[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"trial:NCT05004493":3,"trial-entities:NCT05004493":84,"trial-summary:NCT05004493":91},{"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":26,"primary_purpose":17,"phases":27,"enrollment_info":28,"interventions":31,"primary_outcomes":32,"secondary_outcomes":37,"sex":38,"minimum_age":39,"maximum_age":40,"healthy_volunteers":15,"eligibility_criteria":41,"std_ages":45,"locations":49,"central_contacts":63,"overall_officials":68,"references":69,"see_also_links":83},"NCT05004493","202104462","Biorepository and Registry for Plasma Exchange Patients","Assessment of Changes in Normal and Pathological Immune Factors in Patients Undergoing Plasma Exchange","RECRUITING","2040-12-31","2025-05","2025-05-20","2021-07-28","Charles M Knudson","OTHER",false,"Patients who have immune mediated diseases commonly undergo plasma exchange (PLEX) procedures to remove pathological substances, typically believed to be antibodies. At our facility about 400 of these procedures are performed annually on 40-60 different patients. These procedures are considered within the standard of care for these patients and are covered by insurance. This study will not influence the treatment plan for subjects who participate in this study. The goal of the study is to collect and cryopreserve blood biospecimens (plasma, serum, PBMCs) for current and future studies. Any patient undergoing plasma exchange procedures will be eligible for the study. Patients or the legally authorized representative (LAR) will be consented for the study as soon as feasible after the are referred to DeGowin for plasma exchange. The immediate objective of the study is to examine antibody levels (IgG\u002FIgM) and BAFF levels in the blood of these patients over the course of the plasma exchange treatments. Specimens and clinical data will be collected such that other immune factors that may regulate B cell survival, proliferation and antibody secretion can be studied. Another goal of the study is to isolate and cryopreserve PBMCs at different points during the patient's treatment. This would allow the study of immune cells that may mediate these diseases. The study will also follow pathological antibodies over time in these patients so biospecimens can be obtained even after the completion of their course of plasma exchange treatments. The collection of biospecimens and clinical information from these subjects will help us understand the impact of plasma exchange on both normal and pathological immune factors in a variety of patients undergoing these procedures.",null,[19,20,21,22],"Antibody-mediated Rejection","NMO Spectrum Disorder","TTP","CIDP",[24,25],"plasma exchange","plasmapheresis","OBSERVATIONAL",[],{"count":29,"type":30},200,"ESTIMATED",[],[33],{"measure":34,"description":35,"timeFrame":36},"IgG and IgM antibody levels","The effect of replacement fluids on IgG and IgM antibody levels will be examined.","Levels over the course of treatment will be compared. Typically 1-2 weeks.",[],"ALL","12 Years","99 Years",{"inclusion":42,"exclusion":43,"raw_text":44},[],[],"Pts undergoing plasma exchange therapy are eligible to be in this protocol",[46,47,48],"CHILD","ADULT","OLDER_ADULT",[50],{"facility":51,"status":8,"city":52,"state":53,"zip":54,"country":55,"contacts":56,"geoPoint":60},"DeGowin blood Center","Iowa City","Iowa","52242","United States",[57],{"name":58,"role":59},"charles knudson, MD;PhD","CONTACT",{"lat":61,"lon":62},41.66113,-91.53017,[64],{"name":65,"role":59,"phone":66,"email":67},"Charles Knudson, MD, PHD","+1 319 467-5129","c-knudson@uiowa.edu",[],[70,74,77,80],{"pmid":71,"type":72,"citation":73},"23233554","BACKGROUND","Winters JL. Plasma exchange: concepts, mechanisms, and an overview of the American Society for Apheresis guidelines. Hematology Am Soc Hematol Educ Program. 2012;2012:7-12. doi: 10.1182\u002Fasheducation-2012.1.7.",{"pmid":75,"type":72,"citation":76},"24172059","Reeves HM, Winters JL. The mechanisms of action of plasma exchange. Br J Haematol. 2014 Feb;164(3):342-51. doi: 10.1111\u002Fbjh.12629. Epub 2013 Oct 30.",{"pmid":78,"type":72,"citation":79},"33333233","Mockel T, Basta F, Weinmann-Menke J, Schwarting A. B cell activating factor (BAFF): Structure, functions, autoimmunity and clinical implications in Systemic Lupus Erythematosus (SLE). Autoimmun Rev. 2021 Feb;20(2):102736. doi: 10.1016\u002Fj.autrev.2020.102736. Epub 2020 Dec 14.",{"pmid":81,"type":72,"citation":82},"11509691","Schiemann B, Gommerman JL, Vora K, Cachero TG, Shulga-Morskaya S, Dobles M, Frew E, Scott ML. An essential role for BAFF in the normal development of B cells through a BCMA-independent pathway. Science. 2001 Sep 14;293(5537):2111-4. doi: 10.1126\u002Fscience.1061964. Epub 2001 Aug 16.",[],{"nct_id":4,"conditions":85,"biomarkers":90},[86,87,88,89],"Chronic Inflammatory Demyelinating Polyneuropathy","Hyperacute graft rejection","Neuromyelitis Optica","Thrombotic Thrombocytopenic Purpura",[],{"nct_id":4,"found":92,"summary":93,"prompt_version":103},true,{"design":94,"status":95,"heading":96,"summary":97,"follow_up":98,"word_count":99,"commitments":100,"compensation":101,"drugs_mentioned":102},"This is an observational study, meaning researchers will collect information without influencing your treatment. It plans to enroll 200 participants.","completed","Biorepository for Plasma Exchange Patients","This study is creating a collection of blood samples (a biorepository) from patients undergoing plasma exchange (PLEX) procedures. PLEX is a standard treatment for immune-mediated diseases like Antibody-mediated Rejection, NMO Spectrum Disorder, TTP, and CIDP, where it removes harmful substances, often antibodies, from the blood. You can join if you are between 12 and 99 years old and are receiving PLEX. This study will not change your treatment plan. Researchers will measure IgG and IgM antibody levels over 1-2 weeks to understand how PLEX affects them. The goal is to collect samples for current and future research to learn more about these conditions and treatments. The study aims to enroll 200 participants, but its current status is unclear.","Researchers will measure antibody levels over the course of treatment, typically 1-2 weeks.",118,"Not specified in the trial record.","Not stated in the trial record.",[],"v2"]