[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"c3-glomerulopathy-c3g\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:c3-glomerulopathy-c3g":25},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,4,0,[8,48,81,111],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":4,"eligibilityCriteria":15,"healthyVolunteers":11,"sex":16,"minAge":4,"maxAge":4,"enrollmentInfo":17,"targetDuration":4,"studyType":20,"phases":21,"briefSummary":23,"conditions":24,"keywords":27,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":36,"lastUpdatePostDateStruct":37,"startDateStruct":40,"completionDateStruct":42,"leadSponsor":44,"locationsCount":47},"100650424","phase-4-real-world-effectiveness-and-safety-of-pegcetacoplan-in-patients-with-c3g-or-ic-mpg-a-multi-country-study-100650424",false,"NCT07746895","Real-World Effectiveness and Safety of Pegcetacoplan in Patients With C3G or IC-MPG: A Multi-Country Study","Real-World Effectiveness and Safety of Pegcetacoplan in Patients With C3 Glomerulopathy (C3G) or Primary Immune Complex Membranoproliferative Glomerulonephritis (IC-MPGN): A Multi-Country Study","Inclusion Criteria:\n\n* Have received or plan to receive pegcetacoplan for the treatment of C3G or primary IC-MPGN.\n* Provided signed and dated informed consent. For participants under the legal age signed and dated informed consent is provided by the participant's legally authorised representative. Assent will also be obtained from paediatric participants as required by local regulations.\n\nExclusion Criteria:\n\n* Receiving an investigational treatment for C3G or primary IC-MPGN at the time of pegcetacoplan initiation.\n* Initiated treatment with pegcetacoplan in an interventional study.","ALL",{"count":18,"type":19},150,"ESTIMATED","INTERVENTIONAL",[22],"PHASE4","The purpose of this study is to evaluate the effectiveness and safety of Pegcetacoplan in patients with C3G and primary IC-MPGN in the real-world setting. This study will also assess biomarkers not routinely measured in clinical practice. Results will support the long-term evaluation of the benefit-risk profile of pegcetacoplan in a broad patient population, informing clinical decision-making.",[25,26],"C3 Glomerulopathy (C3G)","Immune Complex Membranoproliferative Glomerulonephritis (IC-MPGN)",[28,29,30,31,32,33,34],"C3 Glomerulopathy","Primary Immune Complex Membranoproliferative","Glomerulonephritis","Pegcetacoplan","Glomerulopathy","Nephrology","Rare disease","RECRUITING","2026-07-30",{"date":38,"type":39},"2026-08-05","ACTUAL",{"date":41,"type":19},"2026-07-09",{"date":43,"type":19},"2032-01-31",{"name":45,"class":46},"Swedish Orphan Biovitrum","INDUSTRY",101,{"id":49,"slug":50,"hasResults":11,"nctId":51,"briefTitle":52,"officialTitle":53,"acronym":54,"eligibilityCriteria":55,"healthyVolunteers":56,"sex":16,"minAge":57,"maxAge":4,"enrollmentInfo":58,"targetDuration":4,"studyType":20,"phases":60,"briefSummary":62,"conditions":63,"keywords":65,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":36,"lastUpdatePostDateStruct":72,"startDateStruct":74,"completionDateStruct":76,"leadSponsor":78,"locationsCount":80},"100630142","phase-1-a-clinical-trial-to-test-the-safety-tolerability-and-how-the-body-processes-cpv-104-in-healthy-people-and-patients-with-c3-glomerulopathy-100630142","NCT07483827","A Clinical Trial to Test the Safety, Tolerability, and How the Body Processes CPV-104 in Healthy People and Patients With C3-Glomerulopathy","A Phase 1 First-in-Human Clinical Trial in Healthy Participants and Patients With C3-Glomerulopathy to Assess Safety, Tolerability, and Pharmacokinetics of CPV-104","Essential One","Inclusion Criteria Healthy Volunteers (Part 1 - SAD-HV) :\n\n* Participants must be at least 18 years old and no more than 50 years old, at the time of consent, and must be able to sign and date the informed consent form (ICF) themselves.\n* Participants who are overtly healthy as determined by medical evaluation including medical history, physical examination, laboratory tests, and cardiac monitoring. A participant with a clinical abnormality or laboratory parameter(s) not specifically listed in the exclusion criteria that is outside the reference range for the population being studied may be included only if the investigator, in consultation with the Medical Monitor, agree and document that the finding is unlikely to introduce additional risk factors and will not interfere with the study procedures or results.\n* Body weight within 50 kg for male\u002F 45 kg for female to 110 kg and BMI within the range 18 - 32 kg\u002Fm2 (inclusive).\n* Childbearing potential (CBP) participants should agree to use a highly effective method of contraception throughout the study and for 90 days after the last dose of the IMP.\n* CBP participants should agree not to donate oocytes or freeze for future use for the purposes of assisted reproduction during the study and for a period of 90 days after the last dose of the IMP. Male participants should agree not to donate sperm or freeze sperm for future use for the purposes of assisted reproduction during the study and for a period of 90 days after the last dose of the IMP.\n* CBP participants should have a negative pregnancy test at screening.\n* Participant provides written informed consent which includes compliance with the requirements and restrictions listed in the ICF and in this protocol.\n\nExclusion Criteria Healthy Volunteers (Part 1 - SAD-HV) :\n\n* Participant has a history of clinically significant disorders or diseases affecting the endocrine, gastrointestinal, cardiovascular, hematological, liver, immune, kidney, respiratory, reproductive, or neurological systems (such as stroke or epilepsy). Participants with a history of minor medical issues may be considered for the study at the investigator's discretion.\n* Participant has any medical or psychiatric condition that, in the opinion of the Investigator, could jeopardize or would compromise the study participant's ability to participate in this study.\n* Participant has a recent history of febrile illness or other evidence of a clinically significant active infection, within 14 days prior to screening.\n* Participant has a history of severe allergies (e.g. to medications, food, or latex) or has experienced an anaphylactic reaction to food or medicine.\n* Participant has a known hypersensitivity to any components of the IMP as stated in this protocol.\n* Alanine transaminase (ALT) or Aspartate aminotransferase (AST) \\>1.5 x upper limit of normal (ULN).\n* Total Bilirubin \\>1 x ULN, \\> 1.5 x ULN if Gilbert's syndrome.\n* Current or chronic history of liver disease or known hepatic or biliary abnormalities (except for Gilbert's syndrome or asymptomatic gallstones).\n* Participant has received any complement modifying treatment within 6 months prior to the first dosing day.\n* Exposure to more than four new chemical entities within 12 months prior to the first dosing day.\n* Participation in any other clinical study with a medical device or investigational medicinal product concurrently or within 5 half-life times or 3 months before the first dosing day (whichever is longer).\n* Presence of a QTc interval \\>450 ms for males or \\>460 ms for females, a history of risk factors for Torsades de Pointes (such as heart failure, cardiomyopathy, or a family history of long QT syndrome), uncorrected hypokalemia or hypomagnesemia, or concurrent use of medications known to prolong the QT\u002FQTc interval.\n* Participant is an employee of the sponsor or an employee or relative of the investigator.\n* Participant is unable to comply with the protocol (e.g. clinically relevant medical condition making implementation of the protocol difficult, unstable social situation, or otherwise unlikely to complete the study) or is, in the opinion of the investigator, otherwise unsuited for the study.\n* Participant has made a blood donation or blood products within 90 days prior to Baseline or plans to donate blood during the study.\n* Participant has an alcohol consumption of more than 21 units (males) or 14 units (females) of alcohol per week. One unit is equivalent to 8 g of alcohol: a half pint (240 mL) of beer, 1 glass (125 mL) of wine, or 1 (25 mL) measure of spirits).\n* Study participant has a high consumption of caffeine- or other xanthine-containing products (≥300 mg of caffeine- or xanthine-equivalent per day) (1 cup of coffee ≈ 100 mg of caffeine; 1 cup of tea ≈ 30 mg of caffeine; 1 glass of cola ≈ 20 mg of caffeine).\n\nInclusion Criteria C3G Patient (Part 2 - MAD-C3G):\n\n* Patient must be at least 18 years old, at the time of consent, and must be able to sign and date the informed consent form (ICF) themselves.\n* Patient must have a diagnosis of C3G confirmed by historical renal biopsy.\n* Patient must have proteinuria at screening.\n* Patient must have stable or worsening renal disease, be on stable and optimized symptomatic treatment, in the opinion of the PI, for at least 30 days prior to screening (treatments may include, but are not limited to, immunosuppressive agents, anti-hypertensives, steroids).\n* Body weight within 50 kg for male\u002F 45 kg for female to 110 kg and BMI within the range 18 - 32 kg\u002Fm2 (inclusive).\n* Childbearing potential (CBP) participants should agree to use a highly effective method of contraception, throughout the study and for 90 days after the last dose of the IMP.\n* CBP participants should agree not to donate oocytes or freeze for future use for the purposes of assisted reproduction during the study and for a period of 90 days after the last dose of the IMP. Male participants should agree not to donate sperm or freeze sperm for future use for the purposes of assisted reproduction during the study and for a period of 90 days after the last dose of the IMP.\n* CBP participants should have a negative pregnancy test at screening.\n* Participant provides written informed consent which includes compliance with the requirements and restrictions listed in the ICF and in this protocol.\n\nExclusion Criteria C3G Patients (Part 2 - MAD-C3G) :\n\n* Patient has a history of clinically significant disorders or diseases affecting the endocrine, gastrointestinal, cardiovascular (including thromboembolic events like deep vein thrombosis, pulmonary embolism, known coagulopathy), hematological, liver, immune, kidney, respiratory, reproductive, or neurological systems (such as stroke or epilepsy). Participants with a history of minor medical issues may be considered for the study at the investigator's discretion.\n* Patient has any medical or psychiatric condition that, in the opinion of the Investigator, could jeopardize or would compromise the study participant's ability to participate in this study.\n* Patient had a recent history of febrile illness or other evidence of a clinically significant active infection, within 14 days prior to screening.\n* Patient has a history of severe allergies (e.g. to medications, food, or latex) or has experienced an anaphylactic reaction to food or medicine.\n* Patient has a known hypersensitivity to any components of the IMP as stated in this protocol.\n* Patient had evidence of monoclonal gammopathy of unclear significance, infections, malignancy, autoimmune diseases, or other conditions to which C3G is secondary.\n* Patient with other renal diseases that would interfere with interpretation of the study.\n* Patient is receiving renal replacement therapy.\n* Patient is receiving or planned for receiving plasmapheresis.\n* Patient had a major organ transplant (e.g. heart, lung, kidney, liver) or hematopoietic stem cell\u002Fmarrow transplant.\n* Patient had a history or presence of any clinically relevant co-morbidities (e.g. advanced cardiac disease (NYHA class 4), severe pulmonary arterial hypertension (WHO class 4).\n* Alanine transaminase (ALT) or Aspartate aminotransferase (AST) \\>2 x upper limit of normal (ULN).\n* Total Bilirubin \\>1 x ULN, \\> 1.5 x ULN if Gilbert's syndrome.\n* Current or chronic history of liver disease, or known hepatic or biliary abnormalities (except for Gilbert's syndrome or asymptomatic gallstones).\n* Patient has received any complement modifying treatment within 6 months prior to the first dosing day.\n* Patient in any other clinical study with a medical device or investigational medicinal product concurrently or within 5 half-life times or 3 months before study start (whichever is longer).\n* Presence of a QTc interval \\>450 ms for males or \\>460 ms for females, a history of risk factors for Torsades de Pointes (such as heart failure, cardiomyopathy, or a family history of long QT syndrome), uncorrected hypokalemia or hypomagnesemia, or concurrent use of medications known to prolong the QT\u002FQTc interval.\n* Participant is an employee of the sponsor or an employee or relative of the investigator.\n* Participant is unable to comply with the protocol (e.g. clinically relevant medical condition making implementation of the protocol difficult, unstable social situation, or otherwise unlikely to complete the study) or is, in the opinion of the investigator, otherwise unsuited for the study.\n* Participant has made a blood donation or blood products within 90 days prior to Baseline or plans to donate blood during the study.\n* Participant has an alcohol consumption of more than 21 units (males) or 14 units (females) of alcohol per week. One unit is equivalent to 8 g of alcohol: a half pint (\\~240 mL) of beer, 1 glass (125 mL) of wine, or 1 (25 mL) measure of spirits).\n* Study participant has a high consumption of caffeine- or other xanthine-containing products (≥300 mg of caffeine- or xanthine-equivalent per day) (1 cup of coffee ≈ 100 mg of caffeine; 1 cup of tea ≈ 30 mg of caffeine; 1 glass of cola ≈ 20 mg of caffeine).",true,"18 Years",{"count":59,"type":19},39,[61],"PHASE1","This study is the first time the new medicine CPV-104 is being tested in people. CPV-104 is designed to regulate the complement system, which can be overactive in diseases such as C3 glomerulopathy (C3G), an ultra-rare kidney disorder.\n\nThe study includes healthy adults and adult patients with C3G to assess safety, tolerability, how the body processes the medicine, and whether the immune system reacts to it. The study is divided in two part; in Part 1 (SAD), healthy volunteers receive one IV dose of CPV-104 or a placebo while in Part 2 (MAD) patients with C3G receive four weekly IV doses of CPV-104 (no placebo).\n\nParticipants will have close monitoring, including side-effect checks, blood and urine tests, ECGs, vital signs, and blood samples to measure drug levels and antibodies. For those with C3G, researchers will also observe kidney function, although the main goal is safety, not testing effectiveness.\n\nA Safety Review Committee will regularly review results to ensure it is safe to continue to the next dose or study group.",[25,64],"Healthy Adult Participants",[66,67,68,69,70,71],"CPV-104","C3G","Complement System","kidney disease","kidney","Factor H",{"date":73,"type":39},"2026-07-31",{"date":75,"type":39},"2025-06-26",{"date":77,"type":19},"2026-11",{"name":79,"class":46},"eleva GmbH",17,{"id":82,"slug":83,"hasResults":11,"nctId":84,"briefTitle":85,"officialTitle":86,"acronym":4,"eligibilityCriteria":87,"healthyVolunteers":11,"sex":16,"minAge":57,"maxAge":4,"enrollmentInfo":88,"targetDuration":4,"studyType":20,"phases":90,"briefSummary":92,"conditions":93,"keywords":96,"overallStatus":100,"whyStopped":4,"lastUpdateSubmitDate":101,"lastUpdatePostDateStruct":102,"startDateStruct":104,"completionDateStruct":106,"leadSponsor":108,"locationsCount":110},"100649182","phase-2-phase-ii-clinical-study-on-the-efficacy-and-safety-of-qls7305-in-patients-with-kidney-disease-part-a-100649182","NCT07730632","Phase II Clinical Study on the Efficacy and Safety of QLS7305 in Patients With Kidney Disease (Part A)","A Phase II Clinical Study Evaluating the Efficacy and Safety of QLS7305 in Patients With Primary IgA Nephropathy (IgAN), C3 Glomerulopathy (C3G), Immune Complex Membranoproliferative Glomerulonephritis (IC-MPGN) and Primary Membranous Nephropathy (PMN)","Inclusion Criteria:\n\n* Body weight ≥ 40 kg, Body Mass Index (BMI) \\\u003C 32.5 kg\u002Fm²\n* Within the five years prior to screening, patients must have been diagnosed with primary IgAN or PMN through renal biopsy, or within one year prior to screening, diagnosed with C3G or IC-MPGN through renal biopsy, accompanied by glomerular C3 deposition; if a renal biopsy has not been previously performed, a renal biopsy must be conducted during the screening period to confirm eligibility criteria.\n* Participants with IgAN and C3G\u002FIC-MPGN: During the screening period, morning urine UPCR or 24-hour UPCR ≥0.75 g\u002Fg or 24-hour UP ≥1 g\u002Fday, with the average of two 24-hour UPCR measurements at baseline ≥0.75 g\u002Fg; PMN participants: During the screening period, morning urine or 24-hour UP ≥3.5 g\u002Fday, with the average of two 24-hour UP measurements at baseline ≥3.5 g\u002Fday.\n* During the screening and baseline periods, eGFR ≥ 30 ml·min-¹·1.73 m-² (using the CKD-EPI formula)\n* Prior to the first administration, the patient should have received the maximum tolerated dose or the maximum dose recommended in the instructions of an angiotensin-converting enzyme inhibitor (ACEi) or an angiotensin II receptor blocker (ARB) for at least 12 weeks, and the dose of the ACEi or ARB should have been stable for at least 4 weeks before the first administration.\n* Voluntarily receive meningococcal and pneumococcal vaccines at least 2 weeks before the first administration of the investigational drug in accordance with the protocol requirements.\n* From the time of signing the informed consent form until 12 months after the last administration of the investigational drug, there are no plans for sperm or egg donation, no plans for pregnancy, and voluntary use of effective contraceptive measures.\n\nExclusion Criteria:\n\n* Renal biopsy pathology indicates tubular atrophy or interstitial fibrosis exceeding 50%.\n* Renal biopsy pathology indicates crescent formation in more than 50% of glomeruli, or clinical presentation suggests the possibility of rapidly progressive glomerulonephritis (RPGN) (eGFR decline ≥50% within 3 months).\n* Participants were evaluated by the investigator as having IgAN, C3G, IC-MPGN, or PMN secondary to conditions such as infection, autoimmune diseases, or monoclonal immunoglobulin-associated diseases.\n* Participants were evaluated by the investigator as having other systemic diseases or other kidney diseases that could lead to proteinuria, such as diabetic nephropathy, IgA vasculitis, lupus nephritis, or ANCA-associated small vessel vasculitis.\n* Participants were determined to have acute kidney injury (AKI) within 30 days prior to screening and before administration of the study drug.\n* Participants were on dialysis at the time of screening or might require dialysis treatment during the study.\n* Participants had received B cell-targeting biologics, such as rituximab or ocrelizumab, within 180 days prior to the first administration of the study drug.\n* Participants had used other biologics, such as infliximab or eculizumab, within 90 days prior to the first administration of the study drug.\n* Participants who received sodium-glucose co-transporter 2 inhibitors (SGLT2i) within 90 days prior to the first administration of the study drug are excluded, except for those who had been on stable SGLT2i therapy for 90 days or more prior to the first administration and continued stable use during the study.\n* Participants who received mineralocorticoid receptor antagonists (MRA), such as spironolactone, eplerenone, or finerenone, within 30 days prior to the first administration of the study drug are excluded, except for those who had been on stable MRA therapy for 90 days or more prior to the first administration and continued stable use during the study.\n* Participants with a history of kidney transplantation, organ transplantation, or hematopoietic stem cell transplantation are excluded.\n* Participants with any history of malignancy within 5 years prior to screening are excluded, except for those who have been cured (such as basal cell carcinoma, cutaneous squamous cell carcinoma, low-risk\u002Fvery low-risk localized prostate cancer, papillary thyroid carcinoma, etc.) or have undergone radical resection of carcinoma in situ (such as ductal carcinoma in situ of the breast, cervical carcinoma in situ, etc.).\n* History of active tuberculosis within 1 year prior to screening, or deemed by the investigator to have active tuberculosis at screening.\n* Participants with chronic recurrent infections within 1 year prior to screening, such as liver abscess, chronic pyelonephritis, etc.\n* Surgery requiring general anesthesia or hospitalization for more than 1 day within 30 days prior to screening or planned during the trial.\n* Administration of live attenuated vaccines other than those allowed in the protocol within 30 days prior to screening or planned during the study.\n* Clinically significant infection requiring systemic anti-infective treatment within 30 days prior to the first administration of the investigational product.\n* History of recurrent invasive infections with encapsulated bacteria (e.g., Neisseria meningitidis and Streptococcus pneumoniae).\n* History of severe drug allergy, or allergic reaction to oligonucleotides or N-acetylgalactosamine (GalNAc).\n* Poorly controlled type 1 or type 2 diabetes, defined as baseline glycated hemoglobin (HbA1c) ≥7.0%.\n* Poorly controlled hypertension, defined as baseline seated resting systolic blood pressure ≥140 mmHg and\u002For diastolic blood pressure ≥90 mmHg.\n* History of renal artery stenosis, chronic hyperkalemia, or other contraindications to RAS inhibitors (RASi).",{"count":89,"type":19},60,[91],"PHASE2","QLS7305 injection is a chemically synthesized double-stranded small interfering RNA (siRNA) targeting complement C3, covalently linked to a ligand containing N-acetylgalactosamine (GalNAc) residues. After subcutaneous (SC) administration, it can inhibit C3 synthesis through the RNA interference (RNAi) mechanism, reduce circulating C3 protein levels, decrease the generation of complement-activated C5 convertase, and inhibit complement pathway activation. It is expected to become an effective treatment for complement-mediated kidney diseases and hematological disorders.",[94,26,25,95],"IgAN - IgA Nephropathy","Primary Membranous Nephropathy",[97,67,98,99],"IC⁃MPGN","PMN","IgAN","NOT_YET_RECRUITING","2026-07-22",{"date":103,"type":39},"2026-07-28",{"date":105,"type":19},"2026-08-10",{"date":107,"type":19},"2028-08-11",{"name":109,"class":46},"Qilu Pharmaceutical Co., Ltd.",1,{"id":112,"slug":113,"hasResults":11,"nctId":114,"briefTitle":115,"officialTitle":115,"acronym":4,"eligibilityCriteria":116,"healthyVolunteers":11,"sex":16,"minAge":57,"maxAge":4,"enrollmentInfo":4,"targetDuration":4,"studyType":117,"phases":4,"briefSummary":118,"conditions":119,"keywords":121,"overallStatus":128,"whyStopped":4,"lastUpdateSubmitDate":129,"lastUpdatePostDateStruct":130,"startDateStruct":4,"completionDateStruct":4,"leadSponsor":132,"locationsCount":4},"100456347","managed-access-programs-for-lnp023-iptacopan-100456347","NCT05222412","Managed Access Programs for LNP023, Iptacopan","Inclusion Criteria:\n\n* An independent request should be received from a licensed physician (in some instances from Health Authorities, Institutions or Governments).\n* The patient has a serious or life-threatening disease or condition and no comparable or satisfactory alternative therapy is available for diagnosis, monitoring or treatment; patient is not medically eligible for available treatment alternatives or has exhausted all available treatment options.\n* The patient is not eligible or able to enroll in a Novartis clinical trial or continue participation in a Novartis clinical trial.\n* There is a potential patient benefit to justify the potential risk of the treatment use, and the potential risk is not unreasonable in the context of the disease or condition to be treated.\n* The patient must meet any other medical criteria established by the medical experts responsible for the product or by the Health Authority in a country (as applicable).\n* Provision of the product will not interfere with the initiation, conduct or completion of a Novartis clinical trial or overall development program.\n* Managed access provision is allowed per local laws\u002Fregulations.","EXPANDED_ACCESS","The purpose of this registration form is to list all Managed Access Programs (MAPs) related to LNP023, Iptacopan",[25,120],"Paroxysmal Nocturnal Hemoglobinuria (PNH)",[122,123,124,125,126,127],"C3 glomerulopathy (C3G)","Paroxysmal nocturnal hemoglobinuria (PNH)","MAP","Manage access program","Iptacopan","LNP023","AVAILABLE","2025-12-01",{"date":131,"type":39},"2025-12-05",{"name":133,"class":46},"Novartis Pharmaceuticals"]