[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"leadSponsorName\":\"Mao Jianhua\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":122},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,4,0,[8,41,67,94],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":4,"eligibilityCriteria":15,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":18,"enrollmentInfo":19,"targetDuration":4,"studyType":22,"phases":23,"briefSummary":25,"conditions":26,"keywords":4,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":29,"lastUpdatePostDateStruct":30,"startDateStruct":33,"completionDateStruct":35,"leadSponsor":37,"locationsCount":40},"100599655","phase-2-a-study-of-anti-cd38-monoclonal-antibody-sg301-subcutaneous-injection-in-children-with-nephrotic-syndrome-with-frequent-relapses-or-steroid-dependence-100599655",false,"NCT07087314","A Study of Anti-CD38 Monoclonal Antibody (SG301) Subcutaneous Injection in Children With Nephrotic Syndrome With Frequent Relapses or Steroid Dependence","A Clinical Study to Evaluate the Initial Efficacy and Safety of Anti-CD38 Monoclonal Antibody (SG301) Subcutaneous Injection in Children With Frequent Relapses or Steroid-Dependent Nephrotic Syndrome","Inclusion Criteria:\n\n1. Aged 6 - 18 years.\n2. Steroid-sensitive nephrotic syndrome with frequent relapses (FRNS) or steroid dependence (SDNS).\n3. Normal renal function: eGFR≥90 ml\u002Fmin\u002F1.73m².\n4. After steroid treatment, morning urine protein\\\u003C1 + or urine protein\u002Fcreatinine\\\u003C0.2 g\u002Fg (\\\u003C20 mg\u002Fmmol) for ≥3 consecutive days.\n5. Within 7 days before enrollment, blood tests (without growth factors or transfusions) must meet: hemoglobin\\>80 g\u002FL; platelets\\>75×10⁹\u002FL; neutrophils\\>1.5×10⁹\u002FL.\n6. Prothrombin time\u002FINR≤1.5×ULN, unless due to anticoagulation.\n7. No Tacrolimus, cyclosporine A, mycophenolate mofetil, belimumab, levamisole, azathioprine, or cyclophosphamide in prior 2 months; no rituximab or obinutuzumab in prior 6 months.\n\nExclusion Criteria:\n\n1. Family history of nephrotic syndrome, chronic glomerulonephritis, or uremia.\n2. Alanine aminotransferase \\>2×ULN or total bilirubin\\>2×ULN with a sustained increase for 2 weeks.\n3. HBsAg or HBcAb positive with Hepatitis B virus DNA above the lower limit of normal; Hepatitis C virus antibody - positive with Hepatitis C virus RNA positive; HIV antibody - positive.\n4. Chronic active infections (e.g., Epstein-Barr Virus, Cytomegalovirus, tuberculosis) that may worsen with steroids\u002F immunosuppressants.\n5. Acute active infection (excluding onychomycosis) requiring systemic antibiotics\u002Fantivirals.\n6. Secondary nephrotic syndrome (e.g.,immunoglobulin A - associated, lupus nephritis); steroid - resistant nephrotic syndrome (SRNS).\n7. Other autoimmune diseases, primary immunodeficiency, or malignancy.\n8. Prior anti - cluster of differentiation 38 (CD38) treatment.\n9. Live\u002Fattenuated vaccine receipt or major surgery (non - diagnostic) within 4 weeks before first dose.","ALL","6 Years","18 Years",{"count":20,"type":21},30,"ESTIMATED","INTERVENTIONAL",[24],"PHASE2","This is an open - label study to evaluate the safety, pharmacokinetics, pharmacodynamics, and preliminary efficacy of SG301 Subcutaneous injection in children with frequently relapsing or steroid - dependent nephrotic syndrome.",[27],"Nephrotic Syndrome in Children","RECRUITING","2026-02-26",{"date":31,"type":32},"2026-02-27","ACTUAL",{"date":34,"type":32},"2025-08-25",{"date":36,"type":21},"2029-07-09",{"name":38,"class":39},"Mao Jianhua","OTHER",1,{"id":42,"slug":43,"hasResults":11,"nctId":44,"briefTitle":45,"officialTitle":46,"acronym":4,"eligibilityCriteria":47,"healthyVolunteers":11,"sex":16,"minAge":48,"maxAge":49,"enrollmentInfo":50,"targetDuration":4,"studyType":22,"phases":52,"briefSummary":54,"conditions":55,"keywords":4,"overallStatus":58,"whyStopped":4,"lastUpdateSubmitDate":59,"lastUpdatePostDateStruct":60,"startDateStruct":62,"completionDateStruct":64,"leadSponsor":66,"locationsCount":40},"100622837","study-of-ripertamab-in-children-with-frequent-relapses-or-steroid-dependent-nephrotic-syndrome-100622837","NCT07388810","Study of Ripertamab in Children With Frequent Relapses or Steroid-Dependent Nephrotic Syndrome","Study of Different Doses of Ripertamab in Children With Frequent Relapses or Steroid-Dependent Nephrotic Syndrome：An Open-label Randomized Controlled Trial","Inclusion Criteria:\n\n1. 16 years old and above with FRNS\u002FSDNS\n2. Before enrollment, achieved complete remission (urine protein\u002Fcreatinine ratio (morning urine or 24-hour urine) ≤ 20mg\u002Fmmol (0.2mg\u002Fmg) or \\\u003C 100mg\u002Fm2\u002Fd, or test strip result negative or trace)\n3. Within 2 months before enrollment, did not use levamisole, alkylating agents such as cyclophosphamide, calcineurin inhibitors such as cyclophosphamide and cyclosporine, or mycophenolate mofetil. Within 6 months before enrollment, did not use other CD20 monoclonal antibodies (such as ofatumumab, otuzumab, etc., excluding rituximab)\n4. Glomerular filtration rate (eGFR) \\> 60ml\u002Fmin\u002F1.73m2\n5. The patient or their guardian agrees to participate in this clinical trial and signs the informed consent form, indicating that they understand the purpose and procedures of this clinical trial and are willing to participate in the study\n\nExclusion Criteria:\n\n1. Known causes (such as systemic lupus erythematosus, IgA nephropathy, other secondary nephrotic syndromes, amyloidosis, malignant tumors, etc.)\n2. Known active chronic infections, including tuberculosis, HIV, HBV, HCV, etc.\n3. Severe leukopenia (white blood cells \\\u003C 3.0×109\u002FL), severe anemia (hemoglobin \\\u003C 8.9 g\u002Fdl), thrombocytopenia (platelets \\\u003C 100×109\u002FL), or liver dysfunction (alanine aminotransferase\u002Faspartate aminotransferase \\> 2 times the upper limit of normal)\n4. Received live vaccines within 1 month prior to screening\n5. Currently participating in other drug clinical trials\n6. Other conditions that the investigator deems make the patient unsuitable for this study","1 Year","16 Years",{"count":51,"type":21},312,[53],"NA","This is an open-label randomized controlled trial to evaluate the efficacy and safety of one dose versus two doses of ripertamab in children with frequent relapses or steroid-dependent nephrotic syndrome (FRNS\u002FSDNS).",[56,57],"FRNS\u002FSDNS","Ripertamab","NOT_YET_RECRUITING","2026-01-29",{"date":61,"type":32},"2026-02-05",{"date":63,"type":21},"2026-02",{"date":65,"type":21},"2028-02",{"name":38,"class":39},{"id":68,"slug":69,"hasResults":11,"nctId":70,"briefTitle":71,"officialTitle":72,"acronym":73,"eligibilityCriteria":74,"healthyVolunteers":11,"sex":16,"minAge":75,"maxAge":4,"enrollmentInfo":76,"targetDuration":4,"studyType":22,"phases":78,"briefSummary":80,"conditions":81,"keywords":4,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":85,"lastUpdatePostDateStruct":86,"startDateStruct":88,"completionDateStruct":90,"leadSponsor":92,"locationsCount":93},"100576731","phase-1-blinatumomab-in-refractory-active-childhood-systemic-lupus-erythematosus-100576731","NCT06789107","Blinatumomab in Refractory Active Childhood Systemic Lupus Erythematosus","Clinical Trial of Blinatumomab in Refractory\u002FActive Systemic Lupus Erythematosus in Children","BRASLE","Inclusion Criteria:\n\nParticipants must meet all the following criteria to be eligible for enrollment:\n\n1. Age: ≥ 5 years old.\n2. Diagnosis: Diagnosed with systemic lupus erythematosus (SLE) based on the 2019 EULAR\u002FACR classification criteria.\n3. Positive Antibody: At least one of the following antibodies positive within 12 months before screening or during the screening period:\n\n   * Antinuclear antibody (ANA) ≥ 1:80.\n   * Anti-double-stranded DNA (anti-dsDNA) antibody above the upper limit of normal (ULN).\n   * Anti-Smith (Anti-Sm) antibody above the ULN.\n4. Treatment Resistance: Inadequate response to at least three of the following:\n\n   * Oral corticosteroids (OCS),\n   * Antimalarials,\n   * Conventional immunosuppressants (e.g., cyclophosphamide, mycophenolate mofetil, azathioprine, methotrexate, cyclosporine, tacrolimus, sirolimus, leflunomide),\n   * Biologics (e.g., TULIP-2, belimumab, rituximab). At least one treatment must involve immunosuppressants or biologics.\n5. SLEDAI-2000 Score: ≥ 6 based on the SLEDAI-2000 scoring system.\n6. Stable Standard Treatment: Currently receiving one or more of the following treatments at a stable dose:\n\n   * OCS (e.g., prednisone acetate or equivalent) at a stable dose for ≥7 days prior to initiation;\n   * Antimalarials: Dose stable for at least 7 days prior to the first dose.\n   * Conventional immunosuppressants: Stable dose for at least 4 weeks before screening and throughout the study.\n7. Laboratory Parameters:\n\n   * Absolute lymphocyte count (ALC) ≥ 0.5 × 10⁹\u002FL.\n   * Peripheral CD19+ B cell count ≥ 25 cells\u002FμL.\n   * Absolute neutrophil count (ANC) ≥ 0.5 × 10⁹\u002FL.\n   * Hemoglobin ≥ 80 g\u002FL.\n   * Platelet count ≥ 75 × 10⁹\u002FL \\*.\n   * Left ventricular ejection fraction (LVEF) ≥ 55% with no significant ECG abnormalities.\n   * Estimated glomerular filtration rate (eGFR) ≥ 30 mL\u002Fmin\u002F1.73m².\n   * Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤ 3 × ULN; total bilirubin ≤ 2 × ULN.\n   * No severe pulmonary lesions, SpO₂ ≥ 92%.\n8. Contraception: Female participants of childbearing potential must have a negative urine pregnancy test and agree to use effective contraception during the study and for 1 year after infusion.\n9. Informed Consent: The participant and their legal guardian must provide written informed consent, demonstrating understanding of the study objectives and willingness.\n\n   * Note: For SLE patients with thrombocytopenia below the inclusion threshold due to immune-related causes, and without active bleeding, investigators may use clinical discretion to determine eligibility.\n\nExclusion Criteria:\n\nParticipants meeting any of the following criteria will be excluded:\n\n1. Central nervous system disease: active or unstable lupus-related neuropsychiatric disease within 60 days, including epilepsy, confusion, cerebrovascular events, etc.;\n2. Acute severe nephritis: renal replacement therapy within 3 months before the screening period or ongoing, or significant kidney disease that, in the opinion of the investigator, may occur and lead to the need for high-dose glucocorticoid (prednisone dose ≥ 2 mg\u002Fkg\u002Fd or equivalent of other hormones), cyclophosphamide or escalated MMF treatment within the first 3 months of the study;\n3. Severe antiphospholipid syndrome within 12 months before or during screening；\n4. Congenital heart disease or a history of acute myocardial infarction within 6 months before screening, or severe arrhythmia (including polymorphic ventricular tachycardia, ventricular tachycardia, etc.); or combined with moderate to large pericardial effusion, severe myocarditis, etc.; or unstable vital signs, patients who need blood pressure-raising drugs to maintain blood pressure;\n5. Suffering from other diseases that require long-term administration of glucocorticoids or immunosuppressive agents;\n6. Having active infections or uncontrollable infections that require systemic treatment within one week before screening;\n7. Having received solid organ transplantation or hematopoietic stem cell transplantation within three months before screening; or having grade 2 or higher acute graft-versus-host disease (GVHD) within two weeks before screening;\n8. History of severe recurrent or chronic infections, especially recurrent or chronic infections associated with respiratory problems.\n9. Immunoglobulin G levels below the lower limit (5-8 years: \\\u003C4.5 g\u002FL, 9 years and older: \\\u003C6.0 g\u002FL);\n10. History of hepatitis B virus (HBV) infection or positive serology indicating current or past HBV infection. Human immunodeficiency virus (HIV; positive HIV antibody test) and active hepatitis C virus (HCV) infection (detectable HCV ribonucleic acid \\[RNA\\]). Active cytomegalovirus (CMV) or Epstein-Barr virus (EBV) infection;\n11. A history of tuberculosis or active tuberculosis; or latent tuberculosis treated before the baseline; or subjects with an indeterminate test result who screened positive for PPD or T-spot can be retested, but if the repeat test is also indeterminate, they are excluded;\n12. Had a history of macrophage activation syndrome within 1 month prior to screening;\n13. Had received any anti-CD19 or anti-CD20 therapy, such as rituximab, obinutuzumab, ocrelizumab, or ofatumumab, within 3 months prior to screening or during screening;\n14. Received a JAK inhibitor, Bruton tyrosine kinase (BTK) inhibitor, or tyrosine kinase 2 (TYK2) inhibitor, such as baricitinib, tofacitinib, upadacitinib, filgotinib, ibrutinib, or zanubrutinib and Fenebrutinib, during screening;\n15. Treatment with cyclophosphamide or a biologic agent within 4 weeks prior to enrollment, including but not limited to adalimumab, etanercept, golimumab, infliximab, Infliximab), Belimumab, Ustekinumab, Anifrolumab, Secukinumab, or Atacicept;\n16. Intolerance or contraindication to the investigational therapy, including a history of severe allergies or allergic reactions to monoclonal antibodies, or a known hypersensitivity to any of the ingredients in belimumab injection;\n17. Live vaccine within 4 weeks prior to screening;\n18. Positive blood pregnancy test;\n19. Patients with known malignant diseases such as tumors before screening;\n20. Patients who have participated in other clinical trials within 3 months prior to enrollment;\n21. Patients with depression or suicidal tendencies;\n22. Other situations where the investigator believes the patient is not suitable for participation in the study.","5 Years",{"count":77,"type":21},6,[79],"PHASE1","The goal of this clinical trial is to learn if blinatumomab works to treat refractory or active systemic lupus erythematosus (SLE) in children and adults. It will also learn about the safety of blinatumomab. The main questions it aims to answer are:\n\nDoes blinatumomab improve symptoms and disease activity in refractory\u002Factive SLE? What side effects or adverse events do participants experience when taking blinatumomab?\n\nParticipants will:\n\nReceive two courses of blinatumomab injections over five consecutive days each Be monitored for 52 weeks to evaluate the treatment's safety and effectiveness Undergo regular blood tests and assessments of disease activity during follow-up visits Researchers will collect data on changes in serological markers, disease symptoms, and adverse events throughout the study.",[82,83,84],"Systemic Lupus Erythematosus (SLE)","Children","Blinatumomab","2025-11-22",{"date":87,"type":32},"2025-11-28",{"date":89,"type":32},"2024-12-08",{"date":91,"type":21},"2027-12-07",{"name":38,"class":39},2,{"id":95,"slug":96,"hasResults":11,"nctId":97,"briefTitle":98,"officialTitle":98,"acronym":4,"eligibilityCriteria":99,"healthyVolunteers":11,"sex":16,"minAge":100,"maxAge":101,"enrollmentInfo":102,"targetDuration":4,"studyType":22,"phases":104,"briefSummary":106,"conditions":107,"keywords":108,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":113,"lastUpdatePostDateStruct":114,"startDateStruct":116,"completionDateStruct":118,"leadSponsor":120,"locationsCount":121},"100522220","phase-3-study-of-adrenocorticotropic-hormone-on-children-with-frequent-relapse-or-steroid-dependent-nephrotic-syndrome-a-prospective-multicenter-randomizedopen-label-clinical-trial-100522220","NCT06079788","Study of Adrenocorticotropic Hormone on Children With Frequent Relapse or Steroid-dependent Nephrotic Syndrome: a Prospective, Multicenter, Randomized，Open-label Clinical Trial.","Inclusion Criteria:\n\n1. Age 2-14 years old;\n2. Sensitive but frequent relapses or steroids dependence nephrotic syndrome\n3. No severe hormonal side effects and\u002For low-dose steroids dependent idiopathic nephrotic syndrome in children (defined as two relapses with an average dose \\\u003C 0.5mg\u002Fkg\u002Fday or equivalent alternate-day dose)\n4. Normal renal function: eGFR≥90ml\u002Fmin\u002F1.73m2;\n5. Morning urine protein \\\u003C1+ or urine protein-creatinine ratio \\\u003C0.2g\u002Fg (\\\u003C20 mg\u002Fmmol) for 3 consecutive days and above when in enroll;\n6. Prednisone dose was 1.5-2 mg\u002Fkg per day before admission;\n7. No use of other immunosuppressants (such as tacrolimus, mortecophenolate, cyclosporin A, cyclophosphamide, levamisole, imidazole ribin, or tripterygium, etc.) within 3 months, and no use of rituximab or beliumab within 6 months.\n\nExclusion Criteria:\n\n1. Family history of nephrotic syndrome, chronic glomerulonephritis, uremia and other kidney diseases;\n2. Patients with congenital or acquired immunodeficiency, or with active tuberculosis, active CMV, EBV, hepatitis B, hepatitis C, HIV infection, deep fungal infection, or other active infections;\n3. Recurrent or persistent hypertension;\n4. Secondary nephrotic syndrome, such as nephrotic syndrome secondary to systemic lupus erythematosus, diabetes, drug poisoning and infection;\n5. Combined with other kidney diseases, such as polycystic kidney, ANCA vasculitis, urinary system malformations, etc.;\n6. Patients with hypertension, diabetes, tuberculosis, suppurative or fungal infection, gastric and duodenal ulcer disease and heart failure; Patients with other serious heart, liver and other important organs, blood system, endocrine system and other system lesions;\n7. Co-occurrence of other monogenic genetic diseases known to affect the condition of nephrotic syndrome;\n8. Patients with serious autoimmune diseases or tumors;\n9. Use of other immunosuppressants (such as tacrolimus, mortecophenolate, cyclosporin A, cyclophosphamide, levamisole, imidazole ribin, or tripterygium, etc.) within 3 months, and no use of rituximab or beliumab within 6 months;\n10. Patients who are known to be allergic to ACTH, glucocorticoids, or any of the components of these drugs, and patients with severe hormone-related side effects\n11. History of organ transplantation (excluding corneal and hair transplantation);\n12. Patients who had participated in other clinical trials within three months prior to enrollment;\n13. Any patient whom the investigator determines is not suitable for inclusion in the trial.","2 Years","14 Years",{"count":103,"type":21},140,[105],"PHASE3","Primary nephrotic syndrome accounts for approximately 90% of the total number of nephrotic syndrome in childhood and it is the most common glomerular disease in children. Although treatment with steroids is useful for primary nephrotic syndrome, proving to cause frequent relapse\u002Fsteroid-dependent nephrotic syndrome after treatment and the usage of immunosuppressive agents has become a new choice for the treatment of such patients. This study is a prospective, multicenter, randomized，open-label clinical trial, evaluating the efficacy and safety of steroid combined with adrenocorticotrophic hormone（ACTH） to children who with frequently relapsing or steroid-dependent nephrotic syndrome, all we wish to obtain the proper drug choice and individualized treatment options for children with nephrotic syndrome.",[27],[109,110,111,112],"Nephrotic Syndrome","Frequently Relapsing Nephrotic Syndrome","Steroid Dependent Nephrotic Syndrome","Adrenocorticotropic Hormone","2023-10-08",{"date":115,"type":32},"2023-10-12",{"date":117,"type":21},"2023-11-01",{"date":119,"type":21},"2026-12-31",{"name":38,"class":39},8,""]