[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"immunosuppresion\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:immunosuppresion":29},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,4,0,[8,48,86,116],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":13,"acronym":4,"eligibilityCriteria":14,"healthyVolunteers":11,"sex":15,"minAge":16,"maxAge":17,"enrollmentInfo":18,"targetDuration":4,"studyType":21,"phases":22,"briefSummary":24,"conditions":25,"keywords":31,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":36,"lastUpdatePostDateStruct":37,"startDateStruct":40,"completionDateStruct":42,"leadSponsor":44,"locationsCount":47},"100590795","early-phase-1-tolerance-through-mixed-chimerism-sip-tego-100590795",false,"NCT06972069","Tolerance Through Mixed Chimerism (Sip-Tego)","Recipient Inclusion Criteria:\n\n1. Male or female 18-65 years of age.\n2. Subjects with chronic kidney disease stage V (GFR\\\u003C15ml\u002Fmin\u002F1.73m2) or ESRD who are treated or imminently be treated with either hemodialysis or peritoneal dialysis.\n3. Candidate for a living-donor renal allograft from an HLA matched or mismatched donor\n4. First or second renal transplant.\n5. EBV Seropositive\n6. Use of FDA-approved methods of contraception by all recipients from the time that study treatment begins until 104 weeks (24 months) after renal transplantation\n7. Ability to understand and provide informed consent.\n8. Negative COVID-19 test during screening and two days prior to procedure\n\nRecipient Exclusion Criteria:\n\n1. ABO blood group-incompatible renal allograft\n2. Participant with a donor-specific antibody (DSA) within 6 months prior to transplant\n3. Persistent Leukopenia (WBC less than 2,000\u002Fmm3) or thrombocytopenia (\\\u003C100,000\u002Fmm3)\n4. Seropositivity for HIV-1, hepatitis B core antigen, or hepatitis C virus (confirmed by hepatitis C virus RNA); or positivity for hepatitis B surface antigen.\n5. Untreated Infection\n6. Left ventricular ejection fraction \\\u003C 40% as determined by TTE or clinical evidence of heart failure.\n7. Forced expiratory volume FEV1 or DLCO \\\u003C 50% of predicted.\n8. Lactation or pregnancy.\n9. Patients with active cancer or those with a high risk of recurrence following the American Transplant Society\n10. Underlying renal disease etiology with a high risk of disease recurrence in the transplanted kidney (such as non-genetic primary focal segmental glomerulosclerosis dense deposit disease, C3 glomerulonephritis, and, atypical hemolytic uremic syndrome).\n11. Prior dose-limiting radiation therapy for treatment of malignant disease.\n12. Known genetic disease or family history that may result in greater sensitivity to the effects of irradiation, or a physical deformity that would preclude adequate shielding or appropriate dosing during the irradiation component of the conditioning regimen. This includes long term cigarette smoking or a family history of malignancy.\n13. Enrollment in other investigational drug studies within 30 days prior to enrollment.\n14. Abnormal (\\>2 times lab normal) values for (a) liver function chemistries (ALT, AST, AP), (b) bilirubin, (c) coagulation studies (PT, PTT) , or any patients on chronic anticoagulation therapy.\n15. Allergy or sensitivity to any component of Cyclophosphamide, tacrolimus, Siplizumab, Tegoprubart, or rituximab.\n16. The presence of any medical condition that the investigator deems incompatible with participation in the trial. This includes a history of alcohol abuse or illicit drug use\u002Fdependence.\n17. Any chronic or intermittent administration of immunosuppressant medication (such as for inflammatory bowel disease or asthma)\n18. Subjects who have non-insulin dependent diabetes (NIDDM) without good blood glucose control (HbA1c\\\u003C8%). Subjects with severe diabetes-related complications, such as advanced retinopathy, gastroparesis, or severe neuropathy that significantly impair their ability to perform normal, independent daily activities, will also be excluded.\n\nDonor Inclusion Criteria:\n\n1. Male or female 18-70 years of age.\n2. For females of childbearing potential: a serum pregnancy test showing negative results.\n3. Excellent health per conventional pre-donor workup (medical and psychosocial evaluation)\n4. Acceptable laboratory parameters (hematology in normal or near-normal range; Liver function \\\u003C2 times the upper limit of normal, and normal creatinine).\n5. Negative for viral infection with HBV (HbsAg and NAT), HIV (antibody and NAT), HCV (NAT), or HTLV-1.\n6. Cardiac\u002Fpulmonary function within normal limits (CXR, ECG).\n7. Ability to understand and provide informed consent.\n8. Meets standard institutional criteria for bone marrow aspiration and kidney donation.\n9. Negative COVID-19 test during screening and two days prior to procedure","ALL","18 Years","65 Years",{"count":19,"type":20},12,"ESTIMATED","INTERVENTIONAL",[23],"EARLY_PHASE1","This is an open-label, single-institution study to assess the safety and the efficacy of the Sip-Tego regimen for the induction of donor-specific immunologic unresponsiveness to a renal allograft. The investigators propose to treat 6 adult subjects in end-stage renal disease (ESRD) who do not demonstrate evidence of prior sensitization.",[26,27,28,29,30],"Kidney Failure","Transplant Recipient (Kidney)","Transplant Tolerance","Immunosuppresion","Immunosuppression After Kidney Transplantation",[32,33,34],"Tolerance","Transplant without immunosuppression","kidney transplant","RECRUITING","2026-06-05",{"date":38,"type":39},"2026-06-08","ACTUAL",{"date":41,"type":39},"2025-05-31",{"date":43,"type":20},"2030-12-31",{"name":45,"class":46},"Tatsuo Kawai, MD, PhD","OTHER",1,{"id":49,"slug":50,"hasResults":11,"nctId":51,"briefTitle":52,"officialTitle":52,"acronym":53,"eligibilityCriteria":54,"healthyVolunteers":55,"sex":56,"minAge":16,"maxAge":57,"enrollmentInfo":58,"targetDuration":4,"studyType":21,"phases":60,"briefSummary":62,"conditions":63,"keywords":70,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":77,"lastUpdatePostDateStruct":78,"startDateStruct":80,"completionDateStruct":82,"leadSponsor":84,"locationsCount":47},"100564074","phase-4-immunomodulatory-effects-of-dexamethasone-tocilizumab-and-anakinra-during-experimental-human-endotoxemia-100564074","NCT06624436","Immunomodulatory Effects of Dexamethasone, Tocilizumab and Anakinra During Experimental Human Endotoxemia","DEDICATE-LPS","Inclusion Criteria:\n\n* Male subjects aged ≥18 and ≤35 years\n* Body mass index (BMI) ≥18 and ≤30 kg\u002Fm2\n* Healthy (as determined by medical history, physical examination, vital signs, 12-lead electrocardiogram and routine clinical laboratory parameters)\n* Able to comprehend and sign the Information letter and Informed Consent (IC) prior to enrolment in the study.\n\nExclusion Criteria:\n\n* Use of any prescription medication or over-the-counter non-steroidal anti-inflammatory drugs\n* Known anaphylaxis or hypersensitivity to any (non-)investigational products or their excipients\n* History of chronic headache or previous post-dural puncture headache (PDPH)\n* History or signs of severe atopic syndrome (asthma, rhinitis with medication and\u002For eczema)\n* History of any disease associated with immune deficiency\n* History of cancer in the last 5 years (excluding localised skin cancer or carcinoma in situ)\n* History or signs of haematological disease\n* History or signs of thromboembolic disorders\n* History of peptic \u002F gastric ulcer disease\n* History of psychiatric disorders\n* Thrombocytopenia (\\<150\\*109\u002FmL) or anaemia (\\<8.0 mmol\u002FL)\n* History, signs or symptoms of cardiovascular disease, in particular:\n\n  * Prone to vagal collapse\n  * History of atrial or ventricular arrhythmia\n  * Cardiac conduction abnormalities on the ECG consisting of a 2nd degree atrio-ventricular block or a complete left bundle branch block\n  * Hypertension (defined as RR systolic \\> 160 or RR diastolic \\> 90 mmHg)\n  * Hypotension (defined as RR systolic \\< 100 or RR diastolic \\< 50 mmHg)\n* Renal impairment (defined as plasma creatinine \\>120 μmol\u002FL)\n* Liver enzyme abnormalities (above 2x the upper limit of normal)\n* Signs of infection (CRP \\> 20 mg\u002FL, white blood cells \\> 12x109\u002FL or\n\n  * lt; 4x109\u002FL)\n* Clinically significant acute illness, including infections or trauma, within 1 month prior to the first LPS challenge\n* Previous (participation in a study with) endotoxin (LPS) administration\n* Participation in an experimental intervention or drug trial within 3 months prior to the first LPS challenge\n* Any vaccination or blood donation within 1 month prior to the first LPS challenge\n* Recent hospital admission or surgery with general anaesthesia within 3 months prior to the first LPS challenge\n* Use of recreational drugs within 2 weeks prior to the first LPS challenge\n* Suspected of not being able to comply with the trial protocol\n* Inability to personally provide written informed consent (e.g. for linguistic or mental reasons) and\u002For take part in the study",true,"MALE","35 Years",{"count":59,"type":20},52,[61],"PHASE4","The goal of this clinical trial is to investigate the immunomodulatory effects of the drugs dexamethasone, tocilizumab and anakinra in healthy male subjects aged 18 to 35 undergoing experimental endotoxemia. The main questions it aims to answer are:\n\n* What are the effects of these drugs on the development of immunoparalysis in a repeated human endotoxemia model?\n* What is the extent of the neuroinflammatory response and how do these drugs affect neuroinflammation in a repeated human endotoxemia model?\n\nResearchers will compare these drugs to a placebo (a look-alike substance that contains no drug).\n\nParticipants will visit the Intensive Care research department on two or five occasions (screening included):\n\n* The intervention group will receive an LPS challenge twice, with a week in between. Before the first LPS challenge, one of the described drugs will be administered. Blood, saliva and tear fluid will be collected regularly during the LPS challenge. Cerebrospinal fluid will also be collected through a catheter in the spinal cord.\n* The control group will not receive an LPS challenge or drug administration and will have only one study day. During this day, blood, saliva, tear fluid and cerebrospinal fluid will be collected as regularly as during the LPS challenge of the intervention group.\n\nDuring an LPS challenge, the investigators mimic blood poisoning by giving an endotoxin, also called LPS. This is a small part of the cell wall of a bacteria. This will cause transient flu-like symptoms for 3-4 hours.",[64,65,29,66,67,68,69],"Sepsis","Neuroinflammatory Response","Endotoxemia","Anakinra","Dexamethasone","Tocilizumab",[64,71,72,73,67,68,69,74,75,76],"Immunosuppression","Systemic inflammation","Neuroinflammation","Human endotoxemia","Immunoparalysis","Hyperinflammatory response","2025-04-01",{"date":79,"type":39},"2025-04-04",{"date":81,"type":39},"2024-10-24",{"date":83,"type":20},"2025-12",{"name":85,"class":46},"Radboud University Medical Center",{"id":87,"slug":88,"hasResults":11,"nctId":89,"briefTitle":90,"officialTitle":91,"acronym":4,"eligibilityCriteria":92,"healthyVolunteers":11,"sex":15,"minAge":93,"maxAge":4,"enrollmentInfo":94,"targetDuration":4,"studyType":21,"phases":96,"briefSummary":98,"conditions":99,"keywords":102,"overallStatus":106,"whyStopped":4,"lastUpdateSubmitDate":107,"lastUpdatePostDateStruct":108,"startDateStruct":110,"completionDateStruct":112,"leadSponsor":114,"locationsCount":47},"100577786","prevent-allosensitization-in-patients-who-have-failed-a-first-renal-transplant-part-100577786","NCT06802822","Prevent Allosensitization in Patients Who Have Failed a First Renal Transplant (PART)","The PART PILOT STUDY: a Pilot Study to Inform the Feasibility of a Definitive Prospective Interventional Study to Prevent Allosensitization in Patients Who Have Failed a First Renal Transplant","Inclusion Criteria:\n\n* Patients ≥ 19 years old with a failed first kidney transplant and planned dialysis start date.\n\nExclusion Criteria:\n\n* Previous extra-renal organ transplant, or more than one previous kidney transplant\n* Not prescribed tacrolimus or cyclosporine at the time of transplant failure\n* Active infection or cancer that precludes IMSN, or non-transplant indication to continue IMSN\n* Receipt of an HLA identical donor transplant kidney with low risk for sensitization\n* Patients without archived donor samples to determine eplet mismatch and donor specific antibodies\n* Planned nephrectomy of the failed allograft\n* Graft survival of ≤ 12 months due to rejection\n* Designated as non-repeat transplant candidates by their transplant center or cPRA ≥ 90% at the time of enrollment in whom further increase in cPRA may permanently preclude repeat transplantation\n* Planned living donor transplant or planned move away from study center","19 Years",{"count":95,"type":20},96,[97],"NA","Kidney transplant is often the best treatment for people with kidney failure, but transplanted kidneys don't always last a lifetime. Many transplanted kidneys fail within 12 years, leaving patients needing dialysis or another transplant. One major issue is something called \"allosensitization,\" which happens when the immune system attacks the donated kidney due to foreign markers on the kidney. This makes it harder to match a patient with another donor kidney in the future.\n\nTo try to prevent this, patients are given immunosuppressants (drugs that weaken the immune system) after a transplant to stop the immune system from attacking the new kidney. However, after a kidney transplant fails and patients return to dialysis, there's no clear evidence that continuing immunosuppressants helps prevent allosensitization. Plus, these drugs have serious risks, including infections, heart disease, and even cancer.\n\nThe PART study is a pilot study designed to explore whether continuing immunosuppression after a failed transplant for two years (instead of stopping after six months) can lower the risk of allosensitization and whether it is safe to do so. This pilot will also gather data that will be used for a larger trial in the future.\n\nThe study will be done at 12 different research centers, and around 96 patients will be enrolled in the pilot trial. The ultimate goal is to better understand if continuing immunosuppressants after transplant failure can make a difference, and whether it's safe enough to proceed to a larger, more definitive trial.",[100,101,29],"Kidney Transplant","Kidney Transplant Failure",[34,103,104,105],"kidney transplant failure","immunosuppression","sensitization","NOT_YET_RECRUITING","2025-01-24",{"date":109,"type":39},"2025-01-31",{"date":111,"type":20},"2025-01",{"date":113,"type":20},"2027-12",{"name":115,"class":46},"University of British Columbia",{"id":117,"slug":118,"hasResults":11,"nctId":119,"briefTitle":120,"officialTitle":121,"acronym":122,"eligibilityCriteria":123,"healthyVolunteers":55,"sex":15,"minAge":124,"maxAge":125,"enrollmentInfo":126,"targetDuration":128,"studyType":129,"phases":4,"briefSummary":130,"conditions":131,"keywords":140,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":156,"lastUpdatePostDateStruct":157,"startDateStruct":159,"completionDateStruct":161,"leadSponsor":162,"locationsCount":47},"100561522","role-of-endomyocardial-biopsy-and-aetiology-based-treatment-in-pediatric-patients-with-inflammatory-heart-disease-in-arrhythmic-and-non-arrhythmic-clinical-presentations-an-integrated-approach-for-the-optimal-diagnostic-and-therapeutic-management-myoped-100561522","NCT06591260","Role of Endomyocardial Biopsy and Aetiology-based Treatment in Pediatric Patients with Inflammatory Heart Disease in Arrhythmic and Non-arrhythmic Clinical Presentations: an Integrated Approach for the Optimal Diagnostic and Therapeutic Management (MYOPED)","Role of Endomyocardial Biopsy and Aetiology-based Treatment in Pediatric Patients with Inflammatory Heart Disease in Arrhythmic and Non-arrhythmic Clinical Presentations: an Integrated Approach for the Optimal Diagnostic and Therapeutic Management","MYOPED","Inclusion Criteria:\n\n* Written informed consent.\n* Age \\< 18 years.\n* Clinically suspected myocarditis.\n* Enrollment performed by one of the participating Centers.\n\nExclusion Criteria:\n\n* Absence of written informed consent.\n* Age \\> 18 years (adults)","0 Years","17 Years",{"count":127,"type":20},20,"30 Years","OBSERVATIONAL","Myocarditis is a complex inflammatory disease, usually occurring secondary to viral infections, autoimmune processes or toxic agents. Clinical presentations are multiple, including chest-pain, heart failure and a broad spectrum of arrhythmias. In turn, outcome is largely unpredictable, ranging from mild self-limiting disease, to chronic stage and progressive evolution towards dilated cardiomyopathy, to rapid adverse outcome in fulminant forms. Subsequently, myocarditis is often underdiagnosed and undertreated, and optimal diagnostic and therapeutic strategies are still to be defined. This study, both retrospective and prospective, originally single-center and subsequently upgraded to multicenter, aims at answering multiple questions about myocarditis, with special attention to its arrhythmic manifestations.\n\nOptimal diagnostic workflow is still to be defined. In fact, although endomyocardial biopsy (EMB) is still the diagnostic gold standard, especially for aetiology identification, it is an invasive technique. Furthermore, it may lack sensitivity because of sampling errors. By converse, modern imaging techniques - cardiac magnetic resonance (CMR) in particular - have been proposed as alternative or complementary diagnostic tool in inflammatory heart disease. Other noninvasive diagnostic techniques, like delayed-enhanced CT (DECT) scan or position emission tomography (PET) scan, are under investigation.\n\nBiomarkers to identify myocarditis aetiology, predisposition, prognosis and response to treatment are still to be defined.\n\nArrhythmic myocarditis is largely underdiagnosed and uninvestigated. Importantly, myocarditis presenting with arrhythmias requires specific diagnostic, prognostic and therapeutic considerations. At the group leader hospital, which is an international referral center for ventricular arrhythmias management and ablation, a relevant number of patients with unexplained arrhythmias had myocarditis as underlying aetiology. The experience of a dedicated third-level center is going to be shared with other centers, to considerably improve knowledge and management of arrhythmic myocarditis.\n\nThe role of CMR, as well as alternative noninvasive imaging techniques, in defining myocarditis healing is a relevant issue. In particular, optimal timing for follow-up diagnostic reassessment is still to be defined, in patients with myocarditis at different inflammatory stages, either with or without aetiology-dependent treatment.\n\nUniformly-designed studies are lacking, to compare myocarditis among different patient subgroups, differing by variables like: clinical presentations, myocarditis stage, associated cardiac or extra-cardiac diseases, aetiology-based treatment, associated arrhythmic manifestations, diagnostic workup, and devices or ablation treatment.",[132,133,134,135,136,137,138,29,139],"Myocarditis","Ventricular Arrhythmia","Inflammatory Cardiomyopathy","Genetic Predisposition","Autoimmunity","Arrhythmia","Cardiomyopathies","Catheter Ablation",[132,141,142,143,144,145,146,147,148,149,150,151,152,153,154,155],"Ventricular arrhythmias","Arrhythmias","Arrhythmogenic inflammatory cardiomyopathy","Endomyocardial biopsy","Cardiac magnetic resonance","Ablation","Positron emission tomography","Electroanatomical mapping","Immunosuppressive therapy","Arrhythmic risk stratification","Genetic predisposition","Environment","Implantable cardioverter defibrillator","Implantable loop recorder","Multicenter","2024-09-11",{"date":158,"type":39},"2024-09-19",{"date":160,"type":39},"2013-01-01",{"date":43,"type":20},{"name":163,"class":46},"Scientific Institute San Raffaele"]