[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"ckd-stage-3\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:ckd-stage-3":27},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,3,0,[8,44,80],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":4,"eligibilityCriteria":15,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":18,"enrollmentInfo":19,"targetDuration":4,"studyType":22,"phases":23,"briefSummary":25,"conditions":26,"keywords":4,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":32,"lastUpdatePostDateStruct":33,"startDateStruct":36,"completionDateStruct":38,"leadSponsor":40,"locationsCount":43},"100630928","phase-2-pharmacokinetics-pharmacodynamics-safety-and-tolerability-evaluation-of-ctap101-extended-release-capsules-in-pediatric-participants-100630928",false,"NCT07494045","Pharmacokinetics, Pharmacodynamics, Safety and Tolerability Evaluation of CTAP101 Extended-release Capsules in Pediatric Participants","An Open-Label, Randomized, Multiple-Dose, Multi-Center Study to Evaluate the Pharmacokinetics, Pharmacodynamics, Safety and Tolerability of CTAP101 Extended-release Capsules in Pediatric Participants \u003C18 Years of Age With Secondary Hyperparathyroidism, Stage 3 or 4 Chronic Kidney Disease and Vitamin D Insufficiency","Inclusion Criteria:\n\nEach participant must meet the following criteria to be enrolled in Cohort 1 of this study:\n\n1. Be 8 to \\\u003C18 years of age with a body weight of ≥40 kg.\n2. Be diagnosed with stage 3 or 4 CKD at least six months prior to the screening visit (Visit 1) and have an eGFR of ≥15 to \\\u003C60 mL\u002Fmin\u002F1.73m2 at screening.\n3. Be without any disease state or physical condition that might impair evaluation of safety or which, in the investigator's opinion, would interfere with study participation.\n4. Exhibit during the initial or, if necessary, a screening visit after washout:\n\n   1. Plasma iPTH \\>85 pg\u002FmL;\n   2. Serum Ca \\\u003C9.8 mg\u002FdL;\n   3. Serum P ≤5.5 mg\u002FdL; and\n   4. Serum 25D \\\u003C30 ng\u002FmL.\n5. If taking calcitriol or other 1α-hydroxylated vitamin D therapy, be willing to forgo treatment with these agents for the duration of the study and complete a 2-week washout period prior to commencing treatment in the study.\n6. If receiving ≤2,000 IU\u002Fday or 50,000 IU\u002Fmonth (1,250 mcg) vitamin D supplementation (ergocalciferol or cholecalciferol) therapy, must agree to remain on a stable dose during the study.\n7. If taking \\>2,000 IU\u002Fday of vitamin D supplementation, must discontinue or decrease the dose to ≤2,000 IU\u002Fday, maintain that dose for the duration of the study and complete a 2-week washout period prior to commencing treatment in the study.\n8. If taking \\>1000 mg\u002Fday of elemental Ca through Ca-based phosphate binder or antacid therapy, must discontinue or decrease the dose to ≤ 1000 mg\u002Fday, maintain that dose for the duration of the study, and complete a 2-week washout period prior to commencing treatment in the study.\n9. If taking any bone metabolism therapy that could interfere with study endpoints, must discontinue use of such agent(s) for the duration of the study.\n10. Willing and able to comply with study procedures and instructions and commit to all study visits for the duration of the study.\n11. Willing and able to safely swallow the CTAP101 capsules whole.\n12. Female participants of childbearing potential must be neither pregnant nor lactating and must have a negative urine pregnancy test at the first screening visit.\n13. All female participants of childbearing potential and male participants with female partners of childbearing potential must agree to use effective contraception (eg, implants, injectables, combined oral contraceptives, intrauterine device, sexual abstinence, vasectomy or vasectomized partner) for the duration of the study.\n14. Each participant or their legal representative must be able to read, understand and sign the ICF.\n\nExclusion Criteria:\n\nParticipants who meet any of the following criteria will be excluded from the study:\n\n1. Kidney transplant within the 26 weeks preceding screening or kidney transplant rejection within the 26 weeks preceding screening.\n2. No history of parathyroidectomy or planned parathyroidectomy.\n3. History (prior three months) of serum Ca ≥9.8 mg\u002FdL.\n4. Use of calcimimetic or calcifediol therapy within three months prior to consent.\n5. Use of bisphosphonate or denosumab therapy within six months prior to consent.\n6. Known or suspected hypersensitivity to any of the constituents in CTAP101 Capsules.\n7. Known previous or concomitant serious illness or medical condition, such as malignancy, human immunodeficiency virus, significant gastrointestinal or hepatic disease or cardiovascular event or hepatitis, or abnormal ECG or physical condition that in the opinion of the investigator may worsen and\u002For interfere with participation in the study.\n8. History of neurological\u002Fpsychiatric disorder, including psychotic disorder, or any reason which, in the opinion of the investigator makes adherence to a treatment or FU schedule unlikely.\n9. Currently participating in, or has participated in, an interventional\u002Finvestigational study within 30 days prior to study screening that in the opinion of the investigator and\u002For sponsor would interfere with the safety, assessments, and results of this study.","ALL","1 Month","17 Years",{"count":20,"type":21},40,"ESTIMATED","INTERVENTIONAL",[24],"PHASE2","The goal of this clinical trial is to evaluate safety, tolerability, and how CTAP101 Capsules work to treat Pediatric Participants with Secondary Hyperparathyroidism, Stage 3 or 4 Chronic Kidney Disease and Vitamin D Insufficiency. The main questions it aims to answer are:\n\n1. To assess the pharmacokinetics (PK) and Pharmacodynamics (PD) of CTAP101 Capsules\n2. To investigate the safety and tolerability of CTAP101 Capsules\n\nParticipants will take a daily dosage of CTAP101 Capsules at bedtime for 8 weeks.",[27,28,29,30],"CKD Stage 3","CKD Stage 4","Secondary Hyperparathyroidism","VDI","NOT_YET_RECRUITING","2026-03-25",{"date":34,"type":35},"2026-03-30","ACTUAL",{"date":37,"type":21},"2026-06",{"date":39,"type":21},"2028-08",{"name":41,"class":42},"OPKO Health, Inc.","INDUSTRY",5,{"id":45,"slug":46,"hasResults":11,"nctId":47,"briefTitle":48,"officialTitle":49,"acronym":50,"eligibilityCriteria":51,"healthyVolunteers":11,"sex":16,"minAge":52,"maxAge":53,"enrollmentInfo":54,"targetDuration":4,"studyType":22,"phases":56,"briefSummary":58,"conditions":59,"keywords":65,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":69,"lastUpdatePostDateStruct":70,"startDateStruct":72,"completionDateStruct":74,"leadSponsor":76,"locationsCount":79},"100630132","multimodal-intervention-for-early-chronic-kidney-disease-in-young-people-dysbiosis-and-inflammation-ckd-100630132","NCT07483697","Multimodal Intervention for Early Chronic Kidney Disease in Young People: Dysbiosis and Inflammation (CKD)","Multimodal Intervention and Its Association With Reduced Dysbiosis and Inflammation in Early Chronic Kidney Disease in Young People: a Prospective Study","CKD","Inclusion Criteria:\n\n* Persistent albuminuria (ACR \\>30 and \\\u003C300 mg\u002Fg).\n* Estimated GFR \\>60 mL\u002Fmin\u002F1.73 m².\n* No identifiable secondary cause of kidney disease.\n\nExclusion Criteria:\n\n* Hypoalbuminemia.\n* Nephrotic syndrome.\n* Persistent macroalbuminuria (ACR \\>300 mg\u002Fg).\n* Secondary or hereditary kidney disease.","14 Years","35 Years",{"count":55,"type":21},200,[57],"NA","Chronic kidney disease (CKD) is a progressive condition associated with substantial morbidity, mortality, and healthcare costs. Early detection and timely intervention are critical to modify disease trajectory, particularly in adolescents and young adults. Emerging evidence supports the role of the gut-kidney axis in CKD progression, whereby intestinal dysbiosis contributes to systemic inflammation and accumulation of microbiota-derived uremic toxins. This randomized controlled clinical trial aims to evaluate whether a multimodal intervention consisting of a controlled diet, structured exercise, and a symbiotic administered for 180 days improves uremic toxin burden, systemic inflammation, and early renal outcomes compared with standard care plus placebo.",[60,61,62,63,27,64],"Exercise","Diet Interventions","Symbiotic","CKD Stage 1","CKD Stage 2",[50,66,67,68],"exercise","symbiotic","diet","2026-03-17",{"date":71,"type":35},"2026-03-19",{"date":73,"type":21},"2026-04-25",{"date":75,"type":21},"2026-11-03",{"name":77,"class":78},"Centenario Hospital Miguel Hidalgo","OTHER",1,{"id":81,"slug":82,"hasResults":11,"nctId":83,"briefTitle":84,"officialTitle":85,"acronym":86,"eligibilityCriteria":87,"healthyVolunteers":11,"sex":16,"minAge":88,"maxAge":89,"enrollmentInfo":90,"targetDuration":4,"studyType":22,"phases":91,"briefSummary":92,"conditions":93,"keywords":95,"overallStatus":100,"whyStopped":4,"lastUpdateSubmitDate":101,"lastUpdatePostDateStruct":102,"startDateStruct":104,"completionDateStruct":106,"leadSponsor":108,"locationsCount":110},"100543785","reducing-fluid-overload-in-heart-failure-patients-using-a-non-invasive-renal-independent-system-100543785","NCT06360380","Reducing Fluid Overload in Heart Failure Patients Using a Non-invasive, Renal Independent System","REFORM-HF™ Reducing Fluid Overload Using Renal Independent SysteM in Heart Failure Patients","REFORM-HF","Inclusion Criteria:\n\n* Age ≥21 years and \\\u003C 80 years\n* Patient, with known decompensated heart failure and\u002For CKD stage 2 or more presenting with fluid overload, defined by a congestion score of ≥3, who are not responding adequately or are resistant to current medical treatment as evidenced by persistent or worsening congestion, despite a daily dose of 40 mg furosemide or greater or the equivalent dose of another loop diuretic.\n* Patients with no Heart Failure related hospitalization in the past 30 days\n* No change in diuretic regimen in the past 7 days\n* Baseline NT-proBNP ≥600 pg\u002FmL\n* Baseline systolic blood pressure ≥100 mmHg\n* Patient is able and willing to provide written informed consent, inclusive of the release of medical information, and Health Insurance Portability and Accountability Act (HIPAA) documentation\n* Patient is not participating in any clinical investigation that may interfere with the data collection or the results of this study\n\nExclusion Criteria:\n\n* Patient considered to be in the acute worsening of heart failure: Requiring ventilation, mechanical support or is clinically unstable requiring pressors, deterioration triggered by arrhythmia, infection, or other medical condition unrelated to fluid overload.\n* Patient has any known or visible lower body (non-facial) skin problems (open wounds, ulcers, infections)\n* Patient with severe peripheral arterial disease\n* Patient is pregnant or planning to become pregnant within the study period, or a lactating woman.\n* Renal disease with eGFR \\\u003C25 ml\u002Fmin\u002F1.73 m2\n* Patients with known hypothalamic disorders\n* Patients with known hypohidrosis disorders\n* Patients with medical technology dependency (gastric (G) tubes, ventilators etc.)\n* Patients with cystic fibrosis\n* Patients with active infections\n* Inability or unwillingness to comply with the study requirements\n* Patients with unstable electrolytes or acid-base balance (per investigator's discretion)\n* Known Severe aortic valve or mitral valve stenosis\n* History of a heart transplant or actively listed for a heart transplant or LVAD\n* Implanted left ventricular assist device or implant anticipated \\\u003C3 months\n* Patients with an active, malignant disease and whose life expectancy is \\\u003C 6 months (per investigator's discretion)\n* Unstable or acutely worsening cardiac or renal conditions (per investigator's discretion)","21 Years","80 Years",{"count":20,"type":21},[57],"The REFORM-HF study aims to test a new technology, AquaPass, designed to assist patients experiencing symptoms of fluid overload due to Heart Failure.\n\nPatients will wear a lightweight suit that helps remove excess fluids through their sweat.\n\nThe investigators want to see if the AquaPass system can remove an additional 500mL of fluids during treatment, alongside patients' regular medications like diuretics.\n\nParticipants will select if to be treated at their home or in the outpatient clinic.",[94,27],"Chronic Heart Failure",[96,97,98,99],"Aquapass","Sweat Enhancement","Fluid removal","CHF","RECRUITING","2024-09-17",{"date":103,"type":35},"2024-09-19",{"date":105,"type":35},"2024-09-05",{"date":107,"type":21},"2025-01-29",{"name":109,"class":42},"AquaPass Medical Ltd.",4]