[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"immunosuppression-after-kidney-transplantation\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:immunosuppression-after-kidney-transplantation":30},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,2,0,[8,48],{"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":53,"acronym":54,"eligibilityCriteria":55,"healthyVolunteers":11,"sex":15,"minAge":16,"maxAge":56,"enrollmentInfo":57,"targetDuration":4,"studyType":21,"phases":59,"briefSummary":61,"conditions":62,"keywords":66,"overallStatus":68,"whyStopped":4,"lastUpdateSubmitDate":69,"lastUpdatePostDateStruct":70,"startDateStruct":72,"completionDateStruct":74,"leadSponsor":76,"locationsCount":5},"100608632","phase-2-tnx-1500-in-kidney-transplant-recipients-100608632","NCT07204080","(TNX-1500) in Kidney Transplant Recipients","Phase II Clinical Trial Evaluating the Safety and Efficacy of Fc-Modified Anti-CD154 mAB (TNX-1500) in Kidney Transplant Recipients","TONIX-1500","Inclusion Criteria:\n\n1. Male or female subjects ≥18 to 75 years of age.\n2. Kidney transplant candidates with chronic kidney disease (stage IV or V) or end-stage kidney disease evaluated and listed for transplantation at Massachusetts General Hospital.\n3. Recipient of an ABO-compatible, non-human leukocyte antigen (HLA) identical living or deceased donor kidney (de novo or second transplant)\n4. Ability to understand the study requirements and provide written informed consent.\n5. Epstein-Barr virus (EBV) seropositive\n\nExclusion Criteria:\n\n1. Recipient seropositive for human immunodeficiency virus (HIV-1), or hepatitis B surface antigen (HBsAg) or core antibody (Anti-HBc); subjects who are seropositive for hepatitis C virus (HCV) are excluded without proof of sustained viral response (SVR) after anti-HCV treatment or spontaneous clearance.\n2. Recipient of a kidney from a donor who tests positive for HIV, HBsAg, Anti-HBc, or HCV NAT.\n3. Subjects with a severe systemic infection, current or within the 2 weeks prior to screening.\n4. Left ventricular ejection fraction \\\u003C 40% as determined by TTE or clinical evidence of heart failure.\n5. Pregnant or nursing (lactating) women confirmed by human chorionic gonadotropin (hCG) laboratory test.\n6. Women of childbearing potential (women capable of becoming pregnant) unless using a highly effective method of contraception during dosing and for 24 weeks after study treatment. Highly effective contraception methods include:\n\n   1. Female sterilization (surgical, bilateral oophorectomy with or without hysterectomy), or tubal ligation at least 6 weeks before taking study treatment.\n   2. Male sterilization (at least 6 months prior to screening); for female subjects on the study, the vasectomized male partners should be the sole partners for that subject.\n   3. Use of injected or implanted hormonal methods of contraception or other hormonal contraception that have comparable efficacy (\\\u003C1% for example, hormone vaginal ring or placement of a long-acting reversible contraceptives, an intrauterine device, or intrauterine system.\n   4. Total abstinence\n7. Use of other investigational products or enrollment in another investigational drug study within 30 days prior to screening or 5 half-lives, whichever is longer.\n8. Subjects with clinically significant lab abnormalities (\\>2.5 x the upper limit of normal (ULN) of the following liver function chemistries unless due to, as judged by the investigator, a benign underlying condition:\n\n   1. Alanine aminotransferase (ALT)\n   2. Aspartate aminotransferase (AST)\n   3. Alkaline phosphatase (ALP)\n   4. Bilirubin\n   5. Coagulation studies (international normalization ratio (INR), prothrombin time (PT), and partial thromboplastin time (PTT))\n9. Any other clinically significant medical condition, active infection, laboratory abnormality, or psychosocial condition (e.g. history of substance use disorder) that would, in the judgement of the investigator, impact the subject's ability to participate in the trial.\n10. Subject receives an organ at high risk for delayed graft function, including from a deceased donor after cardiac death (DCD) or a high Kidney Donor Profile Index ≥85%.\n11. Presence of pre-existing donor-specific antibodies (DSA) or calculated panel reactive antibodies (cPRA) \\>20% based upon results within 6 months prior to transplant.\n12. Virtual crossmatch (VXM) positive transplant with an MFI \\>1000 as assessed by routine methodology (Luminex)\n13. Cytomegalovirus (CMV) high risk combination: donor positive to recipient negative\n14. Multi-organ transplant or tissue recipient.\n15. History of malignancy of any organ system, except for localized excised non-melanomatous skin or carcinoma in situ of the cervix\n16. Subjects with any of the following: hemoglobin \\\u003C8 mg\u002FdL, white blood cell ≤2,000\u002Fmm3, or platelet count ≤75,000\u002Fmm3.","75 Years",{"count":58,"type":20},5,[60],"PHASE2","The primary objective is to investigate the safety and efficacy of TNX-1500, an FC-modified anti-CD154 mAb, in five kidney transplant recipients at 12 months.",[63,64,65,30],"Kidney Transplant","Kidney Transplant Failure and Rejection","Immunosuppression",[63,67],"New Immunosuppression","NOT_YET_RECRUITING","2026-02-24",{"date":71,"type":39},"2026-02-25",{"date":73,"type":20},"2026-07-01",{"date":75,"type":20},"2029-06-30",{"name":77,"class":46},"Ayman Al Jurdi, MD"]