[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"renal-insufficiency\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:renal-insufficiency":36},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,17,0,[8,53,84,114,143,184,208,236,257,281,305,331,365,389,417,447,470],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":15,"eligibilityCriteria":16,"healthyVolunteers":11,"sex":17,"minAge":4,"maxAge":4,"enrollmentInfo":18,"targetDuration":4,"studyType":21,"phases":4,"briefSummary":22,"conditions":23,"keywords":4,"overallStatus":40,"whyStopped":4,"lastUpdateSubmitDate":41,"lastUpdatePostDateStruct":42,"startDateStruct":45,"completionDateStruct":47,"leadSponsor":49,"locationsCount":52},"100172884","product-surveillance-registry-100172884",false,"NCT01524276","Product Surveillance Registry","Medtronic Product Surveillance Registry","PSR","Inclusion Criteria:\n\n* Patient or legally authorized representative provides written authorization and\u002For consent per institution and geographical requirements\n* Patient has or is intended to receive or be treated with an eligible Medtronic product\n* Patient within enrollment window relative to therapy initiation or meets criteria for retrospective enrollment\n\nExclusion Criteria:\n\n* Patient who is, or will be, inaccessible for follow-up\n* Patient with exclusion criteria required by local law\n* Patient is currently enrolled in or plans to enroll in any concurrent drug and\u002For device study that may confound results","ALL",{"count":19,"type":20},100000,"ESTIMATED","OBSERVATIONAL","The purpose of the Registry is to provide continuing evaluation and periodic reporting of safety and effectiveness of Medtronic market-released products. The Registry data is intended to benefit and support interests of patients, hospitals, clinicians, regulatory bodies, payers, and industry by streamlining the clinical surveillance process and facilitating leading edge performance assessment via the least burdensome approach.",[24,25,26,27,28,29,30,31,32,33,34,35,36,37,38,39],"Cardiac Rhythm Disorders","Urological Disorders","Neurological Disorders","Cardiovascular Disorders","Digestive Disorders","Intracranial Aneurysm","Mechanical Circulatory Support","Respiratory Therapy","Aortic, Peripheral Vascular and Venous Disorders","Minimally Invasive Surgical Procedures","Diagnostic Techniques and Procedures","Surgical Procedures, Operative","Renal Insufficiency","Neurovascular","Coronary Artery Disease","Ear, Nose and Throat Disorder","RECRUITING","2026-06-15",{"date":43,"type":44},"2026-06-17","ACTUAL",{"date":46,"type":4},"2012-01",{"date":48,"type":20},"2040-01",{"name":50,"class":51},"Medtronic","INDUSTRY",395,{"id":54,"slug":55,"hasResults":11,"nctId":56,"briefTitle":57,"officialTitle":58,"acronym":4,"eligibilityCriteria":59,"healthyVolunteers":11,"sex":17,"minAge":60,"maxAge":61,"enrollmentInfo":62,"targetDuration":4,"studyType":64,"phases":65,"briefSummary":67,"conditions":68,"keywords":4,"overallStatus":40,"whyStopped":4,"lastUpdateSubmitDate":73,"lastUpdatePostDateStruct":74,"startDateStruct":76,"completionDateStruct":78,"leadSponsor":80,"locationsCount":83},"100633239","moderate-intensity-statin-plus-ezetimibe-in-ckd-and-ascvd-100633239","NCT07524101","Moderate-Intensity Statin Plus Ezetimibe in CKD and ASCVD","Utilizing Lipid-lowering Therapy With Moderate-intensity Statin Plus Ezetimibe in Chronic Kidney Disease Patients With Concomitant Atherosclerotic Cardiovascular Disease: ULTRA-CKD Trial","Inclusion Criteria:\n\n1. Age 19-85 years.\n2. Chronic kidney disease stage III, IV, or V (CKD-EPI eGFR \\\u003C60 \u002F \\\u003C30 \u002F \\\u003C15 mL\u002Fmin\u002F1.73 m² or on dialysis).\n3. Established ASCVD, meeting at least one of the following:\n\n   * Prior acute coronary syndrome (myocardial infarction or unstable angina).\n   * Stable angina confirmed by imaging studies.\n   * History of coronary revascularization (percutaneous coronary intervention or coronary artery bypass grafting).\n   * Peripheral artery disease.\n   * Ischemic stroke or transient ischemic attack.\n\nExclusion Criteria:\n\n1. Baseline LDL cholesterol \\\u003C55 mg\u002FdL in the absence of statin therapy.\n2. Acute liver disease or persistently unexplained serum AST\u002FALT ≥2 × the upper limit of normal.\n3. Allergy or hypersensitivity to statins.\n4. Life expectancy \\\u003C1 year.\n5. Expected inability to complete at least 1 year of follow-up.\n6. Inability to read or understand the informed consent form.","19 Years","85 Years",{"count":63,"type":20},1952,"INTERVENTIONAL",[66],"NA","The ULTRA-CKD trial is a prospective, randomized, open-label, multicenter trial designed to compare the efficacy and safety of moderate-intensity statin plus ezetimibe combination therapy versus high-intensity statin monotherapy in patients with chronic kidney disease (CKD) and concomitant atherosclerotic cardiovascular disease (ASCVD).\n\nPatients with CKD are at very high risk for ASCVD. In this population, it is important to establish a lipid-lowering strategy that optimizes cardiovascular outcomes while ensuring long-term safety. While high-intensity statins are generally considered as initial treatment option for secondary prevention, the optimal strategy for CKD patients remains to be clinicaly defined. This study aims to evaluate whether the combination of moderate-intensity statin and ezetimibe is non-inferior to high-intensity statin monotherapy in terms of 3-year composite of major adverse cardiovascular events.",[36,69,70,71,72],"Atherosclerosis","Dyslipidemia","Hypercholesterolemia","Cardiovascular Diseases","2026-06-11",{"date":75,"type":44},"2026-06-16",{"date":77,"type":44},"2026-05-28",{"date":79,"type":20},"2031-01-22",{"name":81,"class":82},"Yonsei University","OTHER",1,{"id":85,"slug":86,"hasResults":11,"nctId":87,"briefTitle":88,"officialTitle":89,"acronym":4,"eligibilityCriteria":90,"healthyVolunteers":11,"sex":17,"minAge":91,"maxAge":4,"enrollmentInfo":92,"targetDuration":4,"studyType":64,"phases":94,"briefSummary":95,"conditions":96,"keywords":4,"overallStatus":104,"whyStopped":4,"lastUpdateSubmitDate":105,"lastUpdatePostDateStruct":106,"startDateStruct":108,"completionDateStruct":110,"leadSponsor":112,"locationsCount":83},"100484806","a-study-of-the-effect-of-a-nurse-navigator-program-on-high-risk-patients-100484806","NCT05592847","A Study of the Effect of a Nurse Navigator Program on High Risk Patients","The Effect of a Nurse Navigator Program on Readmission Rates for Patients With Elevated BMI, COPD, CHF, Dialysis Use, and H\u002Fo Alcohol Abuse","Inclusion Criteria:\n\n\\- Require total or partial hip or knee replacement and have one or more of the following diagnosis: Heart Failure (HF); Chronic obstructive pulmonary disease (COPD); Dialysis; Alcohol Abuse; Low BMI.\n\nExclusion Criteria:\n\n\\- Decrease cognitive capacity to consent to the study.","18 Years",{"count":93,"type":20},300,[66],"The purpose of this study is to examine if educational intervention in high risk patients can lead to decreased hospital readmissions when compared to patients who are not in the intervention program. Additionally, to determine patient satisfaction with the educational program.",[97,98,99,100,101,36,102,103],"Patient Readmission","Arthroplasty, Replacement, Knee","Arthroplasty, Replacement, Hip","Heart Failure","Pulmonary Disease, Chronic Obstructive","Body Mass Index","Alcoholism","NOT_YET_RECRUITING","2026-03-17",{"date":107,"type":44},"2026-03-19",{"date":109,"type":20},"2027-01",{"date":111,"type":20},"2027-06",{"name":113,"class":82},"Mayo Clinic",{"id":115,"slug":116,"hasResults":11,"nctId":117,"briefTitle":118,"officialTitle":119,"acronym":4,"eligibilityCriteria":120,"healthyVolunteers":121,"sex":17,"minAge":91,"maxAge":61,"enrollmentInfo":122,"targetDuration":4,"studyType":64,"phases":124,"briefSummary":126,"conditions":127,"keywords":4,"overallStatus":40,"whyStopped":4,"lastUpdateSubmitDate":133,"lastUpdatePostDateStruct":134,"startDateStruct":136,"completionDateStruct":138,"leadSponsor":140,"locationsCount":142},"100625726","phase-1-a-study-of-eloralintide-ly3841136-in-participants-with-renal-impairment-and-in-participants-with-normal-renal-function-100625726","NCT07426380","A Study of Eloralintide (LY3841136) in Participants With Renal Impairment and in Participants With Normal Renal Function","A Phase 1, Multicenter, Parallel-Design, Single Dose, Open-Label Study to Evaluate the Pharmacokinetics and Safety of Eloralintide in Participants With Severe Renal Impairment and End Stage Renal Disease (ESRD) Compared With Participants With Normal Renal Function","Inclusion Criteria:\n\n* Have a body weight of 55 kilograms (kg) or more and a body mass index (BMI) within the range of 19.0 to 40.0 kilograms per square meter (kg\u002Fm²), inclusive\n* Have no significant history of spontaneous or ethanol-induced hypoglycemia\n\nAdditional Inclusion Criteria for Group 1\n\n* Are healthy as determined by medical history, physical examination, and other screening procedures, with normal renal function, assessed by estimated glomerular filtration rate (eGFR) of at least 90 milliliters per minute (mL\u002Fmin)\n* Have glycated hemoglobin (HbA1c) less than or equal to 6.5% at screening\n\nAdditional Inclusion Criteria for Groups 2 and 3\n\n* Have stable severe renal impairment, assessed by eGFR less than 30 mL\u002Fmin at screening or with end-stage renal disease (ESRD) who have been on a stable hemodialysis (HD) schedule for at least 3 months prior to planned dosing\n* Have acceptable blood pressure and pulse rate\n* If participants have Type 2 Diabetes Mellitus (T2DM), they must have a HbA1c equal to or less than 10.0% at screening\n\nExclusion Criteria:\n\n* Have a history of chronic liver disease, acute or chronic hepatitis, including a history of autoimmune hepatitis, any evidence for hepatic impairments\n* Have a current, functioning organ transplant. Nonfunctional renal allografts may be considered\n* Have significant history or current cardiovascular, respiratory, hepatic, renal, gastrointestinal (GI), endocrine, hematological, dermatological, or neurological disorders capable of significantly altering the absorption, metabolism, or elimination of drugs; constituting a risk when taking the investigational product; or interfering with the interpretation of data\n\nGroups 2 and 3\n\n* Are receiving continuous HD or peritoneal dialysis.\n* Have used any drug indicated for medical care of the participant's renal impairment, which is not established in dose and administered for at least 7 days before eloralintide administration",true,{"count":123,"type":20},28,[125],"PHASE1","The purpose of the study is to assess the amount of Eloralintide (LY3841136) that reaches the bloodstream and the time it takes for the body to get rid of it when given to participants with renal (kidney) impairment and to healthy participants. The study drug will be administered subcutaneously (SC) (under the skin).\n\nFor each participant, the study will last about 14 weeks, excluding screening.",[128,129,130,131,36,132],"Kidney Disease","Renal Insufficiency Chronic","Kidney Failure, Chronic","Renal Impairment","End Stage Kidney Disease","2026-03-12",{"date":135,"type":44},"2026-03-13",{"date":137,"type":44},"2026-02-24",{"date":139,"type":20},"2026-10",{"name":141,"class":51},"Eli Lilly and Company",2,{"id":144,"slug":145,"hasResults":11,"nctId":146,"briefTitle":147,"officialTitle":147,"acronym":148,"eligibilityCriteria":149,"healthyVolunteers":11,"sex":17,"minAge":91,"maxAge":4,"enrollmentInfo":150,"targetDuration":4,"studyType":64,"phases":152,"briefSummary":153,"conditions":154,"keywords":164,"overallStatus":40,"whyStopped":4,"lastUpdateSubmitDate":175,"lastUpdatePostDateStruct":176,"startDateStruct":178,"completionDateStruct":180,"leadSponsor":182,"locationsCount":123},"100516231","save-fistulas-the-selfwrap-assisted-arteriovenous-fistulas-study-100516231","NCT06001827","SAVE-FistulaS: the SelfWrap-Assisted ArterioVEnous Fistulas Study","SAVE-FistulaS","Inclusion Criteria:\n\n* Age of at least 18 years\n* Referred for creation of a new AVF\n* Willing and able to comply with study requirements, communicate with the study team, and attend follow up visits over a period of 36 months\n\nExclusion Criteria:\n\n* Planned index procedure to revise or repair an existing fistula\n* Target artery inner diameter \\\u003C 2.0 mm, as measured by ultrasound while the target arm is under tourniquet pressure and anesthesia\n* Target vein inner diameter \\\u003C 2.0 mm, as measured by ultrasound while the target arm is under tourniquet pressure and anesthesia\n* Significant (at least 50%) stenosis at the target vein on the side of surgery (between the planned anastomosis site and the axillary vein), as diagnosed by preoperative ultrasound\n* Known central venous stenosis of at least 50% on the side of surgery\n* Presence of a stent or a stent graft within the access circuit\n* Known or suspected coagulation disorder that, in the opinion of the Investigator, puts too much risk on the patient for AVF creation\n* Known or suspected active infection at the time of surgery\n* Congestive heart failure NYHA class 4\n* Prior steal on the side of surgery;\n* Enrolled in another investigational drug, device, or biological study, or was previously enrolled in this study\n* Life expectancy less than 12 months\n* Expected to undergo kidney transplant surgery within 6 months of enrollment\n* Expected to undergo home hemodialysis\n* Females of childbearing potential (premenopausal and not surgically sterile) without documented current negative pregnancy test at screening\n* Presence of a comorbid condition that, in the opinion of the Investigator, may significantly confound the collection of safety and efficacy data in this study\n* Unwillingness or inability to give consent and\u002For comply with the study follow up schedule\n* Any health condition, which in the opinion of the Investigator, would interfere with the safety of the participant or the participant's ability to comply with the study.",{"count":151,"type":20},600,[66],"This is a prospective, randomized, multi-center clinical trial for chronic kidney disease (CKD) patients referred for creation of a new arteriovenous fistula (AVF) in order to assess the safety and effectiveness of SelfWrap, a bioabsorbable perivascular wrap.",[155,156,157,158,159,160,161,162,163,36],"Chronic Kidney Diseases","End Stage Renal Disease","Arteriovenous Fistula","Hemodialysis Access Failure","ESRD","Vascular Access Complication","Renal Failure","Catheter Complications","Catheter Dysfunction",[165,166,167,168,169,170,171,172,173,156,157,174],"Vascular Surgery","Vascular Access","Nephrology","Bioabsorbable","Perivascular Wrap","External Support","Hemodialysis","Dialysis","Chronic Kidney Disease","AVF","2026-02-12",{"date":177,"type":44},"2026-02-17",{"date":179,"type":44},"2024-01-03",{"date":181,"type":20},"2029-12",{"name":183,"class":51},"VenoStent",{"id":185,"slug":186,"hasResults":11,"nctId":187,"briefTitle":188,"officialTitle":189,"acronym":4,"eligibilityCriteria":190,"healthyVolunteers":121,"sex":17,"minAge":91,"maxAge":4,"enrollmentInfo":191,"targetDuration":4,"studyType":64,"phases":193,"briefSummary":195,"conditions":196,"keywords":4,"overallStatus":104,"whyStopped":4,"lastUpdateSubmitDate":199,"lastUpdatePostDateStruct":200,"startDateStruct":202,"completionDateStruct":204,"leadSponsor":206,"locationsCount":83},"100619520","phase-4-a-study-of-the-pharmacokinetics-and-safety-of-anaprazole-sodium-in-special-populations-100619520","NCT07345689","A Study of the Pharmacokinetics and Safety of Anaprazole Sodium in Special Populations","A Study to Evaluate the Pharmacokinetics and Safety of Anaprazole Sodium in Subjects With Hepatic or Renal Impairment and in Elderly Subjects","Inclusion Criteria:\n\n1. Voluntarily sign the informed consent form before any study-related activities commence, demonstrate an understanding of the trial procedures and methodology, and be willing to strictly adhere to the clinical trial protocol for study completion;\n2. Subjects (including their partners) must agree to have no plans for conception from screening until 6 months after the last dose of the investigational drug and to voluntarily practice effective contraception during this period;\n3. Aged 18 to 70 years (inclusive) at the time of signing informed consent, either male or female. For the elderly group, subjects must be aged 65 years or older (inclusive);\n4. Body mass index (BMI) between 18 and 32 kg\u002Fm² (inclusive);\n5. Subjects in the healthy group should be matched as closely as possible to those in the hepatic impairment, renal impairment, and elderly groups in terms of gender and weight, and additionally matched for age with the hepatic and renal impairment groups;\n6. Subjects in the hepatic impairment group must also meet all of the following additional criteria:\n\n   Subjects with chronic liver injury due to primary liver diseases (e.g., hepatitis B, hepatitis C, autoimmune hepatitis, alcoholic liver disease, etc.), classified as Child-Pugh Grade B hepatic insufficiency; Clinically diagnosed cirrhosis; eGFR \\> 59 mL\u002Fmin; Subjects are either those with a stable concomitant medication regimen (for hepatic impairment\u002Fcomplications\u002Fother diseases) for ≥2 weeks pre-dose not requiring anticipated adjustment (excluding, e.g., diuretics\u002Finsulin), or those not on such medications;\n7. Subjects in the renal impairment group must also meet all of the following additional criteria:\n\nDiagnosed with chronic kidney disease (CKD), defined as the presence of any marker of kidney damage or GFR \\\u003C 60 mL\u002Fmin for more than 3 months (evidence may include outpatient records, inpatient records, or laboratory reports); GFR must meet the following criteria: Moderate renal impairment (CKD Stage 3): 30-59 mL\u002Fmin (inclusive); Severe renal impairment (CKD Stage 4): 15-29 mL\u002Fmin (inclusive); Note: Staging will be determined solely based on the second scheduled GFR measurement during the screening period; Renal function must be stable, defined as meeting either of the following criteria based on two GFR measurements taken prior to dosing (with at least a 3-day interval between measurements): Both results fall within the same CKD stage; or the fluctuation between the two GFR results is \\\u003C10% (calculated as: \\[(Second result - First result) \u002F First result\\] × 100%).\n\nExclusion Criteria:\n\n1. Subjects with a history of hypersensitivity or allergic constitution (including severe drug allergies or drug hypersensitivity reactions), or with a known allergy to the investigational drug or any of its excipients;\n2. QTcF (male) \\> 470 ms, QTcF (female) \\> 480 ms;\n3. Uncontrolled hypertension, defined as systolic blood pressure ≥ 160 mmHg or diastolic blood pressure ≥ 100 mmHg despite antihypertensive therapy. This criterion does not apply to subjects in the healthy group;\n4. History of dysphagia or any gastrointestinal disorder that may affect drug absorption, including frequent nausea or vomiting due to any etiology;\n5. History of severe infection, trauma, gastrointestinal surgery, or other major surgery within 4 weeks prior to screening;\n6. Receipt of any vaccine within 14 days prior to screening, or intention to receive any vaccination during the course of the study;\n7. Donation or loss of blood ≥ 400 mL within 3 months prior to screening, or intention to donate blood during the study;\n8. Use of moderate or strong CYP3A4 inhibitors\u002Finducers within 2 weeks prior to screening, or planned concomitant use during the study; or use of CYP3A4-sensitive substrates within 2 weeks prior to screening or planned use during the study;\n9. Use of proton pump inhibitors (PPIs, e.g., rabeprazole, pantoprazole, esomeprazole) within 2 weeks prior to screening or planned concomitant use during the study; medications known to affect serum creatinine clearance (e.g., calcium dobesilate, trimethoprim\u002Fsulfamethoxazole, cimetidine); drugs prone to cause liver injury (e.g., non steroidal anti inflammatory drugs, antibiotics, antituberculosis agents, antifungals, glucocorticoids); or drugs with high plasma protein binding (e.g., warfarin, dicoumarol, diazepam, phenylbutazone, digitoxin);\n10. Consumption of special diets (including pitaya, mango, pomelo, and\u002For xanthine containing foods such as chocolate) within 2 weeks prior to dosing, and\u002For habitual excessive intake of tea, coffee, grapefruit\u002Fgrapefruit juice, or caffeinated beverages (average \\>8 cups per day, 200 mL per cup);\n11. History of excessive alcohol consumption, defined as \\>14 units per week on average, within the 3 months preceding screening (where 1 alcohol unit equals 360 mL of beer, 45 mL of 40% distilled spirits, or 150 mL of wine);\n12. Positive result on alcohol breath test or urine drug screening at screening;\n13. Average cigarette consumption of ≥10 cigarettes per day within 3 months prior to screening;\n14. History of drug abuse or substance misuse;\n15. Pregnant or lactating women, or women of childbearing potential with a positive pregnancy test;\n16. Intolerance to venipuncture or history of needle\u002Fphobia syncope;\n17. Use of any investigational drug within 3 months prior to screening or planned participation in another clinical trial during this study;\n18. Other conditions deemed by the investigator to compromise the subject's suitability for the study;\n\n    Healthy Subjects will be excluded if they meet any of the following criteria:\n19. History of hepatic impairment or renal impairment;\n20. Any clinically significant active or chronic disease affecting major organ systems (e.g., circulatory, endocrine, neurological, digestive, respiratory, hematologic, immunologic, psychiatric, or metabolic systems) at screening, or any other medical condition that could potentially confound the interpretation of study outcomes;\n21. Clinically significant abnormalities (as judged by the investigator) in physical examination, vital signs, laboratory tests, 12 lead ECG, abdominal ultrasound, or chest X ray;\n22. Positive screening result for any of the following: hepatitis B surface antigen (HBsAg), hepatitis C antibody (HCV Ab), HIV antigen\u002Fantibody, or syphilis antibody;\n23. Administration of any prescription medication, non prescription drug, vitamin supplement, or herbal preparation within 14 days prior to screening;\n\n    Subjects in the hepatic impairment group will be excluded if they meet any of the following criteria:\n24. Subjects who present with any of the following conditions and are deemed by the investigator as unsuitable for this study will be excluded:\n\n    Prior liver transplantation; Diseases such as biliary cirrhosis or extrahepatic biliary obstruction;\n\n    Diagnosis of liver cancer or other malignant tumors, with the following exceptions:\n\n    Certain completely cured cancers after surgical resection, such as basal cell carcinoma or squamous cell carcinoma of the skin, or carcinoma in situ of the cervix; Liver cancer patients who have received radical therapy with no recurrence; Liver cancer patients classified as BCLC stage 0. Acute liver failure; History of esophageal or gastric variceal bleeding within 3 months prior to screening;\n25. Laboratory test results at screening meeting any of the following criteria:\n\n    1. Alanine aminotransferase (ALT) or aspartate aminotransferase (AST) \\> 5 × upper limit of normal (ULN);\n    2. Absolute neutrophil count \\\u003C 0.75 × 10⁹\u002FL;\n    3. Hemoglobin \\\u003C 80 g\u002FL;\n    4. Alpha fetoprotein (AFP) \\> 100 ng\u002FmL;\n    5. Platelet count \\\u003C 40 × 10⁹\u002FL; or any other clinically significant laboratory abnormality that, in the investigator's judgment, renders the subject unsuitable for the study;\n26. Positive screening result for HIV antigen\u002Fantibody; Positive syphilis antibody test result with a confirmatory positive rapid plasma reagin (RPR) test;\n27. In addition to the primary hepatic condition, subjects will be excluded if, at screening, they present with any other severe systemic disease-including but not limited to significant gastrointestinal, respiratory, renal, neurologic, hematologic, endocrine, immune, psychiatric, or cardiovascular\u002Fcerebrovascular disorders-that in the investigator's judgment would make them unsuitable for the study;\n\n    Subjects in the renal impairment group will be excluded if they meet any of the following criteria:\n28. Acute renal failure, prior kidney transplantation, or requirement for renal dialysis during the study;\n29. Subjects will be excluded if, in addition to chronic kidney disease and its complications, they have a history or current evidence of any other severe systemic disorder-including but not limited to significant gastrointestinal, respiratory, neurological, hematological, endocrine, oncological (except for completely resected in situ basal cell carcinoma, cutaneous squamous cell carcinoma, cervical carcinoma in situ, or ductal carcinoma in situ of the breast), immunological, psychiatric, or cardiovascular\u002Fcerebrovascular disease-that, in the investigator's opinion, would make participation in the study inappropriate;\n30. ALT ≥ 2 × ULN, AST ≥ 2 × ULN; Serum total bilirubin \\> 1.5 × ULN; Albumin \\\u003C 30 g\u002FL; Absolute neutrophil count \\\u003C 1.3 × 10⁹\u002FL; Hemoglobin \\\u003C 80 g\u002FL; Platelet count \\\u003C 100 × 10⁹\u002FL; Any other clinically significant laboratory abnormality that, in the investigator's judgment, renders the subject unsuitable for the study;\n31. Congestive heart failure classified as New York Heart Association (NYHA) Class III or IV, or Left ventricular ejection fraction (LVEF) \\\u003C 50% at screening;\n32. Positive result for HIV antigen\u002Fantibody; Positive syphilis antibody test result, with a confirmatory positive rapid plasma reagin (RPR) test;\n\n    Elderly subjects will be excluded if they meet any of the following criteria:\n33. Subjects will be excluded if they have any other severe systemic disease at screening - including but not limited to significant gastrointestinal, respiratory, renal, neurologic, hematologic, endocrine, oncologic (except completely resected in situ basal cell carcinoma, squamous cell carcinoma of the skin, carcinoma in situ of the cervix, or ductal carcinoma in situ of the breast), immunologic, psychiatric, or cardiovascular\u002Fcerebrovascular disorders - and if, in the investigator's judgment, participation would be inappropriate;\n34. Fasting blood glucose \\> 7.0 mmol\u002FL;\n35. ALT ≥ 1.5 × ULN, AST ≥ 1.5 × ULN; Serum total bilirubin \\> 1.5 × ULN; Albumin \\\u003C 30 g\u002FL; Creatinine \\> 1.5 × ULN; Albumin \\\u003C 30 g\u002FL; Hemoglobin \\\u003C 100 g\u002FL; Platelet count \\\u003C 100 × 10⁹\u002FL; Any other clinically significant laboratory abnormality that, in the investigator's judgment, renders the subject unsuitable for the study;\n36. Positive screening result for any of the following: hepatitis B surface antigen (HBsAg), hepatitis C antibody (HCV Ab), HIV antigen\u002Fantibody, or syphilis antibody.",{"count":192,"type":20},60,[194],"PHASE4","The objective of this study is to evaluate the pharmacokinetic profile and safety of anaprazole sodium in adult subjects, particularly including the elderly and those with renal or hepatic impairment.",[197,36,198],"Hepatic Insufficiency","Elderly","2026-01-07",{"date":201,"type":44},"2026-01-16",{"date":203,"type":20},"2026-01-30",{"date":205,"type":20},"2027-06-30",{"name":207,"class":51},"Xuanzhu Biopharmaceutical Co., Ltd.",{"id":209,"slug":210,"hasResults":11,"nctId":211,"briefTitle":212,"officialTitle":213,"acronym":214,"eligibilityCriteria":215,"healthyVolunteers":11,"sex":17,"minAge":91,"maxAge":4,"enrollmentInfo":216,"targetDuration":4,"studyType":64,"phases":218,"briefSummary":219,"conditions":220,"keywords":222,"overallStatus":40,"whyStopped":4,"lastUpdateSubmitDate":227,"lastUpdatePostDateStruct":228,"startDateStruct":230,"completionDateStruct":232,"leadSponsor":234,"locationsCount":83},"100480258","food-frequency-questionnaire-to-assess-sodium-intake-100480258","NCT05533645","Food Frequency Questionnaire to Assess Sodium Intake","Development and Validation of a Food Frequency Questionnaire to Assess Sodium Intake in Hospitalized Patients or in Medical Consultation","EVALSEL","Inclusion Criteria:\n\n* Patients with high blood pressure, CKD stages 4-5 and patients free from any diseases\n* Patients over 18 years old\n* Patients in nephrology and cardiology consultation or recruited by CIC\n* Patients with health insurance\n* Patients willing to follow the full study\n\nExclusion Criteria:\n\n* Loss of salt by vomiting, diarrhea or sweating (intense sport or intense fever 3 days before urine collection) which can cause a decreasing natriuresis\n* Modification of the therapeutic management of patients during the study period\n* Taking certain drugs like effervescent drugs, Gaviscon and Tolvaptan during the day of urine collection, as well as diuretics (unless they are taken long-term and the diuresis is stable) which can cause an increasing natriuresis\n* Pregnant or breastfeeding women\n* Patients protected by law",{"count":217,"type":20},99,[66],"EvalSel can precisely assess the salt intake of hospitalized patients in nephrology and cardiology or in medical consultation. It can determine salt consumption to the nearest gram.\n\nThe objectives of this food frequency questionnaire are to arrive at a precise dietary diagnosis and to quickly identify the dietary errors made by the patients.\n\nEvalSel is useful for doctors to quickly obtain an assessment of the salt consumption of their patients, so they can refer them to dietitians if necessary. It can be used on the day of admission to hospital or during medical follow-ups to know the evolution of their consumption over the long term and improve their care.",[221,36],"Hypertension",[223,221,224,225,226],"natriuresis","Renal insufficiency","Sodium","Table salt","2025-12-18",{"date":229,"type":44},"2025-12-26",{"date":231,"type":44},"2023-06-06",{"date":233,"type":20},"2026-06",{"name":235,"class":82},"University Hospital, Lille",{"id":237,"slug":238,"hasResults":11,"nctId":239,"briefTitle":240,"officialTitle":240,"acronym":241,"eligibilityCriteria":242,"healthyVolunteers":11,"sex":17,"minAge":91,"maxAge":4,"enrollmentInfo":243,"targetDuration":4,"studyType":64,"phases":245,"briefSummary":246,"conditions":247,"keywords":4,"overallStatus":40,"whyStopped":4,"lastUpdateSubmitDate":248,"lastUpdatePostDateStruct":249,"startDateStruct":251,"completionDateStruct":253,"leadSponsor":255,"locationsCount":83},"100448284","comparison-of-hydrolink-and-hepran-membranes-in-a-per-dialytic-heparin-weaning-strategy-in-chronic-hemodialysis-patients-100448284","NCT05117450","Comparison of HYDROLINK™ and HeprAN™ mEmbranes in a Per Dialytic Heparin Weaning Strategy in Chronic Hemodialysis Patients","RESTIT","inclusion criteria :\n\n* Patients with Age \\> 18 years\n* Chronic hemodialysis for at least 3 months\n* Hemodialysis three times a week\n* On per dialytic heparin therapy (UFH or LMWH)\n* Affiliated to the French Social Security\n* Having given their consent for this study\n\nexclusion criteria :\n\n* Patients undergoing Hemodiafiltration (HDF)\n* Pregnant or lactating woman\n* Patient participating in another interventional study\n* Persons deprived of liberty by judicial or administrative decision\n* Adults under legal protection (under guardianship or curators)\n* Persons under a legal protection measure\n* Patients with a history of HIT\n* Patients with acquired or congenital coagulation disorders\n* Pathology with active neoplasia (Myeloma, Waldenström disease, solid cancers)\n* Patient on an ACE inhibitor (ACE inhibitor)\n* Patient requiring transfusion during the study period\n* Patient not hemoglobin-stabilized (mean Hb \\\u003C 10g\u002FdL or \\>12 g\u002FdL in the previous month)\n* Patient septic or with significant inflammation (defined as C-reactive protein \\> 25mg\u002FL) at the time of inclusion\n* Patient requiring per-dialytic parenteral nutrition\n* Patient requiring hospitalization or scheduled surgery during the study period\n* Vascular access (Arteriovenous Fistula or Arteriovenous graft with the possibility of 2 needles) not allowing a sufficient blood pump flow (\\\u003C 300 mL\u002Fmin determined during the screening phase = blood flow prescribed by the nephrologist)\n* Patient dialyzing on catheter (\"single line\" or \"double line\") or in unipuncture on Arteriovenous fistula on the day of the screening session\n* Net ultrafiltration on the day of the screening session \\> 4000 mL",{"count":244,"type":20},302,[66],"Chronic kidney disease (CKD) results from the progressive and irreversible destruction of the kidneys. As of December 31, 2018, there were 89,692 people in France undergoing replacement therapy, including 49,271 (55%) on dialysis and 40,421 (45%) with a functioning kidney transplant. The primary treatment modality is currently hemodialysis. It is known to activate the coagulation cascade and blood platelets, leading to thrombus formation and premature termination of the hemodialysis session. This loss of circuitry results in a decrease in session time leading to an insufficient dialysis dose and blood loss in patients who are already often anemic due to their chronic renal failure.\n\nTo avoid this complication, current recommendations recommend the use of unfractionated heparin (UFH) or low molecular weight heparin (LMWH) during the hemodialysis session at the cost of an obligatory hemorrhagic risk due to the systemic administration of heparin. However, this risk of bleeding is already very high, due to platelet dysfunction, a direct consequence of uremic toxin impregnation in these patients. In addition, this hemodialysis population is frequently exposed to antiplatelet agents and anticoagulants (heparin or VKA), which aggravate the hemorrhagic risk inherent to renal pathology.\n\nIn this context, bioactive membranes such as the HeprAN™ membrane, coated in heparin, have been developed to minimize or even eliminate the need for anticoagulation during sessions in chronic hemodialysis patients. Several studies with this membrane have demonstrated the absence of the need for additional heparin in populations with no particular bleeding risk and in populations at risk of bleeding: post-operative (HepZero study), patients on VKA.\n\nThe HYDROLINK™ membrane offers the same anticoagulant prospects as the HeprAN™ membrane, but its mode of action involves the use of a copolymer with hydrophilic properties, making it possible to avoid the presence of heparin. This membrane would have an influence on platelet aggregation. It would also make it possible to avoid the risk of heparin-induced thrombocytopenia (HIT) by completely excluding heparin from the dialysis session",[36],"2025-11-20",{"date":250,"type":44},"2025-11-21",{"date":252,"type":44},"2021-11-17",{"date":254,"type":20},"2026-12-17",{"name":256,"class":82},"CHU de Reims",{"id":258,"slug":259,"hasResults":11,"nctId":260,"briefTitle":261,"officialTitle":262,"acronym":4,"eligibilityCriteria":263,"healthyVolunteers":11,"sex":17,"minAge":91,"maxAge":4,"enrollmentInfo":264,"targetDuration":4,"studyType":64,"phases":266,"briefSummary":267,"conditions":268,"keywords":4,"overallStatus":40,"whyStopped":4,"lastUpdateSubmitDate":272,"lastUpdatePostDateStruct":273,"startDateStruct":275,"completionDateStruct":277,"leadSponsor":279,"locationsCount":83},"100457876","phase-4-extended-release-tacrolimus-following-liver-transplantation-100457876","NCT05242315","Extended-Release Tacrolimus Following Liver Transplantation","Feasibility, Efficacy And Safety Of De Novo Extended-Release Tacrolimus Following Liver Transplantation","Inclusion Criteria:\n\n\\- Adult individuals transplanted at the University of Alberta\n\nExclusion Criteria:\n\n* Individuals with congenital long QT syndrome\n* Patients with elevated bilirubin \\> 100 umol\u002FL post-LT (at day 3)\n* Patients with chronic kidney disease (eGFR \\\u003C 45 ml per minute per 1.73 m2)\n* Patients with acute kidney injury requiring discontinuation of calcineurin inhibitors.\n* Patients who have hepatocellular carcinoma, require a re-transplant, or receive multi-visceral transplant",{"count":265,"type":20},94,[194],"Medications used after transplant to prevent rejection are associated with many side effects. Tacrolimus side effects include kidney dysfunction; tremor, headaches, difficulty sleeping, change in sensation (legs), seizure, or confusion; high blood pressure; anemia, or low blood cell counts; diabetes; abnormal cholesterol and weight gain. The investigators want to use a new, approved, formulation of the standard medication (Envarsus) as they believe it may be associated with reduced side effects. The investigators would like to assess how safe it is to use this medication and how well it works in comparison to currently used formulations. The investigators will study if there are less side effects and will study clinical outcomes (including how well the liver does and if there is need for hospitalizations after transplant).\n\nThe investigators hope that this information will improve the care provided to and outcomes in patients following liver transplant.",[269,36,270,271,72],"Liver Transplant; Complications","Immunosuppressant Adverse Reaction","Metabolic Syndrome","2025-08-19",{"date":274,"type":44},"2025-08-21",{"date":276,"type":44},"2022-05-15",{"date":278,"type":20},"2034-02-15",{"name":280,"class":82},"University of Alberta",{"id":282,"slug":283,"hasResults":11,"nctId":284,"briefTitle":285,"officialTitle":286,"acronym":4,"eligibilityCriteria":287,"healthyVolunteers":121,"sex":17,"minAge":91,"maxAge":288,"enrollmentInfo":289,"targetDuration":4,"studyType":64,"phases":291,"briefSummary":292,"conditions":293,"keywords":294,"overallStatus":40,"whyStopped":4,"lastUpdateSubmitDate":296,"lastUpdatePostDateStruct":297,"startDateStruct":299,"completionDateStruct":301,"leadSponsor":303,"locationsCount":83},"100593053","phase-1-a-pharmacokinetics-and-safety-study-of-azvudine-tablets-in-subjects-with-mild-to-moderate-gfr-decline-in-renal-insufficiency-and-in-healthy-subjects-100593053","NCT07001436","A Pharmacokinetics and Safety Study of Azvudine Tablets in Subjects With Mild-To-Moderate GFR Decline in Renal Insufficiency and in Healthy Subjects","A Non-randomized, Open, Parallel, Single-dose Pharmacokinetics and Safety Study of Azvudine Tablets in Subjects With Mild-To-Moderate GFR Decline in Renal Insufficiency and in Healthy Subjects","Inclusion Criteria:\n\n(一) Renal insufficiency study participants and healthy study participants:\n\n1. Age ≥ 18 years old and ≤ 70 years old, regardless of gender;\n2. Body mass index (BMI) within the range of 18.0-30.0 (including the critical value) (BMI = weight (kg) \u002F height 2 (m2)), the weight of men should be ≥ 50.0kg, and the weight of women should be ≥ 45.0kg;\n3. Females of childbearing potential must have taken reliable and highly effective contraceptive measures and have a negative baseline blood pregnancy test at screening, and are willing to use appropriate and efficient methods of contraception after signing the informed consent form until 3 months after the last dose of the test drug; Male study participants who are willing to do so for the duration of the trial and for 3 months after the last dose of the trial drug Have no plans to have children and voluntarily use highly effective contraception, or have been surgically sterilized;\n4. Understand and sign the informed consent form.\n\n(二) Health study participants (in addition to the above criteria, they should also meet):\n\n1. The health condition is judged by the investigator to be good, and the results of vital signs, physical examination, electrocardiogram, and laboratory examination are normal or abnormal, and there is no clinical significance;\n2. Those who have not taken any prescription drugs, over-the-counter drugs, Chinese herbal medicines, or health care products within 14 days before screening;\n3. Meet the classification standard of glomerular filtration rate of 90≤GFR\\\u003C130 ml\u002Fmin;\n4. Study participants with mild or moderate decline in GFR were matched with the following demographic characteristics: age (mean ± 10 years), weight (mean ±10kg), and gender (±1 cases).\n\n(三) Renal insufficiency study participants (in addition to the above criteria, they should also meet):\n\n1. Stable renal function status: the existing renal function impairment is required to last for more than 3 months, and the GFR results of two tests (with an interval of 72 hours or more) during the screening period are within the same grade and the difference between the two tests is not more than 25%;\n2. No clinically significant abnormalities were found in the pre-test medical history, vital signs, physical examination, laboratory test items (except ALT and AST, total bilirubin, and direct bilirubin) and test-related examinations and were judged by the clinical research physician to be eligible for enrollment (except for abnormalities related to renal impairment);\n3. The drug being taken by the study participant with renal insufficiency, which should not affect the absorption, distribution, metabolism or excretion of the study drug, and has been taken at a stable dose for at least 4 consecutive weeks before giving the study drug, and agrees to continue treatment during the study period;\n4. Two weeks before administration and during the test, Chinese patent medicines, traditional Chinese medicine decoctions, ethnic medicines, SGLT-2i, MRA drugs and benzbromarone are prohibited;\n5. During the screening period, it is necessary to meet: alanine aminotransferase (ALT), aspartate aminotransferase (AST), total bilirubin (TBIL), and direct bilirubin (DBIL) all need to \\\u003C 1.5 upper limit of normal (ULN)\n6. Participants in the study of renal insufficiency of all grades met the grading criteria for glomerular filtration rate (GFR was taken as the average of the two tests during the screening period): Mild decrease in GFR: 60≤ GFR≤89 ml\u002Fmin; Moderate decrease in GFR: 30≤GFR ≤59 ml\u002Fmin.\n\nExclusion Criteria:\n\n(一) Renal insufficiency and health research participants:\n\n1. Allergies, especially those who are allergic to any of the ingredients in this product and excipients;\n2. Those who have undergone gastrointestinal resection in the past, or suffer from digestive diseases that will affect the absorption, distribution, metabolism and excretion of drugs;\n3. Those who have a history of drug abuse within 12 months before screening or those who have tested positive for addictive substances before enrollment;\n4. Those with fever or infectious diseases at the time of screening;\n5. Those who have participated in other clinical trials within 3 months before screening;\n6. Those who have a history of smoking addiction within 12 months before screening (the average number of cigarettes per day ≥5);\n7. Those who have a history of alcohol abuse within 12 months before screening (drinking ≥ 14 units of alcohol per week: 1 unit = 285mL of beer, or 25mL of spirits, or 150mL of wine) or positive alcohol breath test (test value \\>0mg\u002F100mL) before enrollment;\n8. Those who have lost blood or donated 200mL of blood ≥ within 8 weeks before screening;\n9. Hepatitis B surface antigen, hepatitis C virus antibody, human immunodeficiency virus antibody, treponema pallidum antibody or rapid plasma reagin ring card test (RPR) test results are positive.\n10. Pregnant and lactating women;\n11. Those who cannot tolerate vascular puncture blood collection and\u002For have a history of blood sickness, needle fainting and\u002For poor blood collection vascular conditions;\n12. Those who have been vaccinated within 3 months before screening, or plan to be vaccinated during the trial;\n13. Those who are not considered suitable to enter this trial by the investigator.\n\n(二) Renal insufficiency study participants (except for the above criteria):\n\n1. Have undergone kidney transplantation;\n2. Systolic blood pressure outside the range of 90 \\~ 160mmHg, diastolic blood pressure outside the range of 50 \\~ 100mmHg, or heart rate outside the range of 50 \\~ 120bpm;\n3. Frequent occurrence of hypoglycemia and exclusion of drug factors within 3 months prior to screening;\n4. Albumin\\\u003C30g\u002FL;\n5. Hemoglobin value\\\u003C9 g\u002FdL;\n6. Those who have a history of uncontrolled or unstable serious diseases of cardiovascular, liver, pulmonary, digestive tract, nerves, autoimmune, metabolic and musculoskeletal systems, hematopoietic systems and other systems, or those whose diseases are active.","70 Years",{"count":290,"type":20},40,[125],"Azvudine(FNC)，a nucleoside reverse transcriptase inhibitor, make itself a better candidate to be co-formulated in other anti-HIV therapies, thus to improve patient's compliance. FNC is a broad-spectrum RNA virus inhibitor that inhibits the novel coronavirus RNA-dependent RNA polymerase.\n\nThis trial uses a non-randomized, open-label, parallel, single-dose adaptive design aimed at investigating the effects of varying degrees of renal insufficiency on the pharmacokinetics, safety, and tolerability of a single oral dose of 3 mg Azvudine tablets in humans. On the first day of the study, a single oral dose of 3 mg ( 3 tablets ) of Azvudine tablets is taken orally on an empty stomach. Biological sample collection and safety examination will be performed in this trial.",[36],[295],"Azvudine","2025-05-23",{"date":298,"type":44},"2025-06-03",{"date":300,"type":44},"2025-05-20",{"date":302,"type":20},"2025-09-30",{"name":304,"class":51},"Henan Genuine Biotech Co., Ltd.",{"id":306,"slug":307,"hasResults":11,"nctId":308,"briefTitle":309,"officialTitle":310,"acronym":311,"eligibilityCriteria":312,"healthyVolunteers":11,"sex":17,"minAge":91,"maxAge":4,"enrollmentInfo":313,"targetDuration":4,"studyType":21,"phases":4,"briefSummary":315,"conditions":316,"keywords":318,"overallStatus":40,"whyStopped":4,"lastUpdateSubmitDate":322,"lastUpdatePostDateStruct":323,"startDateStruct":325,"completionDateStruct":327,"leadSponsor":329,"locationsCount":83},"100566796","amino-acid-loss-during-continuous-renal-replacement-therapy-100566796","NCT06659835","Amino Acid Loss During Continuous Renal Replacement Therapy","Amino Acid Effluent Loss During Continuous Renal Replacement Therapy: an Explorative Non-interventional Pilot Study","DIAMINO","Inclusion criteria:\n\n* Postoperative ICU patients\n* Age ≥ 18 years\n* Patients on enteral or\u002Fand parenteral nutrition given according to internal standard operating procedure\n\nA) CRRT group:\n\n\\- CRRT treatment planned; all types of CRRT (continuous veno-venous hemodialysis (CVVHD), continuous veno-venous hemodiafiltration (CVVHDF), continuous veno-venous hemofiltration (CVVH))\n\nB)Non-CRRT group:\n\n* no current or previous (\\\u003C30 days) continuous or intermittent RRT\n* no chronic kidney disease stage G3-G5\n\nExclusion criteria:\n\n* Preoperative intensive care patients\n* Patients with liver cirrhosis stage 1-3 according to the Child-Pugh classification\n* Patients with acute liver failure",{"count":314,"type":20},30,"The goal of this observational study is to learn about amino acid loss during continuous renal replacement therapy and plasma amino acid levels in intensive care patients. The main questions it aims to answer are:\n\nWhat amount of amino acids is lost over the duration of continuous renal replacement therapy? How do amino acid plasma concentrations change over time in patients with and without continuous renal replacement therapy?\n\nAmino acid concentrations will be measured in the effluent and in the plasma of patients receiving continuous renal replacement therapy as part of their regular medical care. In addition, plasma concentrations of amino acids will be studied in patients without renal replacement therapy.",[36,317],"Kidney Failure",[319,320,321],"amino acid","continuous renal replacement therapy","effluent loss","2025-05-21",{"date":324,"type":44},"2025-05-25",{"date":326,"type":44},"2025-02-08",{"date":328,"type":20},"2026-12",{"name":330,"class":82},"Medical University of Vienna",{"id":332,"slug":333,"hasResults":11,"nctId":334,"briefTitle":335,"officialTitle":336,"acronym":337,"eligibilityCriteria":338,"healthyVolunteers":11,"sex":339,"minAge":340,"maxAge":341,"enrollmentInfo":342,"targetDuration":4,"studyType":21,"phases":4,"briefSummary":343,"conditions":344,"keywords":350,"overallStatus":40,"whyStopped":4,"lastUpdateSubmitDate":356,"lastUpdatePostDateStruct":357,"startDateStruct":359,"completionDateStruct":361,"leadSponsor":363,"locationsCount":83},"100549884","study-of-the-quality-of-life-in-school-aged-children-with-posterior-urethral-valves-100549884","NCT06439862","Study of the Quality of Life in School Aged-children With Posterior Urethral Valves","Quality of Life in School Aged-children With Posterior Urethral Valves","QUALIVUP","Inclusion Criteria:\n\n* Male patients and their parents\u002Frelatives\n* Aged 6 to 17 years old\n* Treated for PUV in their first year of life between 2006 and 2018\n* Managed in the Femme-Mère-Enfant Hospital in Lyon\n\nExclusion Criteria:\n\n* Children with pre-existing severe cognitive and physical disability (physician's rating) from other condition\n* Children enable to complete QoL questionnaire due to mental or communication impairment","MALE","6 Years","17 Years",{"count":93,"type":20},"Posterior urethral valves (PUV) are the most common congenital obstructive lesion of the urethra, affecting from 1 per 3000 to 1 per 8000 live births. Valve ablation usually resolves the obstruction in PUV but patients still may suffer of deterioration in renal and urinary functions.\n\nRenal insufficiency is the most feared long-term complication. Up to 50 % of the patients will develop chronic kidney disease (CKD), and up to 20 % will develop end-stage renal disease (ESRD) and ultimately will require kidney transplantation. PUV is the first urological cause of ESRD. Progression towards CKD depends on febrile urinary tract infections (UTIs), severity of a vesicoureteral reflux and bladder dysfunction.\n\nBladder dysfunction is due to an overactive and small poorly compliant bladder during infancy. Detrusor overactivity usually decreases in childhood and bladder capacity increases. The most common symptom of this bladder dysfunction is urinary incontinence. 60 % of children are continent at the age of 5 years old and 90 % at 10 years old. In case of persistent bladder dysfunction, medical treatment (anticholinergics, alpha-blockers) may be introduced, or even intermittent catheterizations.\n\nCurrent scientific literature has very few studies on quality of life (QoL) in patients with PUV, mostly in adult patients and very small cohorts. Men treated for PUV in childhood had a good quality of life compared to the normative population, except for sleeping, eating and sexual activity. It seemed that the more severe the urological and nephrological functions were, the lower the QoL was. Children were only asked about intermittent urinary catheterization, and family point of view has never been collected. However, QoL and long-term evolution represent the first concerns of parents-to-be in prenatal counseling, or after diagnosis in an infant with PUV.\n\nHence, the aim of the study is to investigate the quality of life in school-aged children who had been treated for PUV in their first year of life, as measured by the Pediatric Quality of Life Inventory Version 4.0 (PedsQL 4.0).",[345,346,36,347,156,348,349],"Quality of Life","Posterior Urethral Valve","Chronic Renal Disease","Bladder Dysfunction","Urinary Incontinence",[351,352,353,354,355],"Quality of life","Posterior Urethral Valves","Children","Adolescents","Family","2025-05-05",{"date":358,"type":44},"2025-05-07",{"date":360,"type":44},"2024-08-20",{"date":362,"type":20},"2026-08",{"name":364,"class":82},"Hospices Civils de Lyon",{"id":366,"slug":367,"hasResults":11,"nctId":368,"briefTitle":369,"officialTitle":370,"acronym":4,"eligibilityCriteria":371,"healthyVolunteers":11,"sex":17,"minAge":60,"maxAge":4,"enrollmentInfo":372,"targetDuration":4,"studyType":64,"phases":374,"briefSummary":376,"conditions":377,"keywords":4,"overallStatus":104,"whyStopped":4,"lastUpdateSubmitDate":380,"lastUpdatePostDateStruct":381,"startDateStruct":383,"completionDateStruct":385,"leadSponsor":387,"locationsCount":4},"100561388","phase-2-to-evaluate-the-efficacy-and-safety-of-tenofovir-alafenamide-conversion-in-liver-transplant-patients-100561388","NCT06589518","To Evaluate the Efficacy and Safety of Tenofovir Alafenamide Conversion in Liver Transplant Patients","A Prospective, Single Center Study to Evaluate the Efficacy and Safety of Tenofovir Alafenamide Conversion in Liver Transplant Patients","Inclusion Criteria:\n\n1. Patients aged 19 years or older.\n2. Patients who have maintained stable liver graft function for one year after liver transplantation due to HBV and meet the following conditions:\n\n   ALT \\\u003C 3 x ULN and AST \\\u003C 3 x ULN\n3. Patients taking antiviral therapy other than TAF for HBV prophylaxis.\n4. Patients with a tacrolimus trough level maintained between 3-10 ng\u002FmL.\n5. Patients who have voluntarily decided to participate in the clinical trial after fully understanding the detailed explanation of the trial and have provided written consent.\n\nExclusion Criteria:\n\n1. Patients who have undergone transplantation of organs other than the liver or re-transplantation.\n2. Patients who have received BAL system treatment or auxiliary partial orthotopic liver transplantation (APOLT) before the transplantation.\n3. Patients with concurrent viral infections (HCV, HIV).\n4. Patients taking mTOR inhibitors (e.g., Everolimus (Certican), etc.).\n5. Patients with eGFR \\\u003C30 or those undergoing dialysis.\n6. Pregnant or breastfeeding women.\n7. Patients or their spouses\u002Fpartners who do not agree to use medically acceptable and appropriate contraception methods\\* during the clinical trial period.\n\n   * Appropriate contraception methods: hormonal contraception, intrauterine device (IUC or IUS), tubal ligation, tubal occlusion, hysterectomy, vasectomy, double barrier methods (combined use of male or female condoms with cervical caps, diaphragms, or contraceptive sponges), single barrier methods with spermicide.\n\n     8 . Patients with a history of hypersensitivity to Tenofovir. 9 . Patients with genetic disorders such as galactose intolerance, Lapp lactase deficiency, or glucose-galactose malabsorption.\n\n10\\. Patients who are deemed unsuitable for participation in the clinical trial by the investigator.",{"count":373,"type":20},108,[375],"PHASE2","This clinical trial aims to confirm the efficacy and safety of Vemlia® tablets (Tenofovir alafenamide) in liver transplant patients with hepatitis B, focusing on their effects on renal function.\n\nHBV reactivation post-liver transplantation can result in a post-transplant mortality rate of up to 50% within two years, making prophylaxis critical. Currently, a combination therapy of HBIG and nucleotide analogues is commonly used. Among the nucleotide analogues (NA), entecavir (ETV) and tenofovir disoproxil fumarate (TDF) are frequently used as first-line therapies. However, both ETV and TDF have nephrotoxicity, requiring caution in patients with chronic kidney disease. Specifically, 18% of liver transplant patients develop chronic kidney disease due to immunosuppressant use, making the appropriate use of antiviral drugs to preserve renal function crucial.\n\nTAF has been reported through RCTs to be more effective than TDF in preserving renal function and bone density, while showing similar antiviral effects. However, these studies have been conducted exclusively on general chronic liver disease patients. Although multicenter studies have been reported for liver transplant patients, they were retrospective and involved a limited number of patients.\n\nTherefore, the primary objective of this study is to assess the impact of converting to TAF on renal function preservation in liver transplant patients taking antivirals for HBV prophylaxis. The secondary objectives are to evaluate the antiviral effect on HBV, the impact on lipid profiles, and the effectiveness in preserving bone density.",[378,379,36],"Hepatitis B Virus","Liver Transplant","2025-02-03",{"date":382,"type":44},"2025-02-04",{"date":384,"type":20},"2025-03-01",{"date":386,"type":20},"2026-06-30",{"name":388,"class":82},"Jongman Kim",{"id":390,"slug":391,"hasResults":11,"nctId":392,"briefTitle":393,"officialTitle":394,"acronym":395,"eligibilityCriteria":396,"healthyVolunteers":11,"sex":17,"minAge":91,"maxAge":61,"enrollmentInfo":397,"targetDuration":4,"studyType":64,"phases":399,"briefSummary":400,"conditions":401,"keywords":402,"overallStatus":40,"whyStopped":4,"lastUpdateSubmitDate":408,"lastUpdatePostDateStruct":409,"startDateStruct":411,"completionDateStruct":413,"leadSponsor":415,"locationsCount":142},"100472188","tolerability-and-safety-of-cardiomems-intracardiac-continuous-cardiac-hemodynamic-monitoring-device-in-patients-with-cardio-renal-syndrome-with-severe-renal-impairment-100472188","NCT05428631","Tolerability and Safety of CARDIOMEMS™ Intracardiac Continuous Cardiac Hemodynamic Monitoring Device in Patients with Cardio Renal Syndrome with Severe Renal Impairment","Evaluation of the Tolerability and Safety of the CARDIOMEMS™ Intracardiac Continuous Cardiac Hemodynamic Monitoring Device in Patients with Cardio Renal Syndrome with Severe Renal Impairment","CARDIOMEMS","Inclusion Criteria:\n\n* Patient with class NYHA III heart failure having been hospitalized in the previous 12 months for cardiac decompensation (the current indication for the CARDIOMEMS™ system), right heart failure or biventricular heart failure with the definition of TAPSE\\\u003C15mm and\u002For SDTI\\\u003C9.5cm\u002Fs regardless of LVEF, NtproBNP\\>1500 pg\u002Fml.\n* Patient with advanced renal failure with GFR (CKD-EPI) \\\u003C 30 ml\u002Fmin\u002F1.73m2 for more than 3 months confirmed by GFR measurement (Iohexol clearance)\n* Patient with a pulmonary artery greater than 7 mm in diameter.\n* The patient has been informed of the study set-up, objectives, constraints and patient rights.\n* The patient must have given free and informed consent and signed the consent form.\n* The patient must be affiliated or a beneficiary of a health insurance plan. Precautions: if the patient is on anticoagulant therapy, an International Normalized Ratio \\\u003C1.5 is recommended before right heart catheterization and any implantation procedure\n\nExclusion Criteria:\n\n* Patients with a contraindication to the CARDIOMEMS™ HF system (pulmonary embolism with sequelae, artery less than 7 mm, active infection).\n* Patients already on renal replacement therapy.\n* Patients with a history of acute venous thrombosis.\n* Patients unable to tolerate right heart catheterization.\n* Patients with a major cardiovascular event (i.e., myocardial infarction, stroke) within 2 months of the initial examination.\n* Patients with congenital heart disease or mechanical right heart valve(s).\n* Patients with known hypersensitivity or allergy to aspirin and\u002For clopidogrel.\n* Patients with a body mass index \\>35. Measure the patient's chest circumference at the armpit: if the patient's chest circumference is \\> 165 cm, the sensor should not be implanted.\n* Patients unable to take dual anti-platelet therapy or anticoagulant therapy for one month after implantation\n* Patient hypersensitive or allergic to iohexol.\n* Patient is participating in another Class I interventional study, or has participated in another interventional study within the last 3 months.\n* Patient is in an exclusion period determined by a previous study.\n* Patient is under guardianship, conservatorship, or conservatorship.\n* The patient refuses to sign the consent form.\n* It is impossible to give the patient informed information.\n* The patient is pregnant or nursing.",{"count":398,"type":20},10,[66],"Renal failure is present in 40% of heart failure patients, and is one of the main comorbidities of heart failure. Follow-up with pulmonary artery pressure (PAP) monitoring has shown a reduction in mortality and frequency of hospitalization in patients with heart failure alone in the CHAMPION trial. Patients with New York Heart Association class III heart failure and a hospitalization in the previous 12 months were included in that study. They benefited from the \"CardioMEMS™ HF\" device with a sensor implanted in the pulmonary artery to measure PAP. According to that study, the information led to more precise and early adaptation of therapy by avoiding the onset of heart failure symptoms and reducing the number of hospitalizations. However, in that study, patients with impaired renal function (Glomerular Filtration Rate\\\u003C25 mL\u002Fmin\u002F1.73m2) were excluded, limiting the indication for treatment in those patients, and the evolution of renal function during the study was not reported.\n\nPatients with heart failure AND advanced renal failure are defined as having a cardio-renal syndrome, with strong interaction between these 2 organs. In the event of predominant right heart failure, they may require treatment by renal replacement or dialysis. There seems to be a link between high venous pressure, renal repercussions and the need for dialysis. Additional follow-up data in this clinical situation are needed to confirm this link and to suggest the interest of continuous PAP monitoring to improve the management of these patients with cardio-renal syndrome with severe renal impairment defined by a Glomerular Filtration Rate\\\u003C 30 ml\u002Fmin\u002F1.73m2 (KDIGO Cardio-renal 2019). This pilot study aims to evaluate how tolerable the \"CARDIOMEMS™ HF\" device in patients with cardio-renal syndrome and obtain the first information on the relationship between cardiac hemodynamics and renal function in this population.",[100,36],[403,404,405,406,407],"Renal insufficiency,","heart failure,","medical device","blood pressure monitoring","tolerance","2024-12-05",{"date":410,"type":44},"2024-12-10",{"date":412,"type":44},"2022-08-26",{"date":414,"type":20},"2027-08-26",{"name":416,"class":82},"Centre Hospitalier Universitaire de Nīmes",{"id":418,"slug":419,"hasResults":11,"nctId":420,"briefTitle":421,"officialTitle":422,"acronym":423,"eligibilityCriteria":424,"healthyVolunteers":121,"sex":17,"minAge":91,"maxAge":425,"enrollmentInfo":426,"targetDuration":4,"studyType":64,"phases":428,"briefSummary":429,"conditions":430,"keywords":433,"overallStatus":40,"whyStopped":4,"lastUpdateSubmitDate":437,"lastUpdatePostDateStruct":438,"startDateStruct":440,"completionDateStruct":442,"leadSponsor":444,"locationsCount":83},"100420431","renal-function-after-stentgraft-treatment-of-abdominal-aortic-aneurysm-100420431","NCT04754659","Renal Function After Stentgraft Treatment Of Abdominal Aortic Aneurysm","Renal Function After Stentgraft Treatment Of Abdominal Aneurysm With Supra- Versus Infrarenal Fixation - a Randomized Clinical Study","RENOFIX","Inclusion Criteria:\n\n* Willing and able to provide written informed consent\n* Meet criteria for non-ruptured infrarenal\u002Filiac aneurysm\n* Suitable anatomy for treatment with an approved device (CE-marked) stentgraft according to the manufacturers' instructions for use for AAA.\n* Accepted for treatment with endovascular aortic repair (EVAR) by the participating vascular center.\n\nExclusion Criteria:\n\n* Ongoing or planned dialysis\n* AAA treatment requiring stents or stentgrafts in renal and\u002For visceral arteries\n* Inability to independently complete HRQoL questionnaires due to language barriers\n* Anatomical preconditions that do not allow both types of fixation to be used interchangeably, i.e. very advanced suprarenal tortuosity (\\>60 degrees), advanced suprarenal dilatation or infrarenal thrombus \\>25% of circumference.","90 Years",{"count":427,"type":20},252,[66],"This randomized controlled trial aim to determine the impact on renal function after treatment for infrarenal abdominal aortic aneurysm (AAA) with stentgrafts either with active supra- or infrarenal fixation.",[431,36,432],"Aortic Aneurysm, Abdominal","Stent-Graft Thrombosis",[434,435,436],"abdominal aortic aneurysm","postoperative renal failure","stentgraft complication","2024-05-05",{"date":439,"type":44},"2024-05-07",{"date":441,"type":44},"2022-12-19",{"date":443,"type":20},"2027-12",{"name":445,"class":446},"Vastra Gotaland Region","OTHER_GOV",{"id":448,"slug":449,"hasResults":11,"nctId":450,"briefTitle":451,"officialTitle":452,"acronym":4,"eligibilityCriteria":453,"healthyVolunteers":11,"sex":17,"minAge":91,"maxAge":4,"enrollmentInfo":454,"targetDuration":4,"studyType":64,"phases":456,"briefSummary":457,"conditions":458,"keywords":4,"overallStatus":40,"whyStopped":4,"lastUpdateSubmitDate":461,"lastUpdatePostDateStruct":462,"startDateStruct":464,"completionDateStruct":466,"leadSponsor":468,"locationsCount":83},"100543312","phase-2-dv-combined-with-toripalimab-for-renal-preservation-in-solitary-kidney-or-renal-insufficiency-or-bilateral-multiple-utuc-100543312","NCT06354231","DV Combined With Toripalimab for Renal Preservation in Solitary Kidney or Renal Insufficiency or Bilateral Multiple UTUC","A Prospective, Open-label, Single-arm, Clinical Study of Disitamab Vedotin Combined With Toripalimab for Renal Preservation in Solitary Kidney or Renal Insufficiency or Bilateral Multiple Upper Urinary Tract Urothelial Carcinoma","Inclusion Criteria:\n\n* ≥18 years old;\n* Histologically confirmed isolated renal or renal insufficiency or bilateral upper urinary tract urothelial carcinoma;\n* Refusal or ineligibility for RNU;\n* Preoperative risk stratification was defined as high-risk UTUC, defined as patients with any of the following factors:\n\n  1. Hydronephrosis;\n  2. Tumor diameter ≥2cm;\n  3. Urine cytology suggests a high-grade tumor;\n  4. A ureteroscopic biopsy suggests a high-grade tumor;\n  5. CT showed a localized invasion;\n  6. Multifoci diseases;\n  7. With multiple histological subtypes;\n* ECOG 0\\~1;\n* Major organ function is normal (14 days prior to enrollment) if the following criteria are met:\n\n  1. The blood routine examination criteria should meet (no blood transfusion and no granulocyte colony stimulation agent treatment within 14 days before enrollment): HB≥90 g\u002FL; ANC≥1.5×109 \u002FL; PLT≥100×109 \u002FL;\n  2. Non-functional organic diseases shall meet the following criteria: T-BIL≤1.5×ULN (upper limit of normal value); ALT and AST≤2.5 x ULN; Serum creatinine ≤2×ULN, or endogenous creatinine clearance ≥ 30ml\u002Fmin(Cockcroft-Gault formula);\n* Subjects (or their legal representatives) must sign an informed consent form (ICF) indicating that they understand the purpose and procedures of the study and are willing to participate in the study.\n* Pregnant women must have a negative pregnancy test result (beta-hCG) (urine or serum) within 7 days before the first administration of the randomized or study drug.\n\nExclusion Criteria:\n\n* Histopathological examination revealed any small cell component of ureter or pelvis, simple adenocarcinoma, simple squamous cell carcinoma, or simple squamous CIS;\n* Previous treatment with other PD-1\u002FPD-L1 inhibitors and\u002For HER-2 inhibitors;\n* Active malignancies other than the disease being studied for treatment (i.e., disease progression within the last 24 months or requiring a change in treatment), only the following special cases are allowed: i. Skin cancer that has been treated within the last 24 months and has been completely cured ii. Adequately treated lobular carcinoma in situ (LCIS) and ductus CIS iii. History of local breast cancer and is receiving antihormonal drugs or history of local prostate cancer (N0M0) and is receiving androgen blocking therapy;\n* History of uncontrolled cardiovascular disease, including: 1) any of the following in the past 3 months: unstable angina pectoris, myocardial infarction, ventricular fibrillation, torsion ventricular tachycardia, cardiac arrest, or known congestive New York Heart Association Class III-IV heart failure, cerebrovascular accident, or transient ischemic attack; 2) QTc interval prolongation confirmed by ECG evaluation at screening (Fridericia; QTc \\> 480 ms); 3) Pulmonary embolism or other venous thromboembolism within the past 2 months;\n* Pregnant or lactating women;\n* Human immunodeficiency virus (HIV) infection is known unless the subject has been on stable antiretroviral therapy for the past 6 months or longer, has not developed an opportunistic infection in the past 6 months, and has a CD4 count \\> 350 in the past 6 months.\n* Known history of clinically significant liver disease, including viral hepatitis \\[active HBV infection, i.e., HBV DNA positive (\\>1×104 copies \u002FmL or \\>2000 IU\u002Fml) must be excluded for known hepatitis B virus (HBV) carriers; Known hepatitis C virus infection (HCV) and HCV RNA positive (\\>1×103 copies \u002FmL), or other hepatitis, cirrhosis\\];\n* Have not recovered from the toxic effects of previous anticancer treatment (except for those that are not clinically significant, such as hair loss, skin discoloration, neuropathy, and hearing impairment);\n* Delayed wound healing, defined as skin\u002Fbedsore ulcers, chronic leg ulcers, known stomach ulcers, or non-healing of incisions;\n* Major surgery within 4 weeks before day 1 of Cycle 1 (TURBT is not considered a major surgery);\n* Other patients assessed by the investigator as unsuitable for participation in the study.",{"count":455,"type":20},20,[375],"Approximately 20 participants will be enrolled in the study to evaluate the efficacy and safety of the combination of DV (DV, 2.0 mg\u002Fkg, intravenously administered every 2 weeks) and toripalimab (toripalimab, 3.0mg\u002Fkg, intravenously administered every 2 weeks). Subjects will receive 6 cycles of DV and toripalimab, followed by laser surgery to remove ureteral or renal pelvis tumors, followed by 12 cycles of DV and 1 year of toripalimab consolidation therapy. Efficacy and safety were evaluated by cystoscopy, ureteroscopy, laboratory tests, and imaging examinations after treatment.",[36,459,460],"Upper Urinary Tract Urothelial Carcinoma","Solitary Kidney","2024-04-09",{"date":463,"type":44},"2024-04-11",{"date":465,"type":44},"2023-07-20",{"date":467,"type":20},"2026-12-30",{"name":469,"class":82},"Fudan University",{"id":471,"slug":472,"hasResults":11,"nctId":473,"briefTitle":474,"officialTitle":475,"acronym":4,"eligibilityCriteria":476,"healthyVolunteers":121,"sex":17,"minAge":91,"maxAge":4,"enrollmentInfo":477,"targetDuration":4,"studyType":64,"phases":479,"briefSummary":480,"conditions":481,"keywords":497,"overallStatus":104,"whyStopped":4,"lastUpdateSubmitDate":506,"lastUpdatePostDateStruct":507,"startDateStruct":509,"completionDateStruct":511,"leadSponsor":513,"locationsCount":4},"100354774","phase-1-safety-and-clinical-outcomes-with-amniotic-and-umbilical-cord-tissue-therapy-for-numerous-medical-conditions-100354774","NCT03899298","Safety and Clinical Outcomes With Amniotic and Umbilical Cord Tissue Therapy for Numerous Medical Conditions","Safety and Clinical Outcomes Study: Amniotic and Umbilical Cord Tissue Administration for Orthopedic, Neurologic, Urologic, Autoimmune, Renal, Cardiac and Pulmonary Conditions","Inclusion Criteria:\n\n1. Age 18 and over.\n2. Ability to attend follow up visits or at least converse on phone or complete email follow up forms.\n3. Competent to understand the study protocol and provide voluntary informed consent.\n4. Patients with any of the following conditions: Arthritis (Degenerative, Rheumatoid, Psoriatic, Lupus, Gout), Sports or Overuse Injuries (e.g. Rotator Cuff injury, Tennis Elbow), Chronic Kidney Disease (may be on dialysis), Back\u002FNeck Pain, Erectile Dysfunction, Peyronie's Disease, Alzheimer's Disease, Parkinson's Disease, Neuropathy, Post-Stroke, Post-Concussion Syndrome, COPD, Emphysema, Pulmonary Fibrosis, Post myocardial infarction (at least 6 months out), Cardiomyopathy, Congestive Heart Failure.\n\nExclusion Criteria:\n\n1. Active Cancer\n2. Pregnancy, Lactating\n3. Severe Clotting disorder\n4. Myocardial Infarction less than six months ago.",{"count":478,"type":20},5000,[125],"To determine the safety and efficacy of Amniotic and Umbilical Cord Tissue for the treatment of the following condition categories: Orthopedic, Neurologic, Urologic, Autoimmune, Renal, Cardiac and Pulmonary Conditions. The hypotheses are that the treatments are not only extremely safe, but also statistically beneficial for all conditions. Outcomes will be determined by numerous valid outcome instruments that compile general quality of life information along with condition-specific information as well.",[482,483,484,485,486,161,36,487,488,489,490,491,492,493,494,495,496],"Orthopedic Disorder","Neurologic Disorder","Urologic Diseases","Erectile Dysfunction","Autoimmune Diseases","Kidney Diseases","Cardiac Event","Cardiomyopathies","CHF","Pulmonary Disease","COPD","Alzheimer Disease","Stroke","Neuropathy;Peripheral","Arthritis",[498,499,500,501,502,503,504,505],"stem cell therapy","umbilical stem cells","amniotic stem cells","stem cells","regenerative medicine","r3 stem cell","perinatal tissue","placenta stem cell","2019-08-20",{"date":508,"type":44},"2019-08-22",{"date":510,"type":20},"2019-09-01",{"date":512,"type":20},"2029-03-20",{"name":514,"class":51},"R3 Stem Cell"]