[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"ckd\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:ckd":27},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,21,0,[8,51,84,111,141,170,193,228,261,282,305,326,349,372,396,419,448,483,505,524,541],{"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":4,"briefSummary":23,"conditions":24,"keywords":34,"overallStatus":38,"whyStopped":4,"lastUpdateSubmitDate":39,"lastUpdatePostDateStruct":40,"startDateStruct":43,"completionDateStruct":45,"leadSponsor":47,"locationsCount":50},"100638972","periodontal-disease-in-rare-renal-disorders-perio-ra-re-100638972",false,"NCT07575347","Periodontal Disease in Rare Renal Disorders (PERIO-RA-RE)","Periodontal Inflammation in Rare Renal Disorders - A Cross-Sectional Controlled Observational Study Assessing the Burden and Phenotypes of Periodontal Disease","PERIO-RA-RE","Inclusion Criteria:\n\n* Age ≥18 years\n* Ability to provide written informed consent\n* At least 10 natural teeth present\n* Belonging to one of the predefined study groups:\n\n  1. Alport syndrome (genetically or clinically confirmed)\n  2. Fabry disease (enzymatically or genetically confirmed)\n  3. Tuberous sclerosis complex (according to established clinical or genetic criteria)\n  4. Systemic lupus erythematosus defined according to the 2019 EULAR\u002FACR or SLICC 2012 classification criteria, with renal involvement defined by at least one of the following: \\[1\\] Biopsy-proven lupus nephritis, \\[2\\] Persistent proteinuria (\\>0.5 g\u002Fday or equivalent), \\[3\\] Active urinary sediment (hematuria and\u002For cellular casts) consistent with lupus nephritis\n  5. Chronic kidney disease (CKD) of non-rare etiology: defined according to KDIGO criteria (eGFR \\\u003C60 ml\u002Fmin\u002F1.73 m² and\u002For markers of kidney damage)\n  6. Individuals without CKD, recruited from clinical or dental care settings as non-CKD controls\n\nExclusion Criteria:\n\n* Periodontal treatment within the last 6 months\n* Antibiotic therapy within the last 4 weeks\n* Pregnancy\n* Conditions precluding periodontal examination\n* Inability to comply with study procedures","ALL","18 Years",{"count":20,"type":21},100,"ESTIMATED","OBSERVATIONAL","This study aims to evaluate the burden and phenotypic spectrum of periodontal disease in patients with rare kidney disorders (such as Alport syndrome, Fabry disease, and tuberous sclerosis complex) and systemic lupus erythematosus (SLE), compared with chronic kidney disease (CKD) controls and population controls.\n\nThis is a cross-sectional, case-control observational study. Participants will undergo a single structured evaluation including a full-mouth periodontal examination, a clinical questionnaire, and collection of relevant clinical and nephrological data.\n\nThe primary objective is to compare the prevalence of periodontitis across study groups. Secondary objectives include characterization of periodontal disease severity, prevalence of gingivitis and xerostomia, and identification of disease-specific oral phenotypes.\n\nExploratory analyses will assess associations between periodontal disease and clinical variables such as kidney function, proteinuria, and immunosuppressive exposure.",[25,26,27,28,29,30,31,32,33],"Periodontal Disease","Periodontitis","CKD","Chronic Kidney Disease","Alport Syndrome","Fabry Disease","Lupus or SLE","Tuberous Sclerosis Complex (TSC)","Systemic Lupus Erythematosus (SLE)",[25,26,27,35,36,37,32,28],"Rare Kidney Diseases","Alport syndrome","Systemic Lupus Erythematosus","RECRUITING","2026-06-24",{"date":41,"type":42},"2026-06-26","ACTUAL",{"date":44,"type":42},"2026-05-04",{"date":46,"type":21},"2027-12-31",{"name":48,"class":49},"Stefan Lujinschi","OTHER",1,{"id":52,"slug":53,"hasResults":11,"nctId":54,"briefTitle":55,"officialTitle":55,"acronym":4,"eligibilityCriteria":56,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":57,"enrollmentInfo":58,"targetDuration":4,"studyType":59,"phases":60,"briefSummary":62,"conditions":63,"keywords":67,"overallStatus":38,"whyStopped":4,"lastUpdateSubmitDate":75,"lastUpdatePostDateStruct":76,"startDateStruct":78,"completionDateStruct":80,"leadSponsor":82,"locationsCount":50},"100636992","phase-1-adia-med-of-winter-park-llc-chronic-kidney-disease-research-study-100636992","NCT07572890","Adia Med of Winter Park LLC Chronic Kidney Disease Research Study","Inclusion Criteria:\n\n* Age 18-80 years\n* Confirmed CKD diagnosis (eGFR 15-89 mL\u002Fmin\u002F1.73 m²)\n* Willingness to consider experimental treatments and comply with study requirements\n* Ability to obtain required bloodwork\n* Ability to attend all scheduled visits\n* Able to meet study cost requirements ($15,000 study fee) as described in the informed consent\n\nExclusion Criteria:\n\n* Has\n* Severe allergies to study products\n* Significant uncontrolled medical conditions\n* Immunocompromised\n* Malignancy history\n* Unstable medication regimen or inconsistent medication adherence (e.g., frequent medication changes or missed doses) within 30 days prior to Baseline, at Investigator discretion\n* Current dialysis (hemodialysis or peritoneal dialysis) or planned initiation of dialysis during the study period\n* Pregnancy or breastfeeding (if applicable)\n* Participation in another interventional trial within 30 days\n* Has had Kidney transplant\n* Prior stem cell or glutathione therapy: History of stem cell therapy (including umbilical cord blood-derived stem cells or exosomes) or glutathione therapy (intravenous or topical) at any time prior to screening","80 Years",{"count":20,"type":21},"INTERVENTIONAL",[61],"PHASE1","The goal of this clinical trial is to learn whether a new regenerative treatment called AdiaVita, made from umbilical cord blood-derived stem cells and exosomes combined with glutathione, is safe and can help improve kidney function in adults with chronic kidney disease (CKD). In this condition, the kidneys gradually lose their ability to filter blood as well as they should. The main questions it aims to answer are whether AdiaVita plus glutathione improves kidney function better than control treatments, as measured by blood tests for estimated glomerular filtration rate (eGFR) and creatinine levels, and whether the treatment is safe with acceptable side effects. Researchers will compare three groups. One group will receive AdiaVita plus glutathione. A second group will receive glutathione plus a placebo for AdiaVita. The third group will receive placebos for both treatments. A placebo looks like the real treatment but contains no active ingredients. This will help determine if the full treatment works better than the controls. Approximately 100 adults aged 18 to 80 with stage 2 to 4 chronic kidney disease may participate. Participants will be randomly assigned to one of the three treatment groups. They will receive monthly intravenous infusions at the clinic for the first three months and apply a skin spray twice daily at home during that period. The study lasts 12 months total for each participant, with regular visits for blood tests, physical exams, and safety monitoring. Certain participants in the control groups may switch to the active AdiaVita treatment after three months if they meet safety criteria. This is a single-blind study, meaning participants will not know which treatment they receive. Participant safety is closely monitored by the research team and an independent board throughout the study.",[28,64,65,66,27],"Kidney Disease","Kidney Disease, Chronic","Chronic Kidney Disease (CKD)",[68,69,70,71,28,27,72,73,74],"allogeneic stem cells","antioxidant therapy","stem cell therapy","stem cells","Regenerative medicine","Glutathione","Glutathione therapy","2026-06-16",{"date":77,"type":42},"2026-06-17",{"date":79,"type":21},"2026-05-18",{"date":81,"type":21},"2029-01",{"name":83,"class":49},"Adia Med of Winter Park LLC",{"id":85,"slug":86,"hasResults":11,"nctId":87,"briefTitle":88,"officialTitle":89,"acronym":4,"eligibilityCriteria":90,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":91,"targetDuration":4,"studyType":59,"phases":93,"briefSummary":95,"conditions":96,"keywords":98,"overallStatus":38,"whyStopped":4,"lastUpdateSubmitDate":75,"lastUpdatePostDateStruct":102,"startDateStruct":104,"completionDateStruct":106,"leadSponsor":108,"locationsCount":5},"100620241","phase-3-a-study-to-evaluate-the-efficacy-and-safety-of-veverimer-for-the-treatment-of-metabolic-acidosis-100620241","NCT07355062","A Study to Evaluate the Efficacy and Safety of Veverimer for the Treatment of Metabolic Acidosis","A Phase 3, Randomized, Double-Blind Study to Evaluate the Efficacy and Safety of Veverimer in Adults With CKD and Metabolic Acidosis (The REVIVE Study)","Inclusion Criteria:\n\n* Written informed consent.\n* ≥ 18 years old (male\u002Ffemale)).\n* CKD with eGFR \\\u003C 60 mL\u002Fmin\u002F1.73m²; not expected to need dialysis\u002F transplant during study.\n* 2 SBC values 12-21 mmol\u002FL within 6 months pre-screening\n* During screening: 2 central SBC values 12-21 mmol\u002FL\n* Willing to maintain stable diet .\n* Expect to keep oral alkali therapy dose stable.\n* Women of childbearing potential: negative pregnancy test and agree to abstinence or contraception.\n\nExclusion Criteria:\n\n* Any participant deemed by the Investigator to be an inappropriate candidate for physical performance testing (e.g., severe musculoskeletal pain, non-ambulatory status) or with a screening STS5 time \\\u003C 10 seconds (i.e., very mobile).\n* Any participant deemed by the Investigator to be an inappropriate candidate for CPET (e.g., advanced chronic obstructive pulmonary disease \\[COPD\\], major cardiovascular \\[CV\\] event in last 6 months, systolic blood pressure \\[SBP\\] \\> 200 mmHg or diastolic blood pressure \\[DBP\\] \\> 120 mmHg). Only applicable to sites performing CPET and if the participant will take part in CPET.\n* History or current diagnosis of:\n\n  1. Clinically significant gastroparesis or a history of bariatric surgery.\n  2. Bowel obstruction, swallowing disorders, severe gastrointestinal disorders, including inflammatory bowel disease, major gastrointestinal surgery, or known active gastric\u002Fduodenal ulcers.\n  3. Severe recurrent diarrhea or severe recurrent constipation, in the opinion of the Investigator.\n  4. Pernicious anemia, atrophic or autoimmune gastritis, achlorhydria or hypochlorhydria.\n* Active Helicobacter pylori infection at screening.\n* Active, recurrent, or metastatic malignancy at the start of screening.\n* History of malignancy, except under the following conditions:\n\n  1. Carcinoma in situ (e.g., of the cervix, breast, or bladder) that has been completely excised and shows no evidence of residual disease.\n  2. Non-melanoma skin cancers (e.g., basal cell carcinoma, squamous cell carcinoma) that have been completely excised and show no evidence of recurrence.\n  3. Low grade prostate cancer, in the opinion of the Investigator (i.e., no metastasis, Gleason score \\\u003C 6), with no significant worsening for \\> 6 months prior to the screening visit.\n  4. Any other malignancy that was treated with curative intent and has been in complete remission for ≥ 5 years prior to the screening visit.\n* Evidence of acute fluid overload or history of recurrent fluid overload, in the opinion of the Investigator.\n* Screening hemoglobin \\\u003C 10 g\u002FdL.\n* Presence of primary respiratory alkalosis, as assessed by venous blood gas (VBG) analysis at time of screening.\n* Serum gastrin level \\> 500 pg\u002FmL.\n* Investigational medication administration within 28 days prior to start of screening.\n* Use of GI polymer binders or sodium zirconium cyclosilicate within 28 days prior to the start of screening or have an expectation to initiate treatment during the study.\n* Use of acid reducing drugs, including potassium competitive acid blockers, H2-blockers or PPIs within 28 days prior to the start of screening or have an expectation to initiate treatment during the study.\n* Use of GLP-1 inhibitors within 6 months prior to the start of screening or have an expectation to initiate treatment during the study.\n* Participants that are taking any of the following medications and have not been on a stable dose for at least 28 days prior to screening or have an expectation to change dose during the study: diuretics, non-ophthalmic carbonic anhydrase inhibitors, diabetes drugs, RAAS inhibitors, calcium or magnesium supplements, non polymer phosphate binders, and SGLT-2 inhibitors. These medications also should not be started during the study.\n* Participants that are taking more than 30 units of insulin daily.\n* History of alcoholism or drug\u002Fchemical abuse within 1 year prior to the start of screening, in the opinion of the Investigator.\n* Current, regular use of inhaled\u002Fingested cannabis\u002FTHC products.\n* Inability to take the IP or otherwise comply with the protocol.\n* Any medical condition, uncontrolled systemic disease or serious concurrent illness that would significantly decrease study compliance or jeopardize the safety of the participant or affect the validity of the trial results, in the opinion of the Investigator.",{"count":92,"type":21},150,[94],"PHASE3","The purpose of this 26 week study is is to evaluate the efficacy and safety of veverimer in treating adults with moderate-to-severe chronic kidney disease (CKD) and metabolic acidosis.",[27,97],"Metabolic Acidosis",[27,97,99,100,101],"Veverimer","STS5","Bicarbonate",{"date":103,"type":42},"2026-06-18",{"date":105,"type":42},"2026-01-13",{"date":107,"type":21},"2027-06",{"name":109,"class":110},"Renibus Therapeutics, Inc.","INDUSTRY",{"id":112,"slug":113,"hasResults":11,"nctId":114,"briefTitle":115,"officialTitle":116,"acronym":117,"eligibilityCriteria":118,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":119,"targetDuration":4,"studyType":59,"phases":120,"briefSummary":122,"conditions":123,"keywords":126,"overallStatus":38,"whyStopped":4,"lastUpdateSubmitDate":131,"lastUpdatePostDateStruct":132,"startDateStruct":134,"completionDateStruct":136,"leadSponsor":138,"locationsCount":140},"100616377","phase-2-comparative-study-on-the-mode-of-action-of-vicadrostat-and-spironolactone-on-protein-profiles-and-renal-hemodynamic-effects-compare-vs-100616377","NCT07304817","Comparative Study on the Mode of Action of Vicadrostat and Spironolactone on Protein Profiles and Renal Hemodynamic Effects (COMPARE-VS)","Comparative Study on the Mode of Action of Vicadrostat and Spironolactone on Protein Profiles and Renal Hemodynamic Effects in Patients Chronic Kidney Disease With Cardiovascular Disease \u002FHeart Failure","COMPARE-VS","Inclusion Criteria:\n\n1. Provided written and dated informed consent for participation prior to trial admission,\n2. Age ≥18 years, female or male\n3. Patients with\n\n   * Heart failure\\*1 (any LVEF) and eGFR\\*2 between 25-90 mL\u002Fmin\u002F1.73m2 OR\n   * Established cardiovascular disease\\*3 and eGFR between 25-60 mL\u002Fmin\u002F1.73m2 OR\n   * Established cardiovascular disease and type 2 diabetes and eGFR between 25-90 mL\u002Fmin\u002F1.73m2\n4. Serum potassium ≤ 5.0 mmol\n5. Currently treated or eligible for treatment with Empagliflozin\\*4\n6. Not using a MRA or AS inhibitor in the last 6 months prior to enrollment\n7. On stable doses of other guideline directed medical therapies for ≥ 4 weeks prior to enroll-ment\n8. Outpatient.\n\n   * 1 HF is defined as the definition used in the most recent ESC guidelines for HF.\n   * 2 eGFR as assessed by the 2009 CKD-EPI without the race coefficient\n   * 3 Cardiovascular disease is defined as a history of a myocardial infarction, coronary bypass surgery, PCI, or proven coronary artery disease (e.g. by coronary angiography, CT-scan, etc.)\n   * 4 If switching from another SGLT2i to Empagliflozin subjects can be enrolled directly. If the subject is not yet on SGLT2i and starts Empagliflozin enrollment can start 4 weeks later see criteria 8.\n\nExclusion Criteria:\n\n1. Inability to understand and sign informed consent\n2. Absolute contra-indication for aldosterone antagonist\n3. Absolute contra-indication for a SGLT2-inhibitor\n4. Heart failure hospitalization, acute coronary syndrome, cardiac surgery, stroke or transient is-chemic attack in the 90 days prior to enrollment\n5. Women who are pregnant, breastfeeding or may be considering pregnancy during the study duration.",{"count":20,"type":21},[121],"PHASE2","In this study, investigators will compare the effect of vicadrostat combined with empagliflozin with the effect of spironolactone combined with empagliflozin on renal function and changes in protein profiles in blood and urine.\n\nThe hypothesis is that the renal and cardiac responses between vicadrostat and spironolactone differ due to mechanistic differences in their mode of action. Spironolactone is a mineralocorticoid receptor antagonist (MRA) and exerts its effect on a receptor, or a type of \"receiver,\" found on various cells. Vicadrostat is an aldosterone synthase inhibitor (ASI) and inhibits aldosterone production. Therefore, both drugs affect aldosterone.\n\nHowever, studies evaluating the differences between MRAs (such as spironolactone) and ASI (such as vicadrostat) and examining their effects on the kidneys in patients with chronic kidney disease with concurrent cardiovascular disease, and\u002For heart failure are still lacking.\n\nFor this study, all participants will be divided into two groups:\n\n* Group 1. Participants in this group will receive one tablet of vicadrostat (10 mg) and one tablet of empagliflozin (10 mg) daily for 26 weeks.\n* Group 2. Participants in this group will receive one tablet of spironolactone (25 mg) and one tablet of empagliflozin (10 mg) daily for the first four weeks. Participants in this group will then receive two tablets of spironolactone (50 mg) and one tablet of empagliflozin (10 mg) daily for the remaining 22 weeks. The spironolactone dosage may be adjusted during the study period (from 12.5 to 50 mg) based on blood test results.",[27,124,125],"Cardiovascular Diseases","Heart Failure",[117,127,128,27,129,130],"Spironolactone","Vicadrostat","mineralocorticoid receptor antagonist (MRA)","aldosterone synthase inhibitor (ASi)","2026-05-28",{"date":133,"type":42},"2026-05-29",{"date":135,"type":42},"2026-05-12",{"date":137,"type":21},"2028-02",{"name":139,"class":49},"University Medical Center Groningen",2,{"id":142,"slug":143,"hasResults":11,"nctId":144,"briefTitle":145,"officialTitle":145,"acronym":4,"eligibilityCriteria":146,"healthyVolunteers":11,"sex":17,"minAge":147,"maxAge":148,"enrollmentInfo":149,"targetDuration":4,"studyType":59,"phases":151,"briefSummary":153,"conditions":154,"keywords":155,"overallStatus":161,"whyStopped":4,"lastUpdateSubmitDate":79,"lastUpdatePostDateStruct":162,"startDateStruct":164,"completionDateStruct":166,"leadSponsor":168,"locationsCount":50},"100570859","effects-of-dietary-phosphorus-on-phosphorus-and-calcium-whole-body-balance-and-kinetics-in-moderate-ckd-100570859","NCT06712719","Effects of Dietary Phosphorus on Phosphorus and Calcium Whole-Body Balance and Kinetics in Moderate CKD","Inclusion Criteria:\n\n* Men or women, ages 30-75 years old, any race or ethnicity\n* Moderate CKD, defined by KDIGO as eGFR category 3b (30-44 mL\u002Fmin) or 4 (16-29 mL\u002Fmin) with albuminuria categories A1-A3\n* Serum intact parathyroid hormone above assay normal limit\n* Female subjects must be postmenopausal (\\>12 months since last menstrual period), surgically sterile, or confirmed not pregnant by pregnancy test\n* Must be on stable doses of medications (except those noted in exclusion criteria) for at least 4 weeks prior to the study\n* Willing to discontinue supplements (e.g., vitamin D, calcium, multivitamin\u002Fminerals, or others) upon enrollment until completion of the study\n* Adequate vitamin D status defined as serum 25D \\> 20 ng\u002FmL based on National Academy of Medicine (then Institute of Medicine) criteria.\n\nExclusion Criteria:\n\n* Plans to initiate dialysis within 6 months\n* Hypercalcemia defined as corrected serum calcium \\>9.8 mg\u002FdL within past 3 months\n* Hyperkalemia defined as serum potassium \\>5.5 mg\u002FdL within past 3 months\n* Hyperphosphatemia defined as serum phosphate \\>5.5 mg\u002FdL within past 3 months\n* Intestinal disease that alters absorption or normal intestinal function including celiac disease, small bowel resection, bariatric surgery, or chronic diarrhea\u002Fmalabsorption\n* Serious, uncontrolled underlying systemic disease including diabetes, lupus, hypertension in the opinion of their physician\n* Pregnant or breastfeeding\n* Prescribed and taken a phosphate binder medication, calcitriol, vitamin D analogs, calcimimetics, PTH analogues, and other medications that may alter Ca and P metabolism within past 4 weeks\n* Non-English speaking","30 Years","75 Years",{"count":150,"type":21},14,[152],"NA","The aim of the study is to look at the effects of dietary phosphorus on phosphorous and calcium whole-body balance and kinetics in moderate chronic kidney disease (CKD). N = 14 enrolled subjects will be randomly assigned to a cross-over order of (A) Low P Diet, High P Diet. Each cross-over phase will be 19 days and consist of a 7-day outpatient, controlled diet period, followed by a 5- day inpatient, controlled diet, balance, and kinetic study period, followed by a second 7-day outpatient, controlled diet period.",[27],[156,157,158,159,160],"phosphorus","phosphate","balance","diet","calcium","NOT_YET_RECRUITING",{"date":163,"type":42},"2026-05-20",{"date":165,"type":21},"2026-06",{"date":167,"type":21},"2027-05",{"name":169,"class":49},"University of Minnesota",{"id":171,"slug":172,"hasResults":11,"nctId":173,"briefTitle":174,"officialTitle":175,"acronym":176,"eligibilityCriteria":177,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":148,"enrollmentInfo":178,"targetDuration":4,"studyType":59,"phases":180,"briefSummary":181,"conditions":182,"keywords":4,"overallStatus":161,"whyStopped":4,"lastUpdateSubmitDate":184,"lastUpdatePostDateStruct":185,"startDateStruct":187,"completionDateStruct":189,"leadSponsor":191,"locationsCount":50},"100631092","phase-2-a-mechanistic-study-on-the-effect-of-htd1801-versus-placebo-on-kidney-function-in-patients-with-type-2-diabetes-and-chronic-kidney-disease-100631092","NCT07496177","A Mechanistic Study on the Effect of HTD1801 Versus Placebo on Kidney Function in Patients With Type 2 Diabetes and Chronic Kidney Disease.","A Randomized, Double-blind, Placebo-controlled Mechanistic Study to Evaluate the Effect of HTD1801 in Delaying the Progression of Renal Impairment in Patients With Type 2 Diabetes and Chronic Kidney Disease.","Negentropy","Inclusion Criteria:\n\n\\-\n\nSubjects must meet all of the following criteria to be eligible for the study:\n\n1. Male or female, aged between 18 and 75 years (inclusive) at the time of signing the informed consent form.\n2. Clinically diagnosed with Type 2 Diabetes (T2DM) and Chronic Kidney Disease (CKD) before screening, evidenced by:\n\n   1. A urine albumin-to-creatinine ratio (UACR) \\>200 mg\u002Fg on at least two separate occasions before screening.\n   2. A clinical diagnosis of CKD (KDIGO stage G1 to G3b) for at least 3 months, and an estimated glomerular filtration rate (eGFR) between 30 and 120 ml\u002Fmin\u002F1.73 m² at screening (using the CKD-EPI creatinine-cystatin C formula).\n3. Confirmed diagnosis of T2DM. If on medication for T2DM, the dose must have been stable for at least 3 months before enrollment. At screening, HbA1c must be ≤9%.\n4. At screening, on a stable, maximum tolerated or recommended dose of a RAAS inhibitor (e.g., valsartan, irbesartan) for at least 4 weeks. If not on a RAAS inhibitor, must be on at least one other stable, guideline-recommended kidney-protective drug (e.g., GLP-1RA, SGLT-2i, or non-steroidal MRA like finerenone) for at least 4 weeks.\n5. Body Mass Index (BMI) at screening between 18.5 kg\u002Fm² and 40 kg\u002Fm². Weight must be stable (no loss \\>10% in the 3 months before baseline) with no major lifestyle changes in the 3 months before screening.\n6. For women of childbearing potential and sexually active men with partners of childbearing potential: agreement to use highly effective contraception or practice abstinence throughout the study and for 30 days after the last dose.\n7. Able to understand, sign the informed consent form, and comply with the study protocol.\n\nExclusion Criteria:\n\n* Exclusion Criteria Subjects who meet any of the following criteria are excluded from participation in the study. Exclusion criteria based on lab values refer to the most recent results obtained prior to randomization.\n\nKidney Disease:\n\n1. Congenital or hereditary kidney diseases, including polycystic kidney disease, autoimmune kidney diseases (e.g., glomerulonephritis), or congenital urinary tract malformations.\n2. Currently receiving (or within the past 90 days) chronic or intermittent hemodialysis or peritoneal dialysis.\n\n   Liver Disease:\n3. Clinically or histologically confirmed liver cirrhosis (Fibrosis Stage 4).\n4. History of hepatic decompensation (e.g., ascites, hepatic encephalopathy, or variceal bleeding).\n5. Presence of the following acute or chronic liver diseases at screening: autoimmune hepatitis, primary biliary cholangitis, alcoholic liver disease, Wilson's disease, or drug-induced liver injury.\n\n   Gastrointestinal Disease:\n6. History of gastric bypass surgery.\n7. History of peptic or gastrointestinal ulcer within 12 months prior to randomization.\n8. History of clinically active inflammatory bowel disease within 12 months prior to randomization.\n9. Severe gastrointestinal disease at screening that affects drug absorption, distribution, metabolism, or excretion, including chronic conditions causing recurrent diarrhea (e.g., irritable bowel syndrome, ulcerative colitis, Crohn's disease).\n\n   Cardiovascular Disease:\n10. History of myocardial infarction, stroke, uncontrolled arrhythmia, unstable angina, coronary artery bypass grafting, or percutaneous coronary intervention within 6 months prior to screening.\n11. Current or previous history of New York Heart Association (NYHA) Class IV congestive heart failure.\n12. Planned coronary, carotid, or peripheral arterial revascularization.\n13. Uncontrolled hypertension despite antihypertensive therapy, defined as sustained SBP \\>150 mmHg and\u002For DBP \\>100 mmHg.\n\n    Hematologic Disease:\n14. Hematologic disorders or any condition causing hemolysis or red blood cell instability at screening, including but not limited to: glucose-6-phosphate dehydrogenase (G-6-PD) deficiency, hemolytic anemia, iron deficiency anemia, aplastic anemia, chronic malaria, splenectomy, reticulocytopenia.\n\n    Oncology:\n15. History of or current malignancy within the past 2 years, except for basal cell carcinoma or excised non-invasive squamous cell carcinoma of the skin.\n16. Current, planned, or anticipated treatment with radiotherapy, cytotoxic chemotherapy, or immunomodulators (e.g., interleukins, interferons). Long-term stable use of immunosuppressants is permitted if approved by the investigator.\n\n    Diagnostic Assessments:\n17. Clinically significant laboratory abnormalities or ECG changes at screening, including but not limited to:\n\n    1. Platelet count \\\u003C150,000\u002Fmm³.\n    2. International Normalized Ratio (INR) \\>1.3.\n    3. Alkaline Phosphatase (ALP) \\>2 × Upper Limit of Normal (ULN).\n    4. Total bilirubin \\>1.3 × ULN, unless the subject has Gilbert's syndrome.\n    5. Alanine aminotransferase (ALT) or aspartate aminotransferase (AST) ≥5 × ULN.\n    6. Corrected QT interval (QTc) \\>450 ms for males or \\>470 ms for females (Fridericia's formula).\n18. Active severe infection requiring parenteral antibiotic or antifungal therapy within 30 days prior to or at screening.\n19. Evidence of the following viral infections at screening:\n\n    1. Human Immunodeficiency Virus (HIV) infection: defined as positive HIV antibody.\n    2. Syphilis infection: defined as positive Treponema pallidum antibody (TP-Ab).\n    3. Active Hepatitis B Virus (HBV) infection: defined as positive Hepatitis B surface antigen (HBsAg) OR positive Hepatitis B core antibody (HBcAb) with HBV-DNA \\>500 IU\u002FmL or \\>2000 copies\u002FmL.\n    4. Active Hepatitis C Virus (HCV) infection: defined as positive HCV antibody (HCV-Ab) with HCV-RNA above the ULN.\n\n    Other:\n20. Major surgery within 30 days prior to screening.\n21. History of solid organ transplantation or being on a waiting list for such transplantation.\n22. Blood donation or blood loss ≥400 mL within 3 months prior to screening, or anticipated need for blood transfusion within 12 weeks after randomization.\n23. Known exposure to UDCA（Ursodeoxycholic Acid） or BBR（Berberine） within 3 months prior to screening, or known allergy to UDCA or BBR.\n24. History or evidence of Type 1 diabetes.\n25. Female subjects who are pregnant, breastfeeding, planning pregnancy, or of childbearing potential and not using highly effective contraception.\n26. Participation in any clinical study of an approved or investigational product within 30 days prior to screening.\n27. Any condition that, in the investigator's judgment, may jeopardize the subject's safety or compliance with the study protocol.",{"count":179,"type":21},75,[121],"Goal: The goal of this clinical trial is to learn if the investigational drug HTD1801 can slow the progression of kidney damage in adults diagnosed with both Type 2 Diabetes (T2DM) and Chronic Kidney Disease (CKD).\n\nMain Question it Aims to Answer:\n\n▪ Does HTD1801 result in a greater reduction (or a smaller increase) in urine albumin-to-creatinine ratio (UACR) compared to a placebo?\n\nResearchers will compare the group receiving HTD1801 to the group receiving a placebo to see if HTD1801 is more effective in slowing kidney function decline.\n\nParticipants will:\n\n* Undergo screening tests to determine eligibility.\n* Be randomly assigned to receive either HTD1801 capsules or matching placebo capsules twice daily for 12 weeks.\n* Take the study medication twice daily for 12 weeks.\n* Attend scheduled clinic visits (weekly for the first 4 weeks, then every 4 weeks) for assessments and check-ups.\n* Have their safety monitored through reporting of any health changes and routine lab tests.",[183,27],"T2DM","2026-03-22",{"date":186,"type":42},"2026-03-27",{"date":188,"type":21},"2026-05-01",{"date":190,"type":21},"2027-06-30",{"name":192,"class":49},"Institute of Medicinal Biotechnology, Chinese Academy of Medical Sciences",{"id":194,"slug":195,"hasResults":11,"nctId":196,"briefTitle":197,"officialTitle":198,"acronym":4,"eligibilityCriteria":199,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":200,"targetDuration":202,"studyType":22,"phases":4,"briefSummary":203,"conditions":204,"keywords":208,"overallStatus":38,"whyStopped":4,"lastUpdateSubmitDate":219,"lastUpdatePostDateStruct":220,"startDateStruct":222,"completionDateStruct":224,"leadSponsor":226,"locationsCount":140},"100617004","the-cph-mbd-cohort-dietary-substudy---comparison-of-methods-for-dietary-registrations-100617004","NCT07312981","The CPH-MBD Cohort Dietary Substudy - Comparison of Methods for Dietary Registrations","The CPH-MBD Cohort - Substudy on Dietary History","Inclusion Criteria:\n\n* A glomerular filtration rate of \\\u003C30 ml ml\u002Fmin\u002F1.73m2\n* 18 years and above\n\nExclusion Criteria:\n\nNone",{"count":201,"type":21},50,"3 Days","The aim of the study is to assess the association between the calcium and phosphorus balance and the stage of kidney disease measured by creatinine clearence in patients with chronic kidney disease stage 4 and 5. The balance is measured a measurement between the recorded diatery intake and the urinary excretion. Additionally a comparison between image based diatery accessment and weighted records will be measured",[27,205,206,207],"Renal Insufficiency Chronic","CKD-MBD - Chronic Kidney Disease Mineral and Bone Disorder","Pre-dialysis",[209,210,211,212,213,214,215,216,217,218],"Diet","Humans","Observational","Cohort","Phosphate\u002Furine","Calcium\u002Furine","Mineral bone disorder","Elderly","Calcium Balance","Phosphate Balance","2025-12-17",{"date":221,"type":42},"2025-12-31",{"date":223,"type":42},"2025-12-15",{"date":225,"type":21},"2029-05-15",{"name":227,"class":49},"University of Copenhagen",{"id":229,"slug":230,"hasResults":11,"nctId":231,"briefTitle":232,"officialTitle":233,"acronym":4,"eligibilityCriteria":234,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":235,"targetDuration":4,"studyType":59,"phases":237,"briefSummary":238,"conditions":239,"keywords":244,"overallStatus":38,"whyStopped":4,"lastUpdateSubmitDate":254,"lastUpdatePostDateStruct":255,"startDateStruct":256,"completionDateStruct":258,"leadSponsor":259,"locationsCount":50},"100597781","kidney-protective-intervention-with-salt-substitute-after-kidney-tumor-surgery-100597781","NCT07062952","Kidney-protective Intervention With Salt Substitute After Kidney Tumor Surgery","Kidney-protective Intervention With Salt Substitute After Kidney Tumor Surgery: a Single-center Randomized Controlled Study(KISS Study)","Inclusion Criteria:\n\n* Participants must meet all of the following criteria:\n\n  1. Voluntary participation with signed informed consent from both the primary participant and all cohabiting family members, with commitment to study procedures and follow-up;\n  2. Age ≥18 years at enrollment (when signing informed consent), any gender;\n  3. Diagnosed kidney tumor patients who underwent radical nephrectomy or partial nephrectomy (no restrictions on surgical approach);\n  4. Preoperative eGFR \\>60 ml\u002Fmin\u002F1.73m² (calculated by CKD-EPI equation);\n  5. Serum potassium \\\u003C4.8 mmol\u002FL;\n  6. Predominantly home-based dietary habits (\\>90% meals prepared at home, assessed via self-report);\n  7. Normal contralateral renal function at screening;\n  8. Normal cardiopulmonary and hepatic function:\n\nExclusion Criteria:\n\n* Participants will be excluded if they meet any of the following:\n\n  1. Participant or cohabiting family members currently using potassium-sparing diuretics or potassium supplements, or prior use of salt substitutes;\n  2. Post-discharge eGFR \\\u003C45 ml\u002Fmin\u002F1.73m² without significant fluctuation;\n  3. Comorbid chronic kidney diseases (e.g., diabetic nephropathy, lupus nephritis);\n  4. Preoperative history of urinary tract obstruction;\n  5. Cohabiting family member(s) with CKD (eGFR \\\u003C45 ml\u002Fmin\u002F1.73m²);\n  6. Planned postoperative nephrotoxic medications (e.g., anti-neoplastic agents, immunotherapy);\n  7. Uncontrolled diabetes (HbA1c ≥12%);\n  8. Uncontrolled hypertension (seated SBP ≥180 mmHg or DBP ≥110 mmHg), symptomatic hypotension (SBP \\\u003C90 mmHg), or clinically evident hypovolemia;\n  9. Preoperative proteinuria (≥1+ on dipstick);\n  10. Severe cardiovascular disease (NYHA Class III-IV), gastrointestinal obstruction, or hyperkalemia history;\n  11. BMI \\\u003C18.5 kg\u002Fm² or \\>30 kg\u002Fm²;\n  12. Participation in another clinical trial ≤30 days before randomization or concurrently;\n  13. Communication barriers or anticipated non-adherence;\n  14. Structural\u002Ffunctional urological abnormalities (e.g., duplicated kidneys, polycystic kidneys, renal artery stenosis, stones, BPH) or indwelling catheters;\n  15. Prior radiotherapy\u002Fablation\u002Fsurgery on the contralateral kidney;\n  16. Life expectancy \\\u003C6 months (e.g., metastatic renal carcinoma).",{"count":236,"type":21},200,[152],"This clinical trial is an open-label, randomized controlled study designed to evaluate the efficacyand safety of salt substitutes in protecting renal function after kidney tumor surgery, aiming toprovide dietary renal protection strategies for postoperative kidney tumor patients. lt will alsoassess the feasibility of salt substitute intervention. The primary research questions are:\n\n1. Does a salt substitute diet significantly improve estimated glomerular filtration rate (eGFR) compared to a regular salt diet in postoperative kidney tumor patients?\n2. What is the safety profile of salt substitute intervention in postoperative kidney tumor patients?\n3. What is the compliance rate among postoperative kidney tumor patients using saltsubstitutes?\n4. ls the salt substitute intervention feasible?\n\nResearchers will compare the intervention group (salt substitute diet) with the control group (regular salt diet) to determine whether salt substitutes effectively improve postoperative eGFR in kidney tumor patients.\n\nParticipants will be required to:\n\n1. Consume salt substitutes or regular salt daily while strictly adhering to WHO-recommendedsalt intake levels for 1 year.\n2. Undergo scheduled baseline assessments at 1, 3, 6, and 12 months post-surgery, with 24-hoururine tests at months 1 and 6 to evaluate compliance.\n3. Receive regular monitoring of blood electrolytes, eGFR, and other renal function indicators.\n4. Document any adverse events or health status changes during the study period.",[240,27,241,242,243],"Kidney Tumors","Salt Substitute","Nephrectomy","eGFR",[245,27,246,247,243,248,249,250,251,252,253],"kidney tumor","Salt substitute","nephrectomy","kidney protection","kidney function","open-label","randomized controlled trial","Renal function compensation","CKD with clinical significance","2025-12-07",{"date":223,"type":42},{"date":257,"type":42},"2025-04-24",{"date":46,"type":21},{"name":260,"class":49},"Jinling Hospital, China",{"id":262,"slug":263,"hasResults":11,"nctId":264,"briefTitle":265,"officialTitle":266,"acronym":4,"eligibilityCriteria":267,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":268,"enrollmentInfo":269,"targetDuration":4,"studyType":22,"phases":4,"briefSummary":270,"conditions":271,"keywords":4,"overallStatus":161,"whyStopped":4,"lastUpdateSubmitDate":273,"lastUpdatePostDateStruct":274,"startDateStruct":276,"completionDateStruct":278,"leadSponsor":280,"locationsCount":50},"100613608","effect-of-roxadustat-on-heart-failure-patients-with-anaemia-and-moderate-to-severe-chronic-kidney-disease-100613608","NCT07268807","Effect of Roxadustat on Heart Failure Patients With Anaemia and Moderate-to-Severe Chronic Kidney Disease","Effect of Roxadustat on Heart Failure Patients With Anaemia and Moderate-to-Severe Chronic Kidney Disease: A Single-Centre Retrospective Study","Inclusion Criteria:\n\n* aged 18-85 years, regardless of gender;\n* fulfilled the diagnostic criteria for heart failure and chronic kidney disease;\n* haemoglobin level \\\u003C130 g\u002FL for men or \\\u003C120 g\u002FL for women at baseline;\n* had regularly received Roxadustat for over one year;\n* possessed complete clinical data, including information from pre-specified time points.\n\nExclusion Criteria:\n\n* comorbid myelodysplastic syndromes, multiple myeloma, hereditary hematologic diseases (e.g., thalassemia, sickle cell anaemia, pure red cell aplasia), hemosiderosis, hemochromatosis, or other disorders confirmed to cause anaemia due to erythrocyte destruction and\u002For abnormal hematopoietic function;\n* haemoglobin level ≤45 g\u002FL on two or more blood tests, a history of major bleeding within one year, or a history of anaemia corrected by blood transfusion;\n* bilateral nephrectomy, kidney transplantation within ≤6 months, or congenital kidney diseases (e.g., polycystic kidney disease);\n* hypertrophic obstructive cardiomyopathy or congenital heart disease with right-to-left shunt;\n* comorbid malignancy with an investigator-assessed life expectancy of less than 12 months;\n* pregnancy or lactation;\n* known allergy to the study drug (active ingredient or excipients);\n* participation in a drug clinical trial within one year.","85 Years",{"count":236,"type":21},"Previous clinical observations of potential benefit from Roxadustat in this complex patient population prompted this investigation Therefore, the investigators designed this retrospective, observational study to thoroughly investigate the effects of Roxadustat on heart failure treatment and ventricular remodelling in this specific patient population, aiming to provide new insights for patients management.",[125,27,272],"Anemia","2025-12-03",{"date":275,"type":42},"2025-12-08",{"date":277,"type":21},"2025-12-01",{"date":279,"type":21},"2026-09-01",{"name":281,"class":49},"Zhongda Hospital",{"id":283,"slug":284,"hasResults":11,"nctId":285,"briefTitle":286,"officialTitle":287,"acronym":288,"eligibilityCriteria":289,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":57,"enrollmentInfo":290,"targetDuration":4,"studyType":22,"phases":4,"briefSummary":292,"conditions":293,"keywords":294,"overallStatus":161,"whyStopped":4,"lastUpdateSubmitDate":296,"lastUpdatePostDateStruct":297,"startDateStruct":299,"completionDateStruct":301,"leadSponsor":303,"locationsCount":50},"100603831","hyperlipoproteinemia-a-as-a-marker-of-cardiovascular-risk-in-patients-with-stage-4-chronic-kidney-disease-100603831","NCT07141628","Hyperlipoproteinemia A as a Marker of Cardiovascular Risk in Patients With Stage 4 Chronic Kidney Disease","Etude de l'hyperlipoprotéinémie A Comme Marqueur de Risque Cardio-vasculaire Chez Les Patients Atteints de Maladie rénale Chronique au Stade 4","LPACKD45","Inclusion Criteria:\n\n* The patient must have given their free and informed consent and signed the consent form\n* The patient must be a member or beneficiary of a health insurance plan\n* Patient being followed at the Nîmes University Hospital for stage 4 chronic kidney disease without replacement therapy\n* Patient available for follow-up at 18 months\n\nExclusion Criteria:\n\n* The subject is participating in an interventional study, or is in a period of exclusion determined by a previous study\n* The subject refuses to sign the consent\n* It is impossible to give the subject informed information\n* The patient is under safeguard of justice or state guardianship\n* Familial hypercholesterolemia\n* Morbid obesity (BMI \\> 40 kg\u002Fm2).\n* Persons deprived of their liberty by a judicial or administrative decision, persons receiving psychiatric care, and persons admitted to a health or social care facility for purposes other than research (Article L1121-6 of the French Public Health Code)",{"count":291,"type":21},300,"The blood level of lipoprotein A (Lp(a)) is linked to mutations in gene 6 and is associated with atherothrombotic risk and clinical manifestations such as myocardial infarction, ischemic stroke, and aortic valve calcification and stenosis. Several studies show an increased cardiovascular risk for a level \\>125 nmol\u002FL. Patients with severe chronic kidney disease (CKD) or on hemodialysis are at high cardiovascular risk, and Lp(a) levels would allow for better reclassification of this cardiovascular risk in the general population.\n\nThe study authors wished to the heterogeneity of the Lp(a) level in the population with CKD stages 4 without renal replacement therapy and to identify whether a high Lp(a) level is associated with cardiovascular comorbidity defined by the presence of cardiovascular comorbidity after adjustment for known risk factors such as diabetic status, obesity, smoking, LDLc level and medical treatment for cardiovascular prevention (statins, etc.). Furthermore, they will evaluate whether there is a link between a high level (\\> 125 mmol\u002Fl) of Lp(a) at inclusion in the cohort and the occurrence of cardiovascular or renal events (i.e. death of cardiovascular origin or occurrence of MI, stroke, stage 4 peripheral artery disease (PAD) or initiation of renal replacement) over a follow-up period of 18 months which could raise questions about the benefit of a specific treatment which remains to be evaluated.",[27,124],[295],"lipoproteinA","2025-11-20",{"date":298,"type":42},"2025-11-24",{"date":300,"type":21},"2026-01",{"date":302,"type":21},"2027-09",{"name":304,"class":49},"Centre Hospitalier Universitaire de Nīmes",{"id":306,"slug":307,"hasResults":11,"nctId":308,"briefTitle":309,"officialTitle":309,"acronym":4,"eligibilityCriteria":310,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":148,"enrollmentInfo":311,"targetDuration":4,"studyType":59,"phases":313,"briefSummary":315,"conditions":316,"keywords":4,"overallStatus":38,"whyStopped":4,"lastUpdateSubmitDate":318,"lastUpdatePostDateStruct":319,"startDateStruct":321,"completionDateStruct":323,"leadSponsor":324,"locationsCount":50},"100607006","phase-4-the-effect-and-mechanism-of-xiqing-regulating-intestinal-homeostasis-on-drug-efficacy-of-chronic-kidney-disease-100607006","NCT07182942","The Effect and Mechanism of Xiqing Regulating Intestinal Homeostasis on Drug Efficacy of Chronic Kidney Disease","Inclusion Criteria:\n\n1. Written informed consent was obtained;\n2. ranging in age from 18 to 75 years;\n3. CKD stage 3-5, that is, eGFR \\\u003C 60 mL\u002Fmin\u002F1.73 m2 with non-dialysis stage, no dialysis indication, temporarily stable condition and drug control stage;\n4. tolerance of Xiqing and probiotics treatment.\n\nExclusion Criteria:\n\n1. with severe active infection, influence of nutritional status in patients with malignant tumor and other diseases;\n2. patients during pregnancy or lactation;\n3. unstable vital signs, the condition is not stable, need dialysis patients;\n4. patients with intolerance of Xiqing;\n5. patients with intolerance of probiotics;\n6. taking corticosteroids, antibiotics or other immunosuppressive agents within the past 3 months;\n7. taking adsorbent drugs, such as medicinal charcoal tablets, within the past 3 months.",{"count":312,"type":21},120,[314],"PHASE4","Chronic kidney disease (CKD) has become a major public health problem worldwide. Patients with CKD are often accompanied by azotemia due to impaired renal function and excretion of nitrogen metabolic waste, which leads to multiple organ dysfunction, cardiac dysfunction and other complications. Therefore, it is an important strategy in the treatment of CKD to reduce the burden of kidney in CKD patients by removing nitrogen metabolic wastes in the body. Xiqing, which includes coated aldehyde oxystarch capsules, is a drug with adsorption effect. As an effective nitrogen metabolic waste adsorbent, it is widely used in the treatment of CKD patients. Gut is an important organ for the generation of nitrogen metabolic waste in the body. Intestinal homeostasis is an important regulator of nitrogen metabolism, and supplementation of probiotics is one of the main ways to regulate intestinal homeostasis. A study published by the team of investigators in the journal Cell Metabolism in 2021 confirmed that probiotics (Lactobacillus casei Zhang) reduced the BUN level in CKD mice, intestinal inflammation and the permeability of intestinal mucosal barrier, and delay the progression of CKD patients through animal experiments and clinical trials. So, whether the application of Xiqing changes intestinal homeostasis, including intestinal flora structure, function and function of intestinal mucosa, intestinal metabolites? Whether drug effect is affected by intestinal balance of CKD? What is the mechanism? Is Xiqing combined with probiotics more conducive to reducing BUN level and delaying the progression of CKD patients? The discussion of the problem and solution will help clinicians for the pioneering understanding of the use of Xiqing.\n\nIn this study, the investigators designed a prospective, randomized, open-label, blinded end-point clinical trial, using microbial diversity, metagenomics, targeted and non-targeted metabolomics detection and other technologies, through the joint analysis of multi-omics data, to explore the effect of the use of Xiqing on the intestinal homeostasis of CKD, and the extent of the drug efficacy of Xiqing is affected by the intestinal homeostasis of CKD. The effect of Xiqing combined the probiotics regulating intestinal homeostasis on CKD and the molecular mechanism, which provide more research references for the clinical application of Xiqing.",[27,317],"Drug Effect","2025-09-12",{"date":320,"type":42},"2025-09-19",{"date":322,"type":42},"2024-06-07",{"date":221,"type":21},{"name":325,"class":49},"Chujin Cao",{"id":327,"slug":328,"hasResults":11,"nctId":329,"briefTitle":330,"officialTitle":331,"acronym":332,"eligibilityCriteria":333,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":334,"targetDuration":4,"studyType":59,"phases":336,"briefSummary":337,"conditions":338,"keywords":4,"overallStatus":161,"whyStopped":4,"lastUpdateSubmitDate":340,"lastUpdatePostDateStruct":341,"startDateStruct":343,"completionDateStruct":345,"leadSponsor":347,"locationsCount":4},"100601176","a-cluster-randomised-controlled-trial-of-a-multimodal-integrated-intervention-for-kidney-cachexia-100601176","NCT07107087","A Cluster Randomised Controlled Trial of a Multimodal Integrated Intervention for Kidney Cachexia","Multi-Modal Integrated Intervention Combining Exercise, Anti-inflammatory & Dietary Advice (MMIEAD) for Kidney Cachexia: a Mixed-methods Feasibility Cluster Randomised Controlled Trial and Process Evaluation","MMIEAD","Inclusion Criteria:\n\n* \\- CKD Stage 5 patients receiving maintenance HD therapy for \\>3 months, have oedema-free weight loss of at least 5% in 12 months or BMI less than 20 kg\u002Fm2, who have self-reported decreased physical function\u002Fmuscle strength and appetite, increased fatigue, who are male or female, aged \\>18 years and able to provide written informed consent.\n\nExclusion Criteria:\n\n* Patients under 18 years of age Patients within 3 months of initiation of HD (patients in this time frame are generally less clinically stable, many having vascular access procedures performed and with much higher rates of intercurrent events, including death and hospitalisation).\n\nPatients experiencing weight loss due to clinically explainable reasons for example malabsorption or oesophageal blockage.\n\nPatients already receiving chronic anticoagulation therapy or with a history of bleeding with 3 months\u002Factive bleeding issues.\n\nPatients receiving immunosuppressants or immunomodulators. Patients who are pregnant or breast feeding. Patients with a hypersensitivity to any of the constituent components of the omega-3 dietary supplement Patients who have dementia, a psychiatric disorder (who are not treated and stable) or a severe cognitive impairment which would deem them unable to give informed consent.\n\nPatients with expected survival on dialysis of \\\u003C6 months \\[e.g. those with severe heart failure (New York Heart Association ≥3)\\].\n\nPatients for whom dialysis withdrawal is being considered. Patients likely to receive a live-donor transplant or transfer to peritoneal dialysis during the study duration.\n\nPatients with bilateral lower limb amputations. Patients unable to walk without aids or assistance. Patients deemed to be clinically unstable by their treating physician. Patients who are non-English speaking (not having the ability to provide informed consent, read and write English).\n\nPatients who are currently enrolled in any study which involves exercise, fish oil\u002Fomega-3 or have been taking fish oil or omega-3 supplementation in the previous 3 months.\n\nAre not able\u002Fwilling to be involved.",{"count":335,"type":21},40,[152],"This lay description has been written in conjunction with, and the content approved by our Patient and Public Involvement collaborators.\n\nPatients with kidney cachexia will experience extreme muscle loss, reduced strength and symptoms including fatigue, reduced appetite and lower quality of life. Patients are also at an increased risk of hospitalisation and shortened life expectancy. Previous research suggests that treatments that target several causes of the muscle wasting syndrome (known as cachexia), show better outcomes for patients than treatments using just one method (for example only exercise). We want to see if combining different treatments (exercise, dietary advice and anti-inflammatory supplements) will improve outcomes for patients with kidney failure receiving haemodialysis at risk of developing kidney cachexia, compared to patients who only receive routine kidney care alone. However, there is currently no routine treatment for kidney cachexia. Individual treatments, such as exercise, have not been successful to slow the progression of wasting in chronic diseases. Our recent review of scientific literature highlighted dual treatments of exercise and dietary advice is effective to varying degrees. Combined treatments which include anti-inflammatory supplements (including those found in fish oils), alongside exercise and dietary advice, have been successfully trialled in other chronic illnesses, such as cancer for the treatment of cachexia. However, this bundle of three treatments has not been tested in patients with kidney cachexia. It is important to test whether such a combination of treatments will be practical for patients and clinicians. Our study will assess how well this intervention works in the healthcare system and if it shows potential to help patients with kidney cachexia.\n\nPatients at risk of kidney cachexia who are receiving haemodialysis at two renal departments have been assigned to the treatment group (Multi-Modal Integrated intervention combining Exercise, Anti-inflammatory \\& Dietary advice plus routine care) and two have been assigned to the control group (routine care). Over 12 weeks, those in the treatment group will receive an individualised exercise programme, dietary advice and anti-inflammatory (fish oil) nutritional supplements. We will collect data on how successful the trial is (e.g., how many patients took part, completed all components of the study). Additionally, we will collect data on physical functioning, muscle mass, body weight, quality of life and survival. After 12 weeks, we will interview patients and clinicians to evaluate, if any, changes can be made to improve the intervention within what is called a 'process evaluation'.",[339,27],"Cachexia","2025-07-30",{"date":342,"type":42},"2025-08-06",{"date":344,"type":21},"2025-08-01",{"date":346,"type":21},"2027-08-01",{"name":348,"class":49},"Queen's University, Belfast",{"id":350,"slug":351,"hasResults":11,"nctId":352,"briefTitle":353,"officialTitle":353,"acronym":4,"eligibilityCriteria":354,"healthyVolunteers":11,"sex":17,"minAge":355,"maxAge":4,"enrollmentInfo":356,"targetDuration":4,"studyType":59,"phases":358,"briefSummary":359,"conditions":360,"keywords":361,"overallStatus":38,"whyStopped":4,"lastUpdateSubmitDate":363,"lastUpdatePostDateStruct":364,"startDateStruct":366,"completionDateStruct":368,"leadSponsor":370,"locationsCount":50},"100425382","study-of-oral-uremic-toxin-absorbent-and-probiotics-to-retard-the-progression-of-chronic-kidney-disease-100425382","NCT04819217","Study of Oral Uremic Toxin Absorbent and Probiotics to Retard the Progression of Chronic Kidney Disease","Inclusion Criteria:\n\n1. Age ≥ 20 years old on the day of screening.\n2. CKD patients with eGFR 15 \\\u003C eGFR \\\u003C45 ml\u002Fmin\u002F1.73m2 and UACR \\> 100 mg\u002Fg in a stable status, creatinine elevated less than 0.3 mg\u002FdL in at least 30 days before enrollment.\n\nExclusion Criteria:\n\n1. Baseline estimated glomerular filtration rates (eGFR) \\\u003C 15 ml\u002Fmin\u002F1.73m2 according to MDRD equation.\n2. Patients in severe malnutrition status, albumin less than 2.0 g\u002FdL\n3. Patients in severe anemia or active gastrointestinal bleeding with hemoglobulin \\\u003C 8 g\u002FdL.\n4. Peptic ulcer, esophageal varices, ileus or under fasting status\n5. Previous gastrointestinal operation.\n6. Chronic constipation, as defined with less than 3 bowel movements per week, straining, hard stools, incomplete evacuation and inability to pass stool. If usage of oral laxatives can achieve bowel movement, this patient will not be excluded.\n7. Patients with major hemorrhage, as defined with acute hemorrhage and requirement of blood transfusion during index admission.\n8. Patients with a biopsy proved or clinically diagnosed advanced liver cirrhosis, Child classification B or C.\n9. Solid organ or hematological transplantation recipients.\n10. Patients with oliguric kidney injury, as defined with less than 500 cc\u002Fday.\n11. Evidence of obstructive kidney injury or polycystic kidney disease.\n12. Antibiotics or probiotics treatment within the last 2 weeks before enrollment and during follow-up period.\n13. Presence or history of malignant neoplasms within the past 5 years prior to the day of screening.","20 Years",{"count":357,"type":21},180,[152],"In patients with chronic kidney disease (CKD), uremic toxins accumulate when kidney function declines. Those uremic toxins had a greater affinity to circulating proteins are called \"protein bound uremic toxins, PBUT.\" Apart from traditional small or middle molecule uremic toxins, the PBUTs can be rarely eliminated using traditional renal replacement therapy, even using high flux dialysis modalities. Among these molecules identified, indoxyl sulfate (IS), and p-cresol (PC) are mostly studied. Both in vitro and in vivo study, IS and PC are associated with endothelial dysfunction, vascular smooth muscle proliferation, and increased risk for CV outcomes.\n\nThe uremic toxins (IS and PC) are originated in the endogenous environment, mainly from the protein metabolism, food intake, or produced by gut microbiota. Prevention of IS or PC precursors from being absorbed across the intestinal tract has been extensively studied in the renal literature by use of oral adsorbents. In animal models, activated charcoal reduces the serum concentration of creatinine (cre) and may delay CKD progression by alleviating IS overload. An oral form of non-absorbable surface-modified activated bamboo charcoal (ABC), has been demonstrated to effectively reduce circulating and renal IS levels in animal models.\n\nRecently, probiotics, prebiotics or synbiotics have been reported to reduce inflammation, improve kidney function and retard progression of CKD by restoring the symbiosis of gut microflora in patients with CKD. A randomized trial found synbiotics decreased serum PCS without reducing serum IS in non-dialysis CKD. Another study found that synbiotics delayed CKD progression. A systematic review found prebiotic and probiotic therapies reduced IS and PCS in patients with end stage kidney disease (ESKD) on haemodialysis. However, it is unclear whether the results hold true for other patients with CKD. Based on these previous findings, investigators will conduct a prospective randomized open blinded end-point (PROBE) study to see if oral uremic toxin absorbent + probiotics prevent CKD progression. Also, a panel of clinical and biochemical profiles will be checked to investigate possible link between several biomarkers and clinical response.",[27],[362],"CKD oral absorbent probiotics LncRNA, gut microbiota","2025-07-16",{"date":365,"type":42},"2025-07-18",{"date":367,"type":42},"2020-05-01",{"date":369,"type":21},"2030-12-01",{"name":371,"class":49},"National Taiwan University Hospital",{"id":373,"slug":374,"hasResults":11,"nctId":375,"briefTitle":376,"officialTitle":377,"acronym":4,"eligibilityCriteria":378,"healthyVolunteers":11,"sex":17,"minAge":355,"maxAge":4,"enrollmentInfo":379,"targetDuration":4,"studyType":59,"phases":380,"briefSummary":381,"conditions":382,"keywords":384,"overallStatus":38,"whyStopped":4,"lastUpdateSubmitDate":363,"lastUpdatePostDateStruct":389,"startDateStruct":391,"completionDateStruct":393,"leadSponsor":395,"locationsCount":50},"100423059","lncrnas-as-a-biomarker-to-assess-the-therapeutic-impact-of-oral-absorbent--probiotics-in-ckd-patients-with-pad-100423059","NCT04788914","lncRNAs as a Biomarker to Assess the Therapeutic Impact of Oral Absorbent ± Probiotics in CKD Patients With PAD","Circulating Long Noncoding RNA as a Biomarker to Assess the Therapeutic Impact of Oral Uremic Toxin Absorbent ± Probiotics in Chronic Kidney Disease Patients With Peripheral Arterial Disease","Inclusion Criteria:\n\nI: Patients\n\n1. Age \\> 20 years old on the day of screening.\n2. CKD patients with eGFR 15 \\\u003C eGFR \\\u003C 60 ml\u002Fmin\u002F1.73m2 in a stable status, creatinine elevated less than 0.3 mg\u002FdL in at least 30 days before enrollment.\n3. Symptomatic PAD with Rutherford Stage ≥ 2 and ABI \\\u003C 0.9 (or documented by CT-angio, vascular duplex, etc.).\n\nII: Controls\n\n1. Age \\> 20 years old on the day of screening.\n2. With eGFR \\> 60 ml\u002Fmin\u002F1.73m2\n3. No clinical PAD.\n\nExclusion Criteria:\n\n1. Baseline estimated glomerular filtration rates (eGFR) \\\u003C 15 ml\u002Fmin\u002F1.73m2 according to MDRD equation.\n2. Patients in severe malnutrition status, albumin less than 2.0 g\u002FdL\n3. Patients in severe anemia or active gastrointestinal bleeding with hemoglobulin \\\u003C 8 g\u002FdL.\n4. Peptic ulcer, esophageal varices, ileus or under fasting status\n5. Previous gastrointestinal operation.\n6. Chronic constipation, as defined with less than 3 bowel movements per week, straining, hard stools, incomplete evacuation and inability to pass stool. If usage of oral laxatives can achieve bowel movement, this patient will not be excluded.\n7. Patients with major hemorrhage, as defined with acute hemorrhage and requirement of blood transfusion during index admission.\n8. Patients with a biopsy proved or clinically diagnosed advanced liver cirrhosis, Child classification B or C.\n9. Solid organ or hematological transplantation recipients.\n10. Patients with oliguric kidney injury, as defined with less than 500 cc\u002Fday.\n11. Evidence of obstructive kidney injury or polycystic kidney disease.\n12. Antibiotics or probiotics treatment within the last 2 weeks before enrollment and during follow-up period.",{"count":357,"type":21},[152],"Participants with chronic kidney disease (CKD) are at a higher risk of developing atherosclerotic peripheral artery disease (PAD). Retention of uremic toxins such as indoxyl sulfate (IS), p-cresyl sulfate (PCS) and trimethylamine N-oxide (TMAO) during CKD is detrimental to endothelial and vascular function and can predispose to the development and progression of PAD. Many of the uremic toxins originate from gut microbial metabolism. Removal of these uremic toxins by carbonaceous oral adsorbent is beneficial, slowing down the deterioration of renal function and delaying the need for dialysis in CKD patients. However, if carbonaceous oral adsorbent could also improve vascular function and clinical outcomes in CKD patients with established PAD, remains unknown.\n\nIn this proposal, the investigators aim to determine the therapeutic impact of a carbonaceous oral adsorbent made of activated bamboo charcoal (ABC) with\u002Fwithout probiotics on the endothelial\u002Fvascular function, CV outcome and mortality in CKD patients with PAD. In addition, the investigators hypothesize that circulating long noncoding RNA (lncRNA) expression profiles and metabolome may serve as a sensitive and reliable biomarker to predict the adverse CV outcomes and death in CKD patients with established PAD. In addition, it is hypothesized that circulating lncRNAs and linked to adverse CV outcomes in CKD patients with PAD are associated with dysbiosis of gut microbiota. The investigators also hypothesize that the administration of ABC could normalize the dysbiosis of gut microbiota, dysregulated circulating lncRNAs and metabolome that are linked to adverse CV\u002Flimb outcomes in CKD patients with PAD.\n\nThis will be a prospective, randomized, open-labeled, blinded end-point trial for 6 months, followed by integrated assessment of endothelial\u002Fvascular function, changes in conventional athero- and inflammation-relevant biomarkers, circulating long noncoding RNAs, metabolome, and gut microbiota at baseline, ends of the 3rd and 6th month, as well as clinical CV, renal and limb outcomes up to 3 years.",[27,383],"PAD",[385,386,387,27,383,388],"Bamboo charcoal","LncRNA","gut microbiota","Probiotics",{"date":390,"type":42},"2025-07-17",{"date":392,"type":42},"2020-04-21",{"date":394,"type":21},"2025-07-31",{"name":371,"class":49},{"id":397,"slug":398,"hasResults":11,"nctId":399,"briefTitle":400,"officialTitle":401,"acronym":4,"eligibilityCriteria":402,"healthyVolunteers":11,"sex":17,"minAge":355,"maxAge":4,"enrollmentInfo":403,"targetDuration":4,"studyType":59,"phases":404,"briefSummary":405,"conditions":406,"keywords":408,"overallStatus":38,"whyStopped":4,"lastUpdateSubmitDate":363,"lastUpdatePostDateStruct":413,"startDateStruct":414,"completionDateStruct":416,"leadSponsor":418,"locationsCount":50},"100423320","oral-absorbent-and-probiotics-in-ckd-patients-with-pad-on-gut-microbiota-incrna-metabolome-and-vascular-function-100423320","NCT04792320","Oral Absorbent and Probiotics in CKD Patients With PAD on Gut Microbiota, IncRNA, Metabolome, and Vascular Function","Therapeutic Impact of Oral Uremic Toxin Absorbent and Probiotics in Chronic Kidney Disease Patients With Peripheral Arterial Disease--- on Gut Microbiota, Circulating Long Noncoding RNA, Metabolome, and Vascular Function","Inclusion Criteria:\n\nI. CKD\u002FPAD group Patients (Group I)\n\n1. Age \\> 20 years old on the day of screening.\n2. CKD patients with eGFR 15 \\\u003C eGFR \\\u003C 60 ml\u002Fmin\u002F1.73m2 in a stable status, creatinine elevated less than 0.3 mg\u002FdL in at least 30 days before enrollment.\n3. Symptomatic PAD with Rutherford Stage ≥ 2 and ABI ≤ 0.9 (or documented by CT-angio, vascular duplex, etc.). II. non-CKD\u002FPAD group Patients (Group II)\n\n1\\. Age \\> 20 years old on the day of screening. 2.With eGFR \\> 60 ml\u002Fmin\u002F1.73m2 3.No clinical PAD.\n\nExclusion Criteria:\n\n1. Baseline estimated glomerular filtration rates (eGFR) \\\u003C 15 ml\u002Fmin\u002F1.73m2 according to MDRD equation.\n2. Patients in severe malnutrition status, albumin less than 2.0 g\u002FdL\n3. Patients in severe anemia or active gastrointestinal bleeding with hemoglobulin \\\u003C 8 g\u002FdL.\n4. Peptic ulcer, esophageal varices, ileus or under fasting status\n5. Previous gastrointestinal operation.\n6. Chronic constipation, as defined with less than 3 bowel movements per week, straining, hard stools, incomplete evacuation and inability to pass stool. If usage of oral laxatives can achieve bowel movement, this patient will not be excluded.\n7. Patients with major hemorrhage, as defined with acute hemorrhage and requirement of blood transfusion during index admission.\n8. Patients with a biopsy proved or clinically diagnosed advanced liver cirrhosis, Child classification B or C.\n9. Solid organ or hematological transplantation recipients.\n10. Patients with oliguric kidney injury, as defined with less than 500 cc\u002Fday.\n11. Evidence of obstructive kidney injury or polycystic kidney disease.\n12. Antibiotics or probiotics treatment within the last 2 weeks before enrollment and during follow-up period.\n13. Presence or history of malignant neoplasms within the past 5 years prior to the day of screening.\n14. Patients with Acquired Immune Deficiency Syndrome.\n15. Patients with recent acute coronary syndrome, acute myocardial infarction, or severe heart failure.",{"count":357,"type":21},[152],"Taiwan has more chronic kidney disease (CKD) per capita than anywhere in the world, leading to the highest expense of National Health Insurance. By reviewing previous studies, uremic toxins contribute critically to the detrimental effects of CKD on atherosclerotic peripheral artery disease (PAD). When recognized early and managed appropriately, mortality and complications of the participants with CKD and established PAD can be minimized. It is critical to identify novel biomarkers and mediators, which can help identify those with potential poor outcomes and facilitate the discovery\u002Fdevelopment of novel therapeutics for the patients with CKD and PAD. The OMICs studies support the theory that gut microbiome is a major contributor to adverse cardiovascular outcomes and progression of CKD. However, successful integration of multi-omics approach remains sparse. There is no report on the impact of gut microbiota on the host circulating long non-coding RNAs (lncRNAs) expression signature, other CAD\u002FPAD potential marker, and the potential link between gut microbiota, circulating lncRNA levels changes and CKD\u002FPAD. Additionally, although numerous studies indicated that probiotics or activated charcoal have benefits for CKD patients, few studies evaluated the effect of coadministration of activated charcoal\u002Fprobiotics on the patients with CKD\u002FPAD. The mechanisms of therapeutic effect on CKD\u002FPAD patients with coadministration of activated charcoal\u002Fprobiotics involving the cross talk among host, microbiota and metabolites still remain unclear. Thus, in the present study, investigators aim to develop novel diagnostic\u002Fprognostic markers and a new treatment with activated bamboo charcoal (ABC)\u002Fprobiotics for therapeutic opportunities to prevent cardiovascular complications, amputation and death in CKD patients with established PAD. To identify the diagnostic\u002Fprognostic markers, the multi-omics (microbolome and metabolome) and lncRNA will be analyzed. The therapeutic impact of activated bamboo charcoal (ABC)\u002Fprobiotics with optimal formulation, on the renal\u002Fendothelial\u002Fvascular function, cardiovascular (CV) outcome and mortality in CKD patients with PAD will be also determined to evaluate its therapeutic opportunities.",[27,407],"PAD - Peripheral Arterial Disease",[27,407,409,386,410,411,412],"bamboo charcoal probiotics","microbolomics","metabolomics","probiotics",{"date":365,"type":42},{"date":415,"type":42},"2020-06-19",{"date":417,"type":21},"2030-04-30",{"name":371,"class":49},{"id":420,"slug":421,"hasResults":11,"nctId":422,"briefTitle":423,"officialTitle":424,"acronym":4,"eligibilityCriteria":425,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":268,"enrollmentInfo":426,"targetDuration":428,"studyType":22,"phases":4,"briefSummary":429,"conditions":430,"keywords":432,"overallStatus":38,"whyStopped":4,"lastUpdateSubmitDate":439,"lastUpdatePostDateStruct":440,"startDateStruct":442,"completionDateStruct":444,"leadSponsor":446,"locationsCount":50},"100466637","fgf23-and-cardiovascular-damage-in-anemia-with-an-without-chronic-kidney-disease-100466637","NCT05356325","FGF23 and Cardiovascular Damage in Anemia With an Without Chronic Kidney Disease.","The Role of FGF23 on the Induction of Cardiovascular Damage in Anemia With an Without Chronic Kidney Disease","Inclusion Criteria:\n\n* Hemoglobin \\\u003C 11g\u002Fdl\n* Serum ferritin \\\u003C 100 ng\u002Fml or transferrin saturation index \\\u003C 20%\n\nExclusion Criteria:\n\n* Weight \\\u003C 50 Kg or BMI \\\u003C 17\n* Acute bleeding \\> 500 ml, within 72 hours before study inclusion\n* Proliferative hematologic disease. Hemochromatosis\n* Active infections within 30 days before study inclusion\n* Systemic inflammatory illness\n* Human immunodeficiency virus (HIV), Hepatitis C virus (HCV) or Hepatitis B virus (HBV) infection\n* Iron active treatment\n* Blood transfusion in the last 90 days before inclusion.\n* Cardiovascular hospitalization 30 days before study inclusion\n* Anticoagulant treatment with coumarins\n* Chronic liver disease\n* Immunosuppressive therapy\n* Erythropoiesis stimulating agents treatment, radiotherapy or chemiotherapy within 30 days before inclusion\n* Scheduled major surgery during study period\n* Pregnancy or lactation\n* Drugs addiction\n* Participation in others clinical trials.",{"count":427,"type":21},401,"3 Months","Anemia is associated with cardiovascular disease. Iron deficiency is usually induced in chronic kidney disease (CKD). In clinical studies, an inverse association between serum levels of iron and fibroblast growth factor 23 (FGF23), a cardiovascular risk factor, has been demonstrated. In addition, a number of the I.V. iron presentations mostly used to treat anemia show unwanted side effects related to phosphate alterations and increased FGF23. Objectives. The General Objective of this project is to evaluate, through in vivo and in vitro studies, the cardiovascular alterations related to the anemia-induced increase in FGF23 production; as well as the identification of possible molecular targets that may be useful in its prevention and\u002For palliation. Specific Objectives are: 1) To determine in a population with anemia (due to iron deficiency), with and without CKD, an association between the parameters related to iron metabolism, FGF23 and markers of cardiovascular damage. 2) To evaluate in vivo, in a murine experimental model of anemia, with and without CKD, the effects of the modulation (inhibition) of triggers of iron deficiency (hepcidin) and of the increase in FGF23 (HF1α), on markers of cardiovascular damage. 3) To compare in vivo, in an experimental model of anemia with and without CKD, the effect of different I.V. iron presentations (ferrous sulphate, ferric carboxymaltose and ferric citrate) on FGF23 levels and their cardiovascular impact. 4) To evaluate in vitro, in cardiomyocytes cultures, in the presence of iron deficiency, the direct effect of FGF23 on the induction of cardiac damage. 5) To evaluate in vitro, in osteoblasts cultures, the direct effect of ferrous sulphate, ferric carboxymaltose, ferric citrate and hepcidin. Methodology. The levels of intact and C-terminal FGF23 (FGF23i and FGF23c), the differential expression profile of plasma miRNAS and of proteomic, markers of cardiovascular disease, mineral metabolism, inflammation and oxidative stress and intracellular signalling pathways will be evaluated.",[431,272,27],"Fibroblast Growth Factor 23",[433,434,27,435,436,437,438],"FGF23","anemia","iron deficiency","cardiovascular risk","miRNAS","inflammation","2025-02-06",{"date":441,"type":42},"2025-02-07",{"date":443,"type":42},"2021-10-18",{"date":445,"type":21},"2025-07-01",{"name":447,"class":49},"Maimónides Biomedical Research Institute of Córdoba",{"id":449,"slug":450,"hasResults":11,"nctId":451,"briefTitle":452,"officialTitle":453,"acronym":454,"eligibilityCriteria":455,"healthyVolunteers":11,"sex":17,"minAge":456,"maxAge":4,"enrollmentInfo":457,"targetDuration":4,"studyType":59,"phases":459,"briefSummary":460,"conditions":461,"keywords":470,"overallStatus":38,"whyStopped":4,"lastUpdateSubmitDate":474,"lastUpdatePostDateStruct":475,"startDateStruct":477,"completionDateStruct":479,"leadSponsor":481,"locationsCount":201},"100575649","integrated-approach-in-frail-older-people-with-atrial-fibrillation-100575649","NCT06775028","Integrated Approach in Frail Older People with Atrial Fibrillation","AFFIRMO - Atrial Fibrillation Integrated Approach in Frail, Multimorbid and Polymedicated Older People","AFFIRMO","Inclusion Criteria:\n\n* Outpatients of both sexes with age ≥65 years;\n* First diagnosed, paroxysmal, persistent, long-standing persistent or permanent AF, confirmed as per guideline-recommended diagnostic criteria for AF, e.g. with electrocardiogram (ECG) or Holter monitoring;\n* ≥1 additional long-term comorbidity, thus fulfilling the definition of multimorbidity: hypertension (treated with at least 2 antihypertensive drugs), coronary artery disease (CAD), peripheral artery disease, heart failure, stroke\u002FTIA, diabetes mellitus, COPD, CKD.\n\nExclusion Criteria:\n\n* Mechanical prosthetic heart valve or moderate\u002Fsevere mitral stenosis;\n* Patient unwilling to be enrolled and sign written informed consent;\n* Patient unable to understand the study and attend the follow-up;\n* Serious diseases with a life expectancy inferior to 12 months;\n* Patients included in other interventional studies.\n\nOnly for sites randomized to the iABC group:\n\n\\- Patient without a device suitable for iABC use.","65 Years",{"count":458,"type":21},1250,[152],"The study will verify if a structured multidisciplinary approach (called iABC), aimed to improve the appropriate management of elderly AF patients with multimorbidity (the i-ABC group), would provide a clear evidence of an improvement in clinical conditions and quality of life compared to usual clinical care. The i-ABC group in AFFIRMO will follow the ABC pathway, focused on three domains: avoid stroke with anticoagulation (with optimized VKA or label-adherent DOAC use); better symptom management; and optimized management of associated cardiovascular and non cardiovascular comorbidities.\n\nThe study will be conducted in Bulgaria, Denmark, Italy, Romania, Serbia and Spain .",[462,463,464,125,465,466,27,467,468,469],"Atrial Fibrillation (AF)","Hypertension","Coronary Arterial Disease (CAD)","COPD","Peripheral Arterial Disease","Diabetes Mellitus","Stroke","TIA (Transient Ischemic Attack)",[471,472,473],"iABC","Atrial Fibrillation","Cluster Trial","2025-01-09",{"date":476,"type":42},"2025-01-14",{"date":478,"type":42},"2024-04-11",{"date":480,"type":21},"2026-01-31",{"name":482,"class":49},"Heart Care Foundation",{"id":484,"slug":485,"hasResults":11,"nctId":486,"briefTitle":487,"officialTitle":488,"acronym":4,"eligibilityCriteria":489,"healthyVolunteers":11,"sex":490,"minAge":18,"maxAge":491,"enrollmentInfo":492,"targetDuration":4,"studyType":22,"phases":4,"briefSummary":494,"conditions":495,"keywords":4,"overallStatus":161,"whyStopped":4,"lastUpdateSubmitDate":496,"lastUpdatePostDateStruct":497,"startDateStruct":499,"completionDateStruct":501,"leadSponsor":503,"locationsCount":4},"100572807","chronic-kidney-disease-in-pregnant-females-100572807","NCT06738069","Chronic Kidney Disease in Pregnant Females","Frequency of Chronic Kidney Disease Among Pregnant Women at Assuit University Hospitals","Inclusion Criteria:\n\n* -all pregnant women at antenatal care who came to Outpatient clinic at the Women's Health Hospital and Nephrology Outpatient Clinic at Assiut University Hospitals\n* At age of 18 yrs old or above . -Who accept to participate with this study\n\nExclusion Criteria:\n\n* Pregnant women who are known CKD.\n* Pregnant women refuse to participate with this study .\n* Pregnant women with Acute Kidney Injury .","FEMALE","50 Years",{"count":493,"type":21},497,"Screening of Chronic Kidney Disease among pregnant women for early detection",[27],"2024-12-13",{"date":498,"type":42},"2024-12-17",{"date":500,"type":21},"2024-12",{"date":502,"type":21},"2029-12",{"name":504,"class":49},"Assiut University",{"id":506,"slug":507,"hasResults":11,"nctId":508,"briefTitle":509,"officialTitle":509,"acronym":4,"eligibilityCriteria":510,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":456,"enrollmentInfo":511,"targetDuration":4,"studyType":22,"phases":4,"briefSummary":512,"conditions":513,"keywords":514,"overallStatus":161,"whyStopped":4,"lastUpdateSubmitDate":516,"lastUpdatePostDateStruct":517,"startDateStruct":519,"completionDateStruct":521,"leadSponsor":523,"locationsCount":4},"100567623","neutrophil-to-lymphocyte-and-platelet-to-lymphocyte-ratios-as-a-predictor-factors-for-chronic-kidney-disease-progression-100567623","NCT06670599","Neutrophil-to-Lymphocyte and Platelet-to-lymphocyte Ratios as a Predictor Factors for Chronic Kidney Disease Progression","Inclusion Criteria:\n\n* 200 Patients diagnosed with CKD and their age range between 18-65 years old who will be admitted at AUH.\n\nExclusion Criteria:\n\n1. Pediatric patients aged below\\\u003C 18 or elderly patients aged above 65.\n2. Pregnant females.\n3. Patients with Diabetes Mellitus.\n4. Acute kidney injury (AKI).\n5. Patients with current infections.\n6. Patients who have any type of malignancy.\n7. Patients who have any type of multi-organ failure.\n8. CKD patients on dialysis",{"count":236,"type":21},"In this study, we aim to investigate whether NLR and PLR levels are associated with decline of kidney function in patients with CKD.",[27],[515],"NLR & PLR in CKD","2024-10-31",{"date":518,"type":42},"2024-11-01",{"date":520,"type":21},"2024-11-10",{"date":522,"type":21},"2025-11-10",{"name":504,"class":49},{"id":525,"slug":526,"hasResults":11,"nctId":527,"briefTitle":528,"officialTitle":529,"acronym":4,"eligibilityCriteria":530,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":531,"targetDuration":4,"studyType":22,"phases":4,"briefSummary":532,"conditions":533,"keywords":4,"overallStatus":161,"whyStopped":4,"lastUpdateSubmitDate":534,"lastUpdatePostDateStruct":535,"startDateStruct":537,"completionDateStruct":539,"leadSponsor":540,"locationsCount":4},"100556140","different-oral-iron-dosing-regimens-in-treatment-of-iron-deficency-anemia-in-patients-with-chronic-kidney-disease-100556140","NCT06521216","Different Oral Iron Dosing Regimens in Treatment of Iron Deficency Anemia in Patients With Chronic Kidney Disease","Comparing Different Oral Iron Dosing Regimens in Treatment of Iron Deficiency Anemia in Patients With Chronic Kidney Disease","Inclusion Criteria:\n\n* All adult patients above 18 years old with CKD stages 2,3 and 4\n\nExclusion Criteria:\n\n* CKD stage 5 (eGFR below 15 ).\n* Patients with hemolytic anemias.\n* Chronic liver diseases .\n* Autoimmune diseases.\n* Malignancy\n* History of blood transfusion last 3 months before the study\n* Pregnancy\n* Adult polycystic kidney disease ( APCKD)",{"count":92,"type":21},"Comparing between the efficacy of alternate day oral iron dose, once daily and thrice daily dose in improving anemia in CKD patients",[27],"2024-07-24",{"date":536,"type":42},"2024-07-25",{"date":538,"type":21},"2024-08-01",{"date":344,"type":21},{"name":504,"class":49},{"id":542,"slug":543,"hasResults":11,"nctId":544,"briefTitle":545,"officialTitle":546,"acronym":4,"eligibilityCriteria":547,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":548,"targetDuration":4,"studyType":22,"phases":4,"briefSummary":550,"conditions":551,"keywords":558,"overallStatus":38,"whyStopped":4,"lastUpdateSubmitDate":565,"lastUpdatePostDateStruct":566,"startDateStruct":568,"completionDateStruct":570,"leadSponsor":572,"locationsCount":50},"100548112","genetics-in-the-progression-of-nephropathies-100548112","NCT06416761","Genetics in the Progression of Nephropathies","The Genetic Contribution to Progression of Kidney Disease","Inclusion Criteria:\n\n. presence of specific renal disease\n\nExclusion Criteria:\n\n* to be evaluated in the different sub-protocols",{"count":549,"type":21},10000,"This study evaluates the role of genetic in the development and progression of different nephropaties with particular attention to:\n\n* AKI\n* CKD\n* Hypertension\n* ADPKD\n* CKD-MBD\n* Patients with decompensated heart failure undergoing either medical or surgery therapy\n* Patients with hematologic cancer exposed to chemotherapeutic agents or undergoing allogeneic bone marrow transplantation\n* glomerular diseases",[552,27,553,554,555,463,556,557],"AKI","Ckd-Mbd","CKD (Chronic Kidney Disease) Stage 5D","ADPKD","Hematologic Malignancy","Bone Marrow Transplant Complications",[559,560,561,562,563,564],"genetic in hypertensive kidney disease","salt intake in BP control and CKD progression","genetic in CKD","endogenous Ouabain as marker of AKI","protein intake restriction in CKD progression","hypertension in allogenic bone marrow transplantation","2024-05-11",{"date":567,"type":42},"2024-05-16",{"date":569,"type":42},"2006-05-19",{"date":571,"type":21},"2041-05-19",{"name":573,"class":49},"Ospedale San Raffaele"]