[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"chronic-renal-disease\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:chronic-renal-disease":28},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,3,0,[8,43,82],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":13,"acronym":4,"eligibilityCriteria":14,"healthyVolunteers":11,"sex":15,"minAge":16,"maxAge":17,"enrollmentInfo":18,"targetDuration":4,"studyType":21,"phases":22,"briefSummary":24,"conditions":25,"keywords":4,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":31,"lastUpdatePostDateStruct":32,"startDateStruct":35,"completionDateStruct":37,"leadSponsor":39,"locationsCount":42},"100414067","a-study-to-evaluate-the-safety-and-effectiveness-of-the-innavasc-arteriovenous-graft-for-hemodialysis-access-in-patients-with-end-stage-renal-disease-100414067",false,"NCT04671771","A Study to Evaluate the Safety and Effectiveness of the InnAVasc Arteriovenous Graft for Hemodialysis Access in Patients With End-Stage Renal Disease","Inclusion Criteria:\n\nPre-Operative Inclusion Criteria:\n\nPatients must meet the following criteria at screening in order to be scheduled for a procedure and potentially enrolled in the study:\n\n1. Patients with ESRD whose next most appropriate option for AV access is placement of an AV graft to start or maintain hemodialysis therapy;\n2. Age 18 to 90 years old, inclusive;\n3. Suitable anatomy for implantation of upper arm \"straight\" or looped graft, or forearm looped graft (graft not to cross the bend of the elbow);\n4. Ability to continue or commence antiplatelet therapy post graft implant (anticoagulation medication is acceptable if the subject is required to take an anticoagulant for a baseline medical condition);\n5. Able and willing to give informed consent;\n6. Anticipated life expectancy of at least 1 year.\n\nIntra-Operative Inclusion Criteria:\n\nBoth vessels have been exposed and are deemed appropriate for implantation (i.e., based on the surgeon's opinion, artery is of adequate size, has adequate pulse to support AV access flow, is without significant calcification, and is safely clampable; and the vein is of adequate size, free of localized sclerosis, and is free of immediate outflow obstruction).\n\nPre-Operative Exclusion Criteria:\n\nPatients will be excluded from the study at screening if they exhibit any of the following exclusion criteria:\n\n1. History or evidence of severe cardiac disease (i.e., debilitating heart failure, or high risk of MI) in the opinion of the investigator which may preclude participation in and completion of the study;\n2. Uncontrolled diabetes in the opinion of the investigator (i.e., multiple recent diabetes related hospitalizations);\n3. For upper arm straight configuration, an antecubital fossa crease to axillary crease distance \\\u003C 18 cm;\n4. History or evidence of severe peripheral arterial disease in the extremity selected for implant (i.e., arterial inflow insufficient to support hemodialysis access);\n5. Known or suspected central vein stenosis or obstruction on the side of planned graft implantation;\n6. Baseline hypotension or history of frequent hypotensive episodes during dialysis that, in the opinion of the investigator, puts the patient at increased risk of graft thrombosis;\n7. Uncontrolled hypertension, per the opinion of the investigator (i.e., recent history of recurrent hospitalizations for hypertensive related illness);\n8. Baseline hemoglobin \\\u003C7 g\u002FdL;\n9. Baseline platelet count \\\u003C50,000 or \\>500,000 cells\u002Fmm3;\n10. Documented history of stroke within 6 months prior to enrollment;\n11. Treatment with any investigational drug or device within 30 days prior to enrollment;\n12. Female patients who are pregnant, intending to become pregnant, nursing or intending to breastfeed during the study (pregnancy test may only be omitted, if patient is post-menopausal or has a documented history of hysterectomy or permanent sterilization);\n13. History of cancer with active disease or treatment within the previous year, except for non-invasive basal or squamous cell carcinoma of the skin;\n14. Immunodeficiency including documented history of human immunodeficiency virus (HIV) or acquired immunodeficiency syndrome (AIDS) or patients receiving immunosuppressive therapy for treatment of an acute inflammatory event or autoimmune flare. Chronic immunosuppressive therapy is acceptable;\n15. Documented or suspected hypercoagulable condition;\n16. Bleeding diathesis, other than that associated with ESRD;\n17. Documented history of heparin-induced thrombocytopenia (HIT);\n18. Active local or systemic infection as documented from the medical history or bloodwork\u002Fblood culture data. If the infection resolves, the subject must be at least one-week post resolution of that infection before implantation;\n19. Scheduled renal transplant within 6 months;\n20. Any other condition which in the judgment of the investigator would preclude adequate evaluation of the safety and effectiveness of the IG;\n21. Patient is unable or unwilling to complete all required follow-up assessments and questionnaires.","ALL","18 Years","90 Years",{"count":19,"type":20},133,"ESTIMATED","INTERVENTIONAL",[23],"NA","The goal of the CSP-2002 clinical trial is to evaluate the safety and effectiveness of the InnAVasc Arteriovenous Graft (IG) for hemodialysis (HD) access in patients with end-stage renal disease (ESRD). The primary study endpoints are:\n\nPrimary Effectiveness Endpoint: The proportion of subjects with secondary patency at 6 months.\n\nPrimary Safety Endpoint: The incidence of device-related adverse events of special interest (AESIs) through 6 months.\n\nParticipants will be asked to sign an informed consent form. Once enrolled, they will be assessed to receive the study graft implant and asked to participate in periodic follow-up visits and assessments through 2 years following implant.",[26,27,28,29],"End Stage Renal Disease (ESRD)","Kidney Failure","Chronic Renal Disease","Hemodialysis","RECRUITING","2025-12-18",{"date":33,"type":34},"2025-12-22","ACTUAL",{"date":36,"type":34},"2020-12-03",{"date":38,"type":20},"2029-07-01",{"name":40,"class":41},"W.L.Gore & Associates","INDUSTRY",21,{"id":44,"slug":45,"hasResults":11,"nctId":46,"briefTitle":47,"officialTitle":48,"acronym":49,"eligibilityCriteria":50,"healthyVolunteers":11,"sex":51,"minAge":52,"maxAge":53,"enrollmentInfo":54,"targetDuration":4,"studyType":56,"phases":4,"briefSummary":57,"conditions":58,"keywords":65,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":71,"lastUpdatePostDateStruct":72,"startDateStruct":74,"completionDateStruct":76,"leadSponsor":78,"locationsCount":81},"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":55,"type":20},300,"OBSERVATIONAL","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).",[59,60,61,28,62,63,64],"Quality of Life","Posterior Urethral Valve","Renal Insufficiency","End Stage Renal Disease","Bladder Dysfunction","Urinary Incontinence",[66,67,68,69,70],"Quality of life","Posterior Urethral Valves","Children","Adolescents","Family","2025-05-05",{"date":73,"type":34},"2025-05-07",{"date":75,"type":34},"2024-08-20",{"date":77,"type":20},"2026-08",{"name":79,"class":80},"Hospices Civils de Lyon","OTHER",1,{"id":83,"slug":84,"hasResults":11,"nctId":85,"briefTitle":86,"officialTitle":87,"acronym":88,"eligibilityCriteria":89,"healthyVolunteers":11,"sex":15,"minAge":16,"maxAge":4,"enrollmentInfo":90,"targetDuration":4,"studyType":56,"phases":4,"briefSummary":92,"conditions":93,"keywords":4,"overallStatus":94,"whyStopped":4,"lastUpdateSubmitDate":95,"lastUpdatePostDateStruct":96,"startDateStruct":97,"completionDateStruct":99,"leadSponsor":101,"locationsCount":81},"100589931","real-word-study-of-the-de-novo-extended-release-tacrolimus-in-kidney-transplantation-using-an-artificial-intelligence-100589931","NCT06960824","Real-word Study of the de NOVO Extended-release tacrolimuS in Kidney Transplantation Using an ARTificial Intelligence","Real-word Study of the de NOVO Use of Once-daily Extended-release tacrolimuS (LCPT) in Kidney Transplantation Using an ARTificial Intelligence Prognostic System: a Multicenter Prospective Ob-servational Study","NOVOSTART","Inclusion Criteria:\n\n* Kidney recipients aged 18 years and older.\n* Kidney recipients were transplanted from living or deceased donors\n* Patients receiving Envarsus® \\[Life-Cycle Pharma Tacrolimus\\] within 24 hours of kidney transplantation in a once-daily formulation at the discretion of the investiga-tor and in compliance with the summary of product characteristics.\n* Patients are willing to participate in the study and do not oppose the use of their data.\n* Patients are either affiliated with or beneficiaries of a social security scheme.\n\nExclusion Criteria:\n\n* Contraindications to the use of Life-Cycle Pharma Tacrolimus (Envarsus®).\n* Pre-transplant desensitization.\n* ABO is incompatible with a living donor.\n* Combined transplant (e.g. kidney-heart transplant, kidney-liver transplant).\n* Previous bariatric (or bypass) surgery.\n* Gastrointestinal problems are likely to affect the absorption of the Life-Cycle Pharma Tacrolimus (Envarsus®).\n* Diagnosis of Parkinson's disease or any other neurological syndrome causing tremor.\n* Patients who are part of another clinical trial or in a period of exclusion from another clinical trial with a molecule under study.\n* Pregnant women or breastfeeding.\n* Patients under legal protection (guardianship, curatorship) or deprived of their liberty through judicial or administrative decisions.\n* Patients under State Medical Assistance.",{"count":91,"type":20},165,"The purpose of this study is to assess the clinical efficacy of the LCPT En-varsus \\[Life-Cycle Pharma Tacrolimus\\] initiated in de novo (Day 0 of transplantation) using the Biopsy Proven Acute Re-jection and iBox (full and abbreviated algo-rithms).",[28],"NOT_YET_RECRUITING","2025-04-29",{"date":73,"type":34},{"date":98,"type":20},"2025-05",{"date":100,"type":20},"2027-12-31",{"name":102,"class":41},"Chiesi SAS"]