[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"trial:NCT05650619":3,"trial-entities:NCT05650619":111,"trial-summary:NCT05650619":115},{"id":4,"nct_id":4,"org_study_id":5,"brief_title":6,"official_title":7,"overall_status":8,"completion_date":9,"status_verified_date":10,"last_update_date":11,"start_date":12,"sponsor_name":13,"lead_sponsor_class":14,"has_dmc":15,"brief_summary":16,"detailed_description":17,"conditions":18,"keywords":23,"study_type":29,"primary_purpose":15,"phases":30,"enrollment_info":31,"interventions":34,"primary_outcomes":46,"secondary_outcomes":52,"sex":65,"minimum_age":15,"maximum_age":15,"healthy_volunteers":66,"eligibility_criteria":67,"std_ages":75,"locations":79,"central_contacts":99,"overall_officials":107,"references":109,"see_also_links":110},"NCT05650619","HUM00221259","Recurrence Post-transplant Observational Study in Focal Segmental Glomerulosclerosis and Minimal Change Disease","Recurrence Post-transplant Observational Study in Focal Segmental Glomerulosclerosis (FSGS) and Minimal Change Disease (MCD)","RECRUITING","2027-12","2026-04","2026-04-29","2022-12-08","University of Michigan","OTHER",null,"The morbidity of recurrence of focal segmental glomerulosclerosis (FSGS) and minimal change disease (MCD) after transplant is well-recognized and include contemporary reduction in quality of life, edema, early graft loss and mortality. Efforts to understand its mechanisms and improve its treatment have been limited by small sample sizes in single center studies and misclassification in registry studies. Recent advances in the understanding of the mechanisms of FSGS in the native kidney has reinvigorated the scientific community to develop a collaborative community to advance research into the epidemiology, mechanisms, interventions, and outcomes.\n\nThe purpose of RESOLVE is to gather a group of people with FSGS and MCD that have had or will have a kidney transplant to create a bank of information and biospecimens so researchers can more effectively study these diseases.","RESOLVE is a multicenter, observational cohort study to examine the post-transplant course of patients with FSGS and MCD across the lifespan. The study is designed to collect both retrospective and prospective data as well as biospecimens and patient reported information. With multiple enrollment options, the study will allow investigators to define the incidence and prevalence of FSGS recurrence, describe the post-transplant course of patients with FSGS and MCD across the lifespan, and develop a biorepository to support future translational research studies to explore relevant disease mechanisms.",[19,20,21,22],"Focal Segmental Glomerulosclerosis","Minimal Change Disease","FSGS","MCD",[24,25,26,27,28],"Kidney disease","Kidney transplant","Adult","Children","Recurrence","OBSERVATIONAL",[],{"count":32,"type":33},300,"ESTIMATED",[35,41],{"type":14,"name":36,"description":37,"armGroupLabels":38},"Biospecimen collection","Specimens that may be collected include urine, blood, saliva, kidney tissue, etc. Biospecimens will be collected to establish the RESOLVE biobank.",[39,40],"Enrolled participant after transplant","Enrolled participants prior to transplant",{"type":14,"name":42,"description":43,"armGroupLabels":44},"Data collection","Data collection for all groups",[39,40,45],"Retrospective participant data",[47,50],{"measure":48,"timeFrame":49},"Time to FSGS Recurrence","2 years after transplant",{"measure":51,"timeFrame":49},"Time to Graft Failure",[53,56,58,60,63],{"measure":54,"description":55,"timeFrame":49},"Define the Endophenotypes in each group of recurrent FSGS and MCD","Classifications for the dataset using non-hierarchical clustering techniques",{"measure":57,"timeFrame":49},"Proportion of recurrence and time to graft failure",{"measure":59,"timeFrame":49},"Proportion with acute rejection",{"measure":61,"timeFrame":62},"Proteinuria change over time","Baseline (at transplant), 2 years",{"measure":64,"timeFrame":49},"Proportion with delayed graft function","ALL",false,{"inclusion":68,"exclusion":71,"raw_text":74},[69,70],"Retrospective non-consented participant group had a transplant from the year 2000 and onward.","Diagnosis of FSGS or MCD in the native kidney (prior to transplant).",[72,73],"Pathologic diagnosis other than FSGS or MCD","FSGS or MCD secondary to a known disorder (e.g. lupus nephritis, Immunoglobulin A (IgA) nephropathy, malignancy)","Inclusion Criteria:\n\n* Retrospective non-consented participant group had a transplant from the year 2000 and onward.\n* Diagnosis of FSGS or MCD in the native kidney (prior to transplant).\n\nExclusion Criteria:\n\n* Pathologic diagnosis other than FSGS or MCD\n* FSGS or MCD secondary to a known disorder (e.g. lupus nephritis, Immunoglobulin A (IgA) nephropathy, malignancy)",[76,77,78],"CHILD","ADULT","OLDER_ADULT",[80],{"facility":13,"status":8,"city":81,"state":82,"zip":83,"country":84,"contacts":85,"geoPoint":96},"Ann Arbor","Michigan","48109","United States",[86,90,93],{"role":87,"phone":88,"email":89},"CONTACT","734-232-4830","umkidneystudies@umich.edu",{"name":91,"role":92},"Eloise Salmon, MD","PRINCIPAL_INVESTIGATOR",{"name":94,"role":95},"Debbie Gipson, MD","SUB_INVESTIGATOR",{"lat":97,"lon":98},42.27756,-83.74088,[100,104],{"name":101,"role":87,"phone":102,"email":103},"Ashley Rahimi","734-647-5446","asboggs@med.umich.edu",{"name":91,"role":87,"phone":105,"email":106},"734-936-4210","salmonel@med.umich.edu",[108],{"name":91,"affiliation":13,"role":92},[],[],{"nct_id":4,"conditions":112,"biomarkers":114},[19,113],"Minimal Change Glomerulonephritis",[],{"nct_id":4,"found":116,"summary":117,"prompt_version":127},true,{"design":118,"status":119,"heading":120,"summary":121,"follow_up":122,"word_count":123,"commitments":124,"compensation":125,"drugs_mentioned":126},"This is an observational study with a planned enrollment of 300 participants. It will collect both past and current information, as well as biological samples.","completed","Observational Study for FSGS and MCD After Transplant","This observational study, called RESOLVE, is looking at people who have had a kidney transplant and were previously diagnosed with Focal Segmental Glomerulosclerosis (FSGS) or Minimal Change Disease (MCD). Researchers want to understand why these conditions sometimes come back after a transplant and how they affect the new kidney. They will collect information and samples like urine, blood, and kidney tissue to build a biobank for future research. The study aims to track how long it takes for FSGS to return and how long the transplanted kidney continues to work, both measured up to two years after transplant. You can join if you had a transplant in 2000 or later and had FSGS or MCD in your original kidneys. You cannot join if your diagnosis was due to another condition like lupus.","The study will measure outcomes like time to FSGS recurrence and time to graft failure for up to 2 years after transplant.",132,"Participants will provide biospecimens (like urine, blood, saliva, kidney tissue) and data will be collected. The study will track outcomes for up to two years after transplant.","Not stated in the trial record.",[],"v2"]