[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"esrd-end-stage-renal-disease\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:esrd-end-stage-renal-disease":27},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,9,0,[8,49,79,111,137,170,193,223,245],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":15,"eligibilityCriteria":16,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":19,"targetDuration":4,"studyType":22,"phases":23,"briefSummary":25,"conditions":26,"keywords":29,"overallStatus":36,"whyStopped":4,"lastUpdateSubmitDate":37,"lastUpdatePostDateStruct":38,"startDateStruct":41,"completionDateStruct":43,"leadSponsor":45,"locationsCount":48},"100641194","efficacy-of-pha130-hemoadsorption-on-protein-bound-uremic-toxins-and-quality-of-life-in-kidney-failure-100641194",false,"NCT07656168","Efficacy of pHA130 Hemoadsorption on Protein-Bound Uremic Toxins and Quality of Life in Kidney Failure","A Prospective, Multicenter, Randomized Controlled Trial of HAHD With pHA130 Cartridge vs. Conventional High-Flux HD for Clearance of Protein-Bound Uremic Toxins and Quality of Life Improvement in Kidney Failure.","PHOENIX","Inclusion Criteria:\n\n* Age \\> 18 years.\n* On maintenance hemodialysis for \\> 3 months.\n* Receiving hemodialysis 3 times per week, 4 hours per session.\n* Standard Kt\u002FV ≥ 1.2.\n* Voluntarily participates and provides written informed consent.\n\nExclusion Criteria:\n\n* Known allergy to the dialyzer or hemoperfusion device.\n* Platelet count \\\u003C 60×10⁹\u002FL.\n* Serum albumin \\\u003C 30 g\u002FL.\n* 24-hour urine output \\> 200 ml.\n* Inability to achieve a blood flow rate ≥ 200 ml\u002Fmin.\n* Coagulation disorders, severe bleeding tendency, or active bleeding.\n* Pre-dialysis systolic blood pressure \\\u003C 90 mmHg or diastolic blood pressure \\\u003C 60 mmHg.\n* Active malignancy.\n* Active infection, or severe, critical illness of cardiac, pulmonary, hepatic, or nervous systems.\n* Planned living-donor kidney transplant within the next 6 months.\n* Current participation in another interventional clinical study, or participation within the past 3 months in an interventional study that may interfere with the present study (e.g., fecal microbiota transplantation); or use of intestinal microecological regulators such as probiotics.\n* History of unstable angina, myocardial infarction, malignant arrhythmia, cardiac or peripheral vascular surgery, or cerebrovascular accident within the past 8 weeks.","ALL","18 Years",{"count":20,"type":21},100,"ESTIMATED","INTERVENTIONAL",[24],"NA","Patients on maintenance hemodialysis (MHD) face a high risk of cardiovascular mortality and reduced quality of life. Conventional high-flux hemodialysis (HD) is the standard of care but has limited efficacy in clearing middle-molecular and protein-bound uremic toxins (PBUTs). The accumulation of these toxins is associated with adverse long-term outcomes.\n\nThis study evaluates the efficacy and safety of the pHA130 hemoadsorption cartridge, which utilizes a modified resin for enhanced PBUT adsorption, when combined with hemodialysis (HAHD). This is a prospective, open-label, multi-center, randomized controlled trial involving 100 MHD patients. Participants will be randomized 1:1 to either the HAHD group (receiving one HAHD session using the pHA130 cartridge and two standard HD sessions weekly) or the Control group (receiving three standard HD sessions weekly).\n\nThe primary objective is to assess the reduction in serum indoxyl sulfate (IS) and p-cresol sulfate (PCS) levels from baseline to 12 months. Secondary objectives include evaluating changes in quality of life (KDQoL-SF, MMSE), the progression of coronary artery calcification (CAC), the incidence of major adverse cardiovascular events (MACEs), all-cause mortality, and safety profiles. This trial aims to determine if integrating long-term HAHD therapy can optimize blood purification strategies for the MHD population.",[27,28],"ESRD (End-Stage Renal Disease)","Maintenance Hemodialysis",[30,31,32,33,34,35],"Hemoadsorption","Protein-Bound Uremic Toxins","Indoxyl Sulfate","p-Cresyl Sulfate","Cardiovascular Events","Quality of Life","RECRUITING","2026-06-22",{"date":39,"type":40},"2026-06-25","ACTUAL",{"date":42,"type":40},"2026-06-01",{"date":44,"type":21},"2028-08",{"name":46,"class":47},"China-Japan Friendship Hospital","OTHER",1,{"id":50,"slug":51,"hasResults":11,"nctId":52,"briefTitle":53,"officialTitle":54,"acronym":4,"eligibilityCriteria":55,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":56,"targetDuration":4,"studyType":22,"phases":58,"briefSummary":59,"conditions":60,"keywords":4,"overallStatus":69,"whyStopped":4,"lastUpdateSubmitDate":70,"lastUpdatePostDateStruct":71,"startDateStruct":73,"completionDateStruct":75,"leadSponsor":77,"locationsCount":48},"100641241","impact-of-a-tunneled-hemodialysis-catheter-with-endexo-technology-on-catheter-dysfunction-compared-with-historical-catheter-dysfunction-data-in-standard-catheters-100641241","NCT07655544","Impact of a Tunneled Hemodialysis Catheter With Endexo® Technology on Catheter Dysfunction Compared With Historical Catheter Dysfunction Data in Standard Catheters","Impact of a Tunneled Hemodialysis Catheter With Endexo® Technology on Catheter Dysfunction Compared With Historical Catheter Dysfunction Data in Standard Catheters (Silicone or Polyurethane): A Pilot Study","Inclusion Criteria:\n\n* Adult patients aged greater than 18 years\n* Written informed consent\n* Requirement for hemodialysis using a tunneled dialysis catheter\n\nExclusion Criteria:\n\n* Children aged less than 18 years\n* Uncontrolled infection; defined as positive blood culture in the past seven days before catheter insertion and\u002F or elevated C-reactive protein \\[CRP \\>5 mg\u002Fdl (normal \\\u003C0.5 mg\u002Fdl)\\] at screening",{"count":57,"type":21},50,[24],"There is evidence that central venous catheters made of the permanent and non-eluting integral polymer Endexo® are more resistant to intraluminal thrombosis. This has a direct reducing effect on catheter malfunctions. Indirectly, due to reduced handling of the dysfunctional catheter, this may lead to a diminished rate of catheter related infections. Since catheter malfunctions and infections represent leading complications in a dialysis population, dialysis catheters produced with Endexo® technology have the potential to have beneficial clinical effects. In addition to improving patient outcomes, this could also reduce overall costs. In this pilot study the tunneled hemodialysis catheter BioFlo Duramax with Endexo® technology (Merit Medical, Utah, USA) will be compared with historical catheter dysfunction rates in standard tunneled dialysis catheters (silicone or polyurethane) in chronic dialysis population.",[61,62,63,64,65,66,67,68],"Haemodialysis","Haemodialysis Complication","Vascular Access","Vascular Access Complication","ESRD (End Stage Renal Disease)","Dialysis Access Dysfunction","Dialysis Catheter","Dialysis Catheter Infections","NOT_YET_RECRUITING","2026-06-11",{"date":72,"type":40},"2026-06-18",{"date":74,"type":21},"2026-08-01",{"date":76,"type":21},"2027-12-31",{"name":78,"class":47},"Medical University of Vienna",{"id":80,"slug":81,"hasResults":11,"nctId":82,"briefTitle":83,"officialTitle":84,"acronym":85,"eligibilityCriteria":86,"healthyVolunteers":11,"sex":17,"minAge":87,"maxAge":88,"enrollmentInfo":89,"targetDuration":4,"studyType":22,"phases":90,"briefSummary":93,"conditions":94,"keywords":97,"overallStatus":36,"whyStopped":4,"lastUpdateSubmitDate":101,"lastUpdatePostDateStruct":102,"startDateStruct":104,"completionDateStruct":106,"leadSponsor":108,"locationsCount":48},"100610221","phase-1-study-to-evaluate-the-safety-and-efficacy-of-the-ggta1-ko-thymokidney-in-patients-with-esrd-100610221","NCT07224763","Study to Evaluate the Safety and Efficacy of the GGTA1 KO Thymokidney in Patients With ESRD","EXTEND: A Prospective Study to Evaluate the Safety and Efficacy of GGTA1 KO Thymokidney XenoTransplantation in Patients With End-stage Renal Disease (ESRD)","EXTEND","Inclusion Criteria for all Participants (Groups 1 and 2):\n\n1. Provide voluntarily informed consent to participate in the study and for lifetime follow-up.\n2. Have a diagnosis of ESRD at the time of informed consent.\n3. Hemodialysis dependent for a minimum of 6 months and has a functioning arterial-venous fistula\u002Fgraft or permanent catheter at the time of informed consent.\n4. 50 to 70 years of age at the time of informed consent, or 40 to \\\u003C50 years of age with a calculated panel reactive antibody (cPRA) of ≥99.9%.\n5. Evidence of thymic involution on chest computed tomography (CT) scan with a thymic region of interest score of ≤1.\n6. Live within 3 hours travel time of the xenotransplant center.\n7. Female participants must be postmenopausal or permanently sterilized (eg, hysterectomy, bilateral oophorectomy, or bilateral salpingectomy). Male participants must agree to the use of a highly effective method of birth control, if the possibility of conception exists.\n8. Negative xeno-crossmatch at Screening and pre-transplant.\n9. Estimated Post Transplant Survival Calculator score \\>20%.(https:\u002F\u002Foptn.transplant.hrsa.gov\u002Fdata\u002Fallocation-calculators\u002Fepts-calculator\u002F).\n10. Body mass index ≤35 kg\u002Fm2.\n11. Have completed or have initiated and plan to complete (meningococcal A, C, W, Y and meningococcal B vaccine series only) Centers for Disease Control and Prevention-recommended courses of age- and risk-factor-appropriate vaccinations.\n12. Seropositive (immunoglobulin G) for cytomegalovirus and Epstein-Barr virus.\n\nAdditional Inclusion Criteria for Group 1:\n\n1\\. Ineligible for conventional allogeneic kidney transplantation due to medical reason(s) for any of the following:\n\n1. Ineligible for a living donor transplant.\n2. Ineligible for an OPTN kidney transplant waitlist (reason for ineligibility will be collected).\n3. Delisted from OPTN kidney transplant waitlist (reason for delisting will be collected).\n\nAdditional Inclusion Criteria for Group 2:\n\n1. On an OPTN kidney transplant waitlist (active or inactive status).\n2. No approved living kidney donors.\n3. More likely to die or go untransplanted within 5 years than receive a kidney transplant as measured by the Kidney Transplant Decision Aid at the time of informed consent (select United States for \"Choose your state\" field and National average for \"Choose your transplant program\" field; https:\u002F\u002Fwww.srtr.org\u002Ftools\u002Fkidney-transplant-decision-aid\u002F).\n\nExclusion Criteria (pertain to all participants in Groups 1 and 2):\n\n1. Need for multiple organ transplants.\n2. Severe medical co-morbidities including, but not limited to:\n\n   1. Chronic liver disease.\n   2. Advanced cardiovascular disease.\n   3. Severe peripheral vascular disease that limits technical ability to transplant the GGTA1 KO Thymokidney.\n   4. Severe neurologic diseases or conditions that would preclude meaningful recovery or informed consent.\n   5. Oral steroid-dependent airway disorder or chronic pulmonary disease or requires chronic, intermittent, or continuous supplemental oxygen.\n   6. Pulmonary hypertension.\n   7. Uncontrolled diabetes or sequelae of diabetes mellitus including severe non-proliferative diabetic retinopathy.\n   8. Severe neurogenic bladder that requires intermittent catheterization.\n3. ESRD due to hereditary or structural kidney disease.\n4. Active or recently treated malignancy at the time of informed consent.\n5. Non-renal cause of hematological disorders associated with anemia (eg, thalassemia and sickle disease).\n6. Cannot discontinue chronic anticoagulation therapy (low-dose daily aspirin is permissible).\n7. History of major psychiatric disorders with psychiatric hospitalization and\u002For suicidal ideation within 5 years of informed consent.\n8. Being treated for active tuberculosis (TB), have received prophylaxis for positive FDA-approved interferon-gamma release assay, or test positive for TB by FDA-approved interferon-gamma release assay test during Screening.\n9. Nucleic acid test (NAT) positive for hepatitis B virus and\u002For hepatitis C virus, hepatitis B surface antibody (anti-HBs) titer \\\u003C10 mIU\u002FmL unless the participant is determined to be a nonresponder to hepatitis B vaccination (a nonresponder is defined as having an anti-HB titer \\\u003C10 mIU\u002FmL after having completed both the standard vaccine series and a fourth booster dose and\u002For second standard vaccine series), and\u002For positive for human immunodeficiency virus (HIV; HIV-1 and HIV-2 antibody and\u002For NAT).\n10. Not able to independently perform activities of daily life.\n11. Have a history of medical noncompliance that may preclude adherence to the demands and requirements of xenotransplantation (eg, history of substance use disorder \\[SUD\\] within 1 year of informed consent, lack of social support, untreated psychological conditions).","40 Years","70 Years",{"count":57,"type":21},[91,92],"PHASE1","PHASE2","The purpose of this study is to evaluate the safety and efficacy of the GGTA1 KO Thymokidney in patients with end-stage renal disease (ESRD) who are either not eligible for conventional allogeneic kidney transplantation (Group 1) or are on an Organ Procurement and Transplantation Network (OPTN) kidney transplant waitlist, but are more likely to die or go untransplanted within 5 years than receive a kidney transplant (Group 2).\n\nThe study consists of xenotransplantation followed by a 24-week Post-transplant Follow-up Period (Part A) to evaluate the efficacy and safety objectives followed by a Long-term Follow-up Period (Part B) to evaluate participant survival, GGTA1 KO Thymokidney survival, and screening for zoonotic infections. Part B will continue for the lifetime of the participant or for 52 weeks following nephrectomy, if required.",[27,95,96],"Kidney Transplantation","Xenotransplantation",[98,99,96,100],"End-stage renal disease","ESRD","GGTA1 KO Thymokidney","2026-05-26",{"date":103,"type":40},"2026-05-27",{"date":105,"type":21},"2026-06",{"date":107,"type":21},"2076-03",{"name":109,"class":110},"United Therapeutics","INDUSTRY",{"id":112,"slug":113,"hasResults":11,"nctId":114,"briefTitle":115,"officialTitle":115,"acronym":4,"eligibilityCriteria":116,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":117,"targetDuration":119,"studyType":120,"phases":4,"briefSummary":121,"conditions":122,"keywords":124,"overallStatus":69,"whyStopped":4,"lastUpdateSubmitDate":129,"lastUpdatePostDateStruct":130,"startDateStruct":132,"completionDateStruct":133,"leadSponsor":135,"locationsCount":4},"100639317","serum-insulin-like-growth-factor-1-to-albumin-ratio-as-a-biomarker-for-sarcopenia-severity-in-end-stage-renal-disease-patients-on-hemodialysis-100639317","NCT07586956","Serum Insulin-like Growth Factor-1 to Albumin Ratio as a Biomarker for Sarcopenia Severity in End-Stage Renal Disease Patients on Hemodialysis","Inclusion Criteria:\n\n\\- 1. Adult patients (age ≥ 18 years). 2. Diagnosis of ESRD on maintenance hemodialysis for \\> 3 months. 3. Clinically stable (no hospitalization or active infection in the past 4 weeks).\n\n4\\. Willing and able to provide informed consent.\n\nExclusion Criteria:\n\n* 1\\. Active malignancy or recent chemotherapy\u002Fradiotherapy. 2. Decompensated liver cirrhosis (Child-Pugh B or C). 3. Major limb amputation or severe neuromuscular disease precluding functional assessment.\n\n  4\\. Acute inflammatory conditions (e.g., systemic lupus erythematosus flare, vasculitis).\n\n  5\\. Pregnancy.",{"count":118,"type":21},110,"6 Months","OBSERVATIONAL","Sarcopenia is a prevalent and serious complication among patients with End-Stage Renal Disease (ESRD) receiving maintenance dialysis, characterized by progressive loss of skeletal muscle mass, strength, and physical function. It is strongly associated with adverse clinical outcomes, including increased mortality, hospitalization, frailty, and reduced quality of life. The development of sarcopenia in ESRD is multifactorial, involving chronic inflammation, metabolic disturbances, hormonal dysfunction, anorexia, and the catabolic effects of dialysis. Although the 2019 EWGSOP2 guidelines recommend assessment of muscle strength, quantity, and physical performance for diagnosis, routine clinical implementation remains limited due to the need for specialized equipment, time constraints, and variability related to fluid status in dialysis patients. Consequently, there is a growing need for accessible and reliable biochemical markers for early identification of patients at risk.\n\nInsulin-like Growth Factor-1 (IGF-1), an essential anabolic mediator of muscle protein synthesis, is often reduced and functionally impaired in ESRD, contributing to anabolic resistance and muscle wasting. Serum albumin, a conventional indicator of nutritional and inflammatory status, reflects the catabolic and inflammatory processes associated with sarcopenia but lacks specificity when used independently. The IGF-1\u002FAlbumin ratio may provide a more integrated representation of the balance between anabolic and catabolic pathways underlying uremic sarcopenia. Therefore, this study aims to evaluate the association between the serum IGF-1\u002FAlbumin ratio and the presence and severity of sarcopenia, as defined by EWGSOP2 criteria, in stable outpatient dialysis patients.",[123,65],"Sarcopenia",[123,99,125,126,127,128],"dialysis","IGF-1","Serum albumin","IGF-1:albumin ration","2026-05-07",{"date":131,"type":40},"2026-05-14",{"date":42,"type":21},{"date":134,"type":21},"2026-12-01",{"name":136,"class":47},"Sohag University",{"id":138,"slug":139,"hasResults":11,"nctId":140,"briefTitle":141,"officialTitle":142,"acronym":143,"eligibilityCriteria":144,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":145,"targetDuration":4,"studyType":22,"phases":146,"briefSummary":147,"conditions":148,"keywords":151,"overallStatus":69,"whyStopped":4,"lastUpdateSubmitDate":160,"lastUpdatePostDateStruct":161,"startDateStruct":163,"completionDateStruct":165,"leadSponsor":167,"locationsCount":48},"100634332","laser-acupuncture-for-fatigue-in-hemodialysis-patients-100634332","NCT07538310","Laser Acupuncture for Fatigue in Hemodialysis Patients","Laser Acupuncture Improves Fatigue and Quality of Life in Hemodialysis Patients: a Randomized Double-blind Clinical Trial Pilot Study","LA-HD-Fatigue","Inclusion Criteria:\n\n* Patients with End-Stage Renal Disease (ESRD) who require regular maintenance hemodialysis.\n* Must undergo hemodialysis treatment at least 3 times per week.\n* Aged 18 years or older.\n* Willing and able to provide informed consent to participate in the study.\n\nExclusion Criteria:\n\n* Presence of acute infectious symptoms.\n* Unstable vital signs.\n* Diagnosis of malignant tumors.\n* Pregnancy.\n* Presence of open wounds at the sites designated for laser intervention.\n* Patients with implanted cardiac pacemakers or other cardiac devices.",{"count":57,"type":21},[24],"The goal of this clinical trial is to learn if laser acupuncture (low-level laser therapy) works to treat fatigue and improve quality of life in adults with end-stage renal disease (ESRD) undergoing hemodialysis. It will also learn about how laser acupuncture affects blood circulation and autonomic nervous system balance.\n\nThe main questions it aims to answer are:\n\n1. Does laser acupuncture reduce the severity of fatigue and its interference with daily life?\n2. Can laser acupuncture improve related symptoms such as insomnia, poor appetite, and skin itching?\n3. How does laser acupuncture affect objective markers like microcirculation and heart rate variability? Researchers will compare laser acupuncture to a sham treatment (a look-alike procedure using a device that does not emit a laser) to see if laser acupuncture works to treat fatigue.\n\nParticipants will:\n\n1. Receive laser acupuncture or a sham treatment during their regular hemodialysis sessions 3 times a week for 4 weeks.\n2. Have their fatigue and life quality assessed through questionnaires on the first day, at 4 weeks, and at 8 weeks.\n3. Undergo non-invasive tests to measure microcirculation, heart rate variability, and pulse waves, and have photos of their tongue taken for Chinese medicine assessment.",[65,149,150],"Dialysis","Fatigue",[152,153,154,155,150,35,156,157,158,159],"Hemodialysis","End-Stage Renal Disease","Laser Acupuncture","Photobiomodulation","Microcirculation","Low-Level Laser Therapy","Traditional Chinese Medicine","Heart Rate Variability","2026-04-12",{"date":162,"type":40},"2026-04-20",{"date":164,"type":21},"2026-04-08",{"date":166,"type":21},"2027-08-31",{"name":168,"class":169},"Taipei City Hospital","OTHER_GOV",{"id":171,"slug":172,"hasResults":11,"nctId":173,"briefTitle":174,"officialTitle":175,"acronym":176,"eligibilityCriteria":177,"healthyVolunteers":11,"sex":17,"minAge":87,"maxAge":88,"enrollmentInfo":178,"targetDuration":4,"studyType":22,"phases":179,"briefSummary":180,"conditions":181,"keywords":182,"overallStatus":36,"whyStopped":4,"lastUpdateSubmitDate":184,"lastUpdatePostDateStruct":185,"startDateStruct":187,"completionDateStruct":189,"leadSponsor":191,"locationsCount":192},"100583610","phase-1-study-to-evaluate-the-safety-and-efficacy-of-the-10-ge-xenokidney-in-patients-with-esrd-100583610","NCT06878560","Study to Evaluate the Safety and Efficacy of the 10 GE Xenokidney in Patients With ESRD","EXPAND: A Prospective Study to Evaluate the Safety and Efficacy of the 10 GE Xenokidney in Patients With End-stage Renal Disease (ESRD)","EXPAND","Inclusion Criteria for all Participants (Groups 1 and 2):\n\n1. Provide voluntarily informed consent to participate in the study and for lifetime follow up.\n2. Have a diagnosis of ESRD at the time of informed consent.\n3. Hemodialysis dependent for a minimum of 6 months and has a functioning arterial venous fistula\u002Fgraft or permanent catheter at the time of informed consent.\n4. 50 to 70 years of age at the time of informed consent, or 40 to \\\u003C50 years of a age with a calculated panel reactive antibody (cPRA) of ≥99.9%.\n5. Live withing 3 hours travel time of the xenotransplant center.\n6. Female participants must be postmenopausal or permanently sterilized (eg, hysterectomy, bilateral oophorectomy, or bilateral salpingectomy). Male participants must agree to the use of a highly effective method of birth control, if the possibility of conception exists.\n7. Negative xeno-crossmatch at Screening and pre-transplant.\n8. Estimated Post Transplant Survival Calculator score \\>20% (https:\u002F\u002Foptn.transplant.hrsa.gov\u002Fdata\u002Fallocation-calculators\u002Fepts-calculator\u002F).\n9. Body mass index ≤35 kg\u002Fm2.\n10. Have completed or have initiated and plan to complete (meningococcal A, C, W, Y and meningococcal B vaccine series only) Centers for Disease Control and Prevention recommended courses of age and risk factor appropriate vaccinations.\n11. Seropositive (immunoglobulin G) for cytomegalovirus and Epstein-Barr virus.\n\nAdditional Inclusion Criteria for Group 1:\n\n1\\. Ineligible for conventional allogeneic kidney transplantation due to medical reason(s) for any of the following:\n\n1. Ineligible for a living donor transplant.\n2. Ineligible for an OPTN kidney transplant waitlist (reason for ineligibility will be collected).\n3. Delisted from OPTN kidney transplant waitlist (reason for delisting will be collected).\n\nAdditional Inclusion Criteria for Group 2:\n\n1. On an OPTN kidney transplant waitlist (active or inactive status).\n2. No approved living kidney donors.\n3. More likely to die or go untransplanted within 5 years than receive a kidney transplant as measured by the Kidney Transplant Decision Aid at the time of informed consent (select United States for \"Choose your state\" field and National average for \"Choose your transplant program\" field; https:\u002F\u002Fwww.srtr.org\u002Ftools\u002Fkidney-transplant-decision-aid\u002F).\n\nExclusion Criteria (pertain to all participants in Groups 1 and 2):\n\n1. Need for multiple organ transplants.\n2. Severe medical co-morbidities including, but not limited to:\n\n   1. Chronic liver disease.\n   2. Advanced cardiovascular disease.\n   3. Severe peripheral vascular disease that limits technical ability to transplant the 10 GE Xenokidney.\n   4. Severe neurologic diseases or conditions that would preclude meaningful recovery or informed consent.\n   5. Oral steroid-dependent airway disorder or chronic pulmonary disease or requires chronic, intermittent or continuous supplemental oxygen.\n   6. Pulmonary hypertension.\n   7. Uncontrolled diabetes or sequelae of diabetes mellitus including severe non-proliferative diabetic retinopathy.\n   8. Severe neurogenic bladder that requires intermittent catheterization.\n3. ESRD due to hereditary or structural kidney disease.\n4. Active or recently treated malignancy at the time of informed consent.\n5. Non-renal cause of hematological disorders associated with anemia (eg, thalassemia and sickle disease).\n6. Cannot discontinue chronic anticoagulation therapy (low-dose daily aspirin is permissible).\n7. History of major psychiatric disorders with a psychiatric hospitalization and\u002For suicidal ideation within 5 years of informed consent.\n8. Being treated for active tuberculosis (TB), have received prophylaxis for positive FDA-approved interferon-gamma release assay, or test positive for TB by FDA-approved interferon-gamma release assay test during Screening.\n9. Nucleic acid test (NAT) positive for hepatitis B virus and\u002For hepatitis C virus, hepatitis B surface antibody (anti HBs) titer \\\u003C10 mIU\u002FmL unless the participant is determined to be a nonresponder to hepatitis B vaccination (a nonresponder is defined as having an anti-HBs titer \\\u003C10 mIU\u002FmL after having completed both the standard vaccine series and a fourth booster dose and\u002For second standard vaccine series), and\u002For positive for human immunodeficiency virus (HIV; HIV-1 and HIV-2 antibody and\u002For NAT).\n10. Not able to independently perform activities of daily life.\n11. Have a history of medical noncompliance that may preclude adherence to the demands and requirements of xenotransplantation (eg, history of substance use disorder (SUD) within 1 year of informed consent, lack of social support, untreated psychological conditions).",{"count":57,"type":21},[91,92],"The purpose of this study is to evaluate the safety and efficacy of the 10 GE Xenokidney in patients with ESRD who are either not eligible for conventional allogeneic kidney transplantation (Group 1) or are on an Organ Procurement and Transplantation Network (OPTN) kidney transplant waitlist, but are more likely to die or go untransplanted within 5 years than receive a kidney transplant (Group 2).\n\nThe study consists of xenotransplantation followed by a 24-week Post-transplant Follow up Period (Part A) to evaluate the efficacy and safety objectives followed by a Long-term Follow-up Period (Part B) to evaluate participant survival, 10 GE Xenokidney survival, and screening for zoonotic infections. Part B will continue for the lifetime of the participant.",[27,95,96],[183,98,99,96],"10 GE Xenokidney","2026-03-24",{"date":186,"type":40},"2026-03-27",{"date":188,"type":40},"2025-10-29",{"date":190,"type":21},"2075-10",{"name":109,"class":110},2,{"id":194,"slug":195,"hasResults":11,"nctId":196,"briefTitle":197,"officialTitle":198,"acronym":199,"eligibilityCriteria":200,"healthyVolunteers":11,"sex":17,"minAge":201,"maxAge":4,"enrollmentInfo":202,"targetDuration":4,"studyType":22,"phases":204,"briefSummary":206,"conditions":207,"keywords":210,"overallStatus":36,"whyStopped":4,"lastUpdateSubmitDate":213,"lastUpdatePostDateStruct":214,"startDateStruct":216,"completionDateStruct":218,"leadSponsor":220,"locationsCount":222},"100587829","phase-3-a-study-of-a-novel-iron-based-phosphate-binder-ap301-in-patients-with-hyperphosphatemia-in-the-us-and-china-100587829","NCT06933472","A Study of a Novel Iron-based Phosphate Binder AP301 in Patients With Hyperphosphatemia in the U.S. and China","A Randomized, Double-Blind, Multi-Regional, Phase 3 Study to Evaluate the Efficacy and Safety of AP301 on Serum Phosphorus Control in Chronic Kidney Disease Patients Receiving Maintenance Dialysis With Hyperphosphatemia","RESPOND-2","Key Inclusion Criteria:\n\n* Provision of signed and dated ICF\n* Age ≥ 12 years when signing the ICF\n* Patients on dialysis for ≥ 3 months before signing the ICF and throughout the study\n* For HD patients, spKt\u002FV ≥ 1.2; for PD patients, total Kt\u002FV ≥ 1.7\u002Fweek\n* Patients who receive phosphate-lowering drugs over 4 weeks and their serum phosphate level is:\n\n  1. Screening: 1.13 mmol\u002FL (3.5 mg\u002FdL) ≤ serum phosphate \\\u003C 2.58 mmol\u002FL (8.0 mg\u002FdL)\n  2. After washout: 1.94 mmol\u002FL (6.0 mg\u002FdL) ≤ serum phosphate \\\u003C 3.23 mmol\u002FL (10.0 mg\u002FdL)\n\nKey Exclusion Criteria:\n\n* History or plan of kidney transplantation\n* History or plan of parathyroid intervention 6 months before signing the ICF\n* Serum calcium \\\u003C 1.9 mmol\u002FL (7.6 mg\u002FdL) or \\> 2.75 mmol\u002FL (11 mg\u002FdL) at screening\n* Serum intact parathyroid hormone \\> 127 pmol\u002FL (1200 pg\u002FmL) at screening\n* Presence of clinically significant gastrointestinal (GI) disorder\n* History of gastrectomy or duodenectomy, or GI surgery within 3 months before signing the ICF\n* Known allergic to any ingredient of AP301, or known history of severe allergies leading to emergency medical care\n* Female who are breastfeeding","12 Years",{"count":203,"type":21},264,[205],"PHASE3","The goal of this clinical trial is to learn if AP301 could work in the patients receiving maintenance dialysis with elevated blood phosphate. The main questions it aims to answer are:\n\n* Does AP301 lower blood phosphate levels?\n* Does AP301 works on serum calcium level, calcium times phosphate level, and intact parathyroid hormone level?\n* What discomfort or medical problem do the patients have when taking AP301?\n* Does AP301 improve quality of life in Chinese patients?\n\nThe researchers will compare AP301 to an ineffective comparator (a look-alike substance that contains low dose AP301) to see if AP301 works to treat elevated blood phosphate.\n\nIn the study, the patients will experience the following stages in a chronicle order:\n\n* Stop all using blood phosphate-lowering drugs,\n* Take AP301 or the comparator three times a day for 8 weeks,\n* Take AP301 three times a day for 24 weeks, and\n* Take AP301 or the comparator three times a day for 3 weeks.\n\nIn the first 32 weeks, the dose of AP301 will be adjusted upwards or downwards based on the patient's blood phosphate level and the study doctor's judgment.\n\nIf the participant has a blood phosphate level above or below a certain level, they may receive additional treatment to lower the blood phosphate level.",[208,209,27,149],"Hyperphosphatemia","Chronic Kidney Disease, Receiving Dialysis",[208,211,149,212],"AP301","ESKD","2026-01-28",{"date":215,"type":40},"2026-01-29",{"date":217,"type":40},"2025-06-13",{"date":219,"type":21},"2027-01-10",{"name":221,"class":110},"Alebund Pharmaceuticals",42,{"id":224,"slug":225,"hasResults":11,"nctId":226,"briefTitle":227,"officialTitle":228,"acronym":4,"eligibilityCriteria":229,"healthyVolunteers":230,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":231,"targetDuration":4,"studyType":120,"phases":4,"briefSummary":233,"conditions":234,"keywords":4,"overallStatus":69,"whyStopped":4,"lastUpdateSubmitDate":236,"lastUpdatePostDateStruct":237,"startDateStruct":239,"completionDateStruct":241,"leadSponsor":243,"locationsCount":48},"100601383","copper-to-zinc-ratio-in-end-stage-renal-disease-patients-outcome-100601383","NCT07109778","Copper to Zinc Ratio in End Stage Renal Disease Patients Outcome","Impact of Copper to Zinc Ratio on Outcome of End Stage Renal Disease Patients","Inclusion Criteria:\n\n* ESRD patients including those on maintenance HD\n\nExclusion Criteria:\n\n* Acute kidney injury or rapidly progressive glomerulonephritis, acute infections or active inflammatory conditions as sepsis and autoimmune diseases, liver cirrhosis (Child-Pugh Class B or C), gastrointestinal disorders as inflammatory bowel disease, malabsorption, history of organ transplantation excluding kidney transplantation who may be included in a separate analysis if sufficient numbers are recruited, receiving total parenteral nutrition, Cu or Zn metabolism disorders as Wilson's disease, vitamin complex supplementation or antioxidants within the past 6 months, recent hospitalization within the past 3 months, recent surgery within 3 months, recent blood transfusion \\\u003C 3 months, Pregnancy or lactation, Malignancy.",true,{"count":232,"type":21},150,"The goal of this observational clinical trial is to Study the impact of copper to zinc ratio on the outcome of ESRD patients",[65,235],"Control Condition","2025-07-31",{"date":238,"type":40},"2025-08-07",{"date":240,"type":21},"2025-08-01",{"date":242,"type":21},"2026-04-01",{"name":244,"class":47},"Minia University",{"id":246,"slug":247,"hasResults":11,"nctId":248,"briefTitle":249,"officialTitle":249,"acronym":4,"eligibilityCriteria":250,"healthyVolunteers":11,"sex":17,"minAge":4,"maxAge":4,"enrollmentInfo":251,"targetDuration":4,"studyType":22,"phases":252,"briefSummary":253,"conditions":254,"keywords":255,"overallStatus":69,"whyStopped":4,"lastUpdateSubmitDate":261,"lastUpdatePostDateStruct":262,"startDateStruct":264,"completionDateStruct":266,"leadSponsor":268,"locationsCount":4},"100597557","the-effects-of-a-dialysis-specific-formula-rich-in-branched-chain-amino-acids-omega-3-and-dietary-fiber-on-nutritional-status-100597557","NCT07060040","The Effects of a Dialysis-Specific Formula Rich in Branched-Chain Amino Acids, Omega-3, and Dietary Fiber on Nutritional Status","Inclusion Criteria:\n\n* Patients with ESRD who have been receiving dialysis for more than three months\n* Serum albumin (Alb) ≤ 4.0 g\u002FdL, or body mass index (BMI) ≤ 20, or normalized protein catabolic rate (nPCR) ≤ 0.8\n* Male or female patients aged 20 years or older\n\nExclusion Criteria:\n\n* Serum albumin (Alb) \\\u003C 3.0 g\u002FdL\n* Known allergy or intolerance to any component of the product, or deemed by a physician to be unable to complete the trial\n* Patients who refuse to sign the informed consent form or are unable to follow study instructions\n* Pregnant or breastfeeding women\n* Patients with severe illnesses (including burn injuries), undergoing major surgery, with abnormal liver function (GOT and GPT levels more than 5 times the upper limit of normal), or with malignancy (6) Participation in another clinical trial of investigational drugs or concurrent use of investigational drugs within 30 days prior to or during this trial (7) Any other serious medical condition as determined by the investigator that would make the patient unsuitable for participation",{"count":20,"type":21},[24],"The aim of this study is to evaluate the effects of a specialized oral nutritional supplement (SF) enriched with BCAAs, omega-3 fatty acids, and dietary fiber on improving the nutritional status of dialysis patients with mild to moderate malnutrition, and thereby alleviating fatigue and enhancing quality of life. We will assess various aspects of protein-energy wasting (PEW), as well as changes in the Malnutrition Inflammation Score (MIS), Geriatric Nutritional Risk Index (GNRI), fatigue, appetite, serum BCAA levels, uremic toxins, and gut microbiota composition.",[27,149],[256,257,258,259,260,125],"Branched-chain amino acid","Protein-energy malnutrition","fiber","omega-3","oral nutritional supplements","2025-07-01",{"date":263,"type":40},"2025-07-11",{"date":265,"type":21},"2025-07",{"date":267,"type":21},"2027-12",{"name":269,"class":47},"Buddhist Tzu Chi General Hospital"]