[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"chronic-kidney-disease-stage-3-and-4\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:chronic-kidney-disease-stage-3-and-4":28},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,3,0,[8,43,74],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":15,"eligibilityCriteria":16,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":19,"targetDuration":4,"studyType":22,"phases":23,"briefSummary":25,"conditions":26,"keywords":4,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":31,"lastUpdatePostDateStruct":32,"startDateStruct":35,"completionDateStruct":37,"leadSponsor":39,"locationsCount":42},"100582051","phase-3-patiromer-and-diethrqol-in-chronic-dialysis-100582051",false,"NCT06858280","Patiromer and Diet\u002FhrQoL in Chronic Dialysis","Impact of Patiromer Treatment on Dietary Potassium Intake Restriction and Health-related Quality of Life and Nutrition in Patients on Chronic Dialysis Therapy: a Double-Blind, Prospective, Randomized, Placebo-Controlled, Pilot Trial","PRINCE","Inclusion Criteria (to be eligible to participate in this trial, an individual must meet all the following criteria):\n\n* More than 18-year-old\n* Chronic and stable dialysis therapy with three weekly dialysis sessions for at least three months because of ESKD\n* Pre-dialysis (in the long interdialytic period) serum potassium 4 to 5.5 mEq\u002FL confirmed in two consecutive weeks, without any clinical signs or symptoms of hyperkalemia\n* Stable therapy (since at least 3 months) with RAS inhibitors or MRAs. No treatment with potassium sparing diuretics\n* On standardized and stable (moderately or strictly restricted) low-potassium diet\n* Compliance with recommended diet\n* Written informed consent\n\nExclusion Criteria (an individual who meets any of the following criteria will be excluded from participation in this trial):\n\n* Hyperkalemia (pre-dialysis potassium \\>5.5 mEq\u002FL during the long interdialytic period)\n* Hypomagnesemia (serum magnesium \\\u003C1.7 mg\u002FdL)\n* Hypercalcemia (serum calcium \\>10.5mg\u002Fdl)\n* Ongoing treatment with potassium binding medications including Sodium polystyrene sulfonate (SPS, Kayexalate®, Sanofi-Aventis S.p.A) or Sodium zirconium cyclosilate (Lokelma®, Astra Zeneca S.p.A.)\n* Ongoing treatment with potassium-sparing diuretics\n* Pre-dialysis potassium \\\u003C4.0 mEq\u002FL during the long interdialytic period\n* One or two weekly dialysis session\n* Poor compliance to prescribed potassium-restricted diet\n* History of bowel obstruction or major gastrointestinal surgery, severe gastrointestinal disorders, or swallowing disorders\n* Previous history of cardiac arrhythmias potentially related to hypokalemia\n* Known hypersensitivity to the active ingredient or any of the excipients of the study drug\n* Inability to fully understand the potential risks and benefits related to study participation\n* Concomitance of clinical conditions that could jeopardize the completion of the treatment period and\u002For confound data interpretation including:\n* Cancer (except non-metastatic cutaneous cancers)\n* Active systemic autoimmune diseases\n* Concomitant treatment with steroids or any other immunosuppressive agent\n* Severe\u002Funstable heart failure requiring hospitalization or changes in pharmacological therapy or supplementary dialysis sessions over the last three months\n* Refractory severe hypertension (BP \\>180\u002F100 mmHg despite optimized pharmacological treatment with at least three blood pressure-lowering medications)\n* Known to be positive for human immunodeficiency virus\n* Drug or alcohol abuse\n* Pregnancy, lactation, or intention to become pregnant before or during the study period, or within 90 days of the last dose of study treatment\n* Intention to donate ova or sperm over the same period\n* Childbearing potential without highly effective contraception methods according to the 2020 CTFG Recommendations related to contraception and pregnancy testing in clinical trials (https:\u002F\u002Fwww.hma.eu\u002Ffileadmin\u002Fdateien\u002FHuman\\_Medicines\u002F01About\\_HMA\u002FWorking\\_Groups\u002FCTFG\u002F2020\\_09\\_HMA\\_CTFG\\_Contraception\\_guidance\\_Version\\_1.1\\_updated.pdf)\n* Involvement in the study planning and\u002For conduct\n* Participation in another clinical study with an investigational product during the last month","ALL","18 Years",{"count":20,"type":21},40,"ESTIMATED","INTERVENTIONAL",[24],"PHASE3","This is a phase III, prospective, randomized, double-blind, placebo-controlled, single-center, pilot trial, aimed at assessing whether treatment with the oral potassium binder patiromer as compared to placebo allows withdrawal or down-titration of potassium dietary restriction without increasing the risk of hyperkalemia in chronic dialysis patients.",[27,28,29],"Hyperkalaemia","Chronic Kidney Disease Stage 3 and 4","Dietary Intervention","RECRUITING","2025-08-27",{"date":33,"type":34},"2025-09-04","ACTUAL",{"date":36,"type":34},"2025-07-08",{"date":38,"type":21},"2026-07",{"name":40,"class":41},"Mario Negri Institute for Pharmacological Research","OTHER",1,{"id":44,"slug":45,"hasResults":11,"nctId":46,"briefTitle":47,"officialTitle":48,"acronym":49,"eligibilityCriteria":50,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":51,"enrollmentInfo":52,"targetDuration":4,"studyType":22,"phases":54,"briefSummary":56,"conditions":57,"keywords":59,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":65,"lastUpdatePostDateStruct":66,"startDateStruct":68,"completionDateStruct":70,"leadSponsor":72,"locationsCount":5},"100563830","exercise-activity-to-improve-mobility-in-patients-with-ckd-and-pad-100563830","NCT06621264","Exercise Activity to Improve Mobility in Patients With CKD and PAD","EXercise ACTivity to Improve Mobility, Active Behavior and Quality of Life of Chronic Kidney Disease Patients With Peripheral Artery Disease: the EXACTckd-pad Multicenter Randomized Controlled Trial","EXACT-CKDPAD","Inclusion Criteria:\n\n* chronic kidney disease at KDOQI stages III or IV and concomitant Peripheral artery disease at stages I, II, III;\n* ability to walk independently;\n* cognitive function to give informed consent identified by a Mini Mental Status Examination score greater or equal to 20\u002F30\n* absence of clinical conditions contraindicating exercise therapy (e.g., unstable angina, severe heart failure at NYHA class IV, anemia with lower than 10.0 g\u002Fdl).\n\nExclusion Criteria:\n\n* major amputations;\n* major surgery planned in the next 3 months;\n* known comorbid conditions that may limit survival to less than 2 years;\n* inability or unwillingness to comply with protocol requirements.","80 Years",{"count":53,"type":21},124,[55],"NA","People affected by chronic kidney disease and concomitant diagnosed peripheral artery disease at intermediate stages, without contraindications to exercise therapy will be invited to participate in the study.\n\nWhose providing informed consent, will be randomly assigned to one of two groups:\n\n1. Exercise program receiving two daily 10-minute interval walking sessions at a slow increasing speed.\n2. Control group: receiving usual care including optimal medical therapy and nutritional advice.\n\nPatients of both groups will be measured at baseline, after the end of the exercise program (6-month) and at follow up (12-month). Outcome measures will include walking ability by the 6-minute walking test (primary outcome) and lower limbs perfusion, body composition, quality of life, laboratory outcomes and long-term hospitalizations.",[28,58],"Peripheral Artery Disease (PAD)",[60,61,62,63,64],"Exercise therapy;","Mobility","Ageing","Chronic Kidney Disease","Peripheral artery disease","2025-05-30",{"date":67,"type":34},"2025-05-31",{"date":69,"type":34},"2024-10-01",{"date":71,"type":21},"2026-12-31",{"name":73,"class":41},"University Hospital of Ferrara",{"id":75,"slug":76,"hasResults":11,"nctId":77,"briefTitle":78,"officialTitle":79,"acronym":80,"eligibilityCriteria":81,"healthyVolunteers":11,"sex":17,"minAge":82,"maxAge":51,"enrollmentInfo":83,"targetDuration":4,"studyType":85,"phases":4,"briefSummary":86,"conditions":87,"keywords":4,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":89,"lastUpdatePostDateStruct":90,"startDateStruct":92,"completionDateStruct":94,"leadSponsor":96,"locationsCount":42},"100587801","prediction-of-peripheral-neuropathy-with-functional-testing-100587801","NCT06933108","Prediction of Peripheral Neuropathy With Functional Testing","Estimate the Risk of Diabetic and Uremic Peripheral Neuropathy Using Physical and Functional Testing","PredictNP","Inclusion Criteria:\n\n* CKD stage 4-5 and \u002F or diabetes (Type I or II)\n* Able to walk 20 m\n* BMI \\\u003C 35\n\nExclusion Criteria:\n\n* Currently or planning dialysis\n* Musculoskeletal, osteorarticular and neurological disease(s)\n* Cognitive impairment\n* Low-limb amputation","60 Years",{"count":84,"type":21},70,"OBSERVATIONAL","Diabetes and chronic kidney disease (CKD) are two distinct pathologies. The former is defined as an impairment in insulin production and\u002For utilization, while the latter refers to structural or functional abnormalities of the kidneys. However, these two diseases share a common complication: peripheral neuropathy. This condition affects between 50% and 60% of patients with diabetes or CKD.\n\nPeripheral neuropathy involves the destruction of sensory and motor neurons, leading to a wide range of painful symptoms while also reducing force production capacity. Among the diagnostic tests used, the most accessible clinical tests suffer from high variability due to human subjectivity (e.g., the tuning fork test, which requires examiner expertise and verbal patient feedback), whereas laboratory electrophysiological tests can only detect the largest neurons, which are affected at later stages. Although composite clinical tests have been developed to improve neuropathy screening performance, they still inherit the limitations of their individual components. In other words, they remain subject to variability related to the examiner's experience and the patient's ability to understand instructions, while also being performed through various procedures that lack a standardized consensus. Moreover, these composite scores are particularly time-consuming and are therefore rarely used in clinical practice. As a result, no method currently allows for large-scale, early, and reliable screening of peripheral neuropathy.\n\nOur recent work and emerging studies suggest that assessing functional capacities could serve as an objective and early marker of neuropathic impairment, even before clinical diagnosis. Specifically, the quantification of postural balance performance using stabilometric methods (i.e., center of pressure displacement area) and unipedal balance time could predict the presence of diabetes-related peripheral neuropathy with over 95% accuracy compared to diagnosis with a composite clinical method (unpublished results).\n\nTherefore, the aim of this study is to evaluate physical and balance capacities assessed during routine care in adapted physical activity settings, in order to determine whether the development of a composite score could help estimate the risk of peripheral neuropathy in individuals with diabetes and CKD.",[28,88],"Diabetes","2025-04-10",{"date":91,"type":34},"2025-04-18",{"date":93,"type":34},"2025-01-27",{"date":95,"type":21},"2025-05-02",{"name":97,"class":41},"Université catholique de l'Ouest"]