Nephropathy","C3 Glomerulopathy With Monoclonal Gammopathy","Calciphylaxis","Crystalglobulinaemia","Crystal-storing Histiocytosis","Cystinosis","Cystinuria","Dent Disease","Denys-Drash Syndrome","Dominant Hypophosphataemia With Nephrolithiasis and\u002For Osteoporosis","Drug Induced Fanconi Syndrome","Drug-Induced Hypomagnesemia","Drug-Induced Nephrogenic Diabetes Insipidus","Epilepsy, Ataxia, Sensorineural Deafness and Tubulopathy","Fabry Disease","Familial Hypomagnesemia With Hypercalciuria and Nephrocalcinosis","Familial Primary Hypomagnesemia With Hypocalcuria","Familial Primary Hypomagnesaemia With Normocalciuria","Familial Renal Glucosuria","Fanconi Renotubular Syndrome 1","Fanconi Renotubular Syndrome 2","Fanconi Renotubular Syndrome 3","Fibrillary Glomerulonephritis","Fibromuscular Dysplasia","Focal Segmental Glomerulosclerosis","Generalised Pseudohypoaldosteronism Type 1","Gitelman Syndrome","Heavy-Metal-Induced Fanconi Syndrome","Hepatocyte Nuclear Factor 1-Beta-Associated Monogenic Diabetes","Hereditary Renal Hypouricemia","Hereditary Hypophosphatemic Rickets With Hypercalciuria","Hyperuricaemic Nephropathy","IgA Nephropathy","Immunotactoid Glomerulonephritis With Organised Microtubular Mononoclonal Immunoglobulin Deposits","Inherited Renal Cancer Syndromes","Intracapillary Monoclonal IgM Without Cryoglobulin","Intraglomerular\u002FCapillary Lymphoma\u002FLeukaemia","Isolated Autosomal Dominant Hypomagnesaemia Glaudemans Type","Liddle Syndrome","Light Chain Cast Nephropathy","Light Chain Proximal Tubulopathy Without Crystals","Light Chain Proximal Tubulopathy With Crystals","Lowe Syndrome","Membranous Nephropathy","Medullary Cystic Kidney Disease","Minimal Change Nephropathy","Mitochondrial Disease Of The Kidney","Monoclonal Immunoglobulin Deposition Disease","Nail Patella Syndrome","Nephrogenic Diabetes Insipidus","Nephrogenic Syndrome of Inappropriate Antidiuresis","Nephronophthisis","Primary Hypomagnesemia With Secondary Hypocalcemia","Primary Hyperoxaluria","Proliferative Glomerulonephritis With Monoclonal IgG Deposits","Proximal Tubulopathy Without Crystals","Pseudohypoaldosteronism Type 1, 2A-2E","Pure Red Cell Aplasia","Retroperitoneal Fibrosis","Sickle Cell Nephropathy","Shiga Toxin Associated Haemolytic Uraemic Syndrome","Steroid Resistant Nephrotic Syndrome","Steroid-Sensitive Nephrotic Syndrome","Thin Basement Membrane Nephropathy","Thrombotic Microangiopathy With Monoclonal Gammopathy","Type 1 Cryoglobulinaemic Glomerulonephritis","Tuberous Sclerosis","Unclassified Monoclonal Gammopathy Of Renal Significance","Vasculitis","2023-09-26",{"date":331,"type":39},"2023-10-04",{"date":333,"type":39},"2009-11-06",{"date":335,"type":21},"2039-12-31",{"name":337,"class":184},"UK Kidney Association"]