[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"ckd-stage-4\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:ckd-stage-4":28},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,3,0,[8,44,70],{"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":48,"acronym":4,"eligibilityCriteria":49,"healthyVolunteers":11,"sex":16,"minAge":50,"maxAge":4,"enrollmentInfo":51,"targetDuration":4,"studyType":22,"phases":53,"briefSummary":55,"conditions":56,"keywords":4,"overallStatus":58,"whyStopped":4,"lastUpdateSubmitDate":59,"lastUpdatePostDateStruct":60,"startDateStruct":62,"completionDateStruct":64,"leadSponsor":66,"locationsCount":69},"100591565","phase-3-effects-of-sodium-glucose-cotransporter-2-inhibitors-on-kidney-function-in-advanced-chronic-kidney-disease-100591565","NCT06982079","Effects of Sodium-Glucose Cotransporter 2 Inhibitors on Kidney Function in Advanced Chronic Kidney Disease","Inclusion Criteria:\n\n* Adult patients aged eighteen or older.\n* Patients with advanced chronic kidney disease (i.e., eGFR \\\u003C 20 mL\u002Fmin\u002F1.73m2)not on dialysis\n\nExclusion Criteria:\n\n* Autosomal dominant polycystic kidney disease (ADPKD).\n* Type 1 diabetes mellitus\n* Patients on SGLT2 inhibitors.\n* History of ketoacidosis in the last 3 months.\n* Known hypersensitivity to SGLT2 inhibitors.\n* Known hepatic impairment.\n* Pregnant or breastfeeding females.","18 Years",{"count":52,"type":21},60,[54],"PHASE3","The goal of this clinical trial is to evaluate whether dapagliflozin can reduce the risk of worsening kidney function or death from cardiovascular or renal causes in adults with advanced chronic kidney disease (CKD), with or without type 2 diabetes. The main questions it aims to answer are:\n\n1. Does dapagliflozin reduce the rate of decline in kidney function or progression to end-stage kidney disease in adults with advanced CKD?\n2. Does dapagliflozin reduce the risk of death from cardiovascular or renal causes in patients with advanced CKD?\n\nResearchers will compare dapagliflozin to a placebo to see if dapagliflozin improves kidney and cardiovascular outcomes in this high-risk population.",[57,28],"Chronic Kidney Disease Stage 5","RECRUITING","2025-05-19",{"date":61,"type":35},"2025-05-21",{"date":63,"type":35},"2025-05-01",{"date":65,"type":21},"2026-11-01",{"name":67,"class":68},"Ain Shams University","OTHER",1,{"id":71,"slug":72,"hasResults":11,"nctId":73,"briefTitle":74,"officialTitle":75,"acronym":4,"eligibilityCriteria":76,"healthyVolunteers":11,"sex":16,"minAge":77,"maxAge":78,"enrollmentInfo":79,"targetDuration":4,"studyType":22,"phases":81,"briefSummary":83,"conditions":84,"keywords":4,"overallStatus":58,"whyStopped":4,"lastUpdateSubmitDate":89,"lastUpdatePostDateStruct":90,"startDateStruct":92,"completionDateStruct":94,"leadSponsor":96,"locationsCount":69},"100478287","phase-1-early-trial-of-allogeneic-hematopoietic-stem-cell-transplantation-for-patients-who-will-receive-a-kidney-transplant-from-the-same-donor-100478287","NCT05508009","Early Trial of Allogeneic Hematopoietic Stem Cell Transplantation for Patients Who Will Receive a Kidney Transplant From the Same Donor","Phase 1b\u002F2a Trial of Allogeneic Hematopoietic Stem Cell Transplantation (HSCT) From an HLA-partially Matched Related or Unrelated Donor After TCRαβ+ T-cell\u002FCD19+ B-cell Depletion for Patients Who Will Receive a Kidney Transplant (KT) From the Same HSCT\u002FKT Donor","Inclusion Criteria:\n\n* Anticipated need for kidney transplant due to:\n\n  a. Underlying genetic\u002Fimmunologic disease the following conditions i. SIOD ii. FSGS iii. Cystinosis iv. SLE v. Membranoproliferative glomerulonephritis vi. Renal vasculitis characterized by positivity of the presence of ANCA vii. Other genetic diseases leading to kidney disease requiring KT Or b. Patients who have rejected a previous KT regardless of the underlying disease\n* Chronic kidney disease (CKD) stage 3 or greater\n* Steroids \\\u003C 0.5 mg\u002FKg\u002Fday\n* The donor and recipient must be identical, as determined by high resolution typing, at least one allele of each of the following genetic loci: HLA-A, HLA-B, HLA-Cw, HLA-DQB1 and HLA-DRB1\n* Lansky\u002FKarnofsky score \\> 50; the Karnofsky Scale will be used in subjects ≥ 16 years of age, and the Lansky Scale will be used for those \\\u003C 16 years of age.\n* Able to give informed consent or have an LAR available to provide consent\n* Male and female subjects of childbearing potential must agree to use an effective means of birth control to avoid pregnancy throughout the transplant procedure, while on immunosuppression, and if the subject experiences any cGvHD\n\nExclusion Criteria:\n\n* Pregnant or lactating females.\n* Greater than Grade II aGvHD or severe, unmanaged extensive cGvHD due to a previous allograft at the time of inclusion\n* Dysfunction of liver (ALT\u002FAST \\> 10 times upper normal value, or direct bilirubin \\> 3 times upper normal value), unmanageable dysfunction of renal function while undergoing dialysis\n* Severe cardiovascular disease at the time of evaluation unresponsive to nutritional and dialytic support (left ventricular ejection fraction \\\u003C 40%), or clinical or echocardiographic evidence of severe diastolic dysfunction\n* Current active infectious disease. Human immunodeficiency virus (HIV)-infected patients on effective anti-retroviral therapy with undetectable viral load within 6 months are eligible for this trial. For patients with evidence of chronic hepatitis B virus (HBV) infection, the HBV viral load must be undetectable on suppressive therapy, if indicated. Patients with a history of hepatitis C virus (HCV) infection must have been treated and cured. Patients with HCV infection who are currently on treatment are eligible if they have an undetectable HCV viral load.\n* Serious concurrent uncontrolled medical disorders except for primary disease leading to chronic kidney disease\n* Lack of patient\u002Fparent\u002Fguardian informed consent\n* Any severe concurrent disease which, in the judgement of the investigator would place the patient at increased risk during participation in the study","1 Year","30 Years",{"count":80,"type":21},12,[82,24],"PHASE1","This is a single center, non-randomized, non-controlled open-label phase 1b\u002F2a trial of performing sequential αβdepleted-HSCT and KT in patients requiring KT to prevent kidney rejection post-KT, in the absence of any post-KT immunosuppression, to abrogate the need for lifelong immunosuppression, the risk of chronic rejection and, ultimately, the need for repeated transplantation.",[85,86,87,88,28],"SIOD","Cystinosis","FSGS","SLE Nephritis","2023-07-13",{"date":91,"type":35},"2023-07-17",{"date":93,"type":35},"2023-01-10",{"date":95,"type":21},"2034-10",{"name":97,"class":68},"Alice Bertaina"]