[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"immunoglobulin-a-nephropathy\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:immunoglobulin-a-nephropathy":31},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,9,0,[8,57,85,116,140,169,198,223,251],{"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":34,"overallStatus":44,"whyStopped":4,"lastUpdateSubmitDate":45,"lastUpdatePostDateStruct":46,"startDateStruct":49,"completionDateStruct":51,"leadSponsor":53,"locationsCount":56},"100631258","phase-3-study-to-assess-the-efficacy-pharmacokinetics-safety-and-tolerability-of-atrasentan-in-pediatric-patients-with-primary-igan-100631258",false,"NCT07498335","Study to Assess the Efficacy, Pharmacokinetics, Safety and Tolerability of Atrasentan in Pediatric Patients With Primary IgAN","A Single-arm, Multicenter, Phase III Study to Assess Efficacy, Pharmacokinetics, Safety and Tolerability of Atrasentan in Pediatric Patients of 2 to \u003C18 Years of Age With Primary Immunoglobulin A Nephropathy (IgAN)","ADVANCE","Inclusion Criteria:\n\n1. Signed informed consent by parent(s)\u002Flegal guardian(s) for the pediatric patient must be obtained before any study-specific assessment is performed. A consent or assent may also be required for some participants depending upon their age and local requirement.\n2. Male and female participants 2 to \\\u003C 18 years of age as of Day 1.\n3. eGFR ≥ 30 mL\u002Fmin\u002F1.73m2 where eGFR is calculated using the modified Schwartz formula at Screening and confirmed during the Run-in Period.\n4. Kidney biopsy-proven primary IgAN\\*, with biopsy performed within 3 years of Screening with \\\u003C 50% tubulointerstitial fibrosis and \\\u003C 25% crescents. In case a kidney biopsy within 3 years from Screening is not available, a kidney biopsy may be performed if it is part of the planned diagnostic approach and clinical management of the participant.\n5. Proteinuria due to primary diagnosis of IgAN as assessed by UPCR ≥ 1 g\u002Fg (113 mg\u002FmmoL) sampled from FMV at Screening on Day -90 and Day -60 as well as during the Run-in Period despite treatment with maximum tolerated dose of ACE inhibitor\u002FARB for at least 120 days prior to Day 1. Note: UPCR will be assessed based on one FMV sample at Day -90 and based on the geometric mean of 2 FMV samples for the Day -60 visit and during the Run-in Period.\n6. All participants must have been on supportive care including stable dose regimen of ACE inhibitor or ARB at either the locally approved maximal daily dose per body weight, or the maximally tolerated dose (per Investigator's judgment for pediatric use), for at least 120 days before first study drug administration. In addition, if participants are taking diuretics, other antihypertensive medication, or other background medication for IgAN (such as SGLT2 inhibitors), the doses should also be stabilized for at least 120 days prior to the first dosing of study treatment. Note: Participants with allergies or intolerance to ACE inhibitors and ARBs are eligible for the study. Participants with allergies or intolerance to RAS inhibitors are eligible but will not exceed \\~5% of the total population treated (maximum of 2 participants).\n7. The minimum body weight of enrolled pediatric participants is 10 kg at Screening and confirmed on Day 1.\n8. Parent(s)\u002Fguardian(s) are to be able to communicate well with the investigator and to understand and comply with the study's requirements for their child.\n\nExclusion Criteria:\n\n1. Participation in any other investigational drug trial or use of other investigational drugs at the time of enrollment, or within 5 elimination half-lives of enrollment, or within 30 days of enrollment, whichever is longer; or longer if required by local regulations.\n2. History of hypersensitivity to any of the study drugs or its excipients or to drugs of similar chemical classes.\n3. Any secondary IgAN as defined by the investigator; secondary IgAN can be associated with cirrhosis, celiac disease, Human Immunodeficiency Virus (HIV) infection, Herpes Simplex virus infection, dermatitis herpetiformis, seronegative arthritis, small-cell carcinoma, lymphoma, disseminated tuberculosis, bronchiolitis obliterans, inflammatory bowel disease, and familial mediterranean fever before treatment.\n4. A clinical diagnosis of IgA vasculitis (IgAV or Henoch-Schoenlein purpura) based on typical palpable purpura with or without arthralgia and abdominal pain.\n5. Evidence of significant urinary obstruction or difficulty in voiding, any urinary tract disorder causing significant urinary obstruction or difficulty in voiding at Screening and confirmed at Baseline\u002FDay 1.\n6. Concurrent diagnosis of CKD other than IgAN at Screening and before first study drug administration.\n7. Current acute kidney injury (AKI) defined by Acute Kidney Injury Network (AKIN) criteria within 4 weeks of Screening.\n8. Presence of rapidly progressive glomerulonephritis (RPGN) as defined by 50% decline in eGFR within 3 months prior to Screening or during Screening and Run-in periods.\n9. Presence of nephrotic syndrome at Screening based on the investigator's judgement.\n10. BNP value of \\>200 pg\u002FmL at Screening.\n11. Hemoglobin below 9 g\u002FdL at Screening or prior history of blood transfusion for anemia within 3 months of Screening.\n12. Platelet count \\\u003C80,000\u002FμL at Screening.\n13. On Day 1 participants' body weight falls below the lower limit of the cohort in which the participant was initially screened and lower body weight cohort is not open for enrollment.\n14. Known history of congenital heart disease, heart failure or clinically significant fluid retention such as pulmonary edema, uncontrolled peripheral edema, pleural effusion, or ascites before treatment.\n15. Current use of any homeopathic and\u002For herbal medications for the treatment of IgAN disease , such as but not limited to Tripterygium wilfordii (Lei Gong Teng), Caulis sinomenii and Sinomenium acutum before treatment.\n16. History of an alcohol or illicit drug-related disorder within the past 3 years at Screening.\n17. Confirmed blood pressure \\>150 mmHg systolic or \\>95 mmHg diastolic for 12 to \\\u003C18 years of age; \\>140 mmHg systolic or \\>90 mmHg diastolic for 6 to \\\u003C12 years of age; \\>120 mmHg systolic or \\>80 mmHg diastolic for 2 to \\\u003C6 years of age; based on the mean of 3 measurements obtained at Screening; or clinically significant hypotension at screening.\n18. Participants previously treated with immunosuppressive or other immunomodulatory agents such as but not limited to cyclophosphamide, rituximab, infliximab, canakinumab, mycophenolate mofetil (MMF) or mycophenolate sodium (MPS), calcineurin inhibitors, complement inhibitors, oral budesonide in any dose, systemic corticosteroid exposure ≥0.5 mg\u002Fkg\u002Fday or \\> 7.5 mg total exposure in a single day of prednisone\u002Fprednisolone equivalent within 120 days (or 180 days for rituximab) prior to first study drug administration.\n\n    Participants treated with endothelin (receptor) antagonists (including sparsentan) within 120 days prior to first study drug administration.\n19. History of organ transplantation (subjects with history of corneal transplant are not excluded) before treatment.\n20. Major concurrent comorbidities before treatment including but not limited to advanced cardiac disease (e.g., NYHA class III (for ages 6 to \\\u003C18 years), Ross class III (for ages 2 to \\\u003C6years)), severe pulmonary disease (e.g., WHO class III (for age 17 years); Pulmonary Vascular Research Institute (PVRI) class III (for 2-\\\u003C17 years)), or hepatic disease (e.g., active hepatitis) that in the opinion of the investigator precludes subject's participation in the study.\n21. Any medical condition deemed likely to interfere with the subject's participation in the study before treatment.\n22. Active systemic bacterial, viral (including COVID-19) or fungal infection within 14 days prior to study drug administration.\n23. Presence of fever ≥ 38°C (100.4°F) within 7 days prior to study drug administration.\n24. Human immunodeficiency virus (HIV) infection (known history of HIV or test positive for HIV antibody at Screening).\n25. Liver disease, such as active hepatitis B virus (HBV) or hepatitis C virus (HCV) infection defined as Hepatitis B surface antigen (HBsAg) positive or Hepatitis C virus ribonucleic acid (HCV-RNA) positive at Screening, or liver injury as indicated by abnormal liver function tests at Screening and Baseline as defined below:\n\n    * Any single parameter of ALT, AST, GGT, alkaline phosphatase must not exceed 3X upper limit of normal (ULN)\n    * Serum bilirubin must not exceed 2X ULN\n26. History of malignancy of any organ system (other than localized basal cell carcinoma of the skin or in situ cervical cancer treated with curative intent), treated or untreated, within the past 5 years, regardless of whether there is evidence of local recurrence or metastases; for children aged 2 to \\\u003C5 years of age, history of malignancy of any organ system (other than localized basal cell carcinoma of the skin or in situ cervical cancer), treated or untreated, inclusive of malignancies diagnosed at birth and during the neonatal and childhood time, regardless of whether there is evidence of local recurrence or metastases.\n27. Pregnant or nursing (lactating) female participants (of childbearing potential), where pregnancy is defined as the state of a female after conception and until the termination of gestation, confirmed by a positive human chorionic gonadotropin (hCG) laboratory test at Screening.\n28. Subjects taking prohibited therapies before treatment.\n29. Women of childbearing 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 1 month after stopping study treatment.\n\nHighly effective contraception methods 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 screening 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. If local regulations are more stringent than the contraception methods listed above, local regulations apply and will be described in the ICF. 30. For fertile male participants, participants must not intend to father a child or donate sperm while taking study treatment and at least 1 month afterward for males.\n* All fertile male participants in a sexual relationship with a WOCBP must agree to the use of a condom during the trial and for up to one month after last study drug administration. A male participant is considered fertile after puberty unless permanently sterile by bilateral orchidectomy\u002Forchiectomy.","ALL","2 Years","18 Years",{"count":21,"type":22},28,"ESTIMATED","INTERVENTIONAL",[25],"PHASE3","A Phase III, single-arm, multicenter pediatric clinical study evaluating atrasentan in children and adolescents aged 2 to \\\u003C18 years with primary immunoglobulin A nephropathy (IgAN).",[28,29,30,31,32,33],"Berger Disease","Bergers Disease","IgA Nephropathy","Immunoglobulin A Nephropathy","Primary IgAN","Nephritis IgA Type, Nephropathy IgA Type",[35,36,37,38,39,40,41,42,43],"Kidney Diseases","Kidney Disease, Chronic","Glomerulonephritis","Urologic Diseases","Glomerular Disease","Glomerulonephritis, IGA","Glomerulopathy","Immunoglobulin Disease","Atrasentan","NOT_YET_RECRUITING","2026-06-19",{"date":47,"type":48},"2026-06-23","ACTUAL",{"date":50,"type":22},"2026-08-26",{"date":52,"type":22},"2032-12-13",{"name":54,"class":55},"Novartis Pharmaceuticals","INDUSTRY",2,{"id":58,"slug":59,"hasResults":11,"nctId":60,"briefTitle":61,"officialTitle":62,"acronym":63,"eligibilityCriteria":64,"healthyVolunteers":11,"sex":17,"minAge":19,"maxAge":4,"enrollmentInfo":65,"targetDuration":4,"studyType":23,"phases":67,"briefSummary":69,"conditions":70,"keywords":4,"overallStatus":73,"whyStopped":4,"lastUpdateSubmitDate":74,"lastUpdatePostDateStruct":75,"startDateStruct":77,"completionDateStruct":79,"leadSponsor":81,"locationsCount":84},"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":66,"type":22},24,[68],"PHASE2","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.",[31,35,40,37,71,72],"Autoimmune Diseases","Immune System Diseases","RECRUITING","2026-05-29",{"date":76,"type":48},"2026-06-03",{"date":78,"type":48},"2020-12-10",{"date":80,"type":22},"2027-12-31",{"name":82,"class":83},"University of Leicester","OTHER",6,{"id":86,"slug":87,"hasResults":11,"nctId":88,"briefTitle":89,"officialTitle":90,"acronym":91,"eligibilityCriteria":92,"healthyVolunteers":11,"sex":17,"minAge":93,"maxAge":94,"enrollmentInfo":95,"targetDuration":4,"studyType":23,"phases":97,"briefSummary":98,"conditions":99,"keywords":104,"overallStatus":73,"whyStopped":4,"lastUpdateSubmitDate":106,"lastUpdatePostDateStruct":107,"startDateStruct":109,"completionDateStruct":111,"leadSponsor":113,"locationsCount":115},"100439568","phase-2-study-of-sparsentan-treatment-in-pediatrics-with-proteinuric-glomerular-diseases-100439568","NCT05003986","Study of Sparsentan Treatment in Pediatrics With Proteinuric Glomerular Diseases","A Phase 2, Open-Label, Single-Arm, Cohort Study to Evaluate the Safety, Efficacy, and Pharmacokinetics of Sparsentan Treatment in Pediatric Subjects With Selected Proteinuric Glomerular Diseases","EPPIK","Inclusion Criteria for All Subjects (All Three Populations):\n\nA subject must meet all of the following criteria to be eligible for participation in this study:\n\n* The subject or parent\u002Flegal guardian (as appropriate) is willing and able to provide signed informed consent\u002Fassent, and where required, the subject is willing to provide assent before any screening procedures per local requirements.\n* The subject has an estimated glomerular filtration rate (eGFR) ≥30 mL\u002Fmin\u002F1.73 m2 at screening.\n* The subject has a mean seated blood pressure between the 5th and 95th percentile for sex and height.\n\nInclusion Criteria for Population 1:\n\n* The subject is male or female ≥1 year at screening and \\\u003C18 years of age at Day 1 (Baseline).\n* The subject has a UP\u002FC ≥1.5 g\u002Fg (170 mg\u002Fmmol) at screening AND one of the following:\n* Kidney biopsy-proven FSGS or MCD histological patterns and clinical presentation consistent with primary FSGS or MCD and qualifying proteinuria at screening despite history or ongoing treatment with corticosteroids and\u002For other immunosuppressive disease-modifying agents.\n* Documentation of a genetic mutation in a podocyte protein associated with FSGS or MCD. Subjects with a documented podocytic mutation do not require kidney biopsy.\n* Kidney biopsy-proven FSGS histological pattern with medical history and clinical presentation consistent with maladaptive cause of the lesion.\n\nNote: The kidney biopsy may have been performed at any time in the past but must include light microscopy and electron microscopy characteristics and\u002For immunofluorescence findings consistent with FSGS or MCD.\n\nInclusion Criteria for Population 2:\n\n* The subject is male or female ≥2 years at screening and \\\u003C18 years of age at Day 1 (Baseline).\n* The subject has UP\u002FC ≥0.6 g\u002Fg (68 mg\u002Fmmol) at screening AND one of the following diagnoses:\n* Kidney biopsy-confirmed IgAN, IgAV, or AS\n* Diagnosis of AS by genetic testing (pathogenic X-linked Collagen, Type IV, Alpha-5 (COL4A5) mutation OR autosomal-recessive mutations in both alleles of Collagen, Type IV, Alpha-3 (COL4A3) and\u002For Collagen, Type IV, Alpha-4 (COL4A4) OR autosomal-dominant COL4A3 and\u002For COL4A4 and digenic mutations \\[ie, simultaneous mutations in 2 of the COL4A3, COL4A4, and COL4A5 genes\\])\n\nInclusion Criteria for Population 3:\n\n* The subject is male or female ≥8 years at screening and \\\u003C18 years of age at Day 1 (Baseline).\n* The subject has UP\u002FC ≥1.0 g\u002Fg (113 mg\u002Fmmol) at screening AND has kidney biopsy-confirmed IgAN\n* Subject weighs ≥40 kg\n* The subject has been on ACEI and\u002For ARB therapy for at least 12 weeks prior to screening\n\nExclusion Criteria for All Subjects (All Three Populations):\n\nA subject who meets any of the following will be excluded from this study:\n\n* The subject weighs \\\u003C7.3 kg at screening.\n* The subject has FSGS or MCD histological pattern secondary to viral infections, drug toxicities, or malignancies.\n* The subject has immunoglobulin A (IgA) glomerular deposits not in the context of primary IgAN or IgAV (ie, secondary to another condition; eg, systemic lupus erythematosus and liver cirrhosis).\n* The subject has had an acute onset or presentation of glomerular disease or a diagnostic biopsy or a relapse of glomerular disease requiring new or different class of immunosuppressive treatment (including, but not limited to, systemic corticosteroids, calcineurin inhibitors and mycophenolate mofetil, abatacept, cyclophosphamide, rituximab, ofatumumab, and ocrelizumab) within 6 months before screening.\n* Subjects taking chronic immunosuppressive medications (including systemic steroids) not on a stable dose for ≥1 month before screening.\n* The subject requires any of the prohibited concomitant medications as defined in the study protocol.\n* The subject has undergone any organ transplantation, with the exception of corneal transplants.\n* The subject has a documented history of congenital or acquired heart failure (modified Ross heart failure classification for children Class II to Class IV) and\u002For previous hospitalization for heart failure or unexplained dyspnea, orthopnea, paroxysmal nocturnal dyspnea, ascites, and\u002For peripheral edema.\n* The subject has hemodynamically significant cardiac valvular disease.\n* The subject has clinically significant congenital vascular disease.\n* The subject has jaundice, hepatitis, or known hepatobiliary disease, or alanine aminotransferase and\u002For aspartate aminotransferase \\>2 times the upper limit of the normal range at screening.\n* The subject has a history of malignancy within the past 2 years.\n* The subject has a screening hematocrit \\\u003C27% (0.27 L\u002FL) or a hemoglobin value \\\u003C9 g\u002FdL (90 g\u002FL).\n* The subject has a screening potassium value \\>5.5 milliequivalent (mEq)\u002FL (5.5 mmol\u002FL).\n* The subject has any abnormal clinical laboratory screening values that are considered by the Investigator to be clinically significant.\n* The subject has a history of allergic response to any angiotensin II antagonist or endothelin receptor antagonist, including sparsentan, or has a hypersensitivity to any of the excipients in the study medication.\n* The female subject is pregnant, plans to become pregnant during the course of the study, or is breastfeeding.\n* Female subjects of childbearing potential, beginning at menarche, who do not agree to use 1 highly reliable (ie, can achieve a failure rate of \\\u003C1% per year) method of contraception from 7 days before the first dose of the study medication until 28 days after the last dose of study medication. Examples of highly reliable contraception methods include stable oral, implanted, transdermal, or injected contraceptive hormones associated with the inhibition of ovulation or an intrauterine device. One additional barrier method must also be used during vaginal sexual activity, such as a diaphragm, diaphragm with spermicide (preferred), or male partner's use of male condom or male condom with spermicide (preferred), from Day 1\u002FRandomization until 28 days after the last dose of study medication. Female subjects of childbearing potential are defined as those who are fertile after menarche, unless permanently sterile; permanent sterilization methods include hysterectomy, bilateral salpingectomy, and bilateral oophorectomy. All female subjects of childbearing potential must have a negative serum pregnancy test result at screening (Visit 1) and a negative urine pregnancy test result, with positive results confirmed by serum, at every study visit from Day 1 (Visit 3) and after.\n\nNote: Before menarche, pregnancy testing and contraceptive use are not required. However, subjects and their parents\u002Flegal guardians must be advised that, immediately upon menarche, subjects will be required to begin pregnancy testing and initiate contraceptive use. This requirement cannot be waived.\n\n* The subject has participated in a study of another study medication within 28 days before screening or plans to participate in such a study during the course of this study.\n* The subject has had prior exposure to sparsentan.\n* The subject or parent\u002Flegal guardian (as appropriate), in the opinion of the Investigator, are unable to adhere to the requirements of the study including but not limited to, a history of noncompliance and\u002For any other reason that causes the Investigator to believe the subject would not be a good candidate for the study.\n* For Population 3 - the subject is unable to swallow the study medication tablets whole.","1 Year","17 Years",{"count":96,"type":22},67,[68],"To evaluate the safety, efficacy and tolerability of sparsentan oral suspension and tablets, and assess changes in proteinuria after once-daily dosing over 108 weeks.",[100,101,31,102,103],"Focal Segmental Glomerulosclerosis","Minimal Change Disease","IgA Vasculitis","Alport Syndrome",[105],"Alport, AS, FSGS, IgAN, IgAV, MCD, pediatrics, peds","2026-05-08",{"date":108,"type":48},"2026-05-12",{"date":110,"type":48},"2021-08-12",{"date":112,"type":22},"2027-04-12",{"name":114,"class":55},"Travere Therapeutics, Inc.",47,{"id":117,"slug":118,"hasResults":11,"nctId":119,"briefTitle":120,"officialTitle":121,"acronym":4,"eligibilityCriteria":122,"healthyVolunteers":11,"sex":17,"minAge":19,"maxAge":123,"enrollmentInfo":124,"targetDuration":4,"studyType":23,"phases":126,"briefSummary":127,"conditions":128,"keywords":129,"overallStatus":73,"whyStopped":4,"lastUpdateSubmitDate":131,"lastUpdatePostDateStruct":132,"startDateStruct":134,"completionDateStruct":136,"leadSponsor":138,"locationsCount":139},"100577378","phase-2-study-to-evaluate-the-impact-of-iptacopan-on-top-of-soc-on-biopsy-changes-in-kidneys-of-adult-patients-with-igan-100577378","NCT06797518","Study to Evaluate the Impact of Iptacopan on Top of SOC on Biopsy Changes in Kidneys of Adult Patients With IgAN","A Multicenter, Single Arm, Open Label Biopsy Study to Evaluate Structural and Functional Changes in Kidneys of Adult Patients With IgA Nephropathy Receiving Iptacopan on Top of Supportive Care","Inclusion Criteria:\n\n1. Signed informed consent must be obtained prior to participation in the study; participants should be able to communicate well with the investigator, understand and comply with the requirements of the study.\n2. Male and female participants ≥18 years of age with biopsy-confirmed IgA nephropathy and an eGFR ≥ 30 mL\u002Fmin\u002F1.73m2. eGFR will be calculated using the CKD-EPI 2009 formula.\n3. Proteinuria as assessed at screening by UPCR ≥ 0.8g\u002Fg or 1g\u002Fd sampled from FMV.\n4. Biopsy at baseline should confirm IgAN with \\\u003C 50% tubulointerstitial fibrosis.\n5. Participants must be on ACEi or ARB treatment at either the locally approved maximal daily dose or the maximally tolerated dose (per investigators' judgment) for approximately 90 days prior to baseline visit and continue on a stable dose throughout the study. Participants with allergies or intolerance to ACEi and ARB are eligible for the study, but the investigator should clearly document the reasons for not being on maximal ACEi\u002FARB dose in the source documents. In addition, if participants are taking diuretics, other antihypertensive medication or Sodium-Glucose Co-Transporter 2 inhibitors (SGLT2i), the doses should be stabilized for at least 90 days prior to baseline.\n6. Vaccination against Neisseria meningitidis and Streptococcus pneumoniae infections required to be completed at least 2 weeks prior to the start of study treatment. If the participants have not been previously vaccinated, or if a booster is required, vaccine should be given according to local regulations at least 2 weeks prior to first study drug administration. If study treatment must start earlier than 2 weeks post-vaccination, prophylactic antibiotic treatment should be initiated.\n7. Vaccination against Haemophilus influenzae infection should be given, if available and according to local regulations, at least 2 weeks prior to first study drug administration.\n\nExclusion Criteria:\n\n1. Any secondary IgAN (at historic or baseline biopsies) as defined by the investigator and IgA vasculitis Henoch-Scholein Purpura (HSP). Secondary IgAN can be associated with cirrhosis, celiac disease, Human Immunodeficiency Virus (HIV) infection, dermatitis herpetiformis, seronegative arthritis, small-cell carcinoma, lymphoma, disseminated tuberculosis, bronchiolitis obliterans, and inflammatory bowel disease, familial Mediterranean fever, etc.\n2. Any secondary diagnosis at baseline biopsy (other than IgA nephropathy).\n3. Evidence of significant urinary obstruction or difficulty in voiding; any urinary tract disorder other than IgAN at screening and before first study drug administration.\n4. Current or planned usage of any homeopathic and\u002For herbal medications for IgAN disease progression, such as but not limited to Lei Gong Teng.\n5. Current acute kidney injury (AKI) defined by Acute Kidney Injury Network (AKIN) criteria within 4 weeks of screening.\n6. Presence of rapidly progressive glomerulonephritis (RPGN) as defined by 50% decline in eGFR within 3 months prior to screening, or presence of nephrotic syndrome.\n7. Sitting office SBP \\>140 mmHg or DBP \\>90 mmHg at the screening visit.\n8. Participants treated with immunosuppressive or other immunomodulatory agents such as but not limited to cyclophosphamide, rituximab, infliximab, eculizumab, canakinumab, mycophenolate mofetil (MMF) or mycophenolate sodium (MPS), cyclosporine, tacrolimus, sirolimus, everolimus, systemic corticosteroids exposure (\\>7.5 mg\u002Fd prednisone\u002Fprednisolone equivalent) or targeted release formulation (TRF) of budesonide within 90 days (or 180 days for rituximab) prior to first study drug administration. Participants using other medication such us hydroxychloroquine or Endothelin receptor antagonists (ERAs).\n9. Use of other investigational drugs within 5 half-lives or within 30 days of enrollment, whichever is longer.\n10. Prior use of iptacopan or prior enrollment in any other iptacopan clinical trial where study drug was taken, including matching placebo.\n11. All transplanted participants (any solid organ transplantation, including bone marrow transplantation).\n12. History of recurrent invasive infections caused by encapsulated organisms, such as meningococcus and pneumococcus.\n13. Major concurrent comorbidities including but not limited to advanced cardiac disease (e.g., New York Heart Association (NYHA) class IV), severe pulmonary disease (e.g., severe pulmonary hypertension (World Health Organization (WHO) class IV)), or hepatic disease (e.g., active hepatitis) that in the opinion of the investigator precludes participant's participation in the study.\n14. Any medical condition deemed likely to interfere with the participant's participation in the study or that will require the use of prohibited medications.\n15. Active systemic bacterial, viral (including COVID-19) or fungal infection within 14 days prior to study drug administration.\n16. Presence of fever ≥ 38°C (100.4°F) within 7 days prior to study drug administration.\n17. Human immunodeficiency virus (HIV) infection (known history of HIV or test positive for HIV antibody at Screening).\n18. History of hypersensitivity to any of the study drugs or its excipients or to drugs of similar chemical classes.\n19. Liver disease, such as active hepatitis B virus (HBV) or hepatitis C virus (HCV) infection defined as positive HBsAg in conjunction with core antibody (anti-HBc), or HCV-RNA positive at screening, or liver injury as indicated by abnormal liver function tests at screening as defined below:\n\n    * Any single parameter of ALT, AST, GGT, alkaline phosphatase must not exceed 3 × upper limit of normal (ULN)\n    * Serum bilirubin must not exceed 2 × ULN\n20. History of malignancy of any organ system (other than localized basal cell carcinoma of the skin or in situ cervical cancer treated with curative intent), treated or untreated, within the past 5 years, regardless of whether there is evidence of local recurrence or metastases.\n21. Pregnant or nursing (lactating) women, where pregnancy is defined as the state of a female after conception and until the termination of gestation, confirmed by a positive human chorionic gonadotropin (HCG) laboratory test.\n22. Women of child-bearing potential, defined as all women physiologically capable of becoming pregnant, unless they agree to use effective methods of contraception during dosing of investigational drug and for 1 week after stopping of investigational drug.\n\nEffective contraception methods include:\n\n* Total abstinence (when this is in line with the preferred and usual lifestyle of the participant). Periodic abstinence (e.g., calendar, ovulation, symptothermal, post ovulation methods) and withdrawal are not acceptable methods of contraception.\n* Female sterilization (have had surgical bilateral oophorectomy with or without hysterectomy), total hysterectomy or bilateral tubal ligation at least six weeks before taking investigational drug. In case of oophorectomy alone, only when the reproductive status of the woman has been confirmed by follow up hormone level assessment.\n* Male sterilization (at least 6 months prior to screening) of male partner of the female participant.\n* Barrier methods of contraception: condom or occlusive cap (diaphragm or cervical\u002Fvault caps). For UK: with spermicidal foam\u002Fgel\u002Ffilm\u002Fcream\u002Fvaginal suppository.\n* Use of oral, (estrogen and progesterone), injected or implanted hormonal methods of contraception or other forms of hormonal contraception that have comparable efficacy (failure rate \\\u003C1%), for example hormone vaginal ring or transdermal hormone contraception or placement of an intrauterine device (IUD) or intrauterine system (IUS).\n* In case of use of oral contraception women should have been stable on the same pill for a minimum of 3 months before taking investigational drug.\n* If local regulations are more stringent than the contraception methods listed above, local regulations apply and will be described in the ICF.\n* Women are considered post-menopausal if they have had 12 months of natural (spontaneous) amenorrhea with an appropriate clinical profile (e.g., age appropriate, history of vasomotor symptoms). Women are considered not of childbearing potential if they are post-menopausal or have had surgical bilateral oophorectomy (with or without hysterectomy), total hysterectomy or tubal ligation at least six weeks ago. In the case of oophorectomy alone, only when the reproductive status of the woman has been confirmed by follow up hormone level assessment is she considered not of childbearing potential.\n* If local regulations deviate from the contraception methods listed above to prevent pregnancy, local regulations apply and will be described in the ICF.","99 Years",{"count":125,"type":22},20,[68],"A study to investigate the impact of iptacopan treatment on the underlying immunopathology in patients with IgAN by assessing changes in key clinical and molecular markers from baseline to 9 months. The study aims to provide insights into the treatment's systemic and kidney-specific aspects by quantifying the change in mesangial C3c containing fragments deposition, as an indicator of complement activation, and evaluating a variety of biomarkers related to kidney function, damage, and disease progression, including but not limited to Oxford MEST-C score.",[40,31],[130],"IgAN, Renal Biopsy, Iptacopan","2026-04-22",{"date":133,"type":48},"2026-04-27",{"date":135,"type":48},"2025-02-21",{"date":137,"type":22},"2027-11-27",{"name":54,"class":55},18,{"id":141,"slug":142,"hasResults":11,"nctId":143,"briefTitle":144,"officialTitle":145,"acronym":4,"eligibilityCriteria":146,"healthyVolunteers":147,"sex":17,"minAge":19,"maxAge":4,"enrollmentInfo":148,"targetDuration":4,"studyType":23,"phases":150,"briefSummary":152,"conditions":153,"keywords":154,"overallStatus":73,"whyStopped":4,"lastUpdateSubmitDate":159,"lastUpdatePostDateStruct":160,"startDateStruct":162,"completionDateStruct":164,"leadSponsor":166,"locationsCount":168},"100621833","phase-1-a-study-of-mil116-in-healthy-participants-and-patients-with-iga-nephropathy-100621833","NCT07375758","A Study of MIL116 in Healthy Participants and Patients With IgA Nephropathy.","A Phase I\u002FII, Safety, Tolerability, Pharmacokinetics and Pharmacodynamics Study of MIL116 in Healthy Participants and Patients With IgA Nephropathy","Inclusion Criteria:\n\n\\-\n\nPhase Ia:\n\n1. Able to understand and voluntarily sign the written Informed Consent Form (ICF), willing and able to comply with all study requirements;\n2. Healthy participants aged 18 to 55 years (inclusive) at the time of signing the ICF, of either sex;\n3. Have a body mass index (BMI) between 19 to 32 kg\u002Fm² (inclusive) and a body weight ≥ 50 kg at screening;\n4. Assessed to be in good health status based on medical history, physical examination, vital signs, 12-lead electrocardiogram (ECG), and clinical laboratory tests, with no clinically significant abnormalities;\n5. Have a total immunoglobulin G (IgG) level \\> 10 g\u002FL at screening; and immunoglobulin A (IgA) and immunoglobulin M (IgM) levels within the normal reference ranges.\n\nPhase Ib\\&II:\n\n1. Able to understand and voluntarily sign the written ICF, and willing and able to comply with all study requirements;\n2. Aged ≥ 18 years at the time of signing the ICF, of either sex, with a BMI ≥ 16 kg\u002Fm²;\n3. Biopsy-confirmed diagnosis of IgA Nephropathy (IgAN). Participants must have a 24-hour urine protein-to-creatinine ratio (UPCR) ≥ 0.5 g\u002Fg or 24-hour urine protein ≥ 0.75 g prior to the first dose;\n4. Have been receiving an optimized and stable dose of an angiotensin-converting enzyme inhibitor (ACEi) or angiotensin II receptor antagonist (ARB). If currently receiving sodium-glucose cotransporter 2 inhibitors (SGLT2i) and \u002F or endothelin receptor antagonists (ERA), the same administration and dose stability requirements apply for;\n5. Have acceptable hematologic, hepatic, coagulation, and renal function as assessed by clinical laboratory tests.\n\nExclusion Criteria:\n\n\\-\n\nPhase Ia:\n\n1. Nursing, lactating or pregnant, or who have plans to become pregnant during the study\n2. History or evidence of any clinically significant disease, disorder, or condition that, in the investigator's judgment, may pose a risk to the participants' safety, interfere with the study assessments, or render the subject unsuitable for participation, including but not limited to respiratory, renal, hepatic, gastrointestinal, hematological, lymphatic, neurologic, cardiovascular, psychiatric, or other systemic diseases;\n3. Any confirmed or suspected immunosuppressive or immunodeficiency condition, including human immunodeficiency virus (HIV) infection or asplenia; history of recurrent or severe infections, or long-term use of immunosuppressive agents within 6 months prior to screening;\n4. History of chronic infection (e.g., tuberculosis, osteomyelitis) or any infectious disease requiring hospitalization or treatment with antiviral, antibiotic, or antifungal agents within 28 days prior to administration of the study drug;\n5. Use of any prescription medications, over-the-counter (OTC) drugs, herbal products, topical products, or dietary supplements within 28 days prior to administration of the study drug or for within 5 half-lives of the drug (whichever is longer);\n6. Participation in any clinical study of an investigational drug or medical device, or receipt of any investigational study drug, within 3 months prior to administration of the study drug or within 5 half-lives (whichever is longer);\n7. Receipt of any marketed or investigational antibody or biologic therapy (including immunoglobulin products, monoclonal antibodies, or antibody fragments) within 28 days prior to administration of the study drug or within 5 half-lives (whichever is longer);\n8. History of drug abuse or substance dependence, or a positive urine drug abuse screening result during the screening period.\n\nPhase Ib\\&II:\n\n1. Secondary IgAN or IgA vasculitis (Henoch-Schönlein purpura), as diagnosed by the investigator;\n2. Presence of chronic kidney disease of causes other than IgAN;\n3. Other significant pathological abnormalities identified on kidney biopsy;\n4. Kidney biopsy demonstrating tubular-interstitial fibrosis \\> 50% or glomerular crescents involving \\> 25% of glomeruli. Note: The most recent kidney biopsy will be prioritized for eligibility assessment;\n5. Clinical suspicion of rapidly progressive glomerulonephritis based on an estimated glomerular filtration rate (eGFR) decline ≥ 50% within 3 months prior to the screening visit;\n6. Nephrotic syndrome, defined as 24-hour urine protein \\> 3.5 g accompanied by hypoalbuminemia (serum albumin \\\u003C 30 g\u002FL). Subjects with isolated nephrotic-range proteinuria (\\> 3.5 g\u002Fd) are excluded;\n7. Receipt of rituximab or any B-cell depleting agent within 6 months prior to screening. Participants with CD4+ T-cell count \\\u003C 200 cells\u002FμL are excluded;\n8. Total IgG level \\\u003C 6 g\u002FL at screening; uncontrolled type 2 diabetes mellitus, defined as glycated hemoglobin (HbA1c) \\> 8%; or diagnosis of type 1 diabetes mellitus;\n9. History of prior treatment with any APRIL-targeted medication;\n10. Receipt of biologic agents, such as belimumab or eculizumab, within 3 months prior to the first dose of the study drug;\n11. Receipt of cyclophosphamide within 3 months prior to the first dose; use of other immunosuppressive agents within 28 days prior to the first dose, including but not limited to azathioprine, mycophenolate mofetil, leflunomide, tacrolimus, cyclosporine, methotrexate, or tripterygium wilfordii; systemic corticosteroids used at an average daily dose equivalent to ≥40 mg prednisone for more than 14 days within 28 days prior to the screening visit, or use of oral delayed-release budesonide capsules within 1 year prior to the screening visit.",true,{"count":149,"type":22},130,[151,68],"PHASE1","This is a Phase I\u002FII study designed to evaluate the safety, tolerability, PK and PD of subcutaneous MIL116, an anti-APRIL monoclonal antibody, in healthy participants and patients with IgA Nephropathy.",[31],[155,156,157,158],"Anti-APRIL monoclonal antibody","MIL116","IgAN","CLYM116","2026-04-10",{"date":161,"type":48},"2026-04-13",{"date":163,"type":48},"2026-02-05",{"date":165,"type":22},"2029-06",{"name":167,"class":55},"Beijing Mabworks Biotech Co., Ltd.",1,{"id":170,"slug":171,"hasResults":11,"nctId":172,"briefTitle":173,"officialTitle":174,"acronym":4,"eligibilityCriteria":175,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":19,"enrollmentInfo":176,"targetDuration":4,"studyType":23,"phases":177,"briefSummary":178,"conditions":179,"keywords":183,"overallStatus":73,"whyStopped":4,"lastUpdateSubmitDate":188,"lastUpdatePostDateStruct":189,"startDateStruct":191,"completionDateStruct":193,"leadSponsor":195,"locationsCount":197},"100594831","phase-3-study-of-ravulizumab-in-pediatric-participants-with-primary-igan-100594831","NCT07024563","Study of Ravulizumab in Pediatric Participants With Primary IgAN","A Phase 3, Open-Label, Multicenter Study to Evaluate the Pharmacokinetics, Pharmacodynamics, Efficacy, and Safety of Ravulizumab in Pediatric Participants (2 to \u003C 18 Years of Age) With Primary Immunoglobulin A Nephropathy (IgAN)","Inclusion Criteria:\n\n* Participant must be 2 to \\\u003C 18 years of age at the time of signing the informed consent or assent.\n* Stable and maximum allowed or tolerated RASI (ACEI and\u002For ARB) dose for ≥ 3 months prior to Screening with no planned change during Screening through Week 106.\n* UPCR ≥ 1.0 g\u002Fg from the mean of 3 first morning voids (FMV) collected within 1 week during the Screening Period\n* Estimated GFR ≥ 30 mL\u002Fmin\u002F1.73 m2 during Screening\n* Meningococcal infection vaccine\n* Haemophilus influenzae type b and Streptococcus pneumoniae vaccine\n* Participants who are receiving SGLT2i, DEARA (eg, sparsentan), MRA, ERA, or GLP-1 agonists must be on a stable and maximum allowed or tolerated dose for ≥ 3 months prior to Screening with no planned change in dose through Week 34.\n* Established diagnosis of primary IgAN diagnosis based on kidney biopsy within 3 years prior to Screening or during the Screening Period\n\nExclusion Criteria:\n\n* Diagnosis of rapidly progressive glomerulonephritis\n* Secondary forms of IgAN not in the context of primary IgAN or IgAV\n* Concomitant clinically significant renal disease other than IgAN or IgAVN\n* Clinical remission of IgAN\u002FIgAVN or clinically significant improvement in proteinuria within the last 6 months.\n* Uncontrolled diabetes mellitus with HbA1c \\> 8.5%\n* History of kidney transplant or planned kidney transplant during the Primary Evaluation Period.\n* History of other solid organ (heart, lung, small bowel, pancreas, or liver) or bone marrow transplant\n* Splenectomy or functional asplenia\n* Participants with nephrotic syndrome receiving albumin infusions or with acute kidney injury requiring dialysis within the last 6 months prior to Screening.\n* Hemolytic uremic syndrome diagnosed any time prior to Screening.\n* Planned urological surgery expected to influence kidney function within the study time frame.\n* Congenital immunodeficiency\n* Active systemic bacterial, viral, or fungal infection within 14 days prior to enrollment\n* Received biologics for the treatment of IgAN or IgAVN within≤ 6 months prior to Screening",{"count":66,"type":22},[25],"The primary objectives of this study are to characterize ravulizumab pharmacokinetics (PK) and pharmacodynamics (PD), and to evaluate safety and efficacy following ravulizumab IV dosing in pediatric participants with IgAN or IgAVN.",[157,180,31,181,182,102],"IgAVN","Immunoglobulin A Vasculitis Associated Nephritis","Henoch-schonlein Purpura Nephritis",[184,157,180,185,186,187,31,181],"ravulizumab","pediatric","proteinuria","glomerulonephropathy","2026-03-16",{"date":190,"type":48},"2026-03-17",{"date":192,"type":48},"2025-06-14",{"date":194,"type":22},"2029-11-27",{"name":196,"class":55},"Alexion Pharmaceuticals, Inc.",14,{"id":199,"slug":200,"hasResults":11,"nctId":201,"briefTitle":202,"officialTitle":203,"acronym":4,"eligibilityCriteria":204,"healthyVolunteers":11,"sex":17,"minAge":19,"maxAge":4,"enrollmentInfo":205,"targetDuration":4,"studyType":207,"phases":4,"briefSummary":208,"conditions":209,"keywords":210,"overallStatus":73,"whyStopped":4,"lastUpdateSubmitDate":215,"lastUpdatePostDateStruct":216,"startDateStruct":218,"completionDateStruct":220,"leadSponsor":222,"locationsCount":168},"100589285","a-mobile-app-based-study-to-evaluate-disease-burden-and-treatment-patterns-in-immunoglobulin-a-nephropathy-igan-in-the-us-100589285","NCT06952426","A Mobile App-Based Study to Evaluate Disease Burden and Treatment Patterns in Immunoglobulin A Nephropathy (IgAN) in the US","A Mobile App-Based, Prospective, Observational Study to Evaluate Disease Burden and Treatment Patterns in Immunoglobulin A Nephropathy (IgAN) in the US","Inclusion Criteria:\n\n* Diagnosis of IgAN, regardless of symptom or treatment 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* US-based with a proficient understanding of and ability to read the English language\n\nExclusion Criteria:\n\nNone",{"count":206,"type":22},300,"OBSERVATIONAL","The study aims to longitudinally capture the full spectrum of symptoms, treatment utilization, and overall health-related quality of life (HRQoL) experienced by Immunoglobulin A nephropathy (IgAN) patients and their caregivers.",[31],[157,211,212,213,214],"HRQoL","Iptacopan","atrasentan","Immunoglobulin A nephropathy","2025-06-12",{"date":217,"type":48},"2025-06-17",{"date":219,"type":48},"2025-03-04",{"date":221,"type":22},"2025-06-30",{"name":54,"class":55},{"id":224,"slug":225,"hasResults":11,"nctId":226,"briefTitle":227,"officialTitle":228,"acronym":229,"eligibilityCriteria":230,"healthyVolunteers":11,"sex":17,"minAge":19,"maxAge":4,"enrollmentInfo":231,"targetDuration":4,"studyType":23,"phases":233,"briefSummary":235,"conditions":236,"keywords":237,"overallStatus":73,"whyStopped":4,"lastUpdateSubmitDate":242,"lastUpdatePostDateStruct":243,"startDateStruct":245,"completionDateStruct":247,"leadSponsor":249,"locationsCount":56},"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":232,"type":22},878,[234],"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).",[37,31],[238,239,240,241],"IgA nephropathy","Steroids","RAS-blockers","SGLT2-inhibitors","2025-03-28",{"date":244,"type":48},"2025-04-02",{"date":246,"type":48},"2023-05-01",{"date":248,"type":22},"2028-12-31",{"name":250,"class":83},"Fondazione Schena",{"id":252,"slug":253,"hasResults":11,"nctId":254,"briefTitle":255,"officialTitle":256,"acronym":4,"eligibilityCriteria":257,"healthyVolunteers":11,"sex":17,"minAge":19,"maxAge":258,"enrollmentInfo":259,"targetDuration":4,"studyType":23,"phases":261,"briefSummary":262,"conditions":263,"keywords":265,"overallStatus":44,"whyStopped":4,"lastUpdateSubmitDate":266,"lastUpdatePostDateStruct":267,"startDateStruct":269,"completionDateStruct":271,"leadSponsor":273,"locationsCount":168},"100564945","phase-2-a-study-of-the-effect-and-safety-of-hs-10390-in-the-treatment-of-patients-with-primary-iga-nephropathy-100564945","NCT06635772","A Study of the Effect and Safety of HS-10390 in the Treatment of Patients with Primary IgA Nephropathy","A Randomized, Multicenter, Open-label, Active-control Study of the Efficacy and Safety of HS-10390 for the Treatment of Immunoglobulin a Nephropathy","Inclusion Criteria:\n\n* Male or female, between 18 and 65 years age.\n* Biopsy-proven primary IgA nephropathy.\n* Currently on stable dose of ACEI and\u002For ARB therapy, for at least 12 weeks prior to screening (the patient's maximum tolerated dose and is at least one-half of the maximum labeled dose).\n* Average 24-hour urine total protein ≥ 0.75 g\u002F24 h at screening.\n* Estimated GFR (using the CKD-EPI 2009) ≥ 30 mL\u002Fmin per 1.73 m\\^2 at screening.\n* Systolic BP between 100 and 150 mmHg and diastolic BP between 60 and 100 mmHg.\n\nExclusion Criteria:\n\n* IgA nephropathy secondary to another condition\n* IgA nephropathy with rapid decline of renal function; Kidney pathology indicated that more than 50% of the glomerulus had large crescent body formation, which may affect the study results; Tubule atrophy - interstitial fibrosis of more than 50%;\n* Chronic kidney disease (CKD) in addition to IgAN\n* Patients treated with any systemic non-biologic immunosuppressive drugs (including systemic corticosteroids) within 12 weeks prior to randomizing；\n* Require any prohibited medications prior to randomizing;\n* Exposure to an investigational drug within 30 days or 5 half-lives (whichever is longer) prior to screening\n* History of organ transplantation, with exception of corneal transplants\n* Platelet\\\u003C 100×109\u002FL or hemoglobin value \\\u003C 90 g\u002FL) or Hematocrit value \\\u003C 27% (0.27 V\u002FV) at Screening\n* Elevations of transaminases (ALT and\u002For AST) \\>2 times upper limit of normal or total bilirubin and\u002For direct bilirubin exceeding 1.5 times the upper limit of normal (ULN) at screening\n* Potassium \\>5.5 mmol\u002FL at Screening","65 Years",{"count":260,"type":22},90,[68],"This study will evaluate the efficacy and safety of HS-10390 in subjects with primary IgA nephropathy, and explore the optimal dose for the treatment.",[264],"Immunoglobulin a Nephropathy",[31],"2024-10-08",{"date":268,"type":48},"2024-10-10",{"date":270,"type":22},"2024-11",{"date":272,"type":22},"2026-04-30",{"name":274,"class":55},"Hansoh BioMedical R&D Company"]