[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"chronic-kidney-disease-5d\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:chronic-kidney-disease-5d":28},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,10,0,[8,46,87,120,147,174,208,242,264,288],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":4,"eligibilityCriteria":15,"healthyVolunteers":16,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":19,"targetDuration":4,"studyType":22,"phases":23,"briefSummary":26,"conditions":27,"keywords":29,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":34,"lastUpdatePostDateStruct":35,"startDateStruct":38,"completionDateStruct":40,"leadSponsor":42,"locationsCount":45},"100644198","phase-1-intradialytic-exercise-combined-with-creatine-monohydrate-in-patients-with-chronic-kidney-disease-undergoing-hemodialysis-100644198",false,"NCT07666815","Intradialytic Exercise Combined With Creatine Monohydrate in Patients With Chronic Kidney Disease Undergoing Hemodialysis.","Effect of an Intradialytic Physical Exercise Programme Supplemented With Creatine Monohydrate on Body Composition, Biochemical Parameters and Functionality in Patients With Stage 5 Chronic Kidney Disease Undergoing Haemodialysis: Phase II Double-blind Randomised Clinical Trial.","Inclusion Criteria:\n\n* atients who are treated at the State Haemodialysis Centre.\n\n  * Patients who receive haemodialysis three times a week.\n  * Signature of informed consent.\n  * Patients over 18 years of age, both men and women.\n  * Patients who have been on haemodialysis for no more than two years.\n\nExclusion Criteria:\n\nPatients who have had a limb amputated.\n\n* Patients who are in a state of anuria.\n* Inability to perform muscular resistance or aerobic resistance exercises.\n* Patients unable to perform physical exercise.\n* HIV-positive patients. Elimination.\n* Patients who voluntarily withdraw from the project.\n* Inability to perform physical exercise.\n* Death.\n* Adverse events related to creatine consumption.",true,"ALL","18 Years",{"count":20,"type":21},48,"ESTIMATED","INTERVENTIONAL",[24,25],"PHASE1","PHASE2","This study aims to evaluate the effects of creatine monohydrate supplementation and an intradialytic exercise program on body composition, biochemical parameters, and functional capacity in patients with chronic kidney disease (CKD) undergoing maintenance hemodialysis. The study will compare the independent and combined effects of these interventions over an 8-week period to determine their potential benefits in this patient population.",[28],"Chronic Kidney Disease 5D",[30,31,32],"Creatine","Hemodialysis","Functionality","RECRUITING","2026-06-18",{"date":36,"type":37},"2026-06-24","ACTUAL",{"date":39,"type":37},"2026-03-02",{"date":41,"type":21},"2026-08-07",{"name":43,"class":44},"Pedro Julian Flores Moreno","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":22,"phases":57,"briefSummary":59,"conditions":60,"keywords":70,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":78,"lastUpdatePostDateStruct":79,"startDateStruct":81,"completionDateStruct":83,"leadSponsor":85,"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":21},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.",[28,61,62,63,64,65,66,67,68,69],"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",[71,72,73,74,75,76,77],"kidney transplant candidates","prehabilitation","home-based exercise","physical activity program","kidney transplant waiting list","pre-transplant care","physical function","2026-05-05",{"date":80,"type":37},"2026-05-06",{"date":82,"type":37},"2026-03-24",{"date":84,"type":21},"2028-05",{"name":86,"class":44},"University of Pennsylvania",{"id":88,"slug":89,"hasResults":11,"nctId":90,"briefTitle":91,"officialTitle":92,"acronym":93,"eligibilityCriteria":94,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":95,"targetDuration":97,"studyType":98,"phases":4,"briefSummary":99,"conditions":100,"keywords":102,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":111,"lastUpdatePostDateStruct":112,"startDateStruct":114,"completionDateStruct":116,"leadSponsor":118,"locationsCount":45},"100633078","icharus-italian-cooperative-hemoadsorption-study-for-relief-of-uremic-symptoms-100633078","NCT07522008","ICHARUS: Italian Cooperative HemoAdsorption Study for Relief of Uremic Symptoms","ICHARUS: Italian Cooperative HemoAdsorption Study for Relief of Uremic Symptoms. A Prospective Observational Cohort Study to Assess the Effectiveness and Safety of Hemoadsorption in Chronic Hemodialysis Patients With Refractory Uremic Symptoms: An Italian Real-World Registry.","ICHARUS","Inclusion Criteria:\n\n* Adult patients (≥18 years) with end-stage kidney disease (CKD stage 5D) on maintenance hemodialysis.\n* Stable hemodialysis treatment for at least 3 months prior to enrollment.\n* Presence of at least one moderate-to-severe uremic symptom, as identified by the Dialysis Symptom Index at screening.\n* Planned treatment with hemodialysis combined with hemoadsorption according to local clinical practice.\n* Ability to provide written informed consent.\n\nExclusion Criteria:\n\n* Acute illness, active infection, or hospitalization within 4 weeks prior to enrollment.\n* Planned kidney transplantation within the study follow-up period.\n* Life expectancy less than 6 months due to non-renal comorbid conditions.\n* Inability to complete patient-reported outcome questionnaires.\n* Participation in another interventional clinical study that could interfere with study outcomes.",{"count":96,"type":21},120,"6 Months","OBSERVATIONAL","Background:\n\nMany patients receiving maintenance hemodialysis continue to experience persistent uremic symptoms, such as pruritus, fatigue, sleep disorders, reduced physical performance, and impaired quality of life, despite optimized dialysis prescriptions. Conventional dialysis techniques mainly rely on diffusion and convection and may be insufficient to remove certain uremic toxins, particularly protein-bound and middle-molecule solutes.\n\nPurpose:\n\nThe ICHARUS study (Italian Cooperative HemoAdsorption Study for Relief of Uremic Symptoms) is a prospective, observational, real-world registry designed to evaluate the clinical use of hemodialysis combined with hemoadsorption (HAHD) in patients with persistent uremic symptoms.\n\nStudy design:\n\nICHARUS is a multicenter registry enrolling adult patients on maintenance hemodialysis in whom hemoadsorption is prescribed according to routine clinical practice. Hemoadsorption is added to standard dialysis sessions without modifying the underlying dialysis modality or prescription. The study does not involve randomization or experimental interventions.\n\nOutcomes:\n\nThe registry will collect data on patient-reported symptoms, quality of life, selected laboratory parameters, and safety outcomes at baseline and during follow-up at 1, 3, and 6 months. The aim is to describe symptom evolution, tolerability, and real-world treatment patterns associated with HAHD.\n\nSignificance:\n\nBy collecting standardized real-world data across multiple centers, the ICHARUS registry aims to improve understanding of the potential role of hemoadsorption in chronic hemodialysis, support harmonization of clinical practice, and generate hypotheses for future interventional studies.",[28,101],"Uremia; Chronic",[103,31,104,105,106,107,108,109,110],"Hemoadsorption","HAHD","Protein-bound uremic toxins","Middle molecules","Uremic symptoms","Patient-reported outcomes","Quality of life","Real-world registry","2026-04-20",{"date":113,"type":37},"2026-04-21",{"date":115,"type":37},"2026-03-15",{"date":117,"type":21},"2027-07",{"name":119,"class":44},"Azienda Ospedaliera Brotzu",{"id":121,"slug":122,"hasResults":11,"nctId":123,"briefTitle":124,"officialTitle":125,"acronym":4,"eligibilityCriteria":126,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":127,"targetDuration":4,"studyType":98,"phases":4,"briefSummary":129,"conditions":130,"keywords":132,"overallStatus":136,"whyStopped":4,"lastUpdateSubmitDate":137,"lastUpdatePostDateStruct":138,"startDateStruct":140,"completionDateStruct":142,"leadSponsor":144,"locationsCount":45},"100627584","the-practicality-and-utility-of-measured-vs-estimated-gfr-in-adckd-100627584","NCT07450534","The Practicality and Utility of Measured vs Estimated GFR in adCKD","The Practicality & Utility of Estimated vs Measured Renal Function in Advanced Kidney Disease, Whether Treated With Dialysis or Not: Can Better Techniques be Used to Predict the Onset of the Uraemic Syndrome and Guide Dialysis Requirements","Inclusion Criteria:\n\n* Adults (18 year s or older)\n* Able to give informed consent\n* Progressive chronic kidney disease predicted to start renal replacement therapy in the next 6 months OR established on dialysis (either haemodialysis or peritoneal) with residual renal function (Urine output \\>100ml\u002Fday)\n\nExclusion Criteria:\n\n* Under 18 years\n* Known allergy to iodinated contrast media\n* Unable to perform fingerprick blood testing\n* Unable to comply with urine collection\n* Unable or unwilling to give informed consent in English\n* Acute kidney injury expected to recover renal function\n* Pre-dialysis and planned renal transplant within 1 month\n* Pregnant or breast feeding\n* Significant fluid overload (significant peripheral oedema or ascites AND \\>10kg above estimated dry weight)",{"count":128,"type":21},150,"The goal of this observational study is to assess if new ways of measuring kidney function can better predict when individuals will become symptomatic due to kidney failure, and whether residual kidney function can be accurately measured in those already on dialysis.\n\nThe main questions the study is trying to answer is whether measuring kidney function by clearance of iohexol is comparable to the current standard of care methods.\n\nIn addition to routine care, participants will:\n\n* undergo a brief clinical assessment\n* be given an injection of iohexol and asked to perform 4 finger prick blood tests over 24 hours, recording the time of each sample. Samples will be returned in person or posted back\n* be asked to complete a questionnaire on their experience",[131,28],"Chronic Kidney Disease (Stages 4 and 5)",[133,134,135],"mGFR","iohexol","Residual Kidney Function","NOT_YET_RECRUITING","2026-02-27",{"date":139,"type":37},"2026-03-04",{"date":141,"type":21},"2026-02",{"date":143,"type":21},"2027-02",{"name":145,"class":146},"Manchester University NHS Foundation Trust","OTHER_GOV",{"id":148,"slug":149,"hasResults":11,"nctId":150,"briefTitle":151,"officialTitle":152,"acronym":153,"eligibilityCriteria":154,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":155,"targetDuration":4,"studyType":22,"phases":157,"briefSummary":158,"conditions":159,"keywords":161,"overallStatus":136,"whyStopped":4,"lastUpdateSubmitDate":164,"lastUpdatePostDateStruct":165,"startDateStruct":167,"completionDateStruct":169,"leadSponsor":171,"locationsCount":173},"100625430","a-multi-centre-trial-to-assess-the-efficacy-and-safety-of-the-omnipod-5-system-in-people-with-type-2-diabetes-undergoing-haemodialysis-100625430","NCT07422532","A Multi-centre Trial to Assess the Efficacy and Safety of the Omnipod 5 System in People With Type 2 Diabetes Undergoing Haemodialysis","An Open-label, Multi-centre, Randomised Controlled Trial to Assess the Efficacy, Safety and Utility of Automated Insulin Delivery in People With Type 2 Diabetes and Sub-optimal Glycaemia Undergoing Haemodialysis","AID-HD","Inclusion Criteria:\n\n1. Aged 18 years and older\n2. Participant has insulin-treated type 2 diabetes on more than 1 insulin injection per day or insulin pump therapy\n3. Participant has ESKD and is established on out-patient hospital-based haemodialysis treatment at least 3 times a week, via an arterio-venous fistula, graft or central venous catheter\n4. If the participant uses a CGM, the baseline time spent between 3.9 to 10 mmol\u002FL in the last 4 weeks is \\\u003C70%\n5. For those not using CGM screening HbA1c \\>7.0% (53 mmol\u002Fmol) and ≤ 12% (108 mmol\u002Fmol)\n6. Total daily dose of insulin is \\> 10 units and \\\u003C200 units per day\n7. Literate in English for safe study conduct.\n8. Willing to wear study glucose sensors and the AID system\n9. Willing to follow study-specific instructions\n10. Female participants of childbearing age should be on effective contraception, not sexually active \u002F or have no plans for pregnancy\n11. All patients whether transplant-wait listed or not, are eligible for inclusion.\n\nExclusion Criteria:\n\nExclusion Criteria\n\n1. Any other physical disease or people with known severe mental illness (psychotic disorder, bipolar disorder, dementia, substance and alcohol dependence, learning disabilities, active suicidal ideation) that are likely to interfere with the normal conduct of the study and interpretation of the study results as judged by the investigator\n2. Either current use of peritoneal dialysis or planned modality transfer (transplantation from a live donor with a confirmed date, peritoneal dialysis or conservative care) in the next 18 weeks\n3. Only treated with background (basal) insulin\n4. The participant is currently on AID or more than 2 weeks use of AID in the last 4 weeks\n5. Known or suspected allergy against insulin\n6. Treated with sulphonylureas (use of SGLT2 inhibitors are allowed)\n7. Treated with hydroxyurea (sensor interference)\n8. Presence of unstable retinopathy per Investigator's judgement\n9. Severe bilateral visual impairment\n10. Pregnancy, planned pregnancy in the next 3 months or breastfeeding current or planned glucocorticoid use other than inhaled\u002F topical use. Stable long-term steroid use is not an exclusion",{"count":156,"type":21},84,[58],"Diabetes is the leading cause of kidney failure in the UK. Many people with diabetes and advanced kidney failure inject themselves with insulin and do finger-prick blood glucose tests. Managing diabetes in people with advanced kidney disease is challenging, with fluctuating glucose levels and an increased risk of unsafe low glucose levels. We now have continuous glucose monitors (CGM), which allow people to monitor glucose without painful fingerprick tests. CGM can be combined with insulin pumps to create automated insulin delivery systems (AID) that automatically deliver insulin to control glucose levels. AID systems are currently used in people with type 1 diabetes, but they are not used in people with type 2 diabetes. There is little information on how these systems might help people with diabetes and advanced kidney failure, and on dialysis.\n\nThis study will investigate whether automated insulin delivery can improve glucose levels and quality of life in people with type 2 diabetes treated with more than one insulin injection with advanced kidney failure and undergoing regular haemodialysis treatment. This study will be conducted in four UK centres and will be of a parallel design. We estimate that the trial will require 84 participants to be recruited, and 76 participants to be randomised. We aim for 64 participants across both groups to complete the trial. Participants will wear a glucose sensor at the start. In random order, half will be randomised to AID treatment while the other half will continue usual care augmented with continuous glucose monitoring. The duration of each treatment stage is 12 weeks. The study will last about 18 weeks for each participant. We will compare the glucose levels in the AID group with the usual care group to see if there is a difference. Questionnaires and interviews will help us understand participants' experiences. We will carefully monitor the safety of the participants.",[160,28],"Type 2 Diabetes",[160,162,163],"Haemodialysis","Chronic kidney diseases","2026-02-19",{"date":166,"type":37},"2026-02-20",{"date":168,"type":21},"2026-04-01",{"date":170,"type":21},"2027-04-01",{"name":172,"class":44},"Imperial College London",4,{"id":175,"slug":176,"hasResults":11,"nctId":177,"briefTitle":178,"officialTitle":179,"acronym":180,"eligibilityCriteria":181,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":182,"enrollmentInfo":183,"targetDuration":4,"studyType":22,"phases":185,"briefSummary":187,"conditions":188,"keywords":193,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":199,"lastUpdatePostDateStruct":200,"startDateStruct":202,"completionDateStruct":204,"leadSponsor":206,"locationsCount":45},"100596415","phase-4-pegmolesatide-treatment-for-anemia-in-patients-undergoing-long-term-dialysis-100596415","NCT07045155","Pegmolesatide Treatment for Anemia in Patients Undergoing Long-term Dialysis","Pegmolesatide for Anemia Treatment：Investigation Upgrade Therapy in rhuEPO Patients Undergoing Dialysis: A Prospective, Multicenter, Parallel-Group, Controlled, Open-Label Study（PANGU-stepup）","PANGU-stepup","Inclusion Criteria:\n\n1. Aged ≥18 years and ≤80 years, with no restrictions on gender.\n2. Body weight ≥40 kg and body mass index (BMI) ≥18 kg\u002Fm².\n3. Subjects who have received hemodialysis or peritoneal dialysis for ≥3 months prior to enrollment;\n4. Subjects who have been receiving erythropoiesis-stimulating agents (ESAs) for ≥4 weeks prior to randomization, with an average weekly dose \\>6000 IU in the last 4 weeks (equivalent dose converted to short-acting EPO \\>6000 IU, calculated as the total amount of short-acting EPO used in the last 4 weeks divided by 4);\n5. The most recent Hb value during the screening period and the average Hb value between screening and baseline visits must be ≥70 to \\\u003C110 g\u002FL;\n6. Hemodialysis patients with serum ferritin levels ≥200 μg\u002FL; peritoneal dialysis patients with serum ferritin levels ≥100 μg\u002FL, and the investigator determines that renal transplant is not required during the trial;\n7. Understanding the study procedures and voluntarily signing the Informed Consent Form (ICF).\n\nExclusion Criteria:\n\n1. Known to have active malignancy, polycystic kidney disease, hematologic disorders (including congenital and acquired anemias such as thalassemia, Fanconi anemia, pure red cell aplasia, myelodysplastic syndromes, hemolytic anemia, and coagulation disorders), or other causes of anemia (such as gastrointestinal bleeding or hookworm disease);\n2. Known to have experienced stroke, transient ischemic attack, myocardial infarction, thromboembolic events (deep vein thrombosis), pulmonary embolism, or other serious cardiopulmonary diseases within the past 6 months;\n3. Received anabolic steroid (e.g., androgen) therapy within 12 weeks prior to randomization;\n4. Known to have received red blood cell or whole blood transfusion within 12 weeks prior to the study.\n5. History of significant infection within 4 weeks before randomization as determined by the investigator.\n6. Confirmed blood pressure measurements at rest and in a conscious state using standard measurement methods, with at least three non-consecutive day readings reaching or exceeding systolic blood pressure (SBP) ≥180 mmHg and\u002For diastolic blood pressure (DBP) ≥110 mmHg within 4 weeks before enrollment, or changes in antihypertensive medication treatment. The primary basis for judgment is clinic-measured blood pressure values, but \"white coat hypertension\" should be excluded.\n7. Known allergy to iron agents or polyethylene glycol.\n8. Pregnant or breastfeeding women, women of childbearing age with a positive blood β-HCG test result before the trial, or those planning to become pregnant during the study period.\n9. Scheduled for elective surgery during the trial period.\n10. Presence of any other factors that the investigator deems unsuitable for participation in this trial.","80 Years",{"count":184,"type":21},240,[186],"PHASE4","This study is a prospective, multicenter, parallel-controlled, open-label clinical trial, planned to be conducted across multiple research centers in various provinces and cities in China.\n\nIt will enroll 240 dialysis-dependent chronic kidney disease (DD-CKD) patients with anemia who have been receiving rHuEPO treatment for at least 4 weeks, with hemoglobin (Hb) levels of ≥70 g\u002FL and \\\u003C110 g\u002FL. After enrollment, participants will be randomly assigned in a 1:1:1 ratio to the experimental group, control group, and exploratory group. The study will involve a 24-week treatment and observation period, divided into three phases: a screening period (Day -28 to Day -1), a treatment period (Week 0 to Week 16), and an extension period (Week 17 to Week 24).\n\nThe primary objective is to assess the impact of the three treatment regimens on the hemoglobin levels of patients with DD-CKD anemia.",[189,28,190,191,192],"Dialysis; Complications","Renal Anemia of Chronic Kidney Disease","Renal Anaemia","Renal Anemia, Chronic",[194,195,196,197,198],"recombinant human erythropoietin","erythropoietin mimetic peptides","Pegmolesatide","Dialysis","renal anemia","2025-09-08",{"date":201,"type":37},"2025-09-12",{"date":203,"type":37},"2025-08-01",{"date":205,"type":21},"2028-12-30",{"name":207,"class":44},"Chinese PLA General Hospital",{"id":209,"slug":210,"hasResults":11,"nctId":211,"briefTitle":212,"officialTitle":213,"acronym":4,"eligibilityCriteria":214,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":215,"enrollmentInfo":216,"targetDuration":4,"studyType":22,"phases":218,"briefSummary":220,"conditions":221,"keywords":225,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":231,"lastUpdatePostDateStruct":232,"startDateStruct":234,"completionDateStruct":236,"leadSponsor":238,"locationsCount":241},"100602120","phase-3-study-of-the-efficacy-and-safety-of-bcd-131-and-mircera-in-the-treatment-of-anemia-in-patients-with-chronic-kidney-disease-on-dialysis-100602120","NCT07119372","Study of the Efficacy and Safety of BCD-131 and Mircera® in the Treatment of Anemia in Patients With Chronic Kidney Disease on Dialysis","A Randomized, Open-label, Comparative Clinical Study of the Efficacy and Safety of BCD-131 and Mircera® in the Treatment of Anemia in Patients With Chronic Kidney Disease on Dialysis","Inclusion Criteria:\n\n* The patient signed a written ICF for participation in the study.\n* Men and women aged 18 to 75 years inclusive at the time of signing the ICF.\n* End stage kidney disease (documented).\n* The need for dialysis sessions within at least the last 90 days prior to signing the ICF.\n* For patients on hemodialysis - hemodialysis procedures should be at least 3 times a week, for a total duration of at least 12 hours a week.\n* Documented use of recombinant erythropoietin (epoetin alfa, epoetin beta or darbepoetin alfa) for at least 90 days prior to signing the ICF.\n* The dose of recombinant erythropoietins (epoetin alfa or epoetin beta received 1, 2 or 3 times a week, or darbepoetin alfa received once a week\u002Fonce every 2 weeks) should be stable for at least 90 days prior to signing the ICF and the entire screening period (documented).\n* Target hemoglobin level (100-120 g\u002FL inclusive) based on the results of screening examination (two measurements).\n* The efficacy of dialysis established at screening or not more than 14 days before signing the ICF (dialysis dose index (Kt\u002Fv) ≥1.2 in patients on long-term hemodialysis, and weekly Kt\u002Fv ≥1.7 for patients on peritoneal dialysis).\n* Transferrin saturation ≥20%, ferritin level \\>100 ng\u002FmL at screening.\n* Cyancobalamine (vitamin B12) and folic acid levels within the laboratory reference values at screening.\n* Willingness of patients of both sexes and their sexual partners of childbearing potential to use methods of contraception in accordance with the protocol, starting from signing the informed consent form, throughout the study and for up to 90 days after receiving the last dose of the drug in the clinical study, as well as to refrain from donation of eggs for female subjects or sperm for male subjects during this period.\n* The ability of the patient to comply with the Protocol requirements, in the Investigator's opinion.\n\nExclusion Criteria:\n\n* Any other diagnosed forms of anemia, except for anemia of renal disease, including anemia in chronic diseases (C-reactive protein level \\>20 mg\u002FL at screening).\n* Diagnosed lupus nephritis or chronic kidney disease due to systemic vasculitis.\n* Platelet count \\\u003C100×109\u002FL based on the results of screening examination.\n* A high probability of early withdrawal from the study, in particular a planned (i.e., available information about a planned date and\u002For a suitable donor) kidney transplant surgery during the estimated period of participation in the study.\n* A history of severe allergic reactions (anaphylactic shock or multiple drug allergy) according to the patient, and hypersensitivity to recombinant erythropoietins, polyethylene glycol or any components of the study drugs, or to iron (III) hydroxide sucrose complex.\n* Vaccination less than 8 weeks before signing the ICF (according to the patient).\n* Diagnosed liver cirrhosis.\n* HIV infection.\n* ALT, AST \\>3хULN at screening.\n* Decompensated heart disease (NYHA Class IV CHF).\n* Resistant hypertension.\n* Unstable angina.\n* History of acute hemolysis episodes.\n* Documented hemoglobinopathy, myelodysplastic syndrome, hematological malignancy, pure red cell aplasia.\n* Severe secondary hyperparathyroidism (intact PTH\\>1000 pg\u002FmL at screening) or biopsy-confirmed bone marrow fibrosis (myelofibrosis).\n* Documented episodes of gastrointestinal or other bleeding within less than 90 days prior to signing the ICF.\n* Documented history of episodes of thrombosis (acute myocardial infarction, stroke, transient ischemic attacks, deep vein thrombosis, pulmonary thromboembolism within less than 6 months before the signing of the ICF, as well as long-term vascular access thrombosis within 30 days before the signing of the ICF.\n* Seizure syndrome, including a history of or epilepsy during the screening period.\n* Documented major surgery less than 30 days before signing the ICF.\n* Documented blood transfusion within less than 90 days prior to signing the ICF.\n* Any acute or chronic infections in the stage of exacerbation, as well as other chronic diseases that at the time of signing the informed consent, may adversely affect the patient's safety while using the study therapy in the opinion of the investigator.\n* A history of severe depression, suicidal ideation, or attempted suicide.\n* Documented malignancies other than cured basal-cell carcinoma and\u002For cervical carcinoma in situ with a remission duration of more than 5 years at the time of signing the ICF.\n* Known alcohol or drug addiction, or current signs of alcohol\u002Fdrug addiction, which, according to the investigator, is contraindication for the treatment with the test drug\u002Freference drug or limits the treatment adherence.\n* Participation in other clinical studies of medicinal products within less than 90 calendar days prior to signing the informed consent form for participation in this study.\n* Pregnancy or breastfeeding.","75 Years",{"count":217,"type":21},228,[219],"PHASE3","BCD-131 is pegylated darbepoetin beta. This clinical study BCD-131-3 is a randomized, open-label, phase III study of the efficacy and safety of BCD-131 and Mircera used for the treatment of anemia in end-stage chronic kidney disease (CKD) patients on dialysis.",[222,223,224,28],"Anemia","Chronic Kidney Disease","Chronic Kidney Disease Patients on Hemodialysis",[223,226,222,227,228,229,197,31,230],"CKD","Erythropoietin","Darbepoetin","Erythropoiesis-stimulating agent","Renal anemia","2025-08-07",{"date":233,"type":37},"2025-08-13",{"date":235,"type":37},"2025-03-01",{"date":237,"type":21},"2026-11",{"name":239,"class":240},"Biocad","INDUSTRY",2,{"id":243,"slug":244,"hasResults":11,"nctId":245,"briefTitle":246,"officialTitle":247,"acronym":4,"eligibilityCriteria":248,"healthyVolunteers":11,"sex":17,"minAge":249,"maxAge":4,"enrollmentInfo":250,"targetDuration":4,"studyType":98,"phases":4,"briefSummary":252,"conditions":253,"keywords":4,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":255,"lastUpdatePostDateStruct":256,"startDateStruct":258,"completionDateStruct":260,"leadSponsor":262,"locationsCount":45},"100525767","a-observational-study-to-evaluate-the-efficacy-and-safety-of-pacitol-inj-100525767","NCT06126016","A Observational Study to Evaluate the Efficacy and Safety of Pacitol Inj.","A Multi-center, Prospective, Non-interventional, Observational Study to Evaluate the Efficacy and Safety of Pacitol Inj.(Paricalcitol) for Secondary Hyperparathyroidism With Stage 5D Chronic Kidney Disease (CKD 5D) Receiving Hemodialysis","Inclusion Criteria:\n\n* Among hemodialysis patients with secondary hyperparathyroidism due to chronic kidney disease (CKD 5D), those who are scheduled to administer Pacitol Inj. according to the product information.\n* Those who voluntarily signed a written personal information collection and usage agreement to participate in this clinical study after receiving an explanation about the objective and methods of the study.\n* Those able to understand this study, be cooperative in the execution of the study, and participate in the study until its completion.\n\nExclusion Criteria:\n\n* Those with a history of hypersensitivity reactions to this drug or its components\n* Those with evidence of vitamin D toxicity\n* Those with hypercalcemia at enrollment\n* Pregnant or lactating women\n* Those with evidence of parathyroid adenoma who is scheduled to undergo parathyroidectomy.\n* Those who have been administered with investigational drugs of other clinical trials within 12 weeks from the baseline(Visit 1).\n* Those who are judged by the principle Investigator or sub-Investigator to be ineligible to participate in the study.","19 Years",{"count":251,"type":21},1000,"The purpose of this study is to evaluate the efficacy and safety of pacitol Inj.(paricalcitol) for secondary hyperparathyroidism with stage 5D chronic kidney disease (CKD 5D) receiving hemodialysis",[28,254],"Secondary Hyperparathyroidism","2024-12-10",{"date":257,"type":37},"2024-12-12",{"date":259,"type":37},"2023-10-19",{"date":261,"type":21},"2026-04",{"name":263,"class":240},"Boryung Pharmaceutical Co., Ltd",{"id":265,"slug":266,"hasResults":11,"nctId":267,"briefTitle":268,"officialTitle":269,"acronym":4,"eligibilityCriteria":270,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":271,"targetDuration":4,"studyType":22,"phases":272,"briefSummary":273,"conditions":274,"keywords":275,"overallStatus":136,"whyStopped":4,"lastUpdateSubmitDate":279,"lastUpdatePostDateStruct":280,"startDateStruct":282,"completionDateStruct":284,"leadSponsor":286,"locationsCount":45},"100569543","feasibility-of-a-randomized-cluster-trial-for-blood-pressure-targets-in-in-centre-hemodialysis-units-100569543","NCT06695611","Feasibility of a Randomized Cluster Trial for Blood Pressure Targets in In-centre Hemodialysis Units","Evaluating the Feasibility of a Randomized Cluster Trial for Blood Pressure Targets in In-centre Hemodialysis Units (BP in HD Pilot Trial)","Inclusion Criteria:\n\n* Age \\> 18 years old\n* Undergoing in-centre hemodialysis at least twice weekly\n* \\> 90 days since initiation of dialysis\n\nExclusion Criteria:\n\n* Participation in another intervention study that may affect blood pressure other than other cluster RCTs of dialysate composition\n* Inability to measure blood pressures in an upper arm\n* Pregnancy, anticipated pregnancy, or breastfeeding\n* Unmeasurable SBP (e.g., have left ventricular assist device)\n* Life expectancy \\\u003C 4 months\n* Planned transition to home dialysis within 3 months\n* Planned move to a different dialysis unit within 3 months\n* Anticipated living donor kidney transplant within 3 months\n* Other reasons as determined by treating clinician, reasons will be recorded",{"count":56,"type":21},[58],"High blood pressure in people receiving hemodialysis is known to contribute to heart disease and heart-related death from strokes, heart failure, left ventricular hypertrophy (which is a thickening of the heart wall that makes it difficult for the heart to pump blood) and arrythmias (an irregular or abnormal heartbeat). In comparison, low blood pressure can lead to cramps, myocardial stunning, and cerebrovascular ischemia. However, despite, blood pressure management being an important component of hemodialysis care, the \"best\" blood pressure target for people on hemodialysis is unknown.\n\nFinding the \"right\" blood pressure to target can have a major impact on patient lives. We are proposing a large, pragmatic, cluster randomized trial targeting a lower versus higher blood pressure target in in-centre hemodialysis units in Canada. Our initial steps towards this bigger trial are to run a smaller trial including 4 units, to evaluate whether it is feasible to conduct a larger trial. Our ultimate goal is to deliver the definitive randomized trial for blood pressure targets in the hemodialysis population.",[28],[276,277,278,31,197],"Chronic Kidney Diseases","Blood Pressure","End Stage Renal Disease","2024-11-15",{"date":281,"type":37},"2024-11-19",{"date":283,"type":21},"2025-02",{"date":285,"type":21},"2025-12",{"name":287,"class":44},"University of Manitoba",{"id":289,"slug":290,"hasResults":11,"nctId":291,"briefTitle":292,"officialTitle":293,"acronym":294,"eligibilityCriteria":295,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":215,"enrollmentInfo":296,"targetDuration":4,"studyType":22,"phases":298,"briefSummary":299,"conditions":300,"keywords":301,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":306,"lastUpdatePostDateStruct":307,"startDateStruct":309,"completionDateStruct":311,"leadSponsor":313,"locationsCount":45},"100444722","effect-of-inulin-on-gut-microbiota-and-gut-barrier-in-chronic-kidney-disease-100444722","NCT05071131","Effect of Inulin on Gut Microbiota and Gut Barrier in Chronic Kidney Disease","Investigating the Effect of Inulin on Gut Microbiota and Gut Barrier in Advanced Chronic Kidney Disease - a Randomised, Placebo-controlled Trial","RESTORE","Inclusion Criteria:\n\n* Men and women in a ratio of 1:1\n* Age 18-75 years\n* Body mass index 25.0 - 39.9 kg\u002Fm\\^2\n* End-stage kidney disease, which has been treated regularly with hemodialysis for at least 3 months\n\nExclusion Criteria:\n\n* Malignant diseases\n* Recent or current hospitalization\n* Postoperative phase\n* Acute infections\n* Malnutrition\n* Antibiotic treatment within the last 4 weeks\n* Regular intake of probiotics and\u002For prebiotics\n* Change of body weight of more than 2 kg in the month prior to study entry\n* Known drug or alcohol abuse\n\nChanges applied in July 2022 according to amendment no. 1:\n\n* Two inclusion criteria were changed to improve recruitment\n\n  * Age range was changed from 18-70 to 18-75 years\n  * BMI range was changed from 18.5 - 34.9 to 25.0 - 39.9 kg\u002Fm\\^2\n* The intervention scheme was adapted to increase patient adherence\n\n  * A 7-day adaption phase with half of the dose (15 grams per day) at the start of the intervention was introduced, changing treatment duration from 28 to 35 days\n\nChanges applied in January 2024 according to amendment no. 2:\n\n* One inclusion criteria was changed to improve recruitment\n\n  * BMI range was changed from 25 - 39,9 to 18,5 - 39,9 kg\u002Fm²\n* Last visit was brought foward by 4 weeks.",{"count":297,"type":21},40,[58],"An adequate fiber intake is crucial for a well-balanced diet and reduces the risk of chronic diseases. However, nutritional recommendations for chronic kidney disease patients lead to an insufficient fiber intake with possible maladaptive effects on the gut microbiome. Therefore, we want to study the effects of a 35-day inulin supplementation on the gut microbiome, gut barrier function, bacterial metabolites and immune cell states in chronic kidney disease patients.",[28],[31,302,303,304,305],"Fiber","Zonulin","Short chain fatty acids","Dietary analysis","2024-06-24",{"date":308,"type":37},"2024-06-25",{"date":310,"type":37},"2022-02-01",{"date":312,"type":21},"2027-02-01",{"name":314,"class":44},"Charite University, Berlin, Germany"]