[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"end-stage-renal-disease-on-dialysis\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:end-stage-renal-disease-on-dialysis":28},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,19,0,[8,47,78,90,111,141,164,186,209,231,251,275,299,327,364,385,415,441,470],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":4,"eligibilityCriteria":15,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":18,"targetDuration":4,"studyType":21,"phases":22,"briefSummary":24,"conditions":25,"keywords":29,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":35,"lastUpdatePostDateStruct":36,"startDateStruct":39,"completionDateStruct":41,"leadSponsor":43,"locationsCount":46},"100053390","phase-2-a-study-to-evaluate-safety-tolerability-and-efficacy-of-ap306-at-fixed-doses-in-dialysis-participants-with-hyperphosphatemia-100053390",false,"NCT06712654","A Study to Evaluate Safety, Tolerability and Efficacy of AP306 at Fixed Doses in Dialysis Participants With Hyperphosphatemia","A Phase 2b, Randomized, Double-Blind, Placebo-Controlled, Multicenter Study to Evaluate the Safety, Tolerability, and Serum Phosphate Lowering Effect of Fixed Dose AP306 in Participants With Hyperphosphatemia Receiving Maintenance Hemodialysis","Important Inclusion Criteria:\n\n* Signs a written informed consent form (ICF) and is willing to comply with all study requirements in the study\n* Receiving a stable hemodialysis (including hemodialysis, hemodiafiltration, and hemoadsorption) regimen, which is defined as a frequency of three times per week for at least 12 weeks before signing the ICF, and does not plan to change in the study\n* Who has a blood phosphate level within the study-required range\n* Who has a dialysis adequacy, assessed by single pooled Kt\u002FV (SpKt\u002FV, estimated with blood urea) ≥1.20, at screening or any documented value ≥1.20 within 12 weeks prior to signing the ICF\n* If the participant is receiving etelcalcetide, their doses must be unchanged for at least 4 weeks prior to signing the ICF\n* If the participant is receiving any of the following therapies, their doses are stable for at least 14 days prior to signing the ICF: phosphate-lowering products other than tenapanor or phosphate binders, active vitamin D and analogs, cinacalcet, calcitonin, and P-glycoprotein inhibitors\n* Agreement to use highly effective contraception for women of childbearing potentially and non-sterile sexually active males throughout the study and for 90 days after the final dose of study drug\n\nImportant Exclusion Criteria:\n\n* Pregnant or breastfeeding\n* Scheduled for a living donor kidney transplant in the next 6 months, planned change to peritoneal dialysis or home hemodialysis in the study; planned relocation to another dialysis center in the study\n* Any history of a non-pharmacological parathyroid intervention within 6 months prior to the ICF sign off, or planned parathyroid intervention in the study\n* Blood calcium or blood intact parathyroid hormone abnormality\n* Adequate organ and bone marrow function\n* Acute hepatitis or significant chronic liver disease\n* Any clinically significant GI disorders within 4 weeks prior to signing the ICF; or any history of gastrectomy; or any GI tract surgery (excluding appendectomy and polypectomy), within 12 weeks of signing the ICF\n* Uncontrolled hypertension\n* Hospitalization for cardiac or cardiocerebrovascular disease within 24 weeks prior to signing the ICF\n* Significant abnormalities of QT interval and heart rhythm on an electrocardiograph (ECG) test\n* Any clinically significant active infection or infestation or any treatment with systemic antimicrobial treatment within 2 weeks prior to signing the ICF\n* History or presence of malignancy within 3 years prior to signing the ICF, except basal cell skin cancer, in-situ carcinoma of the cervix, and in-situ prostate cancer\n* Taking moderate or strong cytochrome P450 (CYP) 3A inhibitors within 2 weeks or 5 half-lives, whichever is longer, prior to signing the ICF (topical use is allowed)\n* Treatment with any investigational medication or medical device within 30 days prior to signing the ICF\n* Life expectancy less than 12 months","ALL","18 Years",{"count":19,"type":20},168,"ESTIMATED","INTERVENTIONAL",[23],"PHASE2","This study is being conducted to characterize the safety, tolerability, and efficacy of AP306 at fixed doses in adults with hyperphosphatemia receiving maintenance hemodialysis.",[26,27,28],"Hyperphosphatemia","Chronic Kidney Disease Requiring Chronic Dialysis","End Stage Renal Disease on Dialysis",[30,31,32,33],"AP306","AP-306","EOS789","pan-phosphate transporter inhibitor","RECRUITING","2026-07-10",{"date":37,"type":38},"2026-07-13","ACTUAL",{"date":40,"type":38},"2026-06-01",{"date":42,"type":20},"2027-03-31",{"name":44,"class":45},"R1 Therapeutics","INDUSTRY",31,{"id":48,"slug":49,"hasResults":11,"nctId":50,"briefTitle":51,"officialTitle":52,"acronym":4,"eligibilityCriteria":53,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":54,"enrollmentInfo":55,"targetDuration":4,"studyType":21,"phases":57,"briefSummary":59,"conditions":60,"keywords":61,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":67,"lastUpdatePostDateStruct":68,"startDateStruct":70,"completionDateStruct":72,"leadSponsor":74,"locationsCount":77},"100489513","comparing-surgical-and-endovascular-arteriovenous-fistula-creation-100489513","NCT05654103","Comparing Surgical and Endovascular Arteriovenous Fistula Creation","Randomized Controlled Trial Comparing endoAVF Versus surgAVF","Inclusion Criteria:\n\n* ESKD patients aged ≥ 18 who have chosen hemodialysis as their renal replacement option.\n* Ability to give consent to participate in a research study.\n* Upper arm vein diameter of ≥ 2.0 mm.\n\nEllipsys specific inclusion criteria:\n\n* Confirmed radial artery-adjacent vein proximity ≤ 1.5 mm measured lumen edge-to-lumen edge as determined by preprocedural ultrasound and confirmed pre-procedurally.\n* Confirmed radial artery and adjacent vein diameter of ≥ 2.0 mm at site where vein and artery connects.\n\nWavelinQ specific inclusion criteria:\n\n* Target vein diameter ≥ 2.0 mm, target artery diameter ≥ 2.0 mm, and ≤ 2 mm between target artery and vein.\n\nExclusion Criteria:\n\n* People under the age of 18.\n* Inability to understand the consent process and\u002For give consent.\n* Upper arm vein diameter less than 2.0 mm making them unsuitable to receive an surgAVF AND endoAVF.\n* Patients who are deemed by the surgeon to be anatomic candidates for a forearm vascular access, and the surgeon and the patient determine that a forearm access is the optimal access for the patient, in order to preserve more proximal anatomic sites for future accesses.\n* Currently incarcerated individuals.\n* Currently pregnant or planning to get pregnant within the next 6 months.\n* Individuals who choose peritoneal dialysis over hemodialysis and\u002For undergoing a kidney transplant within 6 months of randomization.","99 Years",{"count":56,"type":20},90,[58],"NA","Patients with end-stage kidney disease (ESKD) who use hemodialysis to filter their blood require vascular access for the dialysis machine; the most common type of vascular access is called an arteriovenous fistula (AVF). The AVF is a direct connect between an artery and vein.\n\nUntil recently, AVFs were only created through surgery that requires general anesthesia and opening up the skin. Now there are 2 FDA-approved devices designed to create AVFs using endovascular techniques (endoAVF), which means a device that goes through the skin instead of opening the skin up. Also patients are not required to be under general anesthesia, they can receive local anesthesia instead. Due to the relatively new approval of these devices, there is not a randomized study to compare the results of endoAVF versus surgAVF.\n\nThis study is a pilot study for an eventually larger scale study to compare the results of endoAVF versus surgAVF. The study aims to determine what the proportion of patients seeking hemodialysis access could qualify for receiving either an endoAVF , surgAVF, or both. Patients who are screened for hemodialysis access must undergo a duplex ultrasound of the blood vessels in the arm to confirm correct sizing. If participants qualify for both procedures they will be randomized to either endoAVF or surgAVF and will track the clinical and patient-reported outcomes of each procedure. Our pilot study hopes to enroll 90 participants. Those outcomes will inform a larger scale study. If the potential participant chooses to abstain from participation in the randomized trial, preferring to decide the method of AVF creation, we will offer to them a chance to join an endoAVF\u002FsurgAVF registry that will track the clinical outcomes of the procedure via medical record monitoring.",[28],[62,63,64,65,66],"hemodialysis","arteriovenous fistula","fistula","endoAVF","End Stage Renal Disease","2026-06-29",{"date":69,"type":38},"2026-07-01",{"date":71,"type":38},"2024-11-20",{"date":73,"type":20},"2028-01-01",{"name":75,"class":76},"University of California, Los Angeles","OTHER",2,{"id":79,"slug":4,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":4,"eligibilityCriteria":15,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":80,"targetDuration":4,"studyType":21,"phases":81,"briefSummary":24,"conditions":82,"keywords":83,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":84,"lastUpdatePostDateStruct":85,"startDateStruct":86,"completionDateStruct":87,"leadSponsor":88,"locationsCount":89},"100570854",{"count":19,"type":20},[23],[26,27,28],[30,31,32,33],"2026-06-26",{"date":67,"type":38},{"date":40,"type":38},{"date":42,"type":20},{"name":44,"class":45},30,{"id":91,"slug":92,"hasResults":11,"nctId":93,"briefTitle":94,"officialTitle":95,"acronym":4,"eligibilityCriteria":96,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":97,"targetDuration":4,"studyType":21,"phases":98,"briefSummary":99,"conditions":100,"keywords":4,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":101,"lastUpdatePostDateStruct":102,"startDateStruct":104,"completionDateStruct":106,"leadSponsor":108,"locationsCount":110},"100642119","coated-aldehyde-oxystarch-for-protein-bound-uremic-toxin-reduction-in-end-stage-renal-disease-100642119","NCT07653711","Coated Aldehyde Oxystarch for Protein-Bound Uremic Toxin Reduction in End-Stage Renal Disease","An Exploratory, Single-Center, Self-Controlled Trial of Coated Aldehyde Oxystarch for Reducing Protein-Bound Uremic Toxins in Patients With End-Stage Renal Disease","Inclusion Criteria:\n\n* Age ≥ 18 years, no restriction on sex or ethnicity.\n* Receiving maintenance dialysis for at least 3 months, with dialysis regimen remaining unchanged during the trial period.\n* If taking other medications that do not interfere with gut microbiota prior to enrollment, they must have been stable for at least 1 month and the regimen must remain unchanged during the trial.\n* Ability to understand and voluntarily sign the informed consent form.\n\nExclusion Criteria:\n\n* Known allergy to Coated Aldehyde Oxystarch.\n* History of or planned kidney transplantation within 6 months, or change in dialysis regimen.\n* Use of medications or supplements that may affect gut microbiota (e.g., antibiotics, probiotics, prebiotics, laxatives) within the past 3 months.\n* Diagnosis of serious gastrointestinal diseases, including gastrointestinal bleeding, colitis, inflammatory bowel disease, irritable bowel syndrome, history of intestinal obstruction, history of gastrectomy or duodenectomy.\n* History of cardiovascular or cerebrovascular events within 3 months prior to screening, including hospitalization for stroke, myocardial infarction, unstable angina, congestive heart failure; severe valvular stenosis, uncontrolled atrial fibrillation or arrhythmia; QTc interval \\>500 ms on repeated ECG.\n* Concurrent severe primary diseases of cardiovascular, cerebrovascular, hepatic, hematopoietic systems, or other known life-threatening diseases (e.g., malignancy, AIDS), or patients with mental or legal disabilities.\n* Investigator judges life expectancy ≤6 months.\n* Inability to maintain stable dietary habits during the study period.\n* Inability to maintain original dialysis regimen during the study period.\n* Use of Chinese patent medicines for kidney disease (e.g., Shenkang Injection, Haikun Shenxi Capsule, Shenshuaining, Tripterygium preparations, Niaoduqing Granules) within 1 month prior to enrollment.\n* Participation in another clinical trial within the past 1 month.\n* Intellectual disability, psychiatric disorders, or suspected\u002Fconfirmed history of alcohol or drug abuse that may affect compliance.\n* Any other condition that, in the investigator's judgment, makes the patient unsuitable for participation in this study.",{"count":89,"type":20},[58],"The goal of this clinical trial is to learn if Coated Aldehyde Oxystarch (Xiqing) works to reduce protein-bound uremic toxins (PBUTs) in adults with end-stage renal disease (ESRD). It will also learn about the safety of Coated Aldehyde Oxystarch. The main questions it aims to answer are:\n\nDoes Coated Aldehyde Oxystarch lower the blood levels of protein-bound uremic toxins, such as indoxyl sulfate and p-cresyl sulfate?\n\nWhat medical problems do participants have when taking Coated Aldehyde Oxystarch?\n\nResearchers will compare the levels of PBUTs before treatment (baseline) with those after treatment with Coated Aldehyde Oxystarch to see if it works to reduce these toxins.\n\nParticipants will:\n\nTake Coated Aldehyde Oxystarch (Xiqing) 10 capsules per time, three times daily (each capsule 0.625 g, total daily dose 18.75 g) for 3 months.\n\nVisit the clinic every month for checkups and blood tests.\n\nProvide blood samples to measure protein-bound uremic toxin levels and routine safety parameters.",[28],"2026-06-12",{"date":103,"type":38},"2026-06-17",{"date":105,"type":38},"2025-04-21",{"date":107,"type":20},"2026-08",{"name":109,"class":76},"Peking University People's Hospital",1,{"id":112,"slug":113,"hasResults":11,"nctId":114,"briefTitle":115,"officialTitle":116,"acronym":4,"eligibilityCriteria":117,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":118,"targetDuration":4,"studyType":120,"phases":4,"briefSummary":121,"conditions":122,"keywords":124,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":132,"lastUpdatePostDateStruct":133,"startDateStruct":135,"completionDateStruct":137,"leadSponsor":139,"locationsCount":110},"100638311","changes-in-regional-ventilation-perfusion-match-following-percutaneous-transluminal-angioplasty-for-arteriovenous-graft-thrombosis-100638311","NCT07613632","Changes in Regional Ventilation-Perfusion Match Following Percutaneous Transluminal Angioplasty for Arteriovenous Graft Thrombosis","Changes in Regional Ventilation-Perfusion Match Following Percutaneous Transluminal Angioplasty for Arteriovenous Graft Thrombosis: A Prospective Observation Pilot Study","Inclusion Criteria\n\n1. Age ≥ 18 years.\n2. Diagnosis of end-stage renal disease receiving maintenance hemodialysis.\n3. Documented AVG thrombosis requiring PTA.\n4. Able to cooperate and tolerate EIT monitoring.\n5. Provided written informed consent.\n\nExclusion Criteria\n\n1. Severe respiratory failure incompatible with supine position.\n2. Thoracic skin condition or deformity preventing EIT electrode placement.\n3. Acute pulmonary embolism or acute pulmonary edema before procedure.\n4. NYHA Class IV heart failure or hemodynamic instability.\n5. Pregnancy or breastfeeding.\n6. Any other circumstance judged unsuitable by investigator.",{"count":119,"type":20},20,"OBSERVATIONAL","Patients with end-stage renal disease (ESRD) often require arteriovenous grafts (AVG) for hemodialysis. AVG thrombosis is a common complication, usually managed by percutaneous transluminal angioplasty (PTA) to restore blood flow. PTA achieves patency by balloon-mediated compression and fragmentation of thrombus. Small thrombus fragments may enter the venous circulation and cause transient pulmonary microembolism, leading to ventilation-perfusion (V\u002FQ) mismatch. This study uses electrical impedance tomography (EIT) to noninvasively monitor short-term changes in regional ventilation and perfusion during and after PTA, exploring the immediate pulmonary physiological consequences of thrombus fragmentation and revascularization in dialysis patients.",[123,28],"Arteriovenous Graft Thrombosis",[125,126,127,128,129,130,131],"Percutaneous Transluminal Angioplasty","Electrical Impedance Tomography","Ventilation-Perfusion Matching","Pulmonary Microembolism","Dead Space","Shunt","Pilot Study","2026-05-23",{"date":134,"type":38},"2026-05-29",{"date":136,"type":38},"2024-10-24",{"date":138,"type":20},"2027-12-30",{"name":140,"class":76},"First Affiliated Hospital of Wannan Medical College",{"id":142,"slug":143,"hasResults":11,"nctId":144,"briefTitle":145,"officialTitle":145,"acronym":146,"eligibilityCriteria":147,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":148,"targetDuration":4,"studyType":21,"phases":149,"briefSummary":151,"conditions":152,"keywords":153,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":155,"lastUpdatePostDateStruct":156,"startDateStruct":158,"completionDateStruct":160,"leadSponsor":162,"locationsCount":110},"100490889","phase-4-effect-of-empagliflozin-on-peritoneal-and-kidney-function-in-end-stage-renal-disease-100490889","NCT05671991","Effect of Empagliflozin on Peritoneal and Kidney Function in End Stage Renal Disease","EMPA-PD","Inclusion Criteria\n\n1. Patients actively undergoing PD with a reliably functioning PD catheter\n2. Stable peritoneal dialysis prescription\n3. PD vintage \\> 3 months\n4. Age \\>18 years of age\n\nExclusion Criteria:\n\n1. History of type 1 diabetes, diabetic ketoacidosis, \"brittle\" diabetes or frequent hypoglycemia or severe hypoglycemic episodes requiring emergent intervention (ER visit or EMS response, glucagon administration or forced oral carbs) in the last 6 months\n2. Use of an SGLT2 inhibitor within the prior 30 days\n3. 1 or more episodes of peritonitis in the previous 6 months or active infection of the peritoneal dialysis catheter\n4. Anemia with hemoglobin \\\u003C8g\u002FdL\n5. Inability to give written informed consent or follow study protocol\n6. Contraindication to receiving loop diuretics",{"count":89,"type":20},[150],"PHASE4","The main purpose of the study is to determine if empagliflozin can reduce peritoneal glucose absorption in patients with end stage renal diease (ESRD) on peritoneal dialysis.\n\nThis is a randomized, placebo controlled, acute crossover study of empagliflozin in an anticipated 30 chronic PD patients, with an 8 week \"pre post\" open label extension in all 30 patients where they will receive empagliflozin daily.",[28],[154],"Peritoneal dialysis","2026-05-18",{"date":157,"type":38},"2026-05-22",{"date":159,"type":38},"2023-03-01",{"date":161,"type":20},"2026-12-31",{"name":163,"class":76},"Yale University",{"id":165,"slug":166,"hasResults":11,"nctId":167,"briefTitle":168,"officialTitle":169,"acronym":170,"eligibilityCriteria":171,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":172,"targetDuration":4,"studyType":21,"phases":174,"briefSummary":175,"conditions":176,"keywords":4,"overallStatus":177,"whyStopped":4,"lastUpdateSubmitDate":178,"lastUpdatePostDateStruct":179,"startDateStruct":181,"completionDateStruct":182,"leadSponsor":184,"locationsCount":4},"100634361","vr-study-virtual-reality-for-patients-during-arteriovenous-fistula-surgery-100634361","NCT07538687","VR Study Virtual Reality for Patients During Arteriovenous Fistula Surgery","Virtual Reality for Patients During Arteriovenous Fistula Surgery: A Randomized Controlled Trial","VR","Inclusion Criteria:\n\n* Adults aged ≥18 years scheduled for elective arteriovenous fistula (AVF) creation surgery.\n* Diagnosed with End-Stage Renal Disease (ESRD) and indicated for hemodialysis access.\n* Able to provide informed consent and understand study procedures.\n* Medically stable and cleared for surgery by the anesthesia and surgical teams.\n* Able to wear a virtual reality headset (e.g., no severe claustrophobia or facial injuries preventing use).\n\nExclusion Criteria:\n\n* Patients with a history of seizure disorders or epilepsy triggered by visual stimuli.\n* Severe motion sickness, vertigo, or vestibular disorders that may be exacerbated by virtual reality.\n* Significant cognitive impairment or inability to understand instructions or complete questionnaires.\n* Facial or cranial abnormalities or injuries that prevent proper fitting of the VR headset.\n* Patients requiring general anesthesia.",{"count":173,"type":20},64,[58],"Patients undergoing arterio-venous fistula commonly experience pain and anxiety due to their pre-operative circumstances and the fact that they remain conscious throughout the surgery. It is well documented that perioperative pain and anxiety can cause detrimental effects on patient outcomes and satisfaction. Virtual reality (VR) is increasingly being investigated as an adjunctive tool in various medical and surgical specialties. Current Evidence suggests that VR can be effective in managing both acute and chronic pain, as well as reducing pain, anxiety, stress, and the need for anesthetic agents during surgery. We hypothesize that using VR during AVF surgery will lead to a reduction in anesthetic doses, decreased patient anxiety and pain, and be favorably received by both surgeons and anesthetists.",[28],"NOT_YET_RECRUITING","2026-04-15",{"date":180,"type":38},"2026-04-20",{"date":40,"type":20},{"date":183,"type":20},"2028-12-01",{"name":185,"class":76},"Sir Mortimer B. Davis - Jewish General Hospital",{"id":187,"slug":188,"hasResults":11,"nctId":189,"briefTitle":190,"officialTitle":191,"acronym":4,"eligibilityCriteria":192,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":193,"targetDuration":4,"studyType":21,"phases":195,"briefSummary":197,"conditions":198,"keywords":4,"overallStatus":177,"whyStopped":4,"lastUpdateSubmitDate":200,"lastUpdatePostDateStruct":201,"startDateStruct":203,"completionDateStruct":205,"leadSponsor":207,"locationsCount":110},"100625640","phase-2-a-pilot-trial-of-chinese-medicine-for-patients-with-dialytic-hypotension-100625640","NCT07425262","A Pilot Trial of Chinese Medicine for Patients With Dialytic Hypotension","A Pilot Randomized Waitlist-controlled Trial of a Zheng-based Chinese Medicine Intervention for Patients With Dialytic Hypotension in Taiwan","Inclusion Criteria:\n\n* Maintenance bicarbonate hemodialysis (HD) for more than 1 year, three times a week 3.5 to 4.5 h HD schedule.\n* Have experienced more than 30% episodes of IDH (defined as a systolic BP\\\u003C90 mmHg on dialysis or requirement for clinical intervention) during the exposure assessment period (months 1-3) of this study\n* Cognitive ability to give written informed consent.\n\nExclusion Criteria:\n\n* Allergic history to Chinese herbal medicine\n* Systemic diseases such as coagulation disorders, malignancy, liver diseases and cardiovascular diseases.\n* Estimated survival time \\\u003C 1 year.\n* Mental illness.\n* Participate in other clinical trials.",{"count":194,"type":20},100,[23,196],"PHASE3","To evaluate the epidemiological status of traditional Chinese Medicine (TCM) constitution in patients with dialytic hypotension, and design a clinical study based on a Zheng-based herbal formulation to evaluate the clinical efficacy and safety of TCM",[28,199],"Intradialytic Hypotension","2026-02-23",{"date":202,"type":38},"2026-02-25",{"date":204,"type":20},"2026-02-02",{"date":206,"type":20},"2028-02-01",{"name":208,"class":76},"Chang Gung Memorial Hospital",{"id":210,"slug":211,"hasResults":11,"nctId":212,"briefTitle":213,"officialTitle":213,"acronym":4,"eligibilityCriteria":214,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":215,"targetDuration":4,"studyType":21,"phases":217,"briefSummary":218,"conditions":219,"keywords":220,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":222,"lastUpdatePostDateStruct":223,"startDateStruct":225,"completionDateStruct":227,"leadSponsor":229,"locationsCount":110},"100594028","fight-fatigue-a-progressive-muscle-relaxation-and-walking-intervention-to-reduce-fatigue-in-adults-with-eskd-100594028","NCT07014111","Fight Fatigue: A Progressive Muscle Relaxation and Walking Intervention to Reduce Fatigue in Adults With ESKD","Inclusion Criteria:\n\n* Diagnosis of ESKD diagnosis and receiving hemodialysis for at least 3 months\n* Can read and speak English\n* Fatigue measured via visual analogue scale, score ≥4 over the last week\n* Able to stand and walk one block\n* Has a cell phone that can receive text messages\n\nExclusion Criteria:\n\n* Patient's nephrologist refuses for them to participate\n* Unstable angina\n* Unstable pulmonary disease or pulmonary symptoms that preclude participation\n* Lower-extremity amputation without prosthetic (BKA, AKA) -Orthopedic or neurologic condition that would preclude walking or tensing\u002Freleasing of muscles-\n* Cognitive impairment that, in the judgement of the research team, precludes trial participation\n* Participation in the formative phase of the development of Fight Fatigue",{"count":216,"type":20},40,[58],"Fight Fatigue is evaluating the feasibility and acceptability of a combined progressive muscle relaxation and walking intervention to reduce fatigue for adults with end-stage kidney disease receiving in-center hemodialysis.",[28],[221],"Fatigue","2025-09-25",{"date":224,"type":38},"2025-09-26",{"date":226,"type":38},"2025-09-02",{"date":228,"type":20},"2027-06",{"name":230,"class":76},"University of Illinois at Chicago",{"id":232,"slug":233,"hasResults":11,"nctId":234,"briefTitle":235,"officialTitle":236,"acronym":237,"eligibilityCriteria":238,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":239,"targetDuration":4,"studyType":120,"phases":4,"briefSummary":240,"conditions":241,"keywords":4,"overallStatus":177,"whyStopped":4,"lastUpdateSubmitDate":242,"lastUpdatePostDateStruct":243,"startDateStruct":245,"completionDateStruct":247,"leadSponsor":249,"locationsCount":110},"100602992","assessment-of-d-dimer-and-crp-for-cardiovascular-risk-prediction-in-hemodialysis-patients-100602992","NCT07130721","Assessment of D-dimer and CRP for Cardiovascular Risk Prediction in Hemodialysis Patients","Assessment of Blood Biomarkers (D-dimer and C-Reactive Protein) in Predicting Cardiovascular Complications Among Hemodialysis Patients: A Cross-Sectional Study","BIOCARD-HD","Inclusion Criteria:\n\n* Adults aged ≥18 years\n\nOn regular hemodialysis for at least 3 months\n\nAble and willing to provide informed consent\n\nGroup I: Hemodialysis patients with no clinically documented cardiovascular disease\n\nGroup II: Hemodialysis patients with confirmed cardiovascular disease (by medical records, ECGs, echocardiography, or documented hospital admissions)\n\nExclusion Criteria:\n\n* Acute or recent infection (within the past 4 weeks)\n\nUse of anticoagulant or antiplatelet therapy\n\nActive malignancy\n\nAutoimmune or chronic inflammatory disease\n\nKnown bleeding or thrombotic disorders\n\nPregnancy",{"count":194,"type":20},"This study aims to assess whether two blood markers - C-reactive protein (CRP) and D-dimer - can help predict cardiovascular complications in patients undergoing regular hemodialysis. Cardiovascular disease is a common and serious problem in dialysis patients, and early detection is important.\n\nthe study will include 100 adult patients from the Hemodialysis Unit at Assiut University Hospital. Participants will be divided into two groups: those with and those without known heart disease. Each participant will have a one-time blood test to measure CRP and D-dimer levels. In addition, an electrocardiogram (ECG) will be done once to check for signs of heart problems.",[28],"2025-08-16",{"date":244,"type":38},"2025-08-19",{"date":246,"type":20},"2025-11-01",{"date":248,"type":20},"2026-05-01",{"name":250,"class":76},"Assiut University",{"id":252,"slug":253,"hasResults":11,"nctId":254,"briefTitle":255,"officialTitle":256,"acronym":4,"eligibilityCriteria":257,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":258,"enrollmentInfo":259,"targetDuration":4,"studyType":21,"phases":261,"briefSummary":262,"conditions":263,"keywords":264,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":267,"lastUpdatePostDateStruct":268,"startDateStruct":270,"completionDateStruct":272,"leadSponsor":274,"locationsCount":110},"100601497","efficacy-of-pha130-hemoadsorption-for-4-hours-p4h-study-100601497","NCT07111260","Efficacy of pHA130 Hemoadsorption for 4 Hours (p4H Study)","Comparison of the Efficacy of Hemoadsorption Combined With Hemodialysis of Different Treatment Durations in Clearing Protein-Bound Uremic Toxins: A Randomized Crossover Controlled Trial","Inclusion Criteria:\n\n* Age between 18 and 75 years, regardless of gender\n* Stable maintenance hemodialysis for ≥3 months, with a relatively fixed dialysis regimen\n* Receiving hemodialysis 3 times per week, each session lasting ≥4 hours\n* Single-pool Kt\u002FV (spKt\u002FV) ≥1.2 within 8 weeks prior to enrollment\n* Willing and able to sign the informed consent form\n\nExclusion Criteria:\n\n* Life expectancy less than 1 year\n* White blood cell count \\\u003C 4 × 10⁹\u002FL and\u002For platelet count \\\u003C 60 × 10⁹\u002FL\n* Active or chronic gastrointestinal bleeding, or diagnosed coagulation disorders\n* Active malignant tumor\n* Active infection\n* Pregnant or breastfeeding\n* Participation in another clinical trial within the past month or currently enrolled in one\n* Deemed unsuitable for the study by the investigator","75 Years",{"count":260,"type":20},34,[58],"This is an open-label, randomized, crossover study to evaluate the efficacy of extending the duration of hemoadsorption (HA) combined with hemodialysis (HD) from 2 hours to 4 hours for clearing protein-bound uremic toxins, such as Indoxyl Sulfate (IS), in stable maintenance hemodialysis patients. Patients will be randomized to receive either 2-hour HA or 4-hour HA once a week for 8 weeks, then cross over to the other treatment for another 8 weeks after a 2-week washout period. The primary endpoint is the reduction rate of IS.",[28],[265,266],"Hemoadsorption","Duration","2025-08-06",{"date":269,"type":38},"2025-08-08",{"date":271,"type":38},"2025-07-01",{"date":273,"type":20},"2026-05",{"name":109,"class":76},{"id":276,"slug":277,"hasResults":11,"nctId":278,"briefTitle":279,"officialTitle":280,"acronym":281,"eligibilityCriteria":282,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":258,"enrollmentInfo":283,"targetDuration":4,"studyType":21,"phases":285,"briefSummary":286,"conditions":287,"keywords":4,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":291,"lastUpdatePostDateStruct":292,"startDateStruct":293,"completionDateStruct":295,"leadSponsor":297,"locationsCount":110},"100553206","phase-2-empagliflozin-on-residual-kidney-function-in-incident-peritoneal-dialysis-patients-100553206","NCT06483074","Empagliflozin on Residual Kidney Function in Incident Peritoneal Dialysis Patients","Empagliflozin on Residual Kidney Function in Incident Peritoneal Dialysis Patients: a Pilot Randomized Controlled Trial","EMPIRIC-PD","Inclusion Criteria:\n\n1. Incident PD patients within 90 days of Tenckhoff catheter insertion\n2. Age 18-75 years old\n3. Patient with or without history of Type 2 diabetes\n4. Residual GFR (defined as the average of 24-hour urinary urea and creatinine clearances) \\> 2ml\u002Fmin\u002F1.73m2 AND urine volume \\> 400ml per day\n5. Patients who are willing to provide written informed consent\n\nExclusion Criteria:\n\n1. Patients with history of hemodialysis (≥ 3 months) or renal transplant\n2. Life expectancy \\\u003C6 months\n3. Prior use of any type of SGLT2 inhibitors within 1 month before screening visit\n4. Poorly controlled diabetes with HBA1c \\>11%\n5. Type 1 diabetes\n6. History of any active malignancy within 5 years (except curatively resected basal cell or squamous cell skin cancers)\n7. Peritonitis within 4 weeks\n8. Ketoacidosis within 5 years\n9. Known hypersensitivity to empagliflozin or other SGLT2 inhibitors\n10. Any active acute or chronic physical or mental conditions that, in the opinion of the investigator, might interfere with the compliance of participants to or the performance of this study\n11. Participation in any clinical trial or use of any investigational medicinal product 1 month before screening visit",{"count":284,"type":20},48,[23],"Empagliflozin, a new class of diabetes medication, has demonstrated a reduction in renal function decline among patients with chronic kidney disease, regardless of their diabetes status. However, all previous studies excluded dialysis patients. Patients starting dialysis may still produce a certain amount of urine. Importantly, patients with better preserved residual kidney function tend to have better control of blood pressure and volume status, improved nutrition status, higher quality of life and reduced mortality rate.\n\nThe purpose of this study is to learn about the safety of empagliflozin in patients on peritoneal dialysis, in preparation for a future large clinical trial. Participants who newly initiate peritoneal dialysis will be randomly allocated to either empagliflozin on top of standard of care, or standard of care alone. Over a follow-up period of six months, the investigators will collect information on urine volume, blood pressure and glucose control. Safety, tolerability and drug compliance of empagliflozin will also be evaluated. If empagliflozin is found to be safe and well tolerated in patients on peritoneal dialysis, further large-scale randomized controlled trial may be conducted to evaluate its impact on residual kidney function and other relevant clinical outcomes.",[28,288,289,290],"Peritoneal Dialysis Complication","Sodium-glucose Cotransporter-2 Inhibitor","Residual Kidney Function","2025-08-02",{"date":267,"type":38},{"date":294,"type":38},"2024-07-29",{"date":296,"type":20},"2026-10-31",{"name":298,"class":76},"Chinese University of Hong Kong",{"id":300,"slug":301,"hasResults":11,"nctId":302,"briefTitle":303,"officialTitle":304,"acronym":305,"eligibilityCriteria":306,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":307,"targetDuration":309,"studyType":120,"phases":4,"briefSummary":310,"conditions":311,"keywords":313,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":317,"lastUpdatePostDateStruct":318,"startDateStruct":320,"completionDateStruct":322,"leadSponsor":324,"locationsCount":326},"100504305","registry-of-gore-acuseal-vascular-graft-in-dialysis-access-100504305","NCT05846581","Registry of GORE® ACUSEAL Vascular Graft in Dialysis Access","Observational Prospective Post-Market Clinical Follow-Up (PMCF) Registry of GORE® ACUSEAL Vascular Graft in Dialysis Access","AVG22-09","Inclusion Criteria:\n\n1. The patient requires the creation of vascular access for hemodialysis secondary to a diagnosis of End-Stage Renal Disease and intends to use GORE® ACUSEAL Vascular Graft device for arteriovenous (AV) access.\n2. Age ≥18 years at time of Informed Consent Form (ICF) signature.\n3. Willingness of the patient to adhere to institutional standard of care follow-up.\n4. Informed Consent Form (ICF) is signed by the patient.\n5. The patient is currently on hemodialysis or intended to begin hemodialysis immediately following placement of the GORE® ACUSEAL Vascular Graft device or up to 30 days following placement of the device.\n6. The patient has a reasonable expectation of remaining on hemodialysis for 12 months.\n\nExclusion Criteria:\n\n1. The patient currently has a known or suspected systemic infection.\n2. The patient is pregnant or breastfeeding.\n3. The patient had a separate interventional or surgical vascular procedure within the study limb within 30 days prior to treatment with the GORE® ACUSEAL Vascular Graft device.\n4. The patient had a previous documented (via imaging technique) and unsuccessfully treated ipsilateral central venous stenosis.\n5. The patient is currently taking maintenance corticosteroids and immunosuppressant medication such as rapamycin, mycophenolate or mycophenolic acid, prednisone (\\> 10 mg), cyclosporine, tacrolimus, or cyclophosphamide.\n6. The patient has a known hypercoagulability or bleeding disorder.\n7. The patient has had a previous instance of Heparin Induced Thrombocytopenia type 2 (HIT-2) or has known sensitivity to Heparin.\n8. The patient is enrolled in an investigational study.\n9. The patient has been previously enrolled in this registry.\n10. The patient is currently being considered for a live donor kidney transplant (living donor either related or unrelated to patient).\n11. The patient has life expectancy less than 2 years.",{"count":308,"type":20},72,"24 Months","The goal of this observational study is to evaluate safety and performance of GORE® ACUSEAL Vascular Graft for the treatment of CKD in patients with ESRD in hemodialysis. The main questions it aims to answer are:\n\n* Safety: Freedom from device-related infection adverse events at 24 months from device implant\n* Performance: Secondary patency at 24 months from device implant.\n\nParticipants, after informed consent is obtained, will be implanted with GORE® ACUSEAL Vascular Graft and followed for 24 months in standard of care, to evaluate safety and performance of the device.",[312,28],"Chronic Kidney Diseases",[314,312,66,315,316],"Post-Market Clinical Follow-Up","Hemodialysis","vascular graft","2025-07-08",{"date":319,"type":38},"2025-07-09",{"date":321,"type":38},"2024-01-12",{"date":323,"type":20},"2027-10-27",{"name":325,"class":45},"W.L.Gore & Associates",5,{"id":328,"slug":329,"hasResults":11,"nctId":330,"briefTitle":331,"officialTitle":332,"acronym":4,"eligibilityCriteria":333,"healthyVolunteers":11,"sex":16,"minAge":334,"maxAge":335,"enrollmentInfo":336,"targetDuration":4,"studyType":21,"phases":337,"briefSummary":339,"conditions":340,"keywords":347,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":356,"lastUpdatePostDateStruct":357,"startDateStruct":358,"completionDateStruct":360,"leadSponsor":362,"locationsCount":110},"100597051","phase-1-crispr-edited-hla-donor-kidney-transplant-to-reduce-rejection-risk-100597051","NCT07053462","CRISPR-Edited HLA Donor Kidney Transplant to Reduce Rejection Risk","Phase 1\u002F2, Single-Arm, Open-Label Trial to Evaluate the Safety, Feasibility, and Immunogenicity of Ex Vivo CRISPR-Cas9 Gene-Edited Donor Kidneys (Knockout of HLA-A, HLA-B, and CIITA) in Human Renal Transplant Recipients","Inclusion Criteria:\n\n* Adult patients, age 16 to 85 years, with end-stage renal disease (ESRD) who are candidates for kidney transplantation. This includes patients on dialysis or approaching dialysis who have been evaluated and listed for transplant.\n* Eligible for transplant surgery based on medical assessment (i.e., no contraindications to major surgery and transplantation). The patient's overall health status must be sufficient to undergo the transplant procedure and the required immunosuppression.\n* Suitable donor organ available: A deceased-donor kidney that meets standard acceptable criteria for transplant (e.g., adequate organ function and anatomy) and is ABO blood type compatible with the recipient. The donor kidney must be allocated to the trial and available for ex vivo gene editing prior to transplantation.\n* Informed consent: The patient (or legally authorized representative) is able to understand the experimental nature of the study and has voluntarily signed the informed consent form. The patient must be willing to comply with all study procedures, follow-up visits, and laboratory tests.\n* Negative crossmatch (if applicable): No pre-existing anti-donor reactivity that would cause immediate graft failure. (All recipients should have a negative T and B cell crossmatch with the donor organ prior to transplant, as per standard practice, to ensure no strong baseline donor-specific antibodies, especially against any remaining donor HLA such as HLA-C.)\n* Women of childbearing potential must have a negative pregnancy test and must agree to use effective contraception during the study and for a period after (to be specified, e.g., 1 year post-transplant), given the use of immunosuppressants and the unknown effects of gene-edited organ transplantation on pregnancy. Men with partners of childbearing potential should also agree to use contraception.\n* High immunologic risk patients are eligible: Patients with high panel reactive antibody (PRA) levels or a history of sensitization (from prior transplants, blood transfusions, or pregnancies) are allowed and even anticipated in this trial, as the intervention is designed to benefit patients with broad HLA sensitization. For instance, patients with calculated PRA \\> 80% (who have difficulty finding matched donors) can be included. (Such patients must still meet the crossmatch criterion above - any existing antibodies should not target the antigens remaining on the edited graft.)\n* Geographic availability: Patients must be available for long-term follow-up in the study center in China or able to travel for scheduled follow-up visits. They should be willing to remain in proximity to the transplant center for the initial post-operative period as per standard transplant care.\n\nExclusion Criteria:\n\n* Active infection: Any ongoing severe infection that would contraindicate transplantation or be exacerbated by immunosuppression (e.g., active tuberculosis, untreated Hepatitis B or C, HIV with uncontrolled viremia, etc.). Patients with controlled HIV (on stable antiretroviral therapy with undetectable viral load) may be considered on a case-by-case basis, but active uncontrolled infection is excluded.\n* Pregnancy or breastfeeding: Pregnant women are excluded due to the need for immunosuppressive drugs and the unknown risks of the investigational intervention on a fetus. Women who are breastfeeding are also excluded due to potential drug excretion in milk and unknown risks to the infant.\n* Multi-organ transplant need: Patients requiring more than one organ transplant simultaneously (e.g., kidney + liver, or kidney + heart) are excluded, as this trial focuses on isolated kidney transplant outcomes. (A history of a prior transplant is not an automatic exclusion if the patient now only needs a kidney, but concurrent multi-organ requirements are excluded.)\n* Severe co-morbidities that would significantly increase transplant risk or confound results: for example, uncontrolled cardiovascular disease (e.g., recent myocardial infarction, severe heart failure), uncontrolled diabetes with end-organ damage beyond ESRD, severe liver dysfunction, or other life-threatening illnesses unrelated to kidney failure. Such conditions could make the surgery unsafe or the outcome hard to interpret.\n* Contraindications to immunosuppression: Patients with conditions that preclude standard immunosuppressive therapy (for instance, a history of anaphylaxis to tacrolimus or mycophenolate that cannot be managed, or chronic infection that would be fatally worsened by immunosuppression) are excluded. The trial still relies on baseline immunosuppressants, so patients must be able to tolerate them.\n* Inability to follow the protocol: Patients with significant psychiatric disorders, cognitive impairment, or social situations that would make adherence to the study protocol and follow-up unlikely. This includes inability to give informed consent or lack of support for the intensive follow-up (for example, if the patient is incarcerated or has no fixed address, etc.).\n* Prior gene therapy or organ experiment participation: Patients who have previously received any investigational gene therapy, or who have a donor-specific tolerance induction or other experimental transplant treatments ongoing, may be excluded to avoid confounding effects. (This is a precaution to attribute outcomes specifically to the CRISPR-edited organ intervention.)\n* Laboratory abnormalities: Any clinically significant abnormalities in baseline labs that would pose added risk - for instance, severe leukopenia or thrombocytopenia that could worsen with immunosuppression, or uncontrolled coagulopathy that raises surgical risk.\n* Donor-related exclusions: If the donor kidney, upon retrieval, is found unsuitable for gene editing or transplant (e.g., poor organ quality, unexpected disease in the organ, or if the CRISPR editing fails to achieve sufficient knockout of target genes), the transplant to that patient will not proceed under the study (the patient may either receive a standard transplant off-study or wait for another opportunity). In such a case, the patient might be withdrawn or deferred, but this is a procedural consideration rather than a characteristic of the patient.","16 Years","85 Years",{"count":56,"type":20},[338,23],"PHASE1","This clinical trial investigates the transplantation of donor kidneys that have been genetically modified ex vivo using CRISPR-Cas9 genome editing to reduce immunogenicity and transplant rejection. Donor kidney grafts will have key human leukocyte antigen (HLA) genes disrupted - specifically, knockout of HLA class I heavy chains HLA-A and HLA-B, along with disabling HLA class II expression by targeting the CIITA gene (a master regulator of HLA-DR\u002FDQ\u002FDP). Approximately 90 adult end-stage renal disease patients will receive a CRISPR-edited donor kidney transplant. The primary objectives are to assess the safety and feasibility of this novel intervention, while secondary objectives evaluate the reduction in immune responses (immunogenicity), graft function, and the practicality of implementing ex vivo gene-edited organ transplantation in humans. By knocking out major donor HLA molecules, the trial aims to reduce T-cell and antibody-mediated recognition of the graft, potentially lowering rejection rates and reliance on high-dose immunosuppressants. Safety, including any off-target effects or unanticipated immune reactions, will be closely monitored, and transplant outcomes will be tracked for one year post-transplant.",[341,28,342,343,344,345,346],"End-Stage Renal Disease","End Stage Renal Disease With Renal Transplant","Kidney Transplant Rejection","Kidney Tumor","Kidney Failure","Kidney Ischemia",[348,349,350,345,351,352,353,354,355],"HLA Mismatch Immunogenicity","Transplant Rejection (Immunologic)","Kidney Transplantation (Allograft)","CRISPR-Cas9","Kidney Transplant","Human Leukocyte Antigen (HLA)","Immunogenicity Reduction","Graft Rejection Prevention","2025-06-26",{"date":317,"type":38},{"date":359,"type":38},"2025-06-01",{"date":361,"type":20},"2028-12-28",{"name":363,"class":76},"AMERICAN ORGAN TRANSPLANT AND CANCER RESEARCH INSTITUTE LLC",{"id":365,"slug":366,"hasResults":11,"nctId":367,"briefTitle":368,"officialTitle":369,"acronym":4,"eligibilityCriteria":370,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":371,"targetDuration":4,"studyType":120,"phases":4,"briefSummary":373,"conditions":374,"keywords":375,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":376,"lastUpdatePostDateStruct":377,"startDateStruct":379,"completionDateStruct":381,"leadSponsor":383,"locationsCount":110},"100594238","effects-of-pha-hemoperfusion-plus-hemodialysis-on-protein-bound-uremic-toxins-100594238","NCT07016841","Effects of pHA Hemoperfusion Plus Hemodialysis on Protein-Bound Uremic Toxins","Effects of Conventional Hemodialysis Combined With pHA Hemoperfusion Therapy on Protein-Bound Uremic Toxins in Maintenance Hemodialysis Patients: A Single-Center, Prospective Cohort Study","Inclusion Criteria:\n\n1. Age ≥18 years, with no restriction on gender;\n2. Undergoing regular hemodialysis 3 times per week, 4 hours per session, and has received maintenance hemodialysis treatment for ≥3 months;\n3. Willing and able to receive treatment as per the protocol requirements, and has signed the informed consent form for subjects.\n\nExclusion Criteria:\n\n1. Patients receiving combined hemodialysis (HD) and peritoneal dialysis (PD) treatment;\n2. Patients with known allergy to hemoperfusion device materials, contraindications, or intolerance to the device;\n3. Patients with acute severe infection, severe cardiopulmonary insufficiency, severe cerebrovascular disease, severe bleeding tendency, or active bleeding;\n4. Patients with malignant tumors in the active stage or undergoing treatment for malignant tumors;\n5. Patients with a platelet count \\\u003C 60 × 10⁹\u002FL;\n6. Other conditions deemed unsuitable for enrollment in this study by the researchers.",{"count":372,"type":20},120,"This single-center, prospective cohort Study evaluates whether adding the pHA130 hemoperfusion cartridge to conventional hemodialysis (HD) or hemodiafiltration (HDF) more effectively reduces protein-bound uremic toxins-specifically indoxyl sulfate (IS) and p-cresyl sulfate (PCS)-in maintenance HD patients. Adults on thrice-weekly, 4-hour HD for at least three months are randomized to one of three arms: HD\u002FHDF alone; HD\u002FHDF plus biweekly pHA130 hemoperfusion; or HD\u002FHDF plus biweekly HA130 hemoperfusion. After a four-week washout, toxin levels are measured at baseline and again at Weeks 4, 12, and 24, with the primary endpoint being the reduction in IS and PCS at Week 24. Secondary endpoints include single-session toxin removal, middle-molecule clearance (β₂-microglobulin, PTH), patient-reported outcomes (itching, sleep, quality of life), and rates of hospitalization and mortality. Safety is closely monitored through adverse event reporting and consistent anticoagulation dosing. Findings will clarify the clinical value of pHA130 hemoperfusion for improving toxin clearance and guiding optimal dialysis strategies.",[28],[265,315],"2025-06-10",{"date":378,"type":38},"2025-06-12",{"date":380,"type":38},"2025-05-12",{"date":382,"type":20},"2026-06-30",{"name":384,"class":76},"Xinhua Hospital, Shanghai Jiao Tong University School of Medicine",{"id":386,"slug":387,"hasResults":11,"nctId":388,"briefTitle":389,"officialTitle":390,"acronym":391,"eligibilityCriteria":392,"healthyVolunteers":11,"sex":16,"minAge":393,"maxAge":4,"enrollmentInfo":394,"targetDuration":4,"studyType":21,"phases":396,"briefSummary":397,"conditions":398,"keywords":400,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":406,"lastUpdatePostDateStruct":407,"startDateStruct":409,"completionDateStruct":411,"leadSponsor":413,"locationsCount":77},"100535293","phase-4-empagliflozin-in-heart-failure-with-preserved-ejection-fraction-and-end-stage-renal-disease-100535293","NCT06249945","EMPAgliflozin in Heart Failure With PReserved Ejection Fraction and End Stage Renal Disease","The Safety and Efficacy of Empagliflozin in Patients With End-stage Renal Disease and Heart Failure With Preserved Ejection Fraction - a Randomized Controlled Trial","EMPA-PRED","Inclusion Criteria:\n\n* Age ≥20 years old\n* ESRD under chronic, maintenance dialysis with stable dry weight for the past 6 months\n* Prior diagnosis of HFpEF, as defined by a score of ≥5 on the HFA-PEFF diagnostic algorithm.\n\nExclusion Criteria:\n\n* Age \\\u003C20 years old\n* Ongoing pregnancy\n* NYHA class IV heart failure\n* Any hospitalization for heart failure within the past month Ongoing acute urinary tract infection at the time of screening\n* Known acute genital infection\n* Severe peripheral artery disease (Rutherford category 4-6)\n* Acute coronary syndrome, stroke or transient ischemic attack within the past month\n* Recent initiation of chronic maintenance hemodialysis within 6 months\n* Adjustment of dry weight with changes greater than 5% of body weight within the past month\n* Documented left ventricular ejection fraction =\\\u003C40% by any imaging modality within 1 month of screening\n* Refused informed consent","20 Years",{"count":395,"type":20},150,[150],"The presence of CKD has been linked to the development of HFpEF. Currently, the treatment for HFpEF is limited. SGLT2i are one of the few drug classes that have proven efficacy in HFpEF in randomized controlled trials. The results of mechanistic studies suggest that the benefits of SGLT2i on diastolic heart failure are independent of their glycosuric actions and may still be present in anuric subjects. Despite the significance of HFpEF in patients with CKD, patients with advanced kidney disease have been excluded from studies investigating anti-heart failure drugs. The effects of SGLT2i in patients under maintenance dialysis are largely unknown. Past pharmacokinetics and pharmacodynamics studies on empagliflozin in patients with end-stage renal disease (ESRD) demonstrated that the use of empagliflozin in patients with ESRD seemed safe, yet its efficacy remains to be explored.",[399,28],"Heart Failure With Preserved Ejection Fraction",[401,402,403,404,405],"end-stage renal disease","sodium-glucose co-transporter 2 inhibitors","heart failure","diastolic function","empagliflozin","2024-12-10",{"date":408,"type":38},"2024-12-16",{"date":410,"type":38},"2024-03-05",{"date":412,"type":20},"2030-12-31",{"name":414,"class":76},"National Taiwan University Hospital",{"id":416,"slug":417,"hasResults":11,"nctId":418,"briefTitle":419,"officialTitle":420,"acronym":421,"eligibilityCriteria":422,"healthyVolunteers":11,"sex":16,"minAge":393,"maxAge":4,"enrollmentInfo":423,"targetDuration":4,"studyType":21,"phases":425,"briefSummary":426,"conditions":427,"keywords":429,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":434,"lastUpdatePostDateStruct":435,"startDateStruct":437,"completionDateStruct":439,"leadSponsor":440,"locationsCount":77},"100535292","phase-4-empagliflozin-in-heart-failure-with-reduced-ejection-fraction-and-end-stage-renal-disease-100535292","NCT06249932","Empagliflozin in Heart Failure with Reduced Ejection Fraction and End Stage Renal Disease","The Safety and Efficacy of Empagliflozin in Patients with End-stage Renal Disease and Heart Failure with Reduced Ejection Fraction - a Randomized Controlled Trial","EMPA-RRED","Inclusion Criteria:\n\n* Age ≥20 years old\n* ESRD under chronic, maintenance hemodialysis with stable dry weight for the past 6 months\n* Documented left ventricular ejection fraction \\\u003C50% by any imaging modality within 1 month of screening\n\nExclusion Criteria:\n\n* Age \\\u003C20 years old\n* Ongoing pregnancy\n* NYHA class IV heart failure\n* Any hospitalization for heart failure within the past month\n* Ongoing acute urinary tract infection at the time of screening\n* Known acute genital infection\n* Severe peripheral artery disease (Rutherford category 4-6)\n* Acute coronary syndrome, stroke or transient ischemic attack within the past month\n* Recent initiation of chronic maintenance hemodialysis within 6 months\n* Adjustment of dry weight with changes greater than 5% of body weight within the past month\n* Documented left ventricular ejection fraction ≥50% by any imaging modality within 1 month of screening\n* Refused informed consent",{"count":424,"type":20},95,[150],"In patients with ESRD, up to 20% of patients suffer from HFrEF, leading to significant CV morbidity and mortality. Several drug classes that provide survival benefits for patients with HFrEF, including SGLT2i, lack data regarding their efficacy and safety in patients under chronic hemodialysis. As the primary target of SGLT2i is expressed mostly in the kidneys, the efficacy of SGLT2i in patients with ESRD may be limited. On the other hand, patients with ESRD are at higher risks of experiencing cardiovascular events and may still benefit from treatment. Several mechanistic studies have demonstrated direct actions of SGLT2i on the myocardium, thus it is possible that the benefits of SGLT2i on heart failure are independent of their glycosuric actions and may still be present in anuric subjects. Furthermore, pharmacokinetics and pharmacodynamics studies on empagliflozin demonstrated that peak plasma levels of empagliflozin in subjects with renal failure\u002FESRD were similar to those in subjects with normal renal function. The use of empagliflozin in patients with ESRD seemed safe in terms of pharmacokinetics and pharmacodynamics, yet its efficacy remains to be explored.",[428,28],"Heart Failure with Reduced Ejection Fraction",[430,431,432,405,433],"end stage renal disease","sodium-glucose co-transporter 2 inhibitors,","heart failure with reduced ejection fraction","left ventricular mass","2024-12-09",{"date":436,"type":38},"2024-12-13",{"date":438,"type":38},"2024-03-13",{"date":412,"type":20},{"name":414,"class":76},{"id":442,"slug":443,"hasResults":11,"nctId":444,"briefTitle":445,"officialTitle":446,"acronym":447,"eligibilityCriteria":448,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":449,"targetDuration":4,"studyType":21,"phases":451,"briefSummary":452,"conditions":453,"keywords":455,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":461,"lastUpdatePostDateStruct":462,"startDateStruct":464,"completionDateStruct":466,"leadSponsor":468,"locationsCount":110},"100366036","virtual-reality-intradialysis-last-vs-first-part-of-the-session-100366036","NCT04046042","Virtual Reality Intradialysis: Last vs. First Part of the Session","Virtual Reality Exercise Intradialysis: Tolerance and Dialysis Dose Effects During the Last vs. First Part of the Hemodialysis Session","VRI","Inclusion Criteria:\n\n* At least 3 months in hemodialysis treatment\n* Clinically stable\n\nExclusion Criteria:\n\n* Recent cardiac events (less than 3 months)\n* Unable to exercise",{"count":450,"type":20},50,[58],"The main objective of this investigation is to assess if an intradialysis virtual reality exercise program during the last two hours of the hemodialysis session results in greater hemodynamic stability than exercise performed during the first two hours of the hemodialysis session.\n\nThe secondary aims are to assess the impact of intradialysis virtual reality exercise during the last two hours of the hemodialysis session on dialysis efficacy, postdialysis molecules rebound, adherence to exercise, functional capacity, physical activity level, health-related quality of life, cognitive function, morbidity, frailty and dependency. We will also analyze the reliability of muscle strength assessment of lower limb muscles with a handheld dynamometer during hemodialysis.",[28,454],"Hemodialysis Complication",[456,457,458,459,460],"Exercise","Virtual reality","physical function","health-related quality of life","hemodynamic instability","2024-06-13",{"date":463,"type":38},"2024-06-14",{"date":465,"type":38},"2019-09-02",{"date":467,"type":20},"2024-08-30",{"name":469,"class":76},"Cardenal Herrera University",{"id":471,"slug":472,"hasResults":11,"nctId":473,"briefTitle":474,"officialTitle":475,"acronym":4,"eligibilityCriteria":476,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":477,"targetDuration":4,"studyType":21,"phases":479,"briefSummary":480,"conditions":481,"keywords":4,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":482,"lastUpdatePostDateStruct":483,"startDateStruct":485,"completionDateStruct":487,"leadSponsor":488,"locationsCount":110},"100390191","randomized-clinical-trial-on-the-efficacy-and-safety-of-incremental-hemodialysis-real-life-100390191","NCT04360694","RandomizEd ClinicAL triaL on the Efficacy and saFety of Incremental Hemodialysis (REAL-LIFE)","RandomizEd ClinicAL triaL on the Efficacy and saFety of Incremental Hemodialysis","Inclusion Criteria:\n\n* Adults aged \\> 18 years\n* Start of maintenance hemodialysis treatment due to advanced CKD stage 5D\n* Patients who are about to start HD or have already started HD within a period of ≤ 2 weeks\n* Glomerular filtration rate \\\u003C= 10 mL\u002Fmin\u002F1.73 m2, as estimated by means of CKD-EPI formula.\n\nExclusion Criteria:\n\n* Age \\\u003C 18 years\n* Acute kidney injury or acute on chronic kidney injury\n* eGFR higher than 10 mL\u002Fmin\u002F1.73 m2\n* UO \\\u003C 600 mL\u002Fday\n* Already treated with other replacement therapies (peritoneal dialysis or kidney transplant)\n* Unable or unwilling to give informed consent.\n* Unable to comply with trial procedures, e.g., collection of UO.\n* Likely survival prognosis or planned modality or centre transfer \\\u003C 6 months.\n* Patients who are in the waiting list for a living kidney transplant\n* Associated diseases: active neoplastic disease; refractory congestive heart failure (type IV NYHA, ejection fraction ≤ 30%) requiring high ultrafiltration volumes per session.",{"count":478,"type":20},190,[58],"Background: The thrice-weekly hemodialysis (HD) regimen is widely accepted as a standard prescription. The concept of incremental dialysis has been established as a possible alternative for patients with preserved diuresis and end-stage renal failure in need of HD. The main problems related to prescription of incremental HD are an arbitrary use of infrequent regimens and the lack of clear standards for incorporating residual kidney function (RKF) in the assessment of HD dose. Several models have been proposed for prescription of incremental dialysis. The latest, the variable target model (VTM), gives more clinical weight to the RKF and allows less frequent HD treatments at lower RKF. Despite increasing evidence derived from observational studies to support the use of incremental HD, RCTs are lacking and, therefore, urgently needed.\n\nMethods\u002FDesign:\n\nThe Department of Nephrology, Dialysis and Transplantation of the Azienda Ospedaliero Universitaria Consorziale Policlinico, Bari, Italy and the EUDIAL Working Group of the European Renal Association - European Dialysis Transplant Association (ERA-EDTA) are starting a randomized clinical trial (RCT) in incident HD patients, whose name is \"REAL LIFE\", by using the acronym of its whole definition: RandomizEd clinicAL triaL on the effIcacy and saFety of incremental haEmodialysis. REAL LIFE is a pragmatic, prospective, multicentre, open label RCT, investigator-initiated, comparing the intervention arm (incremental HD) with the control arm (standard 3HD\u002Fwk). The trial, originally conceived by experts at the Division of Nephrology of the Miulli General Hospital, Acquaviva delle Fonti, Italy, consists in starting the HD treatment adopting the new incremental approach guided by the VTM. The primary outcome is the survival of kidney function, with the event defined as urinary output (UO) ≤ 200 mL\u002Fday, confirmed by a further collection after 2 weeks to exclude temporary illness.\n\nDiscussion: REAL LIFE will enable the investigators to know with the highest level of scientific evidence the safety and efficacy of an incremental approach to the start of HD treatment.",[28],"2024-06-11",{"date":484,"type":38},"2024-06-12",{"date":486,"type":38},"2021-05-10",{"date":161,"type":20},{"name":489,"class":76},"Azienda Ospedaliero-Universitaria Consorziale Policlinico di Bari"]