[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"antibody-mediated-rejection\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:antibody-mediated-rejection":61},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,5,0,[8,48,73,106,140],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":15,"eligibilityCriteria":16,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":19,"enrollmentInfo":20,"targetDuration":4,"studyType":23,"phases":24,"briefSummary":26,"conditions":27,"keywords":32,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":36,"lastUpdatePostDateStruct":37,"startDateStruct":40,"completionDateStruct":42,"leadSponsor":44,"locationsCount":47},"100573312","phase-2-phase-2-study-of-alxn2030-in-patients-with-antibody-mediated-rejection-after-kidney-transplantation-100573312",false,"NCT06744647","Phase 2 Study of ALXN2030 in Patients With Antibody-Mediated Rejection After Kidney Transplantation","A Phase 2, Double-Blind, Randomized, Placebo-Controlled, Multicenter Study to Evaluate Efficacy and Safety of ALXN2030 in Adult Patients With Antibody-Mediated Rejection After Kidney Transplantation","CONCORD","Inclusion Criteria:\n\n* Kidney transplant received ≥ 6 months\n* Active or chronic active AMR according to Banff 2022 classification, based on Screening kidney biopsy\n* Either positive C4d on Screening kidney biopsy based on the Central Pathology Laboratory report and\u002For positive HLA Class I and\u002For II antigen-specific DSA as determined by the local laboratory's definition of positivity using single-antigen bead based assays\n* MVI score ≥ 2 (g ≥ 1 and ptc ≥ 1)\n* eGFR ≥ 30 mL\u002Fmin\u002F1.73 m2\n* Must be vaccinated against meningococcal infection from serogroups A, C, W, Y (and B where available) at least 14 days prior to but no more than 3 years prior to Day 1\n* Must be vaccinated for S pneumoniae prior to randomization\n* Must be vaccinated for H influenzae type B (where available) prior to randomization\n* Body weight ≥ 50 kg at Screening\n\nExclusion Criteria:\n\n* Biopsy-based diagnosis of any of the following at Screening:\n* TCMR, according to the Banff grade ≥ 1\n* Polyoma virus nephropathy\n* Severe thrombotic microangiopathy\n* Glomerulonephritis\n* ABO-incompatible transplant\n* uACR \\> 2200 mg\u002Fg\n* Multiorgan transplant recipient (except for previous multiple kidney transplants) or cell transplant (islet, bone marrow, stem cell) recipient\n* Planned or recent treatments, \\\u003C 90 days prior to the Screening Visit and during Screening, for Acute Rejection, AMR (including plasmapheresis, plasma exchange, IVIg, B-cell depleting therapy, IL inhibitors, proteasome inhibitors, high-dose corticosteroids \\[except for tapering\\]), HDS products with known hepatotoxic ingredients, TCMR (including T-cell depleting therapy), excluding the SoC immunosuppressant treatment which will be allowed and should be stable during the entire treatment.\n* Known medical or psychological condition, including substance abuse or use disorder (including alcohol), or risk factor that may interfere with study participation, pose additional risk, or confound study outcomes","ALL","18 Years","75 Years",{"count":21,"type":22},45,"ESTIMATED","INTERVENTIONAL",[25],"PHASE2","The primary objective of this study is to evaluate the efficacy of ALXN2030 compared with placebo on biopsy proven histologic resolution in participants with active or chronic active antibody-mediated rejection (AMR) at Week 52.",[28,29,30,31],"Antibody-Mediated Rejection","Kidney Transplantation","Biopsy-proven Histologic Scores","AMR",[33,28,29,34,31],"ALXN2030","Biopsy-proven histologic scores","RECRUITING","2026-06-17",{"date":38,"type":39},"2026-06-18","ACTUAL",{"date":41,"type":39},"2025-03-07",{"date":43,"type":22},"2028-11-07",{"name":45,"class":46},"Alexion Pharmaceuticals, Inc.","INDUSTRY",55,{"id":49,"slug":50,"hasResults":11,"nctId":51,"briefTitle":52,"officialTitle":53,"acronym":4,"eligibilityCriteria":54,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":55,"targetDuration":4,"studyType":23,"phases":57,"briefSummary":59,"conditions":60,"keywords":4,"overallStatus":62,"whyStopped":4,"lastUpdateSubmitDate":63,"lastUpdatePostDateStruct":64,"startDateStruct":66,"completionDateStruct":68,"leadSponsor":70,"locationsCount":72},"100642473","phase-1-a-two-part-dose-escalation-safety-and-efficacy-study-of-cid-103-in-adults-with-active-and-chronic-active-renal-allograft-antibody-mediated-rejection-abmr-100642473","NCT07641426","A Two Part Dose-escalation Safety and Efficacy Study of CID-103 in Adults With Active and Chronic Active Renal Allograft Antibody Mediated Rejection (ABMR).","A 2 Part Dose-escalation Safety and Efficacy Study of CID-103 in Adults With Active and Chronic Active Renal Allograft Antibody Mediated Rejection.","Inclusion Criteria:\n\n1. At least 18 years old at time of signing of ICF.\n2. Voluntary, written, informed consent prior to study-specific procedures.\n3. Functioning living or deceased donor renal allograft ≥ 180 days post-transplant.\n4. eGFR ≥ 25 mL\u002Fmin\u002F1.73 m2 chronic kidney disease epidemiology collaboration (CKD-EPI 2021, see APPENDIX A).\n5. HLA class I and\u002For II antigen-specific antibodies (preformed and\u002For dnDSA).\n6. Existing diagnosis of active or chronic\u002Factive ABMR (± C4d in peritubular capillaries) within the last 180 days according to the Banff 2022 classification as per local pathology read.\n7. Must have a renal biopsy within 28 days (preferably within 14 days) of first study drug administration for central pathology review. Results of the central pathology review are not required prior to first study drug administration.\n8. Participants who have been diagnosed with pre-existing HLA class I\u002FII DSA at the time of their original renal allograft transplant must have received prior treatment with intravenous immune globulin (IVIG) and plasmapheresis (unless contraindicated).\n9. Participants with active ABMR may have received prior treatment with IVIG and plasmapheresis (not required).\n10. For participants that have received prior IVIG, subcutaneous immunoglobulin (SCIg), plasmapheresis, complement system inhibitors (e.g., eculizumab), proteasome inhibitors (e.g., bortezomib) or an interleukin-6 inhibitor (e.g. tocilizumab), or an anti-CD20 (e.g., rituximab) a washout period ≥12 weeks is required prior to first study drug administration\n11. Standardized immune suppression regimen.\n12. Adequate organ function without transfusions, within 14 days of first dose of study drug.\n13. Contraception.\n\nExclusion Criteria:\n\n1. ABO-incompatible transplant.\n2. Any of the following on baseline biopsy:\n\n   1. T-cell-mediated rejection classified Banff Grade ≥ 1.\n   2. de novo or recurrent severe thrombotic microangiopathy.\n   3. polyoma virus nephropathy.\n   4. de novo or recurrent glomerulonephritis.\n3. Acute rejection treatment within 180 days of dosing.\n4. Contraindication to repeat biopsies.\n5. Previous treatment with other anti-CD38 monoclonal antibodies.\n6. Other immunomodulatory antibodies within ≤ 90 days of dosing.\n7. Receiving other concurrent investigational therapies or have received investigational therapies within four weeks of the first dose of study drug or five half-lives (if shorter).\n8. Participants unable to modify baseline immune suppression.\n9. Active viral, bacterial, or fungal infection precluding intensified immunosuppression.\n10. Known latent or active tuberculosis.\n11. Known active infection with human immunodeficiency virus (HIV).\n12. Known active infection.\n13. IgG \\\u003C 400 mg\u002FdL.\n14. Other chronic or acute disease(s) likely to interfere with study endpoint evaluation.\n15. Active malignant disease or premalignant condition within two years, precluding intensified immunosuppressive therapy.\n16. Administration of a live vaccine ≤ 6 weeks of screening.\n17. Participation in interventional component of another clinical trial.\n18. History or clinical evidence of any surgical or medical condition which the Investigator judges as likely to interfere with the results of the study or pose an additional risk in participating, particularly any pre-existing condition that would put the participant at additional risk should they experience an IRR.\n19. Any unresolved treatment-related AE(s) from prior treatment that have not resolved to Grade 1 or baseline value prior to first dose of study drug.\n20. Known hypersensitivity to CID-103 excipients or prior severe hypersensitivity to a monoclonal antibody.\n21. Participants who experienced a Grade 3 or 4 AE related to prior administration of monoclonal antibodies, which the Investigator feels may recur and\u002For put the participant at significant risk, should be excluded.\n22. Previous Grade 4 anaphylactic reaction to other therapeutic proteins.\n23. Chronic dependence on transfusions or hematopoietic growth factors to maintain acceptable blood counts excluding those participants who require ESAs for documented erythropoietin deficiency. Participants cannot have had a transfusion within the past 14 days prior to first dose of study drug or have had more than 1 transfusion in the past month.\n24. Inability to perform study baseline red blood cell (RBC) type and crossmatch, phenotype (and genotype, if applicable) or lack of available baseline data on RBC phenotype (or genotype, if applicable).\n25. Unable or not willing to agree to the evaluation of RBC antigens by phenotyping or genotyping.\n26. Unable or not willing to comply with the protocol and the visit schedule restrictions and assessments therein.",{"count":56,"type":22},58,[58,25],"PHASE1","The goal of the global Phase 1\u002F2 clinical trial is to evaluate whether CID-103, a novel anti-CD38 monoclonal antibody, is safe and effective in adults with with active and chronic active renal allograft antibody mediated rejection (ABMR). The main questions the study aims to answer are:• To evaluate the safety and tolerability of CID-103 in subjects with ABMR with different increasing doses of CID-103.• To evaluate clinical efficacy of CID-103 at an optimal dose in participants with active and chronic active ABMR following renal allograft transplant. The study will be done in two parts: Part A will test increasing doses of CID-103 to see how safe it is and how well people tolerate it. Researchers will also aim to find a safe dose range. Part B will enroll approximately 40 participants to see how well the medicine works and gather more safety and efficacy information. The goal is to find the optimal dose to use in future studies.CID-103 is given through an intravenous (IV) infusion. During the study, participants may receive treatment for up to 12 months, followed by a post-treatment safety follow-up period to check for ongoing safety and effectiveness. This study is an important step toward developing a new treatment for people living with ABMR. If CID-103 is found to be safe and effective, it could offer a new option for patients who do not respond well to current therapies.",[61],"Antibody Mediated Rejection","NOT_YET_RECRUITING","2026-06-06",{"date":65,"type":39},"2026-06-11",{"date":67,"type":22},"2026-06",{"date":69,"type":22},"2030-12",{"name":71,"class":46},"CASI pharmaceuticals, Inc.",4,{"id":74,"slug":75,"hasResults":11,"nctId":76,"briefTitle":77,"officialTitle":78,"acronym":4,"eligibilityCriteria":79,"healthyVolunteers":11,"sex":17,"minAge":80,"maxAge":81,"enrollmentInfo":82,"targetDuration":84,"studyType":85,"phases":4,"briefSummary":86,"conditions":87,"keywords":92,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":95,"lastUpdatePostDateStruct":96,"startDateStruct":98,"completionDateStruct":100,"leadSponsor":102,"locationsCount":105},"100439607","biorepository-and-registry-for-plasma-exchange-patients-100439607","NCT05004493","Biorepository and Registry for Plasma Exchange Patients","Assessment of Changes in Normal and Pathological Immune Factors in Patients Undergoing Plasma Exchange","Pts undergoing plasma exchange therapy are eligible to be in this protocol","12 Years","99 Years",{"count":83,"type":22},200,"1 Year","OBSERVATIONAL","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.",[88,89,90,91],"Antibody-mediated Rejection","NMO Spectrum Disorder","TTP","CIDP",[93,94],"plasma exchange","plasmapheresis","2025-05-15",{"date":97,"type":39},"2025-05-20",{"date":99,"type":39},"2021-07-28",{"date":101,"type":22},"2040-12-31",{"name":103,"class":104},"Charles M Knudson","OTHER",1,{"id":107,"slug":108,"hasResults":11,"nctId":109,"briefTitle":110,"officialTitle":111,"acronym":112,"eligibilityCriteria":113,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":114,"enrollmentInfo":115,"targetDuration":4,"studyType":23,"phases":117,"briefSummary":119,"conditions":120,"keywords":121,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":129,"lastUpdatePostDateStruct":130,"startDateStruct":132,"completionDateStruct":134,"leadSponsor":136,"locationsCount":139},"100405638","phase-3-tocilizumab-in-latechronic-active-antibody-mediated-rejection-in-kidney-transplant-recipients-100405638","NCT04561986","TocIlizumab in Late\u002FChronic Active Antibody-mediated Rejection in Kidney Transplant Recipients","A Randomized Controlled Open-label Multi-center Study to Assess the Efficacy of TCZ in Treatment of Late\u002FChronic Active Antibody-mediated Rejection in Kidney Transplant Recipients","INTERCEPT","Inclusion Criteria:\n\n1. The subject has given their written informed consent to participate in the study\n2. Recipient of living donor or deceased donor kidney transplant\n3. Age ≥18 years\n4. At least 6 months post-transplantation at randomization\n5. Biopsy-proven diagnosis of late active or chronic active ABMR (≥ 6 months after transplantation) according to the Banff 2022 criteria in index biopsy\n6. eGFR ≥20 ml\u002Fmin\u002F1.73 m2\n7. Epstein-Barr Virus (EBV) IgG-positive\n8. For female participants of childbearing potential:\n\n   * use of adequate contraception and a negative pregnancy test\n9. Subject known to have COVID-19 previously must meet all of the following conditions:\n\n   * Asymptomatic for at least 1 month before the start of screening\n   * Re-established on background immunosuppressants for at least 1 month prior to the randomization\n\nExclusion Criteria:\n\n1. Recipient of multi-organ transplants\n2. De novo or recurrent renal disease that is considered to be the predominant cause of the current graft dysfunction\n3. Active viral infections such as BK virus (BKV), cytomegalovirus (CMV), EBV, COVID-19, hepatitis C virus (HCV) or hepatitis B virus (HBV) infections based on polymerase chain reaction (PCR) testing\n4. Ongoing serious infections as per Investigator's opinion\n5. History of recurrent infections requiring hospitalization\n6. Active tuberculosis (TB)\n7. Latent untreatedTB (positive QuantiFERON-TB-Gold test, Chest X-ray)\n8. Abnormal liver function tests alanine transaminase (ALT), aspartate transaminase (AST), bilirubin \\> 1.5 x upper limit of normal)\n9. Other significant liver disease as per Investigator's opinion\n10. Neutropenia (\\\u003C2 x109\u002FL) or thrombocytopenia (\\\u003C100 x109\u002FL)\n11. Signs of post-transplant lymphoproliferative disorder\n12. Signs of malignancy. Exceptions are basal cell carcinoma\u002Fsquamous cell carcinoma or non-malignant melanoma\n13. History of malignancy, unless subject has been considered to have fully recovered from malignancy since \\> 2 years, without any signs of relapse\n14. History of diverticulitis, inflammatory bowel disease or gastrointestinal perforation\n15. Ongoing alcohol or illicit substance abuse\n16. Serious medical or psychiatric illness likely to interfere with participation in the study as per Investigator's opinion\n17. Mental inability or reluctance that results in difficulties in understanding the meaning of study participation\n18. Woman of childbearing potential who is unwilling\u002Funable to use an acceptable method to avoid pregnancy for the entire study period and for up to 8 weeks after the last dose of study drug\n19. Woman with a positive pregnancy test or who is pregnant or breastfeeding\n20. Current or recent (within last 3 months) participation in another clinical drug trial","100 Years",{"count":116,"type":22},50,[118],"PHASE3","This multi-center study is an investigator-driven randomized controlled parallel group open-label clinical trial designed to evaluate the efficacy of addition of anti-IL-6 antibody tocilizumab (TCZ) to the standard of care (SOC) treatment as compared to the SOC alone in reducing the decline of graft function in kidney transplant recipients with late or chronic antibody-mediated rejection (AMR). A total of 50 recipients will be allocated to receive either TCZ (n=25) added to the standard of care (SOC) or SOC alone (n=25) for a period of 24 months. Patients will be followed for an additional 12 months. Protocol kidney graft biopsies will be performed at 12 and 24 months. The primary outcome is the mean rate of change in graft function as assessed by estimated glomerular filtration rate (eGFR) slope from baseline to 24 months after start of treatment.",[88],[122,123,124,125,126,127,128],"Kidney transplant","Chronic rejection","Antibody-mediated rejection","Graft function","Donor specific antibodies (DSA)","Transplant-specific well-being","Adherence","2025-03-31",{"date":131,"type":39},"2025-04-03",{"date":133,"type":39},"2022-02-01",{"date":135,"type":22},"2028-12",{"name":137,"class":138},"Vastra Gotaland Region","OTHER_GOV",8,{"id":141,"slug":142,"hasResults":11,"nctId":143,"briefTitle":144,"officialTitle":145,"acronym":146,"eligibilityCriteria":147,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":148,"targetDuration":4,"studyType":23,"phases":150,"briefSummary":152,"conditions":153,"keywords":4,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":155,"lastUpdatePostDateStruct":156,"startDateStruct":158,"completionDateStruct":160,"leadSponsor":162,"locationsCount":164},"100524762","a-prospective-randomized-trial-of-ecp-in-subclinical-amr-100524762","NCT06112951","A Prospective Randomized Trial of ECP in Subclinical AMR","The Use of Extracorporeal Photopheresis as Immunomodulatory Therapy of Subclinical Antibody-mediated Rejection After Lung Transplantation: a Prospective RCT","EUROEXPORT-DSA","Inclusion Criteria:\n\n* Bilateral lung transplantation\n* dnDSAs \\> 3 months with a MFI \\> 1000\n* No signs of allograft dysfunction\n* Alemtuzumab induction therapy\n\nExclusion Criteria:\n\n* Inclusion in other studies\n* Retransplantation\n* Multi-organ transplantation\n* \\> 12 months after transplantation",{"count":149,"type":22},80,[151],"NA","The goal of this clinical trial is to evaluate the therapeutic effect of extracorporeal photopheresis in subclinical antibody-mediated rejection after lung transplantation.The main questions it aims to answer are:\n\n1. Does ECP therapy result in a significant reduction in MFI (Mean Fluorescence Intensity) from the baseline MFI in clinically stable patients with persistent (\\>6 months) dnDSAs (MFI\\>1000)?\n2. What is the impact of ECP therapy on the following outcomes in these patients: ACR, clinical AMR, CLAD, infections, drop-out rate, survival, adverse events?\n\nParticipants will be randomized into two groups. Each group will include 40 patients. The control group will be observed and no active treatment will be administered. The treatment group will receive extracorporeal photopheresis. First, a two-day treatment cycle will be performed once every second week for the first two months. Then, a two-day treatment cycle will be performed once a month for 6 months.\n\nResearchers will compare the two groups regarding: MFI value, development of ACR, clinical AMR, CLAD, infections, survival, adverse events, immunophenotyping, miRNA expression profiling, cytokine expression, gene expression signature of PBMCs and proteomic characterization.",[88,154],"Lung Transplant Rejection","2024-07-08",{"date":157,"type":39},"2024-07-09",{"date":159,"type":39},"2024-03-01",{"date":161,"type":22},"2027-06-01",{"name":163,"class":104},"Medical University of Vienna",7]