[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100584485":3},{"organization":4,"armGroups":7,"interventions":18,"overallOfficials":23,"centralContacts":24,"locations":33,"responsibleParty":46,"collaborators":50,"id":54,"slug":23,"hasResults":55,"nctId":56,"briefTitle":57,"officialTitle":58,"acronym":59,"eligibilityCriteria":60,"healthyVolunteers":55,"sex":61,"minAge":62,"maxAge":23,"enrollmentInfo":63,"targetDuration":23,"studyType":66,"phases":67,"briefSummary":69,"conditions":70,"keywords":74,"overallStatus":36,"whyStopped":23,"lastUpdateSubmitDate":77,"lastUpdatePostDateStruct":78,"startDateStruct":81,"completionDateStruct":83,"leadSponsor":85,"locationsCount":86},{"fullName":5,"class":6},"Helsinki University Central Hospital","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Daratumumab as a single agent therapy","ACTIVE_COMPARATOR","Daratumumab",[13],"Drug: Daratumumab",{"label":15,"type":10,"description":16,"interventionNames":17},"Daratumumab combined with stem cell transplantation","Daratumumab in combination with stem cell transplantation",[13],[19],{"type":20,"name":11,"description":21,"armGroupLabels":22,"otherNames":23},"DRUG","All patients will receive either fixed-dose daratumumab as a single agent therapy or fixed-dose daratumumab combined with stem cell transplantation.",[9,15],null,[25,30],{"name":26,"role":27,"phone":28,"phoneExt":23,"email":29},"Minna Seppälä, MD","CONTACT","+358 50 427 1087","minna.seppala@hus.fi",{"name":31,"role":27,"phone":23,"phoneExt":23,"email":32},"Kati Kaartinen, PhD","kati.kaartinen@hus.fi",[34],{"facility":35,"status":36,"city":37,"state":23,"zip":23,"country":38,"countryCode":39,"cosmosGeoPoint":40,"geoPoint":45,"contacts":23},"Helsinki University Hospital","RECRUITING","Helsinki","Finland","FI",{"type":41,"coordinates":42},"Point",[43,44],24.93545,60.16952,{"lat":44,"lon":43},{"type":47,"investigatorFullName":48,"investigatorTitle":49,"investigatorAffiliation":5,"oldNameTitle":23,"oldOrganization":23},"PRINCIPAL_INVESTIGATOR","Minna Seppälä","MD",[51],{"name":52,"class":53},"Janssen, L.P. - Investigator Initiated Studies Program","UNKNOWN","100584485",false,"NCT06889948","The Effect of Daratumumab in Patients with Monoclonal Gammopathy of Renal Significance (MGRS) in Finland","Daratumumab in Monoclonal Gammopathy of Renal Significance in Finland","DAMOCLES","Inclusion Criteria:\n\n1. Males or females ≥ 18 years of age\n2. Subject has provided informed consent prior to initiation of the study or subject's legally acceptable representative has provided informed consent prior to the study when the subject has any kind of condition that, in the opinion of the investigator, may compromise the ability of the subject to give written informed consent.\n3. Renal biopsy confirmed MGRS-disease\n\n   * Renal biopsy must not be older than 3 months before informed consent. However, if renal biopsy is older than 3 mo and the study team is convinced that major histological changes have not occurred, a biopsy older than that can exceptionally be accepted.\n   * Renal transplant patients are allowed\n4. Amount of proteinuria ≥ 500 mg\u002F24 h OR eGFR ≥ 20 ml\u002Fmin prior to the study\n5. Previous anticlonal treatment is allowed if deemed ineffective\n\nExclusion Criteria:\n\n1. Myeloma or systemic AL amyloidosis (smoldering myeloma sized plasma cell clone is allowed when in association with a documented MGRS condition and AHL amyloidosis and AH amyloidosis are included)\n2. Cancer that requires treatment,\n3. MGRS related to B-cell malignant disorders,\n4. Known HIV infection, active hepatitis C infection (subjects with hepatitis C that achieve a sustained virologic response after antiviral therapy are allowed), or hepatitis B infection (subjects with hepatitis B surface antigen or core antibody that achieve sustained virologic response (PCR negativity in HBVNh) with antiviral therapy are permitted with a requirement for regular monitoring for reactivation for the duration of treatment on the study),\n5. Pregnancy or breastfeeding,\n6. Cyclophosphamide within 6 months of enrollment, or oral high-dose prednisone or equivalent within 6 weeks of enrollment;\n\n   * prednisone or its equivalent at a dosage of ≤10 mg daily for a condition unrelated to MGRS (e.g. asthma or gout) allowed.\n   * mycophenolate mofetil (MMF), calcineurin inhibitors (CNI) or azathioprine treated patients are eligible if proteinuria is not improving or if kidney function is declining despite treatment with these medications. Once therapy with daratumumab started, these medications need to be discontinued unless they are used as immunosuppressive medication due to renal transplantation.\n7. In patients who previously received rituximab, reconstitution of B cells (CD19 normalized, Ly-B-CD19 lab.code 8329) required.\n8. Inability to use daratumumab and to comply with the study protocol as assessed by treating nephrologist and\u002For hematologist (e.g. severe psychiatric illness, severe lung disease, known allergy to daratumumab)","ALL","18 Years",{"count":64,"type":65},30,"ESTIMATED","INTERVENTIONAL",[68],"PHASE2","The goal of this clinical trial is to learn if drug daratumumab works to treat kidney diseases other than AL-amyloidosis that fall under the category of monoclonal gammopathy of renal significance (MGRS).\n\nThe main questions it aims to answer are:\n\nDoes daratumumab have an effect on the patients' renal function or the amount of proteinuria?\n\nDoes daratumumab have an effect on the hematological endpoints evaluated by minimal residual disease (MRD) and the difference between involved and uninvolved free light chain (dFLC)?\n\nAlso changes in quality of life (according to EORTC QLQ-C30) and mechanism of complement system activation are evaluated. The number of patiets with partial or very good partial hematological remission and the number of patients with adverse events related to daratumumab are also recorded.",[71,72,73],"Kidney Failure","Paraproteinemias","Glomerulonephritis",[75,76],"Monoclonal gammopathy of renal significance","daratumumab","2025-03-17",{"date":79,"type":80},"2025-03-21","ACTUAL",{"date":82,"type":80},"2024-01-19",{"date":84,"type":65},"2027-06",{"name":5,"class":6},1]