[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"iga-vasculitis\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:iga-vasculitis":26},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,9,0,[8,47,81,113,154,185,207,235,260],{"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":4,"briefSummary":24,"conditions":25,"keywords":28,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":35,"lastUpdatePostDateStruct":36,"startDateStruct":39,"completionDateStruct":41,"leadSponsor":43,"locationsCount":46},"100644243","i-fabp-as-a-predictor-of-gastrointestinal-involvement-in-pediatric-iga-vasculitis-100644243",false,"NCT07664228","I-FABP as a Predictor of Gastrointestinal Involvement in Pediatric IgA Vasculitis","The Role of Intestinal Fatty Acid Binding Protein in Predicting Gastrointestinal Involvement in Pediatric IgA Vasculitis","IFABP-IgAV","Inclusion Criteria:\n\n* Diagnosis of IgA vasculitis (Henoch-Schönlein purpura) according to EULAR\u002FPRINTO\u002FPRES classification criteria.\n* Age between 2 and 18 years.\n* Availability for blood sample collection at diagnosis (baseline visit).\n* Ability to attend a routine follow-up visit approximately 2-4 weeks after diagnosis.\n* Parent or legal guardian able and willing to provide written informed consent.\n\nExclusion Criteria:\n\n* Refusal of informed consent by the parent\u002Flegal guardian.\n* Inability to obtain a baseline blood sample.\n* Inability to complete study follow-up procedures.","ALL","2 Years","18 Years",{"count":21,"type":22},100,"ESTIMATED","OBSERVATIONAL","This prospective observational study aims to evaluate plasma intestinal fatty acid-binding protein (I-FABP) levels in children with IgA vasculitis and investigate their association with gastrointestinal involvement. Blood samples will be collected at diagnosis and during follow-up 2-4 weeks later. The study will assess the potential value of plasma I-FABP as a biomarker for gastrointestinal involvement in pediatric IgA vasculitis.",[26,27],"IgA Vasculitis","Gastrointestinal Involvement",[26,29,30,31,27,32,33],"Henoch-Schönlein Purpura","I-FABP","Intestinal Fatty Acid Binding Protein","Children","Pediatric Rheumatology","RECRUITING","2026-06-17",{"date":37,"type":38},"2026-06-24","ACTUAL",{"date":40,"type":38},"2026-05-15",{"date":42,"type":22},"2027-05-15",{"name":44,"class":45},"Bursa City Hospital","OTHER_GOV",1,{"id":48,"slug":49,"hasResults":11,"nctId":50,"briefTitle":51,"officialTitle":52,"acronym":53,"eligibilityCriteria":54,"healthyVolunteers":11,"sex":17,"minAge":55,"maxAge":56,"enrollmentInfo":57,"targetDuration":4,"studyType":59,"phases":60,"briefSummary":62,"conditions":63,"keywords":68,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":70,"lastUpdatePostDateStruct":71,"startDateStruct":73,"completionDateStruct":75,"leadSponsor":77,"locationsCount":80},"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":58,"type":22},67,"INTERVENTIONAL",[61],"PHASE2","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.",[64,65,66,26,67],"Focal Segmental Glomerulosclerosis","Minimal Change Disease","Immunoglobulin A Nephropathy","Alport Syndrome",[69],"Alport, AS, FSGS, IgAN, IgAV, MCD, pediatrics, peds","2026-05-08",{"date":72,"type":38},"2026-05-12",{"date":74,"type":38},"2021-08-12",{"date":76,"type":22},"2027-04-12",{"name":78,"class":79},"Travere Therapeutics, Inc.","INDUSTRY",47,{"id":82,"slug":83,"hasResults":11,"nctId":84,"briefTitle":85,"officialTitle":86,"acronym":4,"eligibilityCriteria":87,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":19,"enrollmentInfo":88,"targetDuration":4,"studyType":59,"phases":90,"briefSummary":92,"conditions":93,"keywords":98,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":103,"lastUpdatePostDateStruct":104,"startDateStruct":106,"completionDateStruct":108,"leadSponsor":110,"locationsCount":112},"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":89,"type":22},24,[91],"PHASE3","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.",[94,95,66,96,97,26],"IgAN","IgAVN","Immunoglobulin A Vasculitis Associated Nephritis","Henoch-schonlein Purpura Nephritis",[99,94,95,100,101,102,66,96],"ravulizumab","pediatric","proteinuria","glomerulonephropathy","2026-03-16",{"date":105,"type":38},"2026-03-17",{"date":107,"type":38},"2025-06-14",{"date":109,"type":22},"2029-11-27",{"name":111,"class":79},"Alexion Pharmaceuticals, Inc.",14,{"id":114,"slug":115,"hasResults":11,"nctId":116,"briefTitle":117,"officialTitle":117,"acronym":118,"eligibilityCriteria":119,"healthyVolunteers":11,"sex":17,"minAge":120,"maxAge":4,"enrollmentInfo":121,"targetDuration":4,"studyType":23,"phases":4,"briefSummary":123,"conditions":124,"keywords":134,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":143,"lastUpdatePostDateStruct":144,"startDateStruct":146,"completionDateStruct":148,"leadSponsor":150,"locationsCount":153},"100286105","clinical-transcriptomics-in-systemic-vasculitis-cutis-100286105","NCT03004326","Clinical Transcriptomics in Systemic Vasculitis (CUTIS)","CUTIS","Inclusion Criteria:\n\n* Have a cutaneous lesion (purpuric macules, palpable purpura, retiform purpura, nodules, ulcers, or urticarial) believed to be related to active vasculitis\n* Have a suspected or confirmed diagnosis of:\n\n  * Cryoglobulinemic vasculitis (CV)\n  * Drug-induced vasculitis\n  * Eosinophilic granulomatosis with polyangiitis (EGPA)\n  * IgA vasculitis\n  * Isolated cutaneous vasculitis\n  * Granulomatosis with polyangiitis (GPA)\n  * Microscopic polyangiitis (MPA)\n  * Polyarteritis nodosa (PAN)\n  * Urticarial vasculitis\n* Be willing and able to provide written informed consent (or assent for those under\n\nExclusion Criteria:\n\n* You are less than five years old\n* Considered not to be a candidate for a biopsy or have a higher risk of developing an infection, bleeding, etc., from the biopsy, or a doctor believes that the risks for you participating in this study do not outweigh the potential benefit of learning information from your biopsy\n* You have a neutrophil count (type of white blood cell) less than 1500\u002Fmm3, platelet count less than 50,000\u002Fmm3, or a hemoglobin less than 7 g\u002FdL\n* You have an uncontrolled disease that could prevent you from completing the study procedures\n* You have an active infection at or near the potential biopsy site, have poor circulation, or have bony prominence or other structure that would increase your risk of complications if you participated in this study\n* You are pregnant or nursing\n* You are not able to provide informed consent","5 Years",{"count":122,"type":22},50,"Multi-center observational study to evaluate the histopathology and transcriptome of cutaneous lesions in patients with several different types of vasculitis.",[125,126,127,26,128,129,130,131,132,133],"Cryoglobulinemic Vasculitis (CV)","Drug-induced Vasculitis","Eosinophilic Granulomatosis With Polyangiitis (EGPA)","Isolated Cutaneous Vasculitis","Granulomatosis With Polyangiitis (GPA)","Microscopic Polyangiitis (MPA)","Polyarteritis Nodosa (PAN)","Urticarial Vasculitis","Vasculitis",[135,136,137,138,139,140,141,142],"DIV","CSS","EGPA","HSP","GPA","MPA","PAN","Wegeners","2026-01-21",{"date":145,"type":38},"2026-01-22",{"date":147,"type":38},"2017-01",{"date":149,"type":22},"2028-12",{"name":151,"class":152},"Peter Merkel","OTHER",10,{"id":155,"slug":156,"hasResults":11,"nctId":157,"briefTitle":158,"officialTitle":159,"acronym":4,"eligibilityCriteria":160,"healthyVolunteers":11,"sex":17,"minAge":4,"maxAge":4,"enrollmentInfo":161,"targetDuration":4,"studyType":23,"phases":4,"briefSummary":163,"conditions":164,"keywords":175,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":143,"lastUpdatePostDateStruct":178,"startDateStruct":179,"completionDateStruct":181,"leadSponsor":182,"locationsCount":184},"100283245","vcrc-tissue-repository-100283245","NCT02967068","VCRC Tissue Repository","VCRC Tissue Biorepository Collection Protocol","Inclusion Criteria:\n\n* A participant will be deemed eligible for this study if the participant is\u002Fwas enrolled in another one of the VCRC observational\u002Flongitudinal protocols (5502, 5503, 5504, 5505, 5506, 5507, 5563) and\u002For one of the VCRC interventional studies (5522, 5523, 5526, 5527, or 5562).\n\nExclusion Criteria:\n\n* Inability to give informed consent (or their guardians in the case of children) and to sign the consent form.\n* Unwilling to allow the use of their tissue for research.",{"count":162,"type":22},1000,"The purpose of this study is to collect existing tissue specimens from subjects enrolled in Vasculitis Clinical Research Consortium (VCRC) studies. Analysis of these tissue specimens and linked clinical data collected through VCRC studies may lead to the identification and development of a series of translational research projects. Results of these studies will provide vasculitis researchers with insight into the causes of these diseases and generate new ideas for diagnostic tests and therapies, and will be of great interest to the larger communities of researchers investigating vasculitis and other autoimmune, inflammatory, and vascular diseases.",[165,166,167,168,169,170,26,171,172,173,174],"Aortitis","Cutaneous Vasculitis","Eosinophilic Granulomatosis With Polyangiitis","Giant Cell Arteritis","Granulomatosis With Polyangiitis (Wegener's)","Henoch-Schonlein Purpura","Microscopic Polyangiitis","Polyarteritis Nodosa","Takayasu Arteritis","Churg-Strauss Syndrome",[136,137,176,139,140,141,177,138],"GCA","TAK",{"date":145,"type":38},{"date":180,"type":38},"2016-11",{"date":149,"type":22},{"name":183,"class":152},"University of Pennsylvania",8,{"id":186,"slug":187,"hasResults":11,"nctId":188,"briefTitle":189,"officialTitle":189,"acronym":190,"eligibilityCriteria":191,"healthyVolunteers":11,"sex":17,"minAge":19,"maxAge":4,"enrollmentInfo":192,"targetDuration":4,"studyType":59,"phases":194,"briefSummary":195,"conditions":196,"keywords":4,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":143,"lastUpdatePostDateStruct":199,"startDateStruct":201,"completionDateStruct":203,"leadSponsor":205,"locationsCount":206},"100281139","phase-2-a-randomized-multicenter-study-for-isolated-skin-vasculitis-100281139","NCT02939573","A Randomized Multicenter Study for Isolated Skin Vasculitis","ARAMIS","Inclusion Criteria:\n\n1. Patients with primary skin vasculitis, not associated with any significant extra-cutaneous involvement that would require specific immunosuppressive therapy. Eligible patients will have a diagnosis of either:\n\n   * Isolated cutaneous small vessel (SV) or medium-sized vessel (MV) vasculitis or cutaneous polyarteritis nodosa (PAN)\n   * IgA vasculitis (IgA, formerly Henoch-Schönlein purpura), without active and\u002For progressing renal involvement (stable glomerular filtration rate (GFR) \\>60 ml\u002Fmin; absence of, or mild-and-stable microscopic hematuria without red blood cell casts; absence of, or mild-and-stable proteinuria (\\\u003C1g\u002F24 hours); not requiring systemic immunosuppressive therapy).\n\n   These conditions, when skin-limited, are all currently treated in similar manners in practice. Mild arthralgias, myalgias, peripheral limb edema, fatigue, weight loss ≤6 lbs or 3 kg within past 3 months, low-grade fever, and mild anemia (Hb ≥ 10 g\u002FdL) will be allowed.\n2. The diagnosis of vasculitis must have been confirmed by skin biopsy prior to enrollment (earlier, at diagnosis, and\u002For just prior to enrollment) that has included an immunofluorescence study (in the case of small vessel vasculitis).\n3. Patients must have active cutaneous vasculitis lasting for at least 1 month continuously and\u002For have had 2 or more flares over the six months preceding enrollment (post-inflammatory lesions such as hyperpigmentation or healing ulceration(s) are not to be considered active vasculitis).\n4. Patients must have active \u002F ongoing cutaneous vasculitis lesions at the time of enrollment (post-inflammatory lesions such as hyperpigmentation or healing ulceration(s) are not to be considered active vasculitis).\n5. Patients may have a contra-indication to one of the study drug or have been treated prior to enrollment with one of the study medications but failed to respond to it (according to the study definitions of failure and if they have been on the drug at the target dose or higher for 3 months or longer) or had to stop it because of an adverse event. Such patients can be enrolled directly in the second stage of the study and be randomized to receive one of the two other study drugs. The number of such patients enrolled directly in stage 2 will be capped at 10 (10% of the total recruitment target).\n6. Patients may have received systemic glucocorticoids for their cutaneous vasculitis before enrollment. For the patients on prednisone at the time of enrollment, prednisone should be stopped within a maximum of 6 weeks after enrollment and initiation of the study drug, following a pre-defined tapering schedule. Patients on long-term, low and stable dose of glucocorticoids (≤5 mg\u002Fday prednisone-equivalent) for other conditions (e.g., asthma or adrenal insufficiency) can be enrolled if the likelihood of requiring a dose increase for this other condition is low during the 6 month study period (these patients will remain on that low and stable dose during the study period, with the option to receive one short course of prednisone at higher doses for skin vasculitis flare during the first 3 months of the study period, like any other patients enrolled).\n7. Participant age 18 years or greater.\n\nExclusion Criteria:\n\n1. Presence of significant extra-cutaneous manifestations suggestive of a systemic vasculitis or more diffuse condition. The presence of mild arthralgias, myalgias, peripheral limb edema, fatigue, weight loss ≤6 lbs or 3 kg within past 3 months, low-grade fever, and mild anemia \\[Hb ≥ 10 g\u002FdL\\] are not exclusion criteria. Mild and stable microscopic hematuria without RBC casts and\u002For mild and stable proteinuria (\\\u003C1g\u002F24 hours) are not exclusion criteria. These latter patients must not require systemic immunosuppressive therapy because of possible renal involvement and their GFR must be \\>60 ml\u002Fmin.\n2. Known systemic and\u002For non-skin-isolated vasculitis, such as granulomatosis with polyangiitis, eosinophilic granulomatosis with polyangiitis, cryoglobulinemic vasculitis, systemic polyarteritis nodosa, central nervous system vasculitis and patients with detectable antineutrophil cytoplasmic antibody (ANCA) by immunofluorescence or ELISA.\n3. Hypocomplementemic urticarial vasculitis, cryoglobulinemic vasculitis, and other known secondary skin vasculitides such as those secondary to systemic lupus erythematosus, Sjögren syndrome, another auto-immune condition, a cancer, a hematological disorder, an ongoing active infection, or an ongoing medication. Investigators should consider such underlying diagnoses and perform and interpret appropriate laboratory work-up where indicated based on clinical presentation.\n4. History of significant intolerance, allergy or serious adverse events to any of the study medications: such patients can be enrolled directly in the second stage of the study and be randomized to receive one of the two other study drugs. The number of patients enrolled directly in stage 2 of the study will be capped at 10 (10%).\n5. Patients who have contra-indications to two or three of the study drugs (azathioprine, colchicine, or dapsone), or have been treated prior to enrollment with two or three of the study drugs but failed to respond to them, or had to stop two or three of them because of adverse events.\n6. Deficit in glucose-6-phosphate dehydrogenase (G6PD) or history of hemolytic anemia (all patients must be tested for G6PD at the screening visit to assess for their eligibility): such patients can be enrolled directly in the second stage of the study and be randomized to receive one of the two other study drugs (azathioprine or colchicine). The number of patients enrolled directly in stage 2 of the study will be capped at 10 (10%).\n7. Low or absent thiopurine methyltransferase (TPMT) activity (if known, not a requirement for study entry): Patients known to have low or absent TPMT can be enrolled directly in the second stage of the study and be randomized to receive one of the two other study drugs (dapsone or colchicine).\n8. Evidence of significant hepatic insufficiency or liver function tests \\> 2 times the upper limit of normal.\n9. Evidence of significant renal insufficiency or creatinine clearance \\\u003C 60 mL\u002Fmin.\n10. Evidence of significant or symptomatic anemia or Hb \\\u003C 10 g\u002FdL.\n11. Comorbid condition that has moderate or high likelihood of requiring intermittent courses of prednisone within the study period, according to the investigator (e.g. chronic obstructive pulmonary disease (COPD), unstable or severe asthma).\n12. Active cancer or history of malignancy within the previous 5 years (patient in remission of a cancer \\>5 years, or with non-metastatic prostate cancer or treated basal or squamous cell carcinoma of the skin can be enrolled).\n13. Active uncontrolled or serious infection that may compromise or contra-indicate the use of the study medications.\n14. Patient unable to consent.\n15. Pregnant or lactating women.",{"count":193,"type":22},90,[61],"Multi-center sequential multiple assignment randomized trial comparing the effectiveness of three different standard of care treatment options for patients with isolated skin vasculitis.",[197,198,26,29],"Primary Cutaneous Vasculitis","Cutaneous Polyarteritis Nodosa",{"date":200,"type":38},"2026-01-23",{"date":202,"type":38},"2017-01-01",{"date":204,"type":22},"2028-12-31",{"name":183,"class":152},16,{"id":208,"slug":209,"hasResults":11,"nctId":210,"briefTitle":211,"officialTitle":212,"acronym":213,"eligibilityCriteria":214,"healthyVolunteers":11,"sex":215,"minAge":19,"maxAge":216,"enrollmentInfo":217,"targetDuration":218,"studyType":23,"phases":4,"briefSummary":219,"conditions":220,"keywords":4,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":143,"lastUpdatePostDateStruct":229,"startDateStruct":230,"completionDateStruct":232,"leadSponsor":234,"locationsCount":46},"100254637","vasculitis-pregnancy-registry-100254637","NCT02593565","Vasculitis Pregnancy Registry","The Vasculitis Pregnancy Registry (V-PREG)","V-PREG","Inclusion Criteria:\n\n1. Women 18 years of age or older with one of the following diseases may take part in the study:\n\n   * Behçet's disease;\n   * Central nervous system (CNS) vasculitis;\n   * Cryoglobulinemic vasculitis (Cryoglobulinemia);\n   * Eosinophilic granulomatosis with polyangiitis (also called Churg-Strauss Syndrome);\n   * Giant Cell (Temporal) Arteritis (GCA);\n   * Granulomatosis with polyangiitis (also called Wegener's);\n   * IgA vasculitis (Henoch-Schoenlein purpura);\n   * Microscopic polyangiitis (MPA);\n   * Polyarteritis nodosa (PAN);\n   * Takayasu's arteritis (TAK);\n   * Urticarial vasculitis;\n   * Other\u002FSuspected Diagnosis.\n2. Women must be pregnant (self-report) at the time of enrollment into the registry.\n\nExclusion Criteria:\n\n1. Non-English speaking, with the exception of people who speak Spanish, Portuguese, Italian, or Turkish.\n2. Unable to provide consent.","FEMALE","50 Years",{"count":21,"type":22},"12 Months","The purpose of this study is to learn about the experience of women with vasculitis who become pregnant. In particular, the study will consist of several online surveys to assess\n\n1. each woman's vasculitis severity and pregnancy-related experiences, and\n2. pregnancy outcomes.",[133,221,222,223,127,224,129,225,26,226,130,131,227,132,228],"Behcet's Disease","CNS Vasculitis","Cryoglobulinemic Vasculitis","Churg-Strauss Syndrome (CSS)","Wegener's Granulomatosis","Henoch-Schoenlein Purpura (HSP)","Takayasu Arteritis (TAK)","Systemic Vasculitis",{"date":200,"type":38},{"date":231,"type":4},"2015-11",{"date":233,"type":22},"2027-12",{"name":183,"class":152},{"id":236,"slug":237,"hasResults":11,"nctId":238,"briefTitle":239,"officialTitle":240,"acronym":4,"eligibilityCriteria":241,"healthyVolunteers":11,"sex":17,"minAge":242,"maxAge":56,"enrollmentInfo":243,"targetDuration":245,"studyType":23,"phases":4,"briefSummary":246,"conditions":247,"keywords":248,"overallStatus":251,"whyStopped":4,"lastUpdateSubmitDate":252,"lastUpdatePostDateStruct":253,"startDateStruct":254,"completionDateStruct":256,"leadSponsor":258,"locationsCount":4},"100620198","telitacicept-in-the-treatment-of-pediatric-iga-vasculitis-associated-nephritis-100620198","NCT07354503","Telitacicept in the Treatment of Pediatric IgA Vasculitis-Associated Nephritis","The Efficacy and Safety of Telitacicept in the Treatment of Pediatric IgA Vasculitis-Associated Nephritis: A Multicenter Clinical Study","Inclusion Criteria:\n\n1. Age 3-17 years;\n2. Patients diagnosed with IgA vasculitis nephritis (IgAVN) based on clinical manifestations and renal pathological diagnosis;\n3. Urinary protein quantification requirements: urinary protein\u002Fcreatinine ratio (UPCR) of ≥1 mg\u002Fmg (100 mg\u002Fmmol);\n4. Estimated glomerular filtration rate (eGFR) calculated using the modified Schwartz formula of ≥60 mL\u002Fmin\u002F1.73 m².\n5. Renal biopsy is optional (if a renal biopsy is performed, cases classified as International Society of Nephropathology (ISKDC) grade ≥IV must be excluded).\n\nExclusion Criteria:\n\n1. Patients with congenital or acquired immunodeficiency, or those with concurrent tuberculosis, active cytomegalovirus (CMV), Epstein-Barr virus(EBV), hepatitis B, hepatitis C, Human Immunodeficiency Virus(HIV) infection, deep fungal infections, or other active infections;\n2. Patients exhibiting the following abnormal laboratory indicators at the time of initial diagnosis: moderate to severe neutropenia (≤1000\u002FμL); moderate to severe anemia (hemoglobin \\\u003C9.0 g\u002FdL); thrombocytopenia (platelet count \\\u003C100×10\\^12\u002FL); or abnormal liver function (Alanine Aminotransferase(ALT), Aspartate Aminotransferase(AST), or bilirubin exceeding 2.5 times the upper limit of normal and persistently elevated for 2 weeks);\n3. Patients with a history of tumors or severe cardiovascular, digestive system, hematological, endocrine, or other systemic diseases;\n4. Patients with concurrent other urinary system diseases (such as hereditary kidney diseases, etc.);\n5. Subjects with severe osteoporosis requiring treatment;\n6. Subjects diagnosed with uncontrolled mental illness or intellectual disabilities;\n7. Subjects who have received B-cell targeted therapy within the last 6 months;\n8. History of major organ transplant or hematopoietic stem cell\u002Fcell\u002Fbone marrow or kidney transplant;\n9. Vaccination with live attenuated vaccines within 1 month prior to treatment;\n10. Use of various traditional Chinese medicines for treating kidney diseases during the treatment period (patients who have previously used traditional Chinese medicine can be included, but are strictly prohibited from using it after receiving treatment according to the protocol);\n11. Incomplete clinical data.","3 Years",{"count":244,"type":22},300,"48 Weeks","To further evaluate the efficacy and safety of Telitacicept in the treatment of pediatric IgA vasculitis nephritis (IgAVN) within real-world settings, this study employs a multicenter, retrospective and prospective observational research design. It aims to compare the efficacy of Telitacicept with that of glucocorticoids, thereby providing clinicians with a reference for the rational and standardized application of Telitacicept.",[95,26],[249,250,32],"IgAV nephritis","Telitacicept","NOT_YET_RECRUITING","2026-01-15",{"date":143,"type":38},{"date":255,"type":22},"2026-01-01",{"date":257,"type":22},"2028-06-30",{"name":259,"class":152},"The Children's Hospital of Zhejiang University School of Medicine",{"id":261,"slug":262,"hasResults":11,"nctId":263,"briefTitle":264,"officialTitle":265,"acronym":266,"eligibilityCriteria":267,"healthyVolunteers":11,"sex":17,"minAge":19,"maxAge":268,"enrollmentInfo":269,"targetDuration":4,"studyType":59,"phases":271,"briefSummary":273,"conditions":274,"keywords":278,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":286,"lastUpdatePostDateStruct":287,"startDateStruct":289,"completionDateStruct":291,"leadSponsor":293,"locationsCount":295},"100568066","phase-4-which-of-the-commonly-available-and-approved-drugs-in-addition-to-standard-of-care-can-significantly-improve-the-slope-of-estimated-glomerular-filtration-rate-at-two-years-when-compared-to-standard-of-care-alone-in-south-asian-kidney-biopsy-proven-adult-18-years-primary-iga-nephropathy-100568066","NCT06676384","Which of the Commonly Available and Approved Drugs in Addition to Standard of Care Can Significantly Improve the Slope of Estimated Glomerular Filtration Rate at Two Years When Compared to Standard of Care Alone in South-Asian Kidney Biopsy-proven Adult (≥18 Years) Primary IgA Nephropathy?","Randomized Embedded Adaptive Platform Clinical Trial in South Asian Kidney Biopsy-Proven Primary IgA Nephropathy: Multi-center, Multi-arm and Multi-stage","IA-GRACE-IgANT","Inclusion Criteria:\n\n1. Must be able to provide a written informed consent form, which must be obtained before the initiation of study assessments.\n2. Adults between 18-65 years of age.\n3. Males or Females.\n4. Diagnosis of primary IgAN as demonstrated by renal biopsy of any vintage if eGFR ≥45 mL\u002Fmin\u002F1.73 m2 or within the last ten years if eGFR \\\u003C45 mL\u002Fmin\u002F1.73 m2. If diabetic, the biopsy vintage should be less than five years.\n5. eGFR ≥20 mL\u002Fmin\u002F1.73 m2 at screening, as per the Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI) equation.\n6. Total urine protein excretion ≥1 g per 24-hour or UPCR ≥ 0.75 g\u002Fg from an adequately measured 24-hour urine sample (24HUP) during the Screening Period.\n7. Patient on the maximum labelled or tolerated dose of ACEi or ARB AND 10mg\u002Fd of Dapagliflozin (SGLT2i) for at least 12 weeks at screening and from screening to study Day 1.\n8. Systolic blood pressure ≤140 mmHg and diastolic blood pressure ≤90 mmHg at randomisation. Other anti-hypertensives can be optimised during the screening period to achieve the BP goal.\n9. A female is eligible if she is not pregnant and consents to avoid pregnancy during the study duration.\n\nExclusion Criteria:\n\n1. IgAN secondary to another condition (e.g., liver cirrhosis) or other causes of mesangial IgA deposition such as systemic lupus erythematosus (SLE), dermatitis herpetiformis, ankylosing spondylitis, etc. IgA vasculitis (i.e., Henoch-Schonlein purpura) with biopsy-proven mesangial IgA deposition and no active skin vasculitis for the last year can be included.\n2. Evidence of nephrotic syndrome at screening (serum albumin \\\u003C3g\u002FdL AND UPCR \\>3.5 g\u002Fg).\n3. Evidence of rapidly progressive glomerulonephritis defined as loss of ≥ 50% of eGFR in three months before screening.\n4. Concomitant kidney disease in addition to IgAN in kidney biopsy (e.g., diabetic nephropathy, primary focal segmental glomerulosclerosis, membranous nephropathy, C3 glomerulopathy, lupus nephritis).\n5. Female patients planning pregnancy.\n6. Concomitant co-morbidities like systemic autoimmune disorders, chronic active infections like tuberculosis, hepatitis B, hepatitis C and human immunodeficiency virus infection, chronic liver disease, and chronic obstructive pulmonary disease.\n7. Renal or other organ transplantation before, or expected during, the study, except for corneal transplants.\n8. Morbid obesity defined as BMI ≥ 40 kg\u002Fm2 at screening.\n9. Uncontrolled diabetes as defined by HbA1c \\> 8% at screening.\n10. History or diagnosis of demyelinating diseases such as multiple sclerosis or optic neuritis.\n11. Prohibited medications:\n\n    * Participants who received oral steroids over two weeks within 12 weeks before screening.\n    * Immunosuppressive medications (e.g., MMF, azathioprine, cyclophosphamide, hydroxychloroquine) for treating IgAN within 12 weeks before screening.\n    * Use of B-cell-directed biologic therapies, including belimumab, rituximab, and ocrelizumab, within six months before screening.\n    * Use of other biologics (e.g., anti-TNF, abatacept, anti-IL-6) and investigational biologics within the last four weeks or five half-lives, whichever is longer, before the screening.\n    * Use of traditional medications and\u002For Ayurvedic medications within 12 weeks before screening.\n    * Use of endothelin receptor antagonists\u002F oral spironolactone or oral finerenone\u002F GLP-1 agonists\u002F hydroxychloroquine within 12 weeks before screening.\n12. Patients with a history of unstable angina, Class III and IV congestive heart failure, and clinically significant arrhythmia, as judged by the Investigator.\n13. Active clinically significant viral, bacterial, or fungal infection or any major episode of infection requiring hospitalisation or treatment with parenteral anti-infectives within four weeks before or during the Screening Visit.\n14. History of malignancy within the past five years before Screening (except for adequately treated basal cell carcinoma or non-metastatic squamous cell carcinoma of the skin or cervical carcinoma in situ, with no evidence of recurrence).\n15. Known hypersensitivity to any of the interventions.\n16. Major surgery within six weeks before the Screening Visit.\n17. Clinically significant history of alcohol or drug abuse in the one year before the Screening Visit as per the Investigator's opinion.\n18. Unwillingness or lack of capacity to follow all study procedures.","65 Years",{"count":270,"type":22},585,[272],"PHASE4","Global Burden of Diseases ranks chronic kidney disease (CKD) as the 12th leading cause of death, with an estimated 20% increase from 2010 to 2019. India is the most populous country in South Asia, with one-fourth of the global population. CKD prevalence has reached epidemic proportions in South Asia, with 1 in 7 adults affected by it. Glomerular diseases are the most common cause of CKD after diabetes and hypertension. IgAN is the most common primary glomerular disease in adults. In the Caucasian and East Asian populations, IgAN results in end-stage kidney disease (ESKD) in 15-20% of patients within 15-20 years after the first clinical presentation.\n\nOur first prospective observational (GRACE-IgANI) cohort since 2015 showed that South Asians have severe and progressive IgAN, with 39% having a rapid fall in eGFR, 25% having non-remission of proteinuria, and 36% reaching an adverse kidney outcome at three years. Our group has shown that South Asian ethnicity is associated with a severe phenotype, rapid progression, and significant ethnic differences in biomarkers.\n\nOver the last few years, newer anti-proteinuric agents and immunomodulatory drugs have either been approved by the FDA or are in the late phases of clinical trials for various proteinuric kidney diseases. The results of the STOP-IgAN and the recent TESTING trial have shown that the short-term beneficial effects of steroids on proteinuria and eGFR slope at six months wane over time, and there is a need for effective longer-term agents. The KDIGO guidelines development body on glomerular diseases has actively advocated enrolling patients prospectively in 'Clinical Trials'.\n\nPlatform trials are Multi-Arm and Multi-Stage (MAMS) randomised CTs comparing multiple parallel interventional groups against standardised common control groups with central coordination. It allows new interventions to be added, the control group to be updated throughout the trial, and the use of prespecified interim analysis plans for statistical efficiencies. Interventional groups can be introduced after the trial has started based on pre-specified criteria, and futile interventions may be stopped based on pre-specified interim analyses and trial-stopping rules.\n\nThis is a randomised controlled single-blind (outcome assessor) Platform trial, Multi-Arm and Multi-Stage. There is a single overarching protocol called a Master protocol. The master protocol, the common concurrent control arm for multiple interventions,the within-trial adaptations, the pre-specified interim analyses, and the pragmatic nature ensure greater acceptability and allow key trial characteristics to evolve. The overall strategy of the study relies strongly on pragmatic 'real world clinical situations' faced by practising nephrologists when treating adult patients with kidney biopsy-proven primary IgAN in South Asia. It will establish the 'GRACE Clinical Trial Network'.\n\nThe overarching trial hypothesis is that commonly available and approved generic drugs (low-dose oral prednisolone, gut-directed budesonide, mycophenolate mofetil, and hydroxychloroquine) in addition to Standard of Care (SoC), which is the maximal labelled or tolerated dose of renin-angiotensin system blockers (ACEi\u002F ARB) and a steady dose of sodium-glucose cotransporter 2 inhibitors (SGLT2i) can significantly improve the kidney outcomes at two years when compared to Standard of Care (SoC) alone in South Asian kidney biopsy-proven adult (≥18 years) primary IgAN who on follow-up remain at high risk of progression defined as UPCR ≥0.75g\u002Fg and baseline eGFR ≥20ml\u002Fmin\u002F1.73m2 despite good BP control. SoC is defined as a maximal labelled or tolerated dose of ACEi\u002F ARB and a steady dose of SGLT2i with a goal BP \\\u003C140\u002F90 mmHg for at least three months.",[275,276,26,277],"IgA Nephropathy","Renal Insufficiency, Chronic","IGA Glomerulonephritis",[279,280,281,275,282,283,26,284,285],"Platform Trial","Randomised Embedded Trial","MAMS Trial","Chronic kidney disease","Glomerulonephritis","Single blind","Treatment","2025-07-10",{"date":288,"type":38},"2025-07-14",{"date":290,"type":38},"2025-02-15",{"date":292,"type":22},"2029-08",{"name":294,"class":152},"Christian Medical College, Vellore, India",12]