[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"bk-polyomavirus\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:bk-polyomavirus":28},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,3,0,[8,42,80],{"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":4,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":30,"lastUpdatePostDateStruct":31,"startDateStruct":34,"completionDateStruct":36,"leadSponsor":38,"locationsCount":41},"100385002","early-phase-1-treatment-of-bk-virus-infection-with-ctl-cells-in-immunocompromised-transplant-patients-100385002",false,"NCT04293042","Treatment of BK Virus Infection With CTL Cells in Immunocompromised Transplant Patients","A Pilot Study in the Treatment of BK Virus Infection With Cytotoxic T Cells in Immunocompromised Transplant Patients","BK-CTLs","Inclusion Criteria:\n\nPatient Eligibility\n\n* Patients with symptoms of cystitis and elevated BK virus DNA by screening PCR as above (section 4) post allogeneic HSCT, post chemotherapy\n\n  1. Symptoms of cystitis may include: hematuria (microscopic or gross), pain with urination, frequency, bladder spasms.\n  2. Patient may be otherwise treated for cystitis as per local institutional standards. Such treatments may include hydration, antiviral medications, or surgical intervention as deemed appropriate by treating physician.\n* Consent: Written informed consent given (by patient or legal representative) prior to any study-related procedures.\n* Performance Status \\> 30% (Lansky \\\u003C 16 yrs and Karnofsky \\> 16 yrs)\n* Age: 0.1 to 25 years\n* Females of childbearing potential with a negative urine pregnancy test.\n\nDonor Eligibility\n\n* Related donor available with a T-cell response to the BK-virus MACS® PepTivator® antigen(s).\n\n  1. Original allogeneic donor if available, IgG positive for BKV or confirmatory testing to respond to BKV MACS Peptivator®.\n  2. Third Party Allogeneic Donor: If original donor is not available or does not have a T-cell response: third party allogeneic donor (family donor \\> 1 HLA A, B, DR match to recipient) with a T-cell response to the BK MACS® PepTivator.\n\n     AND\n* Allogeneic donor disease screening is complete similar to hematopoietic stem cell donors (Appendix 1).\n\nAND\n\n• Obtained informed consents by donor or donor legally authorized representative prior to donor collection.\n\nExclusion Criteria:\n\nPatient exclusion criteria:\n\nA patient meeting any of the following criteria is not eligible for the present study:\n\n* Patient with acute GVHD \\> grade 2 or extensive chronic GVHD at the time of BK Virus CTL infusion\n* Patient receiving steroids (\\>0.5 mg\u002Fkg prednisone equivalent) at the time of BK Virus CTL infusion or within 3 days of planned infusion.\n* Thymoglobulin (ATG), campath or T cell immunosuppressive monoclonal antibodies within 30 days\n* Patient with poor performance status determined by Karnofsky (patients \\>16 years) or Lansky (patients ≤16 years) score ≤30%\n* Concomitant enrollment in another experimental clinical trial investigating the treatment of refractory BK virus infection.\n* Any medical condition which could compromise participation in the study according to the investigator's assessment\n* Known HIV infection\n* Female patient of childbearing age who is pregnant or breast-feeding or not willing to use an effective method of birth control during study treatment.\n* Known hypersensitivity to iron dextran\n* Patients unwilling or unable to comply with the protocol or unable to give informed consent.\n* Known human anti-mouse antibodies","ALL","5 Weeks","25 Years",{"count":21,"type":22},20,"ESTIMATED","INTERVENTIONAL",[25],"EARLY_PHASE1","This is a pilot study using cytotoxic T lymphocytes (CTLs) manufactured with the Miltenyi CliniMACS Prodigy Gamma-capture system will be effective in decreasing specific viral load in patients with BK virus viremia and BK virus-associated symptoms post-allogeneic hematopoietic stem cell transplantation (HSCT), renal transplantation, and chemotherapy.",[28],"BK Polyomavirus","RECRUITING","2026-06-04",{"date":32,"type":33},"2026-06-05","ACTUAL",{"date":35,"type":33},"2019-10-07",{"date":37,"type":22},"2029-01-30",{"name":39,"class":40},"Children's Hospital of Philadelphia","OTHER",1,{"id":43,"slug":44,"hasResults":11,"nctId":45,"briefTitle":46,"officialTitle":46,"acronym":47,"eligibilityCriteria":48,"healthyVolunteers":11,"sex":17,"minAge":49,"maxAge":4,"enrollmentInfo":50,"targetDuration":4,"studyType":52,"phases":4,"briefSummary":53,"conditions":54,"keywords":63,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":71,"lastUpdatePostDateStruct":72,"startDateStruct":74,"completionDateStruct":76,"leadSponsor":78,"locationsCount":41},"100619680","study-of-the-serotype-and-genotype-of-bk-virus-in-kidney-transplant-recipients-and-their-donors-to-identify-individuals-at-risk-of-nephropathy-100619680","NCT07347769","Study of the Serotype and Genotype of BK Virus in Kidney Transplant Recipients and Their Donors to Identify Individuals at Risk of Nephropathy","TYPIK","Inclusion Criteria:\n\n* Kidney transplant patients with a first positive BK virus viral load in urine. - BK virus viral load in urine \\> 3 log copies\u002FmL.\n* More than 3 months post-transplant and less than 2 years post-transplant.\n* Men or women aged 18 years and older.\n* Followed up at Grenoble Alpes University Hospital.\n* Affiliated with social security or beneficiary of such a scheme.\n* Patients who are not opposed to the TYPIK study.\n\nExclusion Criteria:\n\n* Expected renal graft survival is \\\u003C 6 months, estimated by an eGFR \\\u003C 15 mL\u002Fmin\u002F1.73 m² at the time of BKPyV viruria\n* Patients who object to the use of their data and\u002For samples for research purposes\n* Subjects who are excluded from another study\n* Subjects under administrative or judicial supervision","18 Years",{"count":51,"type":22},100,"OBSERVATIONAL","The aim of this observational study is to characterize the urinary replication of BK polyomavirus (BKV) in kidney transplant recipients. Although BKV reactivation after transplantation is well established, the origin of the replicating virus remains uncertain. Current evidence suggests that BKV detected in recipients may originate either from the transplanted kidney (donor-derived) or from viral reactivation in the recipient. The evaluation of new biomarkers to predict BKV replication are needed.\n\nThis study seeks to address the following key questions:\n\n* Origin of the replicating virus: Is the BKV detected in the recipient identical to the virus originating from the donor kidney?\n* Host immune response and viral genotype: Is there an association between the recipient's immune response and the genotype of the replicating BKV?\n* Differences in immune response according to viral replication profile: Does the immune response differ between patients presenting isolated BKV viruria and those with both viruria and viremia?\n* Can new biomarkers help predict BKV replication and viremia?\n\nPatients will be grouped according to their BKV replication profile:\n\nGroup 1: patients with BKV viruria without viremia Group 2: patients with both BKV viruria and viremia Comparisons between these two groups will help identify whether different viral genotypes or immune responses are associated with systemic dissemination (viremia).\n\nKidney transplant recipients will be included if they present BKV viruria during their post-transplant follow-up. Additional blood samples will be collected during scheduled follow-up visits at the university hospital. These visits are part of routine clinical care, and no extra visits will be required specifically for the study.",[55,56,57,58,59,60,28,61,62],"Nephropathy","Opportunistic Viral Infection","Polyoma Virus Nephropathy","BK Nephropathy","BK Viremia; BKV DNAemia","BK Virus Infection","Immune Response","Neutralizing Antibodies",[64,65,66,67,68,69,70],"TTV","BK polyomavirus","neutralizing antibodies","ELISPOT BKV","genotype","miRNA BKV","urinary chimiokine","2026-05-22",{"date":73,"type":33},"2026-05-27",{"date":75,"type":33},"2026-03-11",{"date":77,"type":22},"2030-09-11",{"name":79,"class":40},"University Hospital, Grenoble",{"id":81,"slug":82,"hasResults":11,"nctId":83,"briefTitle":84,"officialTitle":85,"acronym":86,"eligibilityCriteria":87,"healthyVolunteers":88,"sex":17,"minAge":89,"maxAge":4,"enrollmentInfo":90,"targetDuration":4,"studyType":52,"phases":4,"briefSummary":92,"conditions":93,"keywords":95,"overallStatus":107,"whyStopped":4,"lastUpdateSubmitDate":108,"lastUpdatePostDateStruct":109,"startDateStruct":111,"completionDateStruct":113,"leadSponsor":115,"locationsCount":4},"100592026","study-of-anti-bkpyv-immune-responses-in-kidney-transplant-patients-with-bkpyv-viremia-100592026","NCT06988072","Study of Anti-BKPyV Immune Responses in Kidney Transplant Patients With BKPyV Viremia","Official Title Étude Des réponses Immunes Anti-BKPyV Chez Les Patients transplantés rénaux Avec BKPyV virémie","NEPHRO-BK","Inclusion Criteria:\n\n* No objection to participation in the research study (from patients or legal guardians)\n* Affiliated to the French national social security system\n* Age ≥ 7 years old\n* Weight ≥ 12 kg\n\nAdditional criteria for kidney transplant recipients with BKPyV DNAemia:\n\n* Patients who underwent kidney transplantation within 12 months prior to inclusion, regardless of the initial indication\n* Detectable de novo BKPyV DNAemia within the first 12 months post-transplantation\n\nAdditional criteria for kidney transplant recipients without BKPyV DNAemia:\n\n* Patients who underwent kidney transplantation within 12 months prior to inclusion, regardless of the initial indication\n* No detectable de novo BKPyV DNAemia within the first 12 months post-transplantation\n\nAdditional criteria for healthy donors (controls):\n\n* Age ≥ 18 years old\n* Blood donation to the EFS\n* Consent for the use of their blood donation for research purposes.\n\nExclusion Criteria:\n\n* Objection to participation in the research study",true,"7 Years",{"count":91,"type":22},75,"The human pathogen BK polyomavirus (BKPyV) is a ubiquitous, small, non-enveloped DNA virus that infects over 90% of people, typically in childhood with mild or no symptoms. Following primary infection, BKPyV establishes latency predominantly in the reno-urinary tract, and can occasionally be detected in the urine without any concomitant clinical symptoms. However, among kidney transplant recipients (KTR), due to impaired cellular and humoral immunity, uncontrolled viral replication in renal tubular epithelial cells (RPTE) can occur, leading to high-level BKPyV DNAemia and significant damage to the reno-urinary system (ie polyomavirus-associated nephropathy). In the absence of any effective antiviral drug, the mainstay of therapy for significant BKPyV replication among KTR is reducing immunosuppressive drugs, despite the subsequent of risk of graft rejection. Current efforts to identify new monitoring and therapeutical strategies need to be supported by a better understanding of the dynamics of BKPyV-specific immune responses following transplantation.\n\nAlthough adaptive cellular and humoral immune responses play a crucial role in the control of BKPyV reactivation among healthy individuals, immunosuppression and transplantation disrupt immune homeostasis and reshape the immune response landscape both in terms of function and fitness to new stimuli. Consequently, pre-transplant prediction of patients who will be able to control post-transplant BKPyV reactivation or who will develop BKPyV-related complications remains challenging. This knowledge gap stems from insufficient studies on the comprehensive analysis of immune responses during BKPyV reactivation. In particular, most studies to date have not investigated the role of NK cells in this context, despite their potent antiviral activity, heterogenous repertoire in each patient and their recently uncovered adaptive properties.\n\nThe hypothesis is that among KTR with de novo BKPyV DNAemia, the comprehensive analysis of anti-BKPyV immune responses (including both the description of NK cell repertoire and adaptive immune), could allow\n\n* A better stratification of KTR at-risk for BKPyV-related complications using accessible immune biomarkers.\n* The identification of the most efficient strategies of immunosuppression management for the control of BKPyV DNAemia, that could be further evaluated in a prospective cohort.\n* The identification of immunological correlates for the control of BKPyV DNAemia, which aim at providing a foundation for the development of future immunotherapeutic strategies.",[28,94],"Kidney Transplant",[96,97,98,99,100,101,102,103,104,105,106],"Polyomavirus hominis 1","Natural killer cells","T-lymphocytes","Neutralizing antibodies","Adaptative immunity","Immunologic memory","Innate immunity recognition","Trained immunity","Immune repertoire","Biomarkers","BKPyV-association nephropathy","NOT_YET_RECRUITING","2025-05-16",{"date":110,"type":33},"2025-05-23",{"date":112,"type":22},"2025-05-30",{"date":114,"type":22},"2028-05-30",{"name":116,"class":40},"Assistance Publique - Hôpitaux de Paris"]