[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"ahus---atypical-hemolytic-uremic-syndrome\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:ahus---atypical-hemolytic-uremic-syndrome":27},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,1,0,[8],{"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":4},"100491824","phase-2-study-of-nm8074-in-patients-with-ahus-with-evidence-of-ongoing-thrombotic-microangiopathy-100491824",false,"NCT05684159","Study of NM8074 in Patients With aHUS With Evidence of Ongoing Thrombotic Microangiopathy","A Phase II, Open-Label Study of NM8074 in Patients With Atypical Hemolytic Uremic Syndrome (aHUS)","Inclusion Criteria:\n\n* Patients ≥ 18 years at the time of consent\n* Patients with evidence of resistant or relapsed complement-mediated aHUS with symptoms of Thrombocytopenia, hemolysis, ongoing Thrombotic Microangiopathy and acute kidney injury.\n* Evidence of ongoing Thrombotic Microangiopathy which includes Haptoglobin \\\u003CLLN or undetectable and\u002For presence of schistocytes\n* Acute kidney injury (proteinuria\u002Fcreatinuria \\> ULN and\u002For reduced eGFR)\n* Platelets less than 150,000 per microliter (Thrombocytopenia)\n* Anemia (Hemoglobin ≤10 g\u002FdL) due to hemolysis\n* Lactate dehydrogenase (LDH) level ≥ 1.5 times the upper limit of normal (xULN) during Screening\n* All patients must be vaccinated prior to dosing with MenACWY Menactra® polysaccharide diphtheria toxoid conjugate vaccination against Neisseria meningitidis serogroups A, C, Y, and W-135 and MenB meningococcal serogroup B vaccine (Bexsero®). If the window of vaccination is short, then patients will be prophylactically treated with appropriate antibiotics\n* Willing and able to understand and complete informed consent procedures, including signing and dating the informed consent form (ICF), and comply with the study visit schedule.\n* Male patients and partners of child-bearing potential must agree to use contraceptives and male patients must agree to refrain from donating sperm for the duration of the study.\n* Female partners of child-bearing potential (WOCBP), defined as all women physiologically capable of becoming pregnant, must have a negative pregnancy test at screening and must agree to use highly effective methods of contraception during dosing and for 1 month after stopping the investigational drug.\n\nExclusion Criteria:\n\n* History of bone marrow, hematopoietic stem cell, or solid organ transplantation\n* Treatment with complement blockers\n* Patients with infections\n* HUS due to ADAMTS-13 deficiency (\\\u003C5%)\n* Kidney disease other than aHUS\n* Chronic dialysis (hemo or peritoneal)\n* Liver disease or other major autoimmune diseases\n* Typical HUS (Shiga toxin +)\n* Known Systemic Lupus Erythematosus (SLE), Systemic Sclerosis, or antiphospholipid antibody positivity or syndrome\n* History of currently active primary or secondary immunodeficiency\n* Currently active systemic infection or suspicion of active bacterial, viral, or fungal infection within 2 weeks prior to first dose, or history of unexplained, recurrent bacterial infections\n* Has a currently active or known history of meningococcal disease or N. meningitidis infection\n* Severe concurrent co-morbidities not amenable to active treatment, e.g., patients with severe kidney disease (CKD stage 4, chronic dialysis)\n* Females who have a positive pregnancy test result at Screening or on Day 1.\n* Pregnant, planning to become pregnant, or nursing female subjects.","ALL","18 Years","65 Years",{"count":20,"type":21},12,"ESTIMATED","INTERVENTIONAL",[24],"PHASE2","This is a Phase II, open-label study designed to determine if intravenously administered NM8074 results in remission from TMA in treatment-naïve aHUS patients.",[27],"aHUS - Atypical Hemolytic Uremic Syndrome","NOT_YET_RECRUITING","2026-04-07",{"date":31,"type":32},"2026-04-13","ACTUAL",{"date":34,"type":21},"2027-11",{"date":36,"type":21},"2031-02",{"name":38,"class":39},"NovelMed Therapeutics","INDUSTRY"]