[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"glomerulonephritis\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:glomerulonephritis":28},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,8,0,[8,42,71,113,141,170,197,241],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":15,"eligibilityCriteria":16,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":19,"enrollmentInfo":20,"targetDuration":4,"studyType":23,"phases":24,"briefSummary":26,"conditions":27,"keywords":4,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":30,"lastUpdatePostDateStruct":31,"startDateStruct":34,"completionDateStruct":36,"leadSponsor":38,"locationsCount":41},"100600399","phase-2-impact-of-dapagliflozin-for-the-regulation-of-immunological-activity-in-membranous-nephropathy-100600399",false,"NCT07096986","Impact of Dapagliflozin for the Regulation of Immunological Activity in Membranous Nephropathy","Impact of Dapagliflozin for the Regulation of Immunological Activity in Membranous","FORXIGEM","Inclusion Criteria:\n\n* Participants ≥ 18 years old and \\\u003C 85 years old;\n* Membranous Nephropathy associated with anti-PLA2R1 autoantibodies;\n* Urine Protein Creatinine Ratio (UPCR) between 0.5 g\u002Fg and 3.5 g\u002Fg;\n* Immunological relapse defined by an increase in anti-PLA2R1 antibody concentration \\> 14 RU\u002FmL after a phase of anti-PLA2R1 antibody negativation, (i.e. immunological remission) and complete or partial clinical remission;\n* Antiproteinuric treatment at maximal and stable dose. According to KDIGO 2024 guidelines on management of glomerular diseases and the French recommendations (PNDS GEM 2022), symptomatic treatment of membranous nephropathy should include: (i) a low sodium diet, (ii) a diuretic and (iii) an angiotensin-converting enzyme inhibitor or an angiotensin 2 receptor blocker at maximal tolerated dose (i.e., absence of orthostatic hypotension and no increase in serum creatinine \\>30%).\n\nExclusion Criteria:\n\n* Immunosuppressive treatment for MN in the 6 months prior to the selection visit;\n* Secondary MN (associated with cancer, infectious disease, autoimmune or iatrogenic disease);\n* Active nephrotic syndrome defined according to KDIGO guidelines as proteinuria \\> 3.5 g\u002Fday (or 3.5 g\u002Fg in a urine sample) and albumin \\\u003C 30 g\u002FL;\n* No previous history of immunological remission (anti-PLA2R1 antibodies \\\u003C 14 RU\u002FmL in ELISA or negative indirect immunofluorescence) or clinical remission (partial or complete);\n* Galactose intolerance, total lactase deficiency or glucose-galactose malabsorption disorders\n* Patients at risk for ketoacidosis including patients with a low reserve of functional beta cells (e.g. patients with type 2 diabetes with low C-peptide or latent autoimmune diabetes mellitus or patients with a history of pancreatitis or patients who are receiving insulin treatment), patients with conditions leading to reduced food intake or severe dehydration, patients with low insulin reserve, and patients with increased insulin requirements due to acute medical illness, surgery or excessive alcohol consumption;\n* Type 1 diabetes;\n* Pregnancy or breastfeeding;\n* Estimated CKD-EPI Glomerular Filtration Rate (eGFR) \\\u003C 25 ml\u002Fmin\u002F1.73m2;\n* Severe liver failure (Child-Pugh stage C);\n* NYHA functional class IV heart failure;\n* Patients already currently receiving dapagliflozin or another SGLT2 inhibitor for another condition;\n* Repeated urinary tract infections;\n* Hypersensitivity to the active substance or excipients.","ALL","18 Years","84 Years",{"count":21,"type":22},20,"ESTIMATED","INTERVENTIONAL",[25],"PHASE2","WHY IS THIS RESEARCH BEING CONDUCTED? Membranous glomerulonephritis (MN) is an autoimmune disease that affects the kidneys through autoantibodies, meaning that antibodies produced by your body attack your own kidney cells. The appearance of these autoantibodies can be explained in part by a disruption in the immune response. Patients with this disease are treated with immunosuppressive drugs such as rituximab. The aim of this treatment is to reduce the production of all antibodies, including those responsible for the disease. Despite this treatment, some patients may experience a relapse of the disease. These relapses can be complicated by infections, blood clots in the blood vessels, and, in the long term, can lead to kidney failure and an increased cardiovascular risk. Relapses can also have an impact on patients' social and professional lives.\n\nDapagliflozin is a diuretic medication, which means that it is used to increase urine production and eliminate excess salt and water from the body to reduce edema (swelling). It is currently prescribed and authorized for patients with type 2 diabetes, heart failure and chronic kidney disease. This treatment has been shown to reduce the amount of proteins in the urine and protect the kidneys and cardiovascular system in patients with chronic kidney disease. A study has also shown that dapagliflozin may have an effect on the immune response.\n\nWHAT DOES IT INVOLVE? The aim of our study will be to evaluate the efficacy of dapagliflozin in reducing disease autoantibodies and preventing relapses.\n\nThis research will be conducted at the Nice University Hospital and the Nîmes University Hospital. We expect to 20 patients to be recruited with an anti-PLA2R1 positive MN.\n\nParticipation in the study will last 6 months. The research is funded by Nice University Hospital. WHAT IS THE TREATMENT BEING STUDIED? It is dapagliflozin, a drug that is increasingly used routinely in patients with nephrotic syndrome (including MN) for its ability to reduce protein in the urine. Its effect on the immune system in MN has not yet been studied",[28],"Glomerulonephritis","NOT_YET_RECRUITING","2026-06-18",{"date":32,"type":33},"2026-06-22","ACTUAL",{"date":35,"type":22},"2026-11-01",{"date":37,"type":22},"2027-11",{"name":39,"class":40},"Centre Hospitalier Universitaire de Nice","OTHER",1,{"id":43,"slug":44,"hasResults":11,"nctId":45,"briefTitle":46,"officialTitle":47,"acronym":48,"eligibilityCriteria":49,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":50,"targetDuration":4,"studyType":23,"phases":52,"briefSummary":53,"conditions":54,"keywords":4,"overallStatus":60,"whyStopped":4,"lastUpdateSubmitDate":61,"lastUpdatePostDateStruct":62,"startDateStruct":64,"completionDateStruct":66,"leadSponsor":68,"locationsCount":70},"100413408","phase-2-a-study-of-the-safety-and-activity-of-sparsentan-for-the-treatment-of-patients-with-immunoglobulin-a-nephropathy-100413408","NCT04663204","A Study of the Safety and Activity of Sparsentan for the Treatment of Patients With Immunoglobulin A Nephropathy","A Multi-centre, Open-label, Exploratory Trial of the Safety and Activity of Sparsentan for the Treatment of Incident (Cohort A) and Recurrent (Cohort B) Patients With Immunoglobulin A Nephropathy","SPARTAN","For Cohort A (Patients with Incident IgAN)\n\nInclusion Criteria:\n\n* The patient is willing and able to provide signed informed consent.\n* The patient can understand written and spoken English.\n* The patient is male or female, aged ≥18 years.\n* The patient has been diagnosed with biopsy-proven IgAN within the last 6 months (calculated from the date of kidney biopsy, upon which the IgAN-positive diagnosis was made, to the signing of the informed consent form).\n* The patient has a urine total protein value ≥0.5 g\u002Fday at screening.\n* The patient has an eGFR value ≥30 mL\u002Fmin\u002F1.73 m2 at screening.\n* The patient has not previously been treated with ACEI and\u002For ARB therapy for IgAN OR has not received ACEI and\u002For ARB therapy within the last 12 months.\n* The patient has a systolic BP ≤150 mmHg and ≥100 mmHg, and diastolic blood pressure ≤100 mmHg and ≥60 mmHg at screening.\n* Women of childbearing potential (WOCBP), beginning at menarche, must agree to the use of one highly reliable (ie, can achieve a failure rate of \\\u003C1% per year) method of contraception from 7 days prior to the first dose of trial medication until 90 days after the last dose of trial medication. Highly reliable contraception methods include stable oral, implanted, transdermal, or injected contraceptive hormones associated with inhibition of ovulation, or an intrauterine device (IUD) in place for at least 3 months. One additional barrier method must also be used during sexual activity, such as a diaphragm or diaphragm with spermicide (preferred), or male partner's use of male condom or male condom with spermicide), from Day 1 until 90 days after the last dose of trial medication.\n\nWOCBP are defined as those who are fertile, following menarche and until becoming postmenopausal unless permanently sterile; permanent sterilisation methods include hysterectomy, bilateral salpingectomy, and bilateral oophorectomy. A postmenopausal state is defined as amenorrhoea for more than 24 consecutive months without an alternative medical cause; women on hormone replacement therapy must have a documented plasma follicle-stimulating hormone level ≥40 mIU\u002FmL. All WOCBP must have a negative pregnancy test at Visit 1 (serum test) and Visit 2 (urine, with positive results confirmed by serum).\n\nExclusion Criteria:\n\n* The patient has IgAN secondary to another condition (eg, systemic lupus erythematosus, liver cirrhosis).\n* The patient, in the opinion of the Investigator, has a rapidly progressive glomerulonephritis (rapid decline in GFR and crescents on biopsy).\n* The patient has a history of type 1 diabetes mellitus, uncontrolled type 2 diabetes mellitus (haemoglobin A1c \\[HbA1c\\] \\>8%), or nonfasting blood glucose \\>10 mmol\u002FL (180 mg\u002FdL) at screening.\n* The patient has undergone any organ transplantation, with the exception of corneal transplants.\n* The patient requires any of the prohibited concomitant medications (see Section 14.4).\n* The patient has been taking any systemic immunosuppressive medications for \\>2 weeks within 6 months prior to screening.\n* The patient has a documented history of heart failure (New York Heart Association Class II-IV) and\u002For previous hospitalisation for heart failure or unexplained dyspnoea, orthopnoea, paroxysmal nocturnal dyspnoea, ascites, and\u002For peripheral oedema.\n* The patient has clinically significant cerebrovascular disease (transient ischemic attack or stroke) and\u002For coronary artery disease (hospitalisation for myocardial infarction or unstable angina, new onset of angina with positive functional tests, coronary angiogram revealing stenosis, or a coronary revascularisation procedure) within 6 months prior to screening.\n* The patient has jaundice, hepatitis, or known hepatobiliary disease (including asymptomatic cholelithiasis), or alanine aminotransferase (ALT) or aspartate aminotransferase (AST) \\>2 times the upper limit of the normal range at screening.\n* The patient has a history of malignancy other than adequately treated basal cell or squamous cell skin cancer or cervical carcinoma within the past 2 years.\n* The patient has a screening haematocrit value \\\u003C27% or haemoglobin value \\\u003C90 g\u002FL (9 g\u002FdL).\n* The patient has a screening potassium value of \\>5.5 mmol\u002FL (5.5 mEq\u002FL).\n* The patient has a history of alcohol or illicit drug use disorder (as defined in the Diagnostic and Statistical Manual of Mental Disorders, 5th Edition).\n* The patient has a history of serious side effects or allergic response to any AngII or ERA, including sparsentan, or has a hypersensitivity to any of the excipients in the IMP.\n* The female patient is pregnant, plans to become pregnant during the course of the trial, or is breastfeeding.\n* The patient has participated in a trial of any investigational product within 28 days prior to screening, or plans to participate in such a trial during the course of this trial.\n* The patient, in the opinion of the Investigator, is unable to adhere to the requirements of the trial, including the ability to swallow the IMP whole.\n* The patient, in the opinion of the Investigator, has a medical condition or abnormal clinically significant laboratory screening value not listed above that may interfere with the evaluation of sparsentan safety or activity.\n* Patients with a medical condition or abnormal clinically significant laboratory screening value not listed above that may interfere with the evaluation of sparsentan safety or activity will be reviewed before consideration of the patient for enrolment.\n\nFor Cohort B (Recurrent IgAN following kidney transplantation)\n\nInclusion Criteria:\n\n* Male and female aged ≥18 years\n* Diagnosis of recurrent IgAN based on histological analysis of a transplanted kidney biopsied within the last 6 months\n* A time period of \\>12 months since kidney transplantation\n* UPCR ≥50 mg\u002Fmmol (≥0.44 g\u002Fg) and eGFR value ≥25 mL\u002Fmin\u002F1.73 m2\n* For patients on an ACEI and\u002For ARB, and\u002For SGLT2 inhibitor, the dosing regimen is stable for at least 6 weeks prior to and during the screening period\n* Tacrolimus treatment as part of standard of care immunosuppression following kidney transplantation\n* Systolic BP ≤150 mmHg and ≥100 mmHg, and diastolic blood pressure ≤100 mmHg and ≥60 mmHg at screening.\n* Female patients not of childbearing potential, or of childbearing potential and agreeing to use the contraceptive methods listed in Section 5.1\n\nExclusion Criteria:\n\n* The patient has recurrent IgAN secondary to another condition or cause (eg, systemic lupus erythematosus, liver cirrhosis).\n* Evidence of alternative pathology on the kidney transplant biopsy as the main cause for proteinuria (e.g. diabetic nephropathy, chronic transplant glomerulopathy, mTORi treatment)\n* Patient has multiorgan transplants (with the exception of corneal transplants)\n* Immunosuppressive therapy (IST) regimen for kidney transplant or other chronic immunosuppressive therapies that is not stable for \\>6 weeks prior to Day 1. Exceptions include routine protocol tapering and for tacrolimus, changes in dose to meet target level\n* Treatment with enteric budesonide (nefecon) within 6 months prior to screening, or planned use of enteric budesonide (nefecon) at any time during the study.\n* Current treatment for surgical complications\n* \\\u003C3 months after anti-rejection treatment or active rejection\n* Active bacterial, fungal or viral infection and\u002For active treatment of infection including BKV, CMV, HIV, Hepatitis B and C \\\u003C3 months prior to and during the screening period\n* Current treatment for surgical complications\n* Uncontrolled diabetes mellitus (defined by HbA1C \\>8% (\\>64 mmol\u002Fmol)\n* History of heart failure (New York Heart Association (NYHA) Class II-IV)\n* Jaundice, hepatitis, or known hepatobiliary disease\n* Malignancy within the past 2 years with the exception of adequately treated basal cell carcinoma or non-metastatic squamous cell carcinoma of the skin, with no evidence or recurrence\n* Haematocrit \\\u003C27%, haemoglobin \\\u003C90 g\u002FL (9 g\u002FdL), or potassium \\>5.5 mmol\u002FL (5.5 mEq\u002FL)\n* History of alcohol or illicit drug use disorder (as defined in the Diagnostic and Statistical Manual of Mental Disorders, 5th Edition)\n* History of serious side effects or allergic response to any angiotensin II antagonist or endothelin receptor antagonist (ERA) or dual endothelin and angiotensin receptor antagonist (DEARA e.g. sparsentan)\n* The female patient is pregnant, plans to become pregnant during the course of the study, or is breastfeeding.\n* The patient has participated in a study of any investigational product within 28 days prior to screening, or plans to participate in such a study during the course of this study.\n* The patient, in the opinion of the Investigator, is unable to adhere to the requirements of the study, including the ability to swallow the IMP whole.\n* The patient, in the opinion of the Investigator, has a medical condition or abnormal clinically significant laboratory screening value not listed above that may interfere with the evaluation of sparsentan safety or activity.",{"count":51,"type":22},24,[25],"To determine the nephroprotective potential of treatment with sparsentan in (1: Cohort A) patients newly-diagnosed with immunoglobulin A nephropathy (IgAN) (ie, incident patients) who have not received prior angiotensin-converting enzyme inhibitor (ACEI) or angiotensin receptor blocker (ARB) therapy, and in (2: Cohort B) patients with recurrent IgAN following kidney transplantation.",[55,56,57,28,58,59],"Immunoglobulin A Nephropathy","Kidney Diseases","Glomerulonephritis, IGA","Autoimmune Diseases","Immune System Diseases","RECRUITING","2026-05-29",{"date":63,"type":33},"2026-06-03",{"date":65,"type":33},"2020-12-10",{"date":67,"type":22},"2027-12-31",{"name":69,"class":40},"University of Leicester",6,{"id":72,"slug":73,"hasResults":11,"nctId":74,"briefTitle":75,"officialTitle":76,"acronym":4,"eligibilityCriteria":77,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":78,"enrollmentInfo":79,"targetDuration":4,"studyType":23,"phases":81,"briefSummary":83,"conditions":84,"keywords":90,"overallStatus":60,"whyStopped":4,"lastUpdateSubmitDate":102,"lastUpdatePostDateStruct":103,"startDateStruct":105,"completionDateStruct":107,"leadSponsor":109,"locationsCount":112},"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":80,"type":22},220,[82],"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.",[56,85,86,28,87,57,88,89],"Kidney Diseases, Chronic","Urological Diseases","Glomerular Disease","Glomerulopathy","Immunoglobulin Disease",[91,92,93,94,95,28,96,58,59,56,57,97,98,99,100,101],"Urologic Diseases","Female Urogenital Diseases","Female Urogenital Diseases and Pregnancy Complications","Urogenital Diseases","Male Urogenital Diseases","Nephritis","Primary IgA \u002F Immunoglobulin A nephropathy","eGFR","UPCR","UACR","FUB523","2026-05-28",{"date":104,"type":33},"2026-06-01",{"date":106,"type":33},"2025-07-28",{"date":108,"type":22},"2031-06-25",{"name":110,"class":111},"Novartis Pharmaceuticals","INDUSTRY",18,{"id":114,"slug":115,"hasResults":11,"nctId":116,"briefTitle":117,"officialTitle":118,"acronym":4,"eligibilityCriteria":119,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":120,"targetDuration":4,"studyType":23,"phases":122,"briefSummary":124,"conditions":125,"keywords":130,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":132,"lastUpdatePostDateStruct":133,"startDateStruct":135,"completionDateStruct":137,"leadSponsor":139,"locationsCount":41},"100626153","optimizing-referral-pathways-for-patients-with-hematuria-and-moderate-severe-proteinuria-100626153","NCT07431931","Optimizing Referral Pathways for Patients With Hematuria and Moderate-Severe Proteinuria","Optimizing Referral Pathways for Patients With Hematuria and Moderate-Severe Proteinuria - Phase 2: A Quality Improvement Project","Inclusion Criteria:\n\n* Adults aged ≥18 years\n* Patients receiving care from any Geisinger primary care provider (record of an encounter with a Geisinger PCP within the last 2 years from date of survey implementation)\n* Patients with high-risk glomerulonephritis features i.e. positive test results for hematuria (urine dipstick result with blood 1+ or greater) and proteinuria (2+ or 3+ protein on dipstick or ACR≥300 mg\u002Fg or PCR ≥500 mg\u002Fg) collected within 12 months of index date.\n\nExclusion Criteria:\n\n* Patients with a nephrologist appointment in the last 12 months before the index date\n* Patients with a prior appointment with a nephrologist within the last 2 years before the positive urinalysis test for hematuria (1+ or greater)\n* Patients with a history of glomerulonephritis and\u002For kidney failure (dialysis or eGFR \\\u003C 15 mL\u002Fmin\u002F1.73m2, or kidney transplantation) at any time during the baseline\n* Patients receiving palliative care at any time during the baseline",{"count":121,"type":22},1200,[123],"NA","The purpose of the study is to evaluate prospectively the impact of an electronic health record (EHR) alert on primary care providers' (PCP) referral to Nephrology of Geisinger patients with high risk signs (blood and protein in the urine) of glomerulonephritis. This will help quantify the relative effectiveness of EHR alerts on PCPs' referral patterns.",[126,28,127,128,129],"Referral and Consultation","Hematuria","Proteinuria","Kidney Disease",[131],"Hematuria; Proteinuria; Albuminuria; Glomerulonephritis; Clinical Decision Support; EHR Alert; Referral; Nephrology","2026-05-07",{"date":134,"type":33},"2026-05-12",{"date":136,"type":22},"2026-11",{"date":138,"type":22},"2027-12",{"name":140,"class":40},"Geisinger Clinic",{"id":142,"slug":143,"hasResults":11,"nctId":144,"briefTitle":145,"officialTitle":146,"acronym":147,"eligibilityCriteria":148,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":149,"targetDuration":4,"studyType":23,"phases":151,"briefSummary":153,"conditions":154,"keywords":155,"overallStatus":60,"whyStopped":4,"lastUpdateSubmitDate":160,"lastUpdatePostDateStruct":161,"startDateStruct":163,"completionDateStruct":165,"leadSponsor":167,"locationsCount":169},"100413371","phase-4-multicentre-clinical-study-to-evaluate-the-effect-of-personalized-therapy-on-patients-with-immunoglobulin-a-nephropathy-100413371","NCT04662723","Multicentre Clinical Study to Evaluate the Effect of Personalized Therapy on Patients With Immunoglobulin A Nephropathy.","Multicentre Prospective Open Label Clinical Study to Evaluate the Effect of Personalized Therapy on Patients With Immunoglobulin A Nephropathy.","CLIgAN","Inclusion Criteria:\n\n* Only adult patients (age 18-70 years) with biopsy-proven idiopathic IgAN.\n* IgAN patients with active or chronic or moderate renal lesions\n\nExclusion Criteria\n\n* Patients with idiopathic IgAN and nephrotic syndrome (minimal change disease at kidney biopsy)\n* IgAN patients with hematuria and acute renal failure\n* IgAN patients with rapidly progressive glomerulonephritis (extracapillary lesions in more than 50% of glomeruli)\n* Patients with secondary IgAN (lupus nephritis, Schoenlein-Henoch purpura, liver cirrhosis)\n* Any prior immunosuppressive therapy\n* Superimposed IgAN in kidney transplant\n* Severe liver diseases\n* Infections\n* Malignancies\n* Pregnancy\n* Patients with myocardial infarction or cerebrovascular stroke in the previous 6 months\n* Uncontrolled diabetes\n* Aseptic necrosis of any bone\n* Other conditions that can be exacerbated by corticosteroids\n* Previous adverse side effects to RASBs\n* Previous adverse side effects to SGLT2is\n* Patients with mild renal lesions (M0,E0,S0,T0,C0), minor urinary findings, proteinuria \\\u003C 0.5 g\u002Fday, normal GFR and normal blood pressure",{"count":150,"type":22},878,[152],"PHASE4","Idiopathic immunoglobulin A nephropathy (IgAN) is the most common biopsy-proven glomerulonephritis in the world. Approximately 40% of IgAN patients reach end-stage kidney disease (ESKD) 20 years after their kidney biopsy. The high prevalence of ESKD suggests the need to move from a generalized therapy for all patients to personalized therapy.\n\nMany RCTs have been conducted stratifying patients based on the laboratory findings (serum creatinine, eGFR and daily proteinuria). In contrast, data from the kidney biopsy has been used only for clinical diagnosis. Therefore, IgAN patients with active or chronic renal lesions have not been equally distributed in experimental and control arms of the randomized clinical trials (RCTs) Our clinical study of IgAN (CLIgAN) is a multicentre, prospective, controlled and open-label randomized clinical trial based on patients' stratification at the time of their kidney biopsy. The investigators will consider, first, the type of renal lesions followed by the serum creatinine values, eGFR and proteinuria. IgAN patients with active renal lesions (n=132) will be enrolled in the first RCT (ACIgAN) in which they will receive corticosteroids (pulse therapy) plus oral corticosteroids combined with RASB or RASB followed by oral corticosteroids. IgAN patients with chronic or moderate renal lesions at high or very high risk of chronic renal disease (n=294) will be enrolled in the second RCT (CHRONIgAN) in which they will receive the SGLT2 inhibitor combined with RASB compared with RASB combined with oral corticosteroids. Using this approach, the investigators hypothesize that patients could receive personalized therapy based on renal lesions to ensure that the right drug gets to the right patient at the right time.\n\nRecently, we developed a Clinical Decision Support System (CDSS) tool using artificial intelligence (artificial neural networks) to identify IgAN patients at high risk of developing ESKD. The IgAN tool (DialCheck) was validated in a retrospective cohort of IgAN patients but not in a prospective clinical study. The investigators propose to measure the power of the DiaCheck tool in patients enrolled in both RCTs to determine whether personalized therapy can slow the decline of the renal function to delay the ESKD.\n\nThe CLIgAN study also includes a cutting-edge molecular study for precision therapy (PRECIgAN).",[28,55],[156,157,158,159],"IgA nephropathy","Steroids","RAS-blockers","SGLT2-inhibitors","2025-03-28",{"date":162,"type":33},"2025-04-02",{"date":164,"type":33},"2023-05-01",{"date":166,"type":22},"2028-12-31",{"name":168,"class":40},"Fondazione Schena",2,{"id":171,"slug":172,"hasResults":11,"nctId":173,"briefTitle":174,"officialTitle":175,"acronym":176,"eligibilityCriteria":177,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":178,"targetDuration":4,"studyType":23,"phases":180,"briefSummary":181,"conditions":182,"keywords":185,"overallStatus":60,"whyStopped":4,"lastUpdateSubmitDate":188,"lastUpdatePostDateStruct":189,"startDateStruct":191,"completionDateStruct":193,"leadSponsor":195,"locationsCount":41},"100584485","phase-2-the-effect-of-daratumumab-in-patients-with-monoclonal-gammopathy-of-renal-significance-mgrs-in-finland-100584485","NCT06889948","The Effect of Daratumumab in Patients with Monoclonal Gammopathy of Renal Significance (MGRS) in Finland","Daratumumab in Monoclonal Gammopathy of Renal Significance in Finland","DAMOCLES","Inclusion Criteria:\n\n1. Males or females ≥ 18 years of age\n2. Subject has provided informed consent prior to initiation of the study or subject's legally acceptable representative has provided informed consent prior to the study when the subject has any kind of condition that, in the opinion of the investigator, may compromise the ability of the subject to give written informed consent.\n3. Renal biopsy confirmed MGRS-disease\n\n   * Renal biopsy must not be older than 3 months before informed consent. However, if renal biopsy is older than 3 mo and the study team is convinced that major histological changes have not occurred, a biopsy older than that can exceptionally be accepted.\n   * Renal transplant patients are allowed\n4. Amount of proteinuria ≥ 500 mg\u002F24 h OR eGFR ≥ 20 ml\u002Fmin prior to the study\n5. Previous anticlonal treatment is allowed if deemed ineffective\n\nExclusion Criteria:\n\n1. Myeloma or systemic AL amyloidosis (smoldering myeloma sized plasma cell clone is allowed when in association with a documented MGRS condition and AHL amyloidosis and AH amyloidosis are included)\n2. Cancer that requires treatment,\n3. MGRS related to B-cell malignant disorders,\n4. Known HIV infection, active hepatitis C infection (subjects with hepatitis C that achieve a sustained virologic response after antiviral therapy are allowed), or hepatitis B infection (subjects with hepatitis B surface antigen or core antibody that achieve sustained virologic response (PCR negativity in HBVNh) with antiviral therapy are permitted with a requirement for regular monitoring for reactivation for the duration of treatment on the study),\n5. Pregnancy or breastfeeding,\n6. Cyclophosphamide within 6 months of enrollment, or oral high-dose prednisone or equivalent within 6 weeks of enrollment;\n\n   * prednisone or its equivalent at a dosage of ≤10 mg daily for a condition unrelated to MGRS (e.g. asthma or gout) allowed.\n   * mycophenolate mofetil (MMF), calcineurin inhibitors (CNI) or azathioprine treated patients are eligible if proteinuria is not improving or if kidney function is declining despite treatment with these medications. Once therapy with daratumumab started, these medications need to be discontinued unless they are used as immunosuppressive medication due to renal transplantation.\n7. In patients who previously received rituximab, reconstitution of B cells (CD19 normalized, Ly-B-CD19 lab.code 8329) required.\n8. Inability to use daratumumab and to comply with the study protocol as assessed by treating nephrologist and\u002For hematologist (e.g. severe psychiatric illness, severe lung disease, known allergy to daratumumab)",{"count":179,"type":22},30,[25],"The goal of this clinical trial is to learn if drug daratumumab works to treat kidney diseases other than AL-amyloidosis that fall under the category of monoclonal gammopathy of renal significance (MGRS).\n\nThe main questions it aims to answer are:\n\nDoes daratumumab have an effect on the patients' renal function or the amount of proteinuria?\n\nDoes daratumumab have an effect on the hematological endpoints evaluated by minimal residual disease (MRD) and the difference between involved and uninvolved free light chain (dFLC)?\n\nAlso changes in quality of life (according to EORTC QLQ-C30) and mechanism of complement system activation are evaluated. The number of patiets with partial or very good partial hematological remission and the number of patients with adverse events related to daratumumab are also recorded.",[183,184,28],"Kidney Failure","Paraproteinemias",[186,187],"Monoclonal gammopathy of renal significance","daratumumab","2025-03-17",{"date":190,"type":33},"2025-03-21",{"date":192,"type":33},"2024-01-19",{"date":194,"type":22},"2027-06",{"name":196,"class":40},"Helsinki University Central Hospital",{"id":198,"slug":199,"hasResults":11,"nctId":200,"briefTitle":201,"officialTitle":201,"acronym":202,"eligibilityCriteria":203,"healthyVolunteers":204,"sex":17,"minAge":4,"maxAge":18,"enrollmentInfo":205,"targetDuration":207,"studyType":208,"phases":4,"briefSummary":209,"conditions":210,"keywords":216,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":232,"lastUpdatePostDateStruct":233,"startDateStruct":235,"completionDateStruct":237,"leadSponsor":239,"locationsCount":4},"100576988","biomarkers-and-outcome-predictors-of-pediatric-nephrotic-syndrome-a-genetic-transcriptomic-and-secretome-multiomics-study-100576988","NCT06792448","Biomarkers and Outcome Predictors of Pediatric Nephrotic Syndrome: A Genetic, Transcriptomic, and Secretome Multiomics Study","PRECISE","Inclusion Criteria:\n\n* Clinical diagnosis of idiopathic nephrotic syndrome (INS) with nephrotic range proteinuria (uPr\u002FuCr ratio \\> 2 mg\u002Fmg).\n* Hypoalbuminemia with serum albumin \\\u003C 3.0 g\u002FdL.\n* Presence of edema.\n* No prior treatment for idiopathic nephrotic syndrome.\n* Age between 1 and 18 years at the time of enrollment.\n* igned informed consent by a parent or legal guardian.\n\nExclusion Criteria:\n\n* Diagnosis of congenital or infantile nephrotic syndrome (age \\\u003C 1 year).\n* Diagnosis of secondary nephrotic syndrome.\n* Presence of glomerulonephritis, autoimmune diseases, or vasculitis.\n* Lack of signed informed consent by a parent or legal guardian.\n* Previous treatment with prednisone or prednisolone for nephrotic syndrome.",true,{"count":206,"type":22},350,"1 Year","OBSERVATIONAL","Idiopathic Nephrotic Syndrome is a rare disease of the kidneys, which typically affects children. For most affected children there is the need of a prolonged treatment with drugs reducing the activity of the immune system, also resulting in many side effects. Those patients, who do not respond to treatment, are at risk of kidney damage and of dialysis or kidney transplantation. It is currently impossible to predict the response to treatment, leading to unnecessary therapies with side effects as well as unclear prognosis in the affected children. The response of the idiopathic nephrotic syndrome to medications acting on the immune system explains its important role in the occurrence of the disease.\n\nWith this study we aim to obtain predictors of the response to treatment right at the beginning of the disease, to adapt the therapy avoiding needless side effects. This will be done evaluating the blood and urine of affected children using state of the art molecular characterisation. We will evaluate the genetic predisposition, the cell trait changes and the presence of molecules in blood and urine that may affect the interaction between the immune system and the kidneys. We expect that the findings will improve treatment of children with idiopathic nephrotic syndrome and reduce the number of children suffering from unnecessary drugs related side effects.",[211,212,213,28,128,214,56,215],"Nephrotic Syndrome Steroid-Dependent","Nephrotic Syndrome Steroid-Resistant","Nephrotic Syndrome in Children","Hypoalbuminemia","Chronic Kidney Disease",[217,218,219,220,221,222,223,224,225,226,227,228,229,230,231],"Pediatric nephrotic syndrome","Idiopathic nephrotic syndrome","Steroid-resistant nephrotic syndrome","Steroid-sensitive nephrotic syndrome","Biomarkers discovery","Genetic risk factors","Epigenetic analysis","Adaptive immune system profiling","Liquid biopsy","Serum and urine proteomics","Multiomics approach","Personalized treatment","Disease progression prediction","Molecular characterization","Pediatric kidney disease","2025-01-28",{"date":234,"type":33},"2025-01-30",{"date":236,"type":22},"2025-02-15",{"date":238,"type":22},"2028-06-01",{"name":240,"class":40},"Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico",{"id":242,"slug":243,"hasResults":11,"nctId":244,"briefTitle":245,"officialTitle":246,"acronym":4,"eligibilityCriteria":247,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":248,"enrollmentInfo":249,"targetDuration":4,"studyType":23,"phases":251,"briefSummary":252,"conditions":253,"keywords":254,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":258,"lastUpdatePostDateStruct":259,"startDateStruct":261,"completionDateStruct":263,"leadSponsor":265,"locationsCount":4},"100479053","phase-2-efficacy-safety-pharmacokinetics-and-pharmacodynamics-of-kp104-to-treat-glomerulonephritis-100479053","NCT05517980","Efficacy, Safety, Pharmacokinetics, and Pharmacodynamics of KP104 to Treat Glomerulonephritis","An Open-label, Phase 2 Study to Evaluate the Efficacy, Safety, Pharmacokinetics, and Pharmacodynamics of KP104 in Subjects With IgA Nephropathy (IgAN) and Complement 3 Glomerulopathy (C3G)","Inclusion Criteria:\n\n* Weight of \\>35 kilograms (kg) at Screening\n* Body mass index (BMI) of \\\u003C35 kilograms per square meter (kg\u002Fm\\^2)\n* UPCR \\>1.0 grams per gram (g\u002Fg) by 24-hour urine collection at Screening\n* Documented diagnosis and clinical status of IgAN or C3G as follows:\n\nIgAN:\n\n* Diagnosis of IgAN verified by biopsy taken within the past 3 years prior to enrolment.\n* On stable regimen of angiotensin converting enzyme or angiotensin blocking agents for 12 weeks and\u002For sodium-glucose cotransporter-2 (SGLT2) inhibitors for 6 weeks at Screening\n\nC3G:\n\n* Diagnosis of C3G verified by biopsy taken within the past 3 years prior to enrolment.\n* On stable regimen of angiotensin converting enzyme or angiotensin blocking agents for 12 weeks and\u002For SGLT2 inhibitors for 6 weeks at Screening\n\n  * Females of childbearing potential and males must practice effective contraception from Screening until 28 days after the end of study (EOS) visit.\n  * Females of childbearing potential must have a negative pregnancy test at Screening and within 1 day prior to dosing of study drug\n\nExclusion Criteria:\n\n* Any clinically significant, poorly controlled underlying illness other than IgAN or C3G, as determined by the investigator\n* Treatment of any infection with IV (within 30 days of Screening) or oral (within 14 days of Screening) antibiotics, antivirals, or antifungals\n* History of infections with encapsulated organisms\n* History of untreated tuberculosis\n* Positive serology for hepatitis C virus (HCV) ribonucleic acid (RNA) or human immunodeficiency virus (HIV) at Screening\n* History of bone marrow or stem cell transplantation\n* Absolute neutrophil count (ANC) \\\u003C500 cells per microliter (cells\u002FμL)\n* eGFR \\\u003C30 milliliters per minute per 1.73 square meter (mL\u002Fmin\u002F1.73 m\\^2) using the Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI) formula\n* Presence of crescent formation in \\>50 percent (%) of glomeruli assessed on renal biopsy\n* Nephrotic syndrome defined as presence of substantial proteinuria (\\> 3.5 g\u002F24 hours), hypoalbuminemia (\\\u003C 30 grams per liter \\[g\u002FL\\]), and edema\u002Fhyperlipidemia. Nephrotic range proteinuria alone is acceptable.\n* Rapidly progressive glomerulonephritis, defined as a fall in eGFR of \\> 30 mL\u002Fmin\u002F1.73 m\\^2 within 24 weeks prior to the Screening Visit\n* Receiving renal replacement therapy or anticipated to require renal replacement therapy during the duration of the study\n\nNOTE: Other protocol defined Inclusion\u002FExclusion criteria may apply.","75 Years",{"count":250,"type":22},52,[25],"The purpose of this study is to evaluate the efficacy, safety, pharmacokinetics (PK), and pharmacodynamics (PD) of KP104 in participants with IgAN and C3G. The study will start with enrolling the IgAN cohort. Approximately 42 participants with IgAN will be enrolled in 2 stages: Stage 1 will be used to collect safety, immunogenicity, PK, and PD data to select the optimal biologic dose (OBD) of KP104 for IgAN, as well as to preliminarily explore the effect of KP104 on C3G. Stage 2 will be used to collect safety, immunogenicity, PK, PD, and efficacy data at the OBD dose of KP104 for IgAN and C3G. As soon as the OBD for IgAN is determined, eligible participants with C3G will be enrolled and dosed at the OBD for IgAN for a minimum of 48 weeks for weekly maintenance dosing and a minimum of 47 weeks for biweekly maintenance dosing. Approximately 10 participants with C3G will be enrolled.",[28],[255,55,256,257],"KP104","Compliment-mediated Glomerulonephritis","Complement Inhibitor","2024-10-25",{"date":260,"type":33},"2024-10-28",{"date":262,"type":22},"2025-03",{"date":264,"type":22},"2027-04",{"name":266,"class":111},"Kira Pharmacenticals (US), LLC."]