[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"chronic-kidney-disease-stage-4\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:chronic-kidney-disease-stage-4":66},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,9,0,[8,46,88,120,142,163,199,226,253],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":4,"eligibilityCriteria":15,"healthyVolunteers":16,"sex":17,"minAge":18,"maxAge":19,"enrollmentInfo":20,"targetDuration":4,"studyType":23,"phases":24,"briefSummary":26,"conditions":27,"keywords":4,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":34,"lastUpdatePostDateStruct":35,"startDateStruct":38,"completionDateStruct":40,"leadSponsor":42,"locationsCount":45},"100573038","phase-1-bzlf1-peptide-vaccine-osu-2131-with-qs-21-for-the-prevention-of-epstein-barr-virus-related-cancer-in-patients-awaiting-solid-organ-transplants-100573038",false,"NCT06741072","BZLF1 Peptide Vaccine (OSU-2131) With QS-21 for the Prevention of Epstein-Barr Virus Related Cancer in Patients Awaiting Solid Organ Transplants","A Phase 1B Double Blinded Randomized Trial Evaluating Safety, Tolerability, and Immune Response of OSU-2131 a BZLF1 Peptide Vaccine With Stimulon™ QS-21 Solution Adjuvant in Healthy Volunteers and Patients Awaiting Solid Organ Transplantation","Inclusion Criteria:\n\n* Healthy volunteers and patients awaiting solid organ transplantation (SOT) must have at least one allele for HLA-B\\*08:01\n* Subjects can be Epstein-Barr virus (EBV) seronegative or seropositive\n* Subjects must be seronegative for HIV\n* Subjects must be seronegative for hepatitis B and C\n* Have baseline chemistry and hematology (hemoglobin, white blood cells, absolute neutrophil count, eosinophils) within normal limits\n* Prothrombin time (PT) and partial thromboplastin time (PTT) below the upper limit of normal\n* Platelets above the lower limit of normal (LLN)\n* Basophils, lymphocytes, and monocytes must be within 1.2 x upper limit of normal (ULN) or 0.8 x LLN and considered not clinically significant by the investigator\n* Total creatine kinase (CK) laboratory values \\\u003C 1.25 x the upper limit of normal (according to the normal reference ranges of the Ohio State University \\[OSU\\] laboratory) at baseline (screening \\& pre-study visit) and considered not clinically significant by the investigator\n* Subjects must not be taking antiviral therapy\n* Must be ≥ 18 years of age and ≤ 65 years of age and willing to either use an effective method of contraception or abstain from sexual activity for at least 3 months following the last dose of vaccination\n* Female of childbearing potential must have a negative serum pregnancy test prior to the first study drug\u002Fplacebo (PBS) administration\n* Agree not to receive any other investigational drug while enrolled in this study\n* Provide written informed consent according to International Conference on Harmonization-Good Clinical Practice (ICH-GCP) and local regulations\n* Following successful completion of safety evaluation for the phase 1 dose escalation phase of this trial in healthy volunteers and review of this data by the Sponsor and Food and Drug Administration (FDA), we plan to enroll a second cohort of patients awaiting solid organ transplantation (SOT). We will recruit patients with end stage renal disease (ESRD) who are awaiting kidney transplantation. ESRD is defined according to 2012 Kidney Disease: Improving Global Outcomes (KDIGO) Clinical Practice Guidelines for the Evaluation and Management of Chronic Kidney Disease (Acosta-Ochoa et al, J Clin Med, 8(9):1323, 2019). KDIGO defines ESRD as: stage 4: severe reduction in glomerular filtration rate (GFR) (15 to 29 mL\u002Fmin); stage 5: renal failure (GFR less than 15 mL\u002Fmin). Patients will qualify for ESRD \u002F kidney transplantation per need for maintenance dialysis due to one or more of the criteria related to renal insufficiency: volume overload, metabolic acidosis, electrolyte disturbance, drug toxicity, etc. Patients will be regularly undergoing hemodialysis or peritoneal dialysis for metabolic support. Patients will be excluded from the study if they have any unstable medical conditions which the investigator believes would preclude participation in the study. These conditions include but are not limited to cardiorenal and hepatorenal syndromes\n\nExclusion Criteria:\n\n* Severe active infection, compromised cardiopulmonary function, or other serious medical illness that, in the opinion of the principal investigator, would prevent study completion\n* History of chronic active EBV infection, active infectious mononucleosis (or infectious mononucleosis within 6 months of enrollment), or other EBV-related disorder as determined by principal investigator (PI)\n* History of immune suppression or autoimmune disorder\n* Concomitant use of systemic corticosteroids or other immunosuppressive medications (including nasal and inhaled steroids). The use of nasal steroids for seasonal rhinitis is acceptable\n* Pregnant or breastfeeding subjects\n* For patient enrollment on the second cohort, \"patients awaiting SOT\", we will consider patients awaiting kidney transplantation who are receiving maintenance renal replacement therapy (dialysis). Most patients on routine renal replacement therapy (dialysis) will present with stable chemistry, acid base balance, volume status and clear mental status. For patients who are non-compliant with routine dialysis, laboratory abnormalities and acid base, volume status can become abnormal. Specific dose limiting toxicity (DLT) criteria that may relate to patients with ESRD include laboratory parameters that may altered due to missed dialysis session(s). Most laboratory abnormalities in such patients can be corrected by restarting dialysis or blood transfusions. Outside these specific variables, we do not expect to see specific DLT criteria for patients with ESRD on this study. Metabolic derangement such as acid base imbalance, hyperkalemia and volume overload as a result of missing dialysis session. Study stopping rule for subjects awaiting organ transplant: Occurrence of this event in two or more subjects should result in study pause. Patients who are unable to adhere to routine dialysis will be excluded from the study if they have any unstable medical conditions which the investigator believes would preclude participation in the study. These conditions include but are not limited to cardiorenal and hepatorenal syndromes",true,"ALL","18 Years","65 Years",{"count":21,"type":22},55,"ESTIMATED","INTERVENTIONAL",[25],"PHASE1","This phase 1B trial tests the safety, side effects and best dose of rh-Hsc70- BZLF1 peptide complex (OSU-2131) with Stimulon (Trademark) QS-21 and evaluates how well it works in preventing Epstein-Barr virus (EBV) infection and related cancers in healthy volunteers and patients awaiting a solid organ transplant. Currently, patients who receive an organ transplant receive immune suppression therapy which can make it harder for the body to fight infections. This treatment also increases the risk for cancers that are triggered by the EBV. Vaccines made from synthetic peptide (RAKFKQLL) derived from the BZLF1 protein, may help the body build an effective immune response against EBV infections. QS-21, a saponin adjuvant, is a substance from plants that, when given with vaccine therapy, may improve the way the immune system responds to disease. Giving OSU-2131 with QS-21 may help the immune system fight EBV and protect against EBV infection and the cancers that it can cause in patients awaiting solid organ transplants.",[28,29,30,31,32],"Chronic Kidney Disease, Stage 4","Chronic Kidney Disease, Stage 5","EBV-Related Lymphoproliferative Disorder","EBV-Related Malignant Neoplasm","Post-Transplant Lymphoproliferative Disorder","RECRUITING","2026-06-30",{"date":36,"type":37},"2026-07-02","ACTUAL",{"date":39,"type":37},"2026-06-28",{"date":41,"type":22},"2027-12-31",{"name":43,"class":44},"Ohio State University Comprehensive Cancer Center","OTHER",1,{"id":47,"slug":48,"hasResults":11,"nctId":49,"briefTitle":50,"officialTitle":51,"acronym":52,"eligibilityCriteria":53,"healthyVolunteers":11,"sex":17,"minAge":54,"maxAge":4,"enrollmentInfo":55,"targetDuration":4,"studyType":23,"phases":57,"briefSummary":59,"conditions":60,"keywords":71,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":79,"lastUpdatePostDateStruct":80,"startDateStruct":82,"completionDateStruct":84,"leadSponsor":86,"locationsCount":45},"100627258","kidney-transplant-improvement-through-new-exercise-training-to-increase-capacity-100627258","NCT07446296","Kidney Transplant Improvement Through New Exercise Training to Increase Capacity","KINETIC -- Kidney Transplant Improvement Through New Exercise Training to Increase Capacity","KINETIC","Inclusion Criteria:\n\n* be at least 60 years old\n* receive transplant care at Penn Medicine\n* be on the kidney transplant waiting list\n* speak and comprehend English\n* be able to walk\n* have at least one physical function limitation OR at least one frailty metric\n* have access to a device capable of connecting to the Internet and downloading an application\n* be able to provide written informed consent\n* be cleared for participant via the Physical Activity Readiness Questionnaire (PARQ) verified against medical record or via written medical clearance from a clinician\n\nExclusion Criteria:\n\n* Have had a myocardial infarction or a stroke in the 3 months immediately prior to enrollment\n* Be unable to self-monitor with study devices (i.e., have a condition such as dementia)\n* Not cleared by PARQ or receive written medical clearance to exercise\n* Participate in another physical activity study\n* Have any other reason they do not expect to be able to complete the study","60 Years",{"count":56,"type":22},60,[58],"NA","The goal of this clinical trial is to learn if a home-based exercise program can be safely and feasibly used to improve physical activity and physical function in adults waiting for a kidney transplant. The study will also learn how acceptable and useful this program is for participants.\n\nThe main questions it aims to answer are:\n\n* Can a remote exercise program be delivered successfully to people on the kidney transplant waiting list?\n* Do participants follow the exercise program and wear a physical activity tracker as asked?\n* Is the program safe and well tolerated?\n\nResearchers will compare two groups to see if the exercise program leads to higher physical activity and better physical function:\n\n* Usual pre-transplant care with a physical activity tracker\n* Usual pre-transplant care plus an online exercise program\n\nParticipants will:\n\n* Wear a wrist activity tracker to measure daily physical activity\n* Complete a one-week baseline period before being assigned to a study group\n* Be randomly assigned (like flipping a coin) to one of two groups\n* If assigned to the exercise group, take part in online exercise classes at home for 12 weeks with reminders and feedback, and then another 12 weeks without reminders and feedback\n* Answer questionnaires about their health, activity, and experience in the study\n\nThis study may help researchers learn how to better support people waiting for kidney transplant through safe, home-based exercise programs.",[61,62,63,64,65,66,67,68,69,70],"Chronic Kidney Disease 5D","Chronic Kidney Disease Stage 5","Kidney Failure","Kidney Failure,Chronic","Renal Insufficiency Chronic","Chronic Kidney Disease Stage 4","Kidney Transplantation","Waiting List","Transplant Candidate","Exercise Theraphy",[72,73,74,75,76,77,78],"kidney transplant candidates","prehabilitation","home-based exercise","physical activity program","kidney transplant waiting list","pre-transplant care","physical function","2026-05-05",{"date":81,"type":37},"2026-05-06",{"date":83,"type":37},"2026-03-24",{"date":85,"type":22},"2028-05",{"name":87,"class":44},"University of Pennsylvania",{"id":89,"slug":90,"hasResults":11,"nctId":91,"briefTitle":92,"officialTitle":93,"acronym":94,"eligibilityCriteria":95,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":96,"targetDuration":4,"studyType":23,"phases":98,"briefSummary":99,"conditions":100,"keywords":101,"overallStatus":110,"whyStopped":4,"lastUpdateSubmitDate":111,"lastUpdatePostDateStruct":112,"startDateStruct":114,"completionDateStruct":116,"leadSponsor":118,"locationsCount":45},"100609978","the-agenda-setting-for-kidney-disease-open-pilot-trial-100609978","NCT07221604","The Agenda-Setting for Kidney Disease Open Pilot Trial","Setting the Agenda: An Open Pilot of a Structured Clinical Visit Agenda-Setting Intervention for Rural-Residing People With Advanced Chronic Kidney Disease","ASK","Inclusion Criteria:\n\n* Adults \\>18 years old who have been diagnosed with advanced CKD (stages 4-5).\n* Care partners, clinicians and staff supporting these CKD patients who are willing and able to provide informed consent\n* English-speaking\n* Able to provide informed consent\n* Patient must be attending outpatient visits \\*(in-person and\u002For telehealth allowable).\n\nExclusion Criteria:\n\n* Children under 18 years old will not be included\n* Non-English-speaking patients and\u002For care partners\n* Patients on dialysis\n* Individuals unable or unwilling to provide informed consent",{"count":97,"type":22},30,[58],"The goal of this open pilot is to practice using an intervention and surveys before a larger pilot stepped wedge clinical trial. The intervention the researchers plan to use is Chronic Kidney Disease (CKD) Topics, and it is a structured clinical agenda-setting intervention (SAS), or a customized list of discussion topics. The people the researchers are practicing using the SAS with have advanced CKD (stages 4-5), and many of them live in rural areas. The researchers will practice administering CKD Topics, along with survey questions. By doing the open pilot, the researchers will learn if they need to modify the steps they plan to take in the larger trial.\n\nThe main questions the researchers aim to answer are:\n\n* Do the steps for identifying eligible participants work?\n* Do the steps for administering CKD Topics work?\n* Do the steps to administer survey questions work?",[66],[102,103,104,105,106,107,108,109],"Chronic kidney disease","Chronic kidney disease stage 4","Chronic kidney disease stage 5","Agenda-setting","Patient engagement","Rural","Participatory research","Open pilot","NOT_YET_RECRUITING","2025-10-27",{"date":113,"type":37},"2025-10-28",{"date":115,"type":22},"2026-07",{"date":117,"type":22},"2026-09",{"name":119,"class":44},"Dartmouth-Hitchcock Medical Center",{"id":121,"slug":122,"hasResults":11,"nctId":123,"briefTitle":124,"officialTitle":125,"acronym":94,"eligibilityCriteria":95,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":126,"targetDuration":4,"studyType":23,"phases":128,"briefSummary":129,"conditions":130,"keywords":131,"overallStatus":110,"whyStopped":4,"lastUpdateSubmitDate":134,"lastUpdatePostDateStruct":135,"startDateStruct":137,"completionDateStruct":139,"leadSponsor":141,"locationsCount":45},"100594861","the-agenda-setting-for-kidney-disease-trial-100594861","NCT07024953","The Agenda-Setting for Kidney Disease Trial","Setting the Agenda: A Pilot Stepped Wedge Cluster Randomized Trial of a Structured Clinical Visit Agenda-Setting Intervention for Rural-Residing People With Advanced Chronic Kidney Disease",{"count":127,"type":22},108,[58],"The goal of this clinical trial is to learn if a tool with a list of discussion topics, called a structured clinical visit agenda-setting intervention (SAS), works for people with advanced chronic kidney disease (CKD) who receive care at a clinic that serves people who live in rural areas. The SAS is called CKD Topics. The researchers will compare the SAS intervention to usual care (the way clinicians usually practice) to see how well it works for people with advanced CKD. This is a special type of clinical trial called a stepped wedge randomized clinical trial (RCT). In this type of trial, every participant will get to experience both usual care and CKD Topics, but for different amounts of time.\n\nThe researchers will learn if doing a clinical trial of CKD Topics is possible (feasible) and get information about how well CKD Topics helps people with advanced CKD shape visit discussions (self-advocacy) in their appointments with their clinicians. The information the researchers collect in this trial will help design a future trial with more participants.\n\nThe main questions the researchers aim to answer are:\n\n* Is it possible to conduct this type of study of a SAS intervention? i.e. feasibility\n* Does the SAS intervention help people with advanced CKD shape discussions (self-advocacy) with their clinicians? If so, how much? i.e. preliminary efficacy",[66,62],[132,103,104,105,107,106,133,108],"Chronic Kidney Disease","Randomized trial","2025-06-18",{"date":136,"type":37},"2025-06-24",{"date":138,"type":22},"2026-09-01",{"date":140,"type":22},"2028-12",{"name":119,"class":44},{"id":143,"slug":144,"hasResults":11,"nctId":145,"briefTitle":146,"officialTitle":147,"acronym":4,"eligibilityCriteria":148,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":149,"targetDuration":4,"studyType":23,"phases":151,"briefSummary":153,"conditions":154,"keywords":4,"overallStatus":110,"whyStopped":4,"lastUpdateSubmitDate":155,"lastUpdatePostDateStruct":156,"startDateStruct":157,"completionDateStruct":159,"leadSponsor":161,"locationsCount":4},"100595078","phase-4-effect-of-henagliflozin-on-renal-outcomes-in-non-dialysis-patients-with-advanced-chronic-kidney-disease--a-multicenter-prospective-randomized-controlled-trialhero--ackd-100595078","NCT07027774","Effect of Henagliflozin on Renal Outcomes in Non-dialysis Patients With Advanced Chronic Kidney Disease : A Multicenter Prospective, Randomized Controlled Trial（HERO -aCKD）","A Multicenter, Prospective, Randomized, Controlled Study Evaluating the Progression of Renal Function in Patients With Late-Stage Chronic Kidney Disease Treated With Henagliflozin","Inclusion Criteria:\n\n* The investigator considers that the participant does not require Henagliflozin or any other SGLT-2 inhibitor therapy, nor deems such therapy absolutely inappropriate; and based on local laboratory results within 6 months before the screening visit and at the screening visit, the following criteria must be met:\n\n  1. 10 mL\u002Fmin\u002F1.73m² ≤ eGFR \\\u003C 30 mL\u002Fmin\u002F1.73m² (CKD-EPI equation), and\n  2. 150 mg\u002Fg (16.95 mg\u002Fmmol) ≤ Urine Albumin-to-Creatinine Ratio (UACR) \\\u003C 5000 mg\u002Fg (565 mg\u002Fmmol)\n* Age ≥ 18 years, male or femal\n* Participants with 20 mL\u002Fmin\u002F1.73m² ≤ eGFR \\\u003C 30 mL\u002Fmin\u002F1.73m² must be on a stable and tolerated dose of an ACE inhibitor (ACEI) or ARB for at least 4 weeks, unless intolerant (reasons for intolerance must be documented). Participants with 10 mL\u002Fmin\u002F1.73m² ≤ eGFR \\\u003C 20 mL\u002Fmin\u002F1.73m² should have ACEI\u002FARB use determined by the investigator based on the patient's clinical status and KDIGO guideline recommendations;\n* Anticipated time to requiring dialysis is greater than 1 month;\n* Provision of written informed consent (illiterate participants may use a thumbprint in lieu of a signature).\n\nExclusion Criteria:\n\n* Received SGLT2 inhibitor treatment within 8 weeks prior to enrollment or with a history of SGLT2 inhibitor intolerance;\n* Receiving combined therapy with an ACE inhibitor (ACEi) and an ARB, or a renin inhibitor combined with ACEi or ARB (based on self-report at screening and randomization visits);\n* On maintenance dialysis, has a functioning kidney transplant, or is a planned living donor transplant recipient (based on self-report at screening and randomization visits);\n* Polycystic kidney disease, active lupus nephritis, or systemic vasculitis;(5) Symptomatic hypotension, or systolic blood pressure \\\u003C90 mmHg or \\>180 mmHg at screening;\n* ALT or AST levels \\>3 times the upper limit of normal (ULN) at screening;\n* Received any intravenous immunosuppressive therapy within the previous 3 months; or any subject who received prednisone \\>45 mg\u002Fday (or equivalent dose) within the previous 3 months;\n* Current use or use within 12 weeks prior to enrollment of glucagon-like peptide-1 (GLP-1) receptor agonist medications (e.g., liraglutide, semaglutide, dulaglutide, etc.) or current participation in another clinical trial of glucose-lowering drugs that may affect kidney or cardiovascular outcomes;(9) Severe malnutrition (serum albumin \\\u003C25 g\u002FL) and\u002For severe anemia (hemoglobin \\\u003C70 g\u002FL);\n* Known poor adherence to clinical follow-up or medication;\n* Myocardial infarction, unstable angina, or stroke within 12 weeks prior to enrollment;\n* Underwent coronary revascularization (percutaneous coronary intervention \\[PCI\\] or coronary artery bypass grafting \\[CABG\\]) or valve repair\u002Freplacement within 12 weeks prior to enrollment, or plans to undergo any of these procedures after randomization;(13) Any disease other than kidney or cardiovascular disease (e.g., but not limited to, malignancy) that, in the investigator's clinical judgment, is associated with a life expectancy of less than 2 years;\n* Active malignancy requiring treatment at the time of the first visit (except for successfully treated basal cell carcinoma, treated squamous cell carcinoma, or thyroid cancer);\n* Currently pregnant, breastfeeding, or a woman of childbearing potential (WOCBP) unless using a highly effective method of contraception;\n* Type 1 diabetes;(17) Investigator considers the patient unable to understand and\u002For comply with the study procedures and\u002For follow-up, or any condition that, in the investigator's opinion, may lead to the patient's inability to complete the study.\n* Additionally, subjects will be excluded at the randomization visit if any of the following occur:\n\n  1. Did not adhere to the run-in treatment;\n  2. No longer willing to be randomized and followed for at least 2 years;\n  3. Considered unsuitable for randomization by the local investigator; OR experienced ketoacidosis, heart attack (myocardial infarction), stroke, hospitalization for heart failure, hospitalization for urinary tract infection, or acute kidney injury during the run-in period.",{"count":150,"type":22},429,[152],"PHASE4","This is a multicenter, prospective, randomized, controlled study that will enroll approximately 429 subjects. The screening period will last 4-8 weeks. Subjects will undergo pre-screening based on eGFR and urinary albumin-to-creatinine ratio (UACR). Only non-dialysis subjects meeting the following criteria confirmed by local laboratories within 6 months prior to screening will be eligible for central laboratory screening:\n\n10 mL\u002Fmin\u002F1.73m² ≤ eGFR \\\u003C 30 mL\u002Fmin\u002F1.73m² and 150 mg\u002Fg (16.95 mg\u002Fmmol) ≤ UACR \\\u003C 5000 mg\u002Fg (565 mg\u002Fmmol).\n\nUnless contraindicated due to intolerance, subjects with 20 mL\u002Fmin\u002F1.73m² ≤ eGFR \\\u003C 30 mL\u002Fmin\u002F1.73m² must receive stable, maximally tolerated labeled daily doses of ACEi or ARB for at least 4 weeks prior to randomization. For subjects with 10 mL\u002Fmin\u002F1.73m² ≤ eGFR \\\u003C 20 mL\u002Fmin\u002F1.73m², investigators will determine ACEi\u002FARB treatment based on patient condition per KDIGO guidelines. Other antihypertensive, lipid-lowering, and glucose-lowering therapies should be stabilized for approximately 4 weeks before randomization. Investigators are encouraged to maintain stability of medications known to affect serum creatinine levels during screening and approximately 2 weeks prior to any serum chemistry measurements throughout the study. Eligible subjects will be randomized in a 1:1:1 ratio to receive Henagliflozin (10 mg q.d., 5 mg q.d.) or conventional therapy.\n\nThereafter, subjects will undergo laboratory assessments, concomitant medication review, adverse event collection, and clinical endpoint ascertainment at Week 4 (Day 30), Week 12 (Day 90), and Week 24 (Day 180), followed by every 12-week intervals. Throughout the study, all subjects will receive glycemic, blood pressure (target SBP \\\u003C140 mmHg and DBP \\\u003C90 mmHg), and lipid management according to current guidelines. All subjects will complete an end-of-study visit. Subjects discontinuing study drug prematurely should continue all subsequent study visits.",[66],"2025-06-11",{"date":134,"type":37},{"date":158,"type":22},"2025-07-10",{"date":160,"type":22},"2027-12-30",{"name":162,"class":44},"First Affiliated Hospital of Wannan Medical College",{"id":164,"slug":165,"hasResults":11,"nctId":166,"briefTitle":167,"officialTitle":168,"acronym":4,"eligibilityCriteria":169,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":170,"targetDuration":4,"studyType":23,"phases":172,"briefSummary":173,"conditions":174,"keywords":176,"overallStatus":110,"whyStopped":4,"lastUpdateSubmitDate":190,"lastUpdatePostDateStruct":191,"startDateStruct":193,"completionDateStruct":195,"leadSponsor":197,"locationsCount":45},"100589627","clinical-effectiveness-of-mynutrikidney-100589627","NCT06956872","Clinical Effectiveness of MyNutriKidney®","Clinical Effectiveness of MyNutriKidney® for Dietary Self-management in Chronic Kidney Disease Patients: Protocol for a Pragmatic Randomized Controlled Trial","Participants must meet all of the following inclusion criteria and none of the exclusion criteria to be eligible for enrolment into the study.\n\nInclusion Criteria:\n\n1. Clinically diagnosed Chronic Kidney Disease (CKD):\n\n   1.1. eGFR \\\u003C 60 ml\u002Fmin\u002F1.73m² for ≥ 3 months (applicable to pre-dialysis patients, Stages 3-5)\n2. Aged 18 years or older.\n3. Possesses a personal smartphone compatible with the MyNutriKidney® application and is willing to use the health app if randomized to the intervention group.\n4. Alert and oriented, and deemed capable of providing informed consent and participating in study procedures.\n5. Able to communicate and understand study procedures in English, Bahasa Melayu, or Mandarin.\n\nExclusion Criteria:\n\n1. Inability to effectively use the smartphone application due to significant impairments (e.g., severe visual or motor problems).\n2. Smartphone owned by the participant does not meet the minimum technical requirements for the MyNutriKidney® application installation and operation\n3. Presence of significant cognitive impairment or severe psychological conditions (e.g., uncontrolled anxiety or depression) likely to impede consistent participation or adherence to study requirements.\n4. Known unwillingness or inability to comply with core study procedures, including dietary assessment components.\n5. Concurrent participation in another interventional research study.\n6. Participation in another research study involving an investigational product in the 12 weeks preceding potential enrollment.\n7. Female participants who are pregnant, currently lactating, or planning a pregnancy during the course of the trial.\n8. Currently receiving primary nutritional support via enteral tube feeding or parenteral (intra-venous) nutrition.\n9. Currently receiving active treatment for cancer (e.g., chemotherapy, radiotherapy).",{"count":171,"type":22},200,[58],"This study is a 6-month, pragmatic, multi-center, sequentially recruited, stratified, open-label randomized controlled trial (RCT) conducted in Malaysia. It aims to determine the clinical effectiveness of a culturally adapted, gamified mobile health app (MyNutriKidney®) supplementing standard care, compared to standard care alone, for improving dietary self-management among 200 adults with Chronic Kidney Disease (CKD) stages 3-5. Participants will be randomly assigned (1:1, stratified by age and education) into either (i) the intervention group (MyNutriKidney® app + standard care) or (ii) the control group (standard care, including routine dietary counseling and printed materials). The co-primary outcomes are changes in Dietary Adherence (measured by CKD Diet Score) and Nutrition Literacy (measured by NLS score) from baseline to 6 months.",[175,132,62,66],"Chronic Kidney Disease Stage 3",[177,178,179,180,181,182,183,184,185,186,187,188,189],"MyNutriKidney","chronic kidney disease","CKD","Dietary Adherence","Nutrition Literacy","Self-management","Mobile Health","Dietitian","mHealth","Telemedicine","Digital Health","Malaysia","Kidney Diseases","2025-05-01",{"date":192,"type":37},"2025-05-04",{"date":194,"type":22},"2025-07-01",{"date":196,"type":22},"2027-02-01",{"name":198,"class":44},"Universiti Putra Malaysia",{"id":200,"slug":201,"hasResults":11,"nctId":202,"briefTitle":203,"officialTitle":204,"acronym":4,"eligibilityCriteria":205,"healthyVolunteers":11,"sex":17,"minAge":19,"maxAge":4,"enrollmentInfo":206,"targetDuration":4,"studyType":23,"phases":208,"briefSummary":209,"conditions":210,"keywords":211,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":217,"lastUpdatePostDateStruct":218,"startDateStruct":220,"completionDateStruct":222,"leadSponsor":224,"locationsCount":45},"100577564","a-communication-priming-intervention-to-improve-shared-decision-making-between-older-adults-with-advanced-ckd-and-clinicians-100577564","NCT06799936","A Communication-Priming Intervention to Improve Shared Decision-Making Between Older Adults With Advanced CKD and Clinicians","A Communication-Priming Intervention to Improve Shared Decision-Making Between Older Adults With Advanced Chronic Kidney Disease and Clinicians: A Cluster-Randomized Controlled Trial","Inclusion criteria for the two groups of participants (i.e. Clinicians and Patients):\n\n1. Clinicians\n\n   \\- Nephrology specialists or higher physician trainees who provide specialty care to older adults with advanced chronic kidney disease\n2. Patients\n\n   * Diagnosis of advanced CKD Stage 4 or 5 (eGRF \\\u003C30 ml\u002Fmin)\n   * Chinese- or English-speaking\n   * Identified as patient with whom their clinician plans to discuss advanced kidney disease treatment options in the upcoming clinic visit\n   * Able to provide written informed consent and complete questionnaires\n   * Can be contacted by phone\n\nExclusion criteria for patients:\n\n* Patients will be excluded if they are eligible for kidney transplant, currently on dialysis, or lack decision-making capacity",{"count":207,"type":22},280,[58],"To achieve the goal of reaching consensus about the preferred treatment option that best aligns with the goals and values of patients, the investigators developed a 'CKD Jumpstart- Tips\" priming tool tailored for older adults with advanced CKD that is based on communication principles from VitalTalk and Elwyn's goal-based SDM model.\n\nThe investigators hypothesize that compared with patients in the usual care group, patients in the 'CKD Jumpstart- Tips' intervention group will have:\n\n1. increased level of shared decision-making (observer-based and patient-reported),\n2. improved quality of communication,\n3. increased patient involvement in decision-making,\n4. lower decisional conflict,\n5. lower decision regret,\n6. decreased time to decision,\n7. improved adherence to treatment choice, and\n8. improved health-related quality-of-life.",[66,62],[212,213,214,215,102,216],"Communication","Priming","Decision-making","Older adults","CKD-Priming Jumpstart","2025-03-31",{"date":219,"type":37},"2025-04-02",{"date":221,"type":37},"2025-02-04",{"date":223,"type":22},"2027-06-30",{"name":225,"class":44},"The University of Hong Kong",{"id":227,"slug":228,"hasResults":11,"nctId":229,"briefTitle":230,"officialTitle":231,"acronym":4,"eligibilityCriteria":232,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":233,"targetDuration":4,"studyType":235,"phases":4,"briefSummary":236,"conditions":237,"keywords":238,"overallStatus":110,"whyStopped":4,"lastUpdateSubmitDate":244,"lastUpdatePostDateStruct":245,"startDateStruct":247,"completionDateStruct":249,"leadSponsor":251,"locationsCount":4},"100579136","improving-medication-safety-for-kidney-disease-with-a-digital-drug-dosing-tool-in-nova-scotia-community-pharmacy-practice-100579136","NCT06820372","Improving Medication Safety for Kidney Disease With a Digital Drug Dosing Tool in Nova Scotia Community Pharmacy Practice.","Improving Medication Safety and Prescribing for Individuals Chronic Kidney Disease (CKD) Through the Implementation and Evaluation of an Electronic Drug Dosing and Decision Support Kidney (eDoseCKD) Tool for Nova Scotia Community Pharmacy.","Inclusion Criteria:\n\n* individuals with an eGFR \\\u003C 60 mL\u002Fmin\u002F1.73m2 AND\n* receiving at least 1 tool target medication\n\nExclusion Criteria:\n\n* individuals on dialysis\n* unable to provide informed consent",{"count":234,"type":22},125,"OBSERVATIONAL","Chronic kidney disease (CKD) is a common condition. It occurs in approximately 7 out of 100 Canadians and is highest in rural settings. The kidneys are responsible for the removal of many drugs from the body. These drugs may require adjustment to avoid buildup. Individuals with CKD also tend to have multiple chronic conditions, are older, and are on many medications. Considering these factors, the risk for unwanted drug effects or harm are high. A recent medication review of a group of Nova Scotians with CKD referred from primary care to a specialist kidney clinic revealed that nearly 20% of high-risk medications should have been dose-adjusted or avoided. In Nova Scotia, community pharmacists' scope of practice now enables them to modify a prescription or prescribe a medication for a chronic condition except CKD. They are in an ideal position to protect or preserve kidney function through appropriate prescribing. Interviews of Nova Scotia community pharmacists in 2022 identified barriers and facilitators for kidney function assessment, medication dose adjustment and prescribing. Key findings indicated the need to develop a tool which would include agreed upon drug dosing based on kidney function, monitoring, medication specific benefits and harms, appropriate alternatives considering drug coverage and ideal medication prescribing to protect and preserve the kidneys. This study objective is to develop, validate, implement, and evaluate an electronic drug dosing and decision support kidney tool (eDoseCKD) in community pharmacy to improve medication safety and optimize kidney health. This project will consist of three phases. Phase one encompassed developing the tool based on evidence, clinician expertise and information learned from a previous study of pharmacists' interviews. Phase two will entailed tool validation or consensus by community pharmacists. In the present study, phase three, the implementation and evaluation of the tool in community pharmacies in Nova Scotia will be undertaken. We aim to answer, will this tool improve medication safety and prescribing in Nova Scotians with CKD? Participating patients will be surveyed to determine satisfaction with quality of care. Participating pharmacists will be interviewed after 6 months to assess barriers to and faciliators for using the computerized decision support alogirthms in community pharmacy practice.",[66,62],[132,239,240,241,242,243],"Community Pharmacy","Medication","Tool","mediation safety","decision support algorithms","2025-02-05",{"date":246,"type":37},"2025-02-11",{"date":248,"type":22},"2025-06-01",{"date":250,"type":22},"2026-05-01",{"name":252,"class":44},"Nova Scotia Health Authority",{"id":254,"slug":255,"hasResults":11,"nctId":256,"briefTitle":257,"officialTitle":258,"acronym":259,"eligibilityCriteria":260,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":261,"targetDuration":4,"studyType":23,"phases":263,"briefSummary":264,"conditions":265,"keywords":270,"overallStatus":110,"whyStopped":4,"lastUpdateSubmitDate":273,"lastUpdatePostDateStruct":274,"startDateStruct":276,"completionDateStruct":277,"leadSponsor":279,"locationsCount":45},"100574543","fluorescein-angiography-in-patients-with-diabetes-and-chronic-kidney-disease-100574543","NCT06760650","Fluorescein Angiography in Patients With Diabetes and Chronic Kidney Disease","Fluorescein-Induced Acute Kidney Injury in Patients With Diabetes and Chronic Kidney Disease","Fluo-AKI","Inclusion Criteria:\n\n* \\>18 years old with type 2 or type 1 diabetes and chronic kidney disease stage 3b to 5 (eGFR\\\u003C45 mL\u002Fmin\u002F1.73 m2)\n\nExclusion Criteria:\n\n* Patients who do not give their consent\n* Patients who are allergic to fluorescein\n* Patients who are on dialysis\n* Patients who had fever, vomiting, diarrhea or any dehydration 48 hours before the intervention\n* Patients who had a treatment modification one week before the intervention",{"count":262,"type":22},35,[58],"Our study hypothesizes that fluorescein exposure in diabetic patients with advanced chronic kidney disease results in deterioration of kidney function. It will therefore aim to evaluate the incidence of acute kidney injury induced by fluorescein in diabetic patients with CKD. The objective is to determine the incidence, severity and risk factors associated with this deterioration to improve the care of this specific population.",[66,266,62,267,268,269],"Chronic Kidney Disease Stage 3B","Diabetes Mellitus","Fluorescein Angiography","Acute Kidney Injury",[268,271,102,272],"Acute kidney injury","Diabetes","2025-01-03",{"date":275,"type":37},"2025-01-07",{"date":275,"type":22},{"date":278,"type":22},"2025-10-10",{"name":280,"class":44},"Saint-Joseph University"]