[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"renal-al-amyloidosis\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:renal-al-amyloidosis":26},{"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":13,"acronym":14,"eligibilityCriteria":15,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":18,"targetDuration":4,"studyType":21,"phases":22,"briefSummary":24,"conditions":25,"keywords":4,"overallStatus":27,"whyStopped":4,"lastUpdateSubmitDate":28,"lastUpdatePostDateStruct":29,"startDateStruct":32,"completionDateStruct":34,"leadSponsor":36,"locationsCount":5},"100548374","phase-2-dapagliflozin-in-renal-al-amyloidosis-floral-100548374",false,"NCT06420167","DapagliFLOzin in Renal AL Amyloidosis (FLORAL)","FLORAL","Inclusion Criteria:\n\n* Provision of signed and dated informed consent form.\n* Stated willingness to comply with study procedures, including remote telehealth consultations with the study team, confirming availability, and agreeing to use mobile\u002Fweb applications for study purposes.\n* Age ≥18 years.\n* Histopathologic diagnosis of renal AL amyloidosis confirmed by biopsy of any tissue and evidence of \\>1.0 g\u002Fday proteinuria without any other identifiable cause.\n* Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) 0, 1 or 2.\n* Plateau in any renal response (i.e., reduction in proteinuria) for at least 3 months prior to enrollment, as determined by the enrolling physician.\n* Residence in the state of Michigan.\n\nExclusion Criteria:\n\n* Either ongoing first line induction with anti-plasma cell therapy or ongoing post- induction maintenance for \\\u003C6 months prior to enrollment.\n* Diagnosis of symptomatic multiple myeloma, including presence of lytic bone disease, plasmacytomas, ≥60% plasma cells in the bone marrow, or hypercalcemia, either currently or in the past.\n* Women of child-bearing potential (i.e., those who have not undergone chemical or surgical sterilization or are not postmenopausal) and who are unwilling to use a medically accepted and reliable form of contraception while participating in the study and for 2 weeks following the last dose of study medication, as determined by the investigator, or have a positive pregnancy test at the time of enrolment or are currently breastfeeding.\n* Known allergic reactions to components of the dapagliflozin.\n* Treatment requiring type 1 or type 2 diabetes mellitus.\n* Baseline eGFR \\\u003C25 mL\u002Fmin\u002F1.73m2.\n* Acute or chronic liver disease with severe impairment of liver function (e.g., ascites, esophageal varices or coagulopathy)\n* Current or previous use of any SGLT2i.\n* Initiation or dose modification of angiotensin converting enzyme inhibitors (ACE inhibitors) and angiotensin receptor blockers (ARBs) \\\u003C3 months prior to enrollment.\n* Active malignancy requiring treatment (other than AL amyloidosis and non-melanoma skin cancers).","ALL","18 Years",{"count":19,"type":20},20,"ESTIMATED","INTERVENTIONAL",[23],"PHASE2","The goal of this clinical trial is to learn if an oral drug called dapagliflozin is safe and can reduce high protein levels in the urine of patients with renal amyloid light-chain (AL) amyloidosis using a decentralized study design.\n\nParticipants will be:\n\n* screened for the trial via an online platform\n* contacted by study personal to obtain electronic consent\n* enrolled in the trial if eligible and consented\n* contacted by study personal for further instructions and directions\n* sent dapagliflozin oral medication (supplied by the site pharmacy)\n* followed up regularly with the study team via telemedicine or other online avenues\n* monitored using lab work, inquiries about side effects and assessment of protocol adherence at 1 month, 3 months and 6 months\n* continue treatment for 6 months",[26],"Renal AL Amyloidosis","RECRUITING","2026-06-23",{"date":30,"type":31},"2026-06-26","ACTUAL",{"date":33,"type":31},"2024-07-11",{"date":35,"type":20},"2028-04",{"name":37,"class":38},"Barbara Ann Karmanos Cancer Institute","OTHER"]