[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"trial:NCT06476132":3,"trial-entities:NCT06476132":256,"trial-summary:NCT06476132":262},{"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":20,"study_type":27,"primary_purpose":28,"phases":29,"enrollment_info":31,"interventions":34,"primary_outcomes":45,"secondary_outcomes":50,"sex":75,"minimum_age":76,"maximum_age":17,"healthy_volunteers":77,"eligibility_criteria":78,"std_ages":82,"locations":86,"central_contacts":243,"overall_officials":244,"references":249,"see_also_links":250},"NCT06476132","DAIT CTOT-47","Belumosudil to Block Chronic Lung Allograft Dysfunction (CLAD) in High Risk Lung Transplant Recipients","Belumosudil to Block Chronic Lung Allograft Dysfunction (CLAD) in High Risk Lung Transplant Recipients: A Randomized, Multicenter, Double Blind, Placebo-Controlled Trial (CTOT-47)","RECRUITING","2027-06-30","2026-08","2026-08-10","2025-03-12","National Institute of Allergy and Infectious Diseases (NIAID)","NIH",true,"The purpose of this study is to see if taking the study drug, Belumosudil, for 52 weeks in addition to your usual care and medication, will prevent Chronic Lung Allograft Dysfunction (CLAD) in participants who have a lung biopsy that shows evidence of rejection or inflammation to the transplanted lung(s). For this study, biopsies that show evidence of Acute Rejection (AR), Lymphocytic Bronchiolitis (LB), Organizing Pneumonia (OP) or Acute Lung Injury (ALI) are referred to as \"Qualifying Biopsies\"; patients who had evidence of one or more of these conditions on a recent biopsy are eligible for enrollment in this study. Belumosudil is an investigational drug that blocks a molecule in the body that reduces inflammation and scarring and may play a role in the development and progression of CLAD. Belumosudil is a drug approved by the FDA to treat adults and children 12 years and older with chronic graft-versus-host disease (cGVHD), a condition with some similarities to CLAD.\n\nThe primary objective it to determine the efficacy of treatment with Belumosudil + maintenance immunosuppression (IS) versus placebo + maintenance IS on preventing the subsequent development of probable or definite CLAD, lung retransplant, or death.",null,[19],"Lung Transplant",[19,21,22,23,24,25,26],"Belumosudil","CLAD","Acute Rejection","Lymphocytic Bronchiolitis","Organizing Pneumonia","Acute Lung Injury","INTERVENTIONAL","TREATMENT",[30],"PHASE2",{"count":32,"type":33},234,"ESTIMATED",[35,40],{"type":36,"name":21,"description":37,"armGroupLabels":38},"DRUG","Participants will receive Belumosudil 200 mg daily (increased to 200 mg twice daily in participants receiving concurrent strong CYP3A inducers or PPIs) + maintenance IS for a duration of one year from randomization.",[39],"Belumosudil plus maintenance IS",{"type":36,"name":41,"description":42,"armGroupLabels":43},"Placebo for Belumosudil","Participants will receive Placebo for Belumosudil 200 mg daily (increased to 200 mg twice daily in participants receiving concurrent strong CYP3A inducers or PPIs) + maintenance IS for a duration of one year from randomization.",[44],"Placebo + maintenance IS",[46],{"measure":47,"description":48,"timeFrame":49},"Time from randomization to the first occurrence of probable or definite CLAD (per ISHLT 2019 standard defined criteria), lung retransplant, or death","Probable CLAD is defined as a \\>= 20% decline in Forced Expiratory Volume in 1 Second (FEV1) compared to the baseline value on 2 measurements taken at least 3 weeks apart and after exclusion or adequate treatment of potential secondary causes of allograft dysfunction.\n\nThe baseline FEV1 value is defined as the average of the 2 best posttransplant FEV1s taken at least 3 weeks apart","From randomization until study completion - scheduled assessments: minimum of 1 year, maximum of 3 years",[51,54,57,60,63,66,69,72],{"measure":52,"description":53,"timeFrame":49},"Time from randomization to first occurrence of probable or definite CLAD (per ISHLT 2019 standard defined criteria) or lung retransplant","Definite CLAD is a sustained decline in pulmonary function as defined by a persistent decline in lung function meeting the definition of probable CLAD but sustained for a duration of at least 3 months",{"measure":55,"timeFrame":56},"Time from randomization to death","From date of randomization until the date of death, through study completion; participants are scheduled to be assessed for a minimum of 1 year up to a maximum of 3 years",{"measure":58,"timeFrame":59},"Time from randomization to first occurrence of the specific CLAD phenotypes of Restrictive Allograft Syndrome (RAS), Bronchiolitis Obliterans Syndrome (BOS), mixed, or undefined","From date of randomization until study completion - scheduled assessments: minimum of 1 year, maximum of 3 years",{"measure":61,"timeFrame":62},"Frequency of Acute Rejection (AR)","Number of AR events occurring from date of randomization until date of end of treatment visit, an average of 1 year",{"measure":64,"timeFrame":65},"Frequency of Lymphocytic Bronchiolitis (LB)","Number of LB events occurring from date of randomization until date of end of treatment visit, an average of 1 year.",{"measure":67,"timeFrame":68},"Frequency of Organizing Pneumonia (OP)","Number of OP events occurring from date of randomization until date of end of treatment visit, an average of 1 year.",{"measure":70,"timeFrame":71},"Frequency of Acute Lung Injury (ALI)","Number of ALI events occurring from date of randomization until date of end of treatment visit, an average of 1 year.",{"measure":73,"timeFrame":74},"Rate of change in lung function measures (forced expiratory volume [FEV1] and forced vital capacity [FVC])","Rate of change occurring from date of randomization until date of end of treatment visit, an average of 1 year.","ALL","12 Years",false,{"inclusion":79,"exclusion":80,"raw_text":81},[],[],"Inclusion Criteria:\n\n1. Participant and\u002For parent or guardian must be able to understand the purpose of the study, willing to participate, sign the informed consent, and if applicable assent.\n2. Single or bilateral lung transplant recipient age ≥ 12 years\n3. A qualifying biopsy obtained 60 to 760 days after lung transplant with evidence of allograft injury histology; a qualifying biopsy must have one or more of the following features alone or in combination: Acute Rejection (AR), Lymphocytic Bronchiolitis (LB), Organizing Pneumonia (OP), or Acute Lung Injury (ALI). The presence of any grade AR (A1 or greater) or LB (B1 or greater) qualifies for inclusion\n4. Females of reproductive potential and males with female partners of reproductive potential must agree to use effective contraception during treatment with belumosudil or placebo and for at least 3 months after the last dose. Participants must agree to refrain from donating or cryopreserving sperm, eggs (ova or ovocytes) for the purpose of reproduction during treatment with belumosudil or placebo and for at least 3 months after the last dose.\n5. Meeting hematologic laboratory criteria: absolute neutrophil count (ANC) \\>= 0.5 x 10(9)\u002FL and platelet count \\>= 50 x 10(9)\u002FL within 30 days of enrollment\n6. Meeting all blood chemistry laboratory criteria: aspartate aminotransferase (AST) or alanine transaminase (ALT) \\\u003C 2x upper limit of normal (ULN), bilirubin \\\u003C 1.5x ULN unless due to Gilbert's syndrome, estimated glomerular filtration rate (eGFR) ≥ 30 mL\u002Fmin\u002F1.73m2 within 30 days of enrollment\n7. Cytomegalovirus (CMV) polymerase chain reaction (PCR) negative or, if detected, \\\u003C200 IU\u002Fml in the absence of any signs of active infection, within 30 days of enrollment\n8. In the absence of contraindications, must have received adult vaccinations or documented immunity as outlined in current National Institute of Allergy and Infectious Diseases (NIAID) Division of Allergy, Immunology, and Transplantation (DAIT) Guidance for Patients in Transplant Trials\n9. Intent to receive calcineurin inhibitor (CNI)-based maintenance Immunosuppression (IS) regimen\n\nExclusion Criteria:\n\n1. Multi-organ transplants involving more than one organ type (e.g., heart-lung)\n2. Prior organ transplant or prior bone marrow transplant\u002Fhematopoietic stem cell transplantation\n3. Greater than 160 days after a qualifying biopsy\n4. Active AMR unless resolved and no treatments with prohibited medications for \\> 90 days prior to enrollment\n5. Diagnosed with probable or definite CLAD according to International Society for Heart and Lung Transplantation (ISHLT) guidelines prior to enrollment.\n6. Posttransplant treatment with anti-thymocyte globulin within 30 days or alemtuzumab or any other prohibited medication within 90 days prior to enrollment.\n7. Epstein-Barr virus (EBV) seronegative recipient who received EBV positive donor lung(s).\n8. Treatment with any other investigational pharmacologic agent within 30 days prior to enrollment.\n9. Significant active uncontrolled infection which, in the opinion of the investigator, would place the participant at increased risk.\n10. Current use of sirolimus or everolimus.\n11. Recipient human immunodeficiency virus (HIV) positive.\n12. Recipient Hepatitis B surface antigen positive or Hepatitis B core antibody positive.\n13. Received lung(s) from a donor with known Hepatitis B virus (HBV) including Hepatitis B core antibody positive donors.\n14. Incompletely treated Hepatitis C (absence of ongoing treatment and post-transplant negative HCV PCR)\n15. History of clinically significant surgical factors (such as phrenic nerve damage, transplant lung resection, chest wall surgery), or mechanical factors (such as posttransplant airways disease including bronchial dehiscence, stenosis, dilation, or stent placement, pleural disease) that impedes lung function.\n16. Past or current medical problems, psychosocial concerns, or findings from physical examination or laboratory testing that are not listed above, which, in the opinion of the investigator, may pose undue risk from participation in the study, may interfere with the participant's ability to comply with study requirements, or that may impact the quality or interpretation of the data obtained from the study.\n17. Pregnant or breastfeeding",[83,84,85],"CHILD","ADULT","OLDER_ADULT",[87,102,114,127,140,153,165,178,191,203,216,229],{"facility":88,"status":8,"city":89,"state":90,"zip":91,"country":92,"contacts":93,"geoPoint":99},"University of California, Los Angeles (Site #: 71123)","Los Angeles","California","90095","United States",[94],{"name":95,"role":96,"phone":97,"email":98},"Paul Lopez","CONTACT","310-794-1999","PLopez@mednet.ucla.edu",{"lat":100,"lon":101},34.05223,-118.24368,{"facility":103,"status":8,"city":104,"state":90,"zip":105,"country":92,"contacts":106,"geoPoint":111},"Stanford University (Site #: 71141)","Palo Alto","94304",[107],{"name":108,"role":96,"phone":109,"email":110},"Hannah Mudgett","650-319-6877","hmudgett@stanford.edu",{"lat":112,"lon":113},37.44188,-122.14302,{"facility":115,"status":8,"city":116,"state":117,"zip":118,"country":92,"contacts":119,"geoPoint":124},"Johns Hopkins (Site #: 71119)","Baltimore","Maryland","21287",[120],{"name":121,"role":96,"phone":122,"email":123},"Viktoryiya Livchits","607-591-4747","vlivchi1@jh.edu",{"lat":125,"lon":126},39.29038,-76.61219,{"facility":128,"status":8,"city":129,"state":130,"zip":131,"country":92,"contacts":132,"geoPoint":137},"University of Minnesota (Site 71151)","Minneapolis","Minnesota","55455",[133],{"name":134,"role":96,"phone":135,"email":136},"Dean Krueger","612-301-4015","krue0100@umn.edu",{"lat":138,"lon":139},44.97997,-93.26384,{"facility":141,"status":8,"city":142,"state":143,"zip":144,"country":92,"contacts":145,"geoPoint":150},"Washington University (Site #: 71157)","St Louis","Missouri","63130",[146],{"name":147,"role":96,"phone":148,"email":149},"Brigitte Mittler","314-747-1931","b.mittler@wustl.edu",{"lat":151,"lon":152},38.62727,-90.19789,{"facility":154,"status":8,"city":155,"state":155,"zip":156,"country":92,"contacts":157,"geoPoint":162},"NYU Langone Health (Site #: 71177)","New York","10016",[158],{"name":159,"role":96,"phone":160,"email":161},"Cecilia Deterville","212-263-3620","cecilia.deterville@nyulangone.org",{"lat":163,"lon":164},40.71427,-74.00597,{"facility":166,"status":8,"city":167,"state":168,"zip":169,"country":92,"contacts":170,"geoPoint":175},"Duke University (Site #: 71139)","Durham","North Carolina","27710",[171],{"name":172,"role":96,"phone":173,"email":174},"Katelyn Arroyo","919-684-6140","katelyn.arroyo@duke.edu",{"lat":176,"lon":177},35.99403,-78.89862,{"facility":179,"status":8,"city":180,"state":181,"zip":182,"country":92,"contacts":183,"geoPoint":188},"Cincinnati Children's Hospital Medical Center (Site #: 71017)","Cincinnati","Ohio","45229",[184],{"name":185,"role":96,"phone":186,"email":187},"Maryam Mysorewala","513-636-4578","maryam.mysorewala@cchmc.org",{"lat":189,"lon":190},39.12711,-84.51439,{"facility":192,"status":8,"city":193,"state":181,"zip":194,"country":92,"contacts":195,"geoPoint":200},"Cleveland Clinic (Site #: 71101)","Cleveland","44195",[196],{"name":197,"role":96,"phone":198,"email":199},"Abigail Camiener","216-390-5108","camiena3@ccf.org",{"lat":201,"lon":202},41.4995,-81.69541,{"facility":204,"status":8,"city":205,"state":206,"zip":207,"country":92,"contacts":208,"geoPoint":213},"University of Pennsylvania (Site #: 71111)","Philadelphia","Pennsylvania","19104",[209],{"name":210,"role":96,"phone":211,"email":212},"Maddy Fair","215-573-4701","Maddy.fair@pennmedicine.upenn.edu",{"lat":214,"lon":215},39.95238,-75.16362,{"facility":217,"status":8,"city":218,"state":219,"zip":220,"country":92,"contacts":221,"geoPoint":226},"Vanderbilt University Medical Center (Site #: 71174)","Nashville","Tennessee","37232",[222],{"name":223,"role":96,"phone":224,"email":225},"Briana Swanner","615-327-7232","briana.swanner@vumc.org",{"lat":227,"lon":228},36.16589,-86.78444,{"facility":230,"status":8,"city":231,"state":232,"country":233,"contacts":234,"geoPoint":240},"University Health Network\u002FToronto General Hospital (Site #: 71121)","Toronto","Ontario","Canada",[235],{"name":236,"role":96,"phone":237,"phoneExt":238,"email":239},"Lianne Singer","(416)340-4800","4996","Lianne.Singer@uhn.ca",{"lat":241,"lon":242},43.70643,-79.39864,[],[245],{"name":246,"affiliation":247,"role":248},"Scott M. Palmer, M.D., M.H.S.","Duke University Medical Center: Transplantation","STUDY_CHAIR",[],[251,254],{"label":252,"url":253},"Division of Allergy, Immunology, and Transplantation (DAIT)","https:\u002F\u002Fwww.niaid.nih.gov\u002Fabout\u002Fdait",{"label":13,"url":255},"https:\u002F\u002Fwww.niaid.nih.gov\u002F",{"nct_id":4,"conditions":257,"biomarkers":261},[26,23,258,259,260],"Lung Transplantation","Lymphocytic Colitis","Organized pneumonia",[],{"nct_id":4,"found":15,"summary":263,"prompt_version":273},{"design":264,"status":265,"heading":266,"summary":267,"follow_up":268,"word_count":269,"commitments":270,"compensation":271,"drugs_mentioned":272},"This is an interventional study comparing Belumosudil to a placebo. It plans to enroll 234 participants.","completed","Belumosudil for Preventing Lung Transplant Complications","This study is testing if a drug called Belumosudil can help prevent Chronic Lung Allograft Dysfunction (CLAD) in people who have received a lung transplant. CLAD is a serious problem where the transplanted lung doesn't work as well over time. You might be able to join if you are 12 years or older, have had a single or bilateral lung transplant, and a recent biopsy (a small tissue sample) showed signs of rejection or inflammation in your transplanted lung(s). These signs include Acute Rejection (AR), Lymphocytic Bronchiolitis (LB), Organizing Pneumonia (OP), or Acute Lung Injury (ALI). Participants will take Belumosudil or a placebo (an inactive substance) for one year, along with their usual medications. The main goal is to see if Belumosudil can delay or prevent CLAD, the need for another lung transplant, or death. The study is currently recruiting about 234 participants.","You will be followed from the start of the study until its completion, with scheduled assessments for a minimum of 1 year and a maximum of 3 years.",143,"You would take Belumosudil or a placebo daily for one year, along with your regular maintenance medications.","Not stated in the trial record.",[21],"v2"]