[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"kidney-diseases-chronic\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:kidney-diseases-chronic":29},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,3,0,[8,46,93],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":15,"eligibilityCriteria":16,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":19,"enrollmentInfo":20,"targetDuration":4,"studyType":23,"phases":24,"briefSummary":26,"conditions":27,"keywords":4,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":35,"lastUpdatePostDateStruct":36,"startDateStruct":39,"completionDateStruct":41,"leadSponsor":43,"locationsCount":4},"100622168","phase-4-anrikefon-vs-nalfurafine-for-sleep-quality-in-hemodialysis-patients-with-ckd-ap-100622168",false,"NCT07380113","Anrikefon vs Nalfurafine for Sleep Quality in Hemodialysis Patients With CKD-aP","An Exploratory Study Comparing Anrikefon With Nalfurafine in Improving Sleep Quality Among CKD-aP Patients Undergoing Hemodialysis: An Open-Label Randomized Controlled Clinical Trial","Anrikefon","Inclusion Criteria:\n\n1. Be able to understand the procedures and methods of this trial, be willing to strictly follow the clinical research protocol to complete this trial, and voluntarily sign the informed consent form.\n2. Male or female individuals aged 18 or above and 75 or above.\n3. Patients with end-stage renal disease received regular hemodialysis three times a week before the screening period (whether they met the requirements for regular dialysis was determined based on the opinions of the researchers).\n4. Meet the diagnostic criteria for chronic kidney disease-associated pruritus (CKD-aP).\n\n   1. Patients with chronic kidney disease (CKD) presenting with pruritus, with other identifiable causes of pruritus excluded.\n   2. Pruritus occurring on at least 3 days within a 2-week period, with multiple episodes per day, each lasting for several minutes, and having an impact on the patient's daily life.\n   3. Recurrent pruritus persisting for at least 6 weeks.A diagnosis requires that all three criteria above be met simultaneously.\n5. The subjects were evaluated using the Worst Itch Numerical Rating Scale (WI-NRS) for the most severe pruritus intensity and met the baseline pruritus intensity of ≥ 4 points.\n6. The subjects have completed the Pittsburgh Sleep Quality Index (PSQI) assessment during the screening period and met the baseline PSQI score \\> 7 points.\n\nExclusion Criteria:\n\n1. Participants with other serious systemic diseases that may affect their ability to participate in the study, as assessed by the investigator, including but not limited to:\n\n   1. Severe cardiovascular diseases, such as unstable angina, myocardial infarction, severe arrhythmias, World Health Organization (WHO) heart function classification III-IV during screening, poorly controlled hypertension or hypotension despite active treatment, and recurrent asthma.\n   2. A history of cerebrovascular accident (CVA) within the last 6 months.\n   3. Malignant tumors, excluding those that are curable, such as cervical carcinoma in situ, basal cell carcinoma or squamous cell carcinoma of the skin, or any other cancer that has been cured (with no evidence of disease recurrence for 5 years).\n2. It is expected to undergo kidney transplantation and\u002For parathyroidectomy during the study period.\n3. The subjects are currently undergoing ultraviolet B treatment or are expected to receive such treatment during the study period.\n4. Have participated in any clinical trials of other drugs or medical devices within one month prior to screening (treatment with drugs or medical devices that have received clinical trials).\n5. Patients who have used the following drugs within 7 days before screening:\n\n   1. those who have used opioids.\n   2. those who must use opioids other than the investigational drug during the study period.\n   3. those who has used gabapentin, pregabalin and calcineurin inhibitors;\n   4. those who use drugs that can affect the efficacy judgment of anti-itching, including but not limited to antipsychotic drugs, sedative-hypnotic drugs, selective serotonin reuptake inhibitors (SSRIs), anti-anxiety drugs, or tricyclic antidepressants.\n6. After screening and enrollment, new antihistamines (such as antihistamines and corticosteroids, etc. (oral, intravenous or topical)) were prescribed, or the types, dosages or frequencies of these drugs were changed.\n7. Patients who have used any hypnotic or sedative medications (including benzodiazepine hypnotics, non-benzodiazepine hypnotics, melatonin receptor agonists, etc.) within 1 month prior to the screening period and baseline assessment.\n8. There is a history of allergy to opioid drugs, or it is known that there is a history of allergy to investigatory drugs or components of remedial drugs or other drugs or excipients with similar chemical structures.\n9. Severe hematological and liver function abnormalities during screening, meeting any one of the following clinical laboratory test results:\n\n   1. Hematology: Hemoglobin \\\u003C 80g\u002FL.\n   2. Liver function:\n\n      * Alanine aminotransferase (ALT) or aspartate aminotransferase (AST) \\> 2.5× upper limit of normal (ULN).\n      * Total bilirubin (TBIL) \\> 2×ULN.\n10. Subjects who had any active infections during screening and whom the researchers considered unsuitable for inclusion (including but not limited to acute hepatitis, skin infections, etc.).\n11. As determined by the researchers, any other physical or mental illness or condition that may increase the risk of the trial, affect the subjects' compliance with the protocol, or affect the subjects' completion of the trial.","ALL","18 Years","75 Years",{"count":21,"type":22},50,"ESTIMATED","INTERVENTIONAL",[25],"PHASE4","The goal of this clinical trial is to compare a new intravenous drug, Anruikefen, with a traditional oral medication, nalfurafine orally disintegrating tablets, in improving sleep quality in patients with chronic kidney disease-associated pruritus. Sleep quality will be primarily assessed using the Pittsburgh Sleep Quality Index (PSQI). The study will also evaluate the safety of Anruikefen.\n\nThe main questions it aims to answer are:\n\n* Does Anruikefen injection improve sleep quality better than oral nalfurafine?\n* Does Anruikefen injection improve patients' quality of life more than oral nalfurafine? Researchers will compare Anruikefen with nalfurafine (an active control drug) to evaluate differences in their effects on sleep quality in patients with chronic kidney disease-associated pruritus.\n\nParticipants will:\n\n* Receive either Anruikefen injection (0.3 μg\u002Fkg, three times per week) or nalfurafine hydrochloride orally disintegrating tablets (2.5 μg once daily).\n* Continue treatment for 4 weeks, followed by a 1-week safety follow-up.\n* Complete the Pittsburgh Sleep Quality Index and other quality-of-life questionnaires after one month.",[28,29,30,31,32,33],"Pruritus Chronic","Kidney Diseases, Chronic","Renal Insufficiency, Chronic","Uremia; Chronic","Pruritus Due to Systemic Disorder (Disorder)","Pruritus Due to Hemodialysis","NOT_YET_RECRUITING","2026-06-14",{"date":37,"type":38},"2026-06-16","ACTUAL",{"date":40,"type":22},"2026-07-01",{"date":42,"type":22},"2027-12-31",{"name":44,"class":45},"Zhujiang Hospital","OTHER",{"id":47,"slug":48,"hasResults":11,"nctId":49,"briefTitle":50,"officialTitle":51,"acronym":4,"eligibilityCriteria":52,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":53,"enrollmentInfo":54,"targetDuration":4,"studyType":23,"phases":56,"briefSummary":58,"conditions":59,"keywords":67,"overallStatus":81,"whyStopped":4,"lastUpdateSubmitDate":82,"lastUpdatePostDateStruct":83,"startDateStruct":85,"completionDateStruct":87,"leadSponsor":89,"locationsCount":92},"100582054","phase-3-open-label-extension-study-of-zigakibart-in-adults-with-iga-nephropathy-100582054","NCT06858319","Open-label Extension Study of Zigakibart in Adults With IgA Nephropathy.","A Multicenter Open-label Extension Study to Evaluate the Long-term Safety and Tolerability of Zigakibart in Adults With Primary IgA Nephropathy.","Inclusion Criteria:\n\n1. Signed informed consent must be obtained prior to participation in the OLE study.\n2. Completion of the parent study (both participants assigned to receive the investigational product and placebo) as defined by the respective protocol.\n3. Per Investigator's clinical judgment, the participant may benefit from receiving open-label treatment of zigakibart 600 mg s.c. Q2W.\n\nExclusion Criteria:\n\n1. Participants who prematurely withdrew from zigakibart parent studies in IgAN for any reason.\n2. Participants who at the time of first study treatment administration in the OLE are receiving chronic dialysis (≥30 days) or who require kidney transplantation.\n3. Acute kidney injury (AKI), defined by AKIN criteria (Mehta et al 2007) within 4 weeks of first study treatment administration in the OLE study.\n4. Clinical suspicion or diagnosis of rapidly progressive glomerulonephritis (RPGN), defined by KDIGO guidelines, or another glomerulopathy at the time of first study treatment administration in the OLE study.\n5. Received a live vaccination within 12 weeks prior to first study treatment administration in the OLE study or plan to have a live vaccination within 6 months after the last dose of study treatment.\n6. Use of systemic corticosteroid therapy (including budesonide) or other immunosuppressive therapy such as but not limited to mycophenolate, azathioprine, cyclosporine, tacrolimus, cyclophosphamide, etc., and herbs such as Tripterygium Wilfordii Hook F, Caulis sinomenii, and Sinomenium acutum for \\> 2 weeks in the 12 weeks prior to first study treatment administration in the OLE study; use of rituximab within 180-days of first study treatment administration in the OLE study.\n7. Current severe infection at the time of first study treatment in the OLE study or history of recurrent, severe, infections as determined by the Investigator.\n8. Newly diagnosed positive serology for hepatitis A virus IgM antibodies (anti-HAV IgM), hepatitis B surface antigen (HBsAg), detectable hepatitis B virus (HBV) DNA, hepatitis C virus (HCV) antibodies (participants who completed treatment and are persistently antibody positive but have documentation of negative HCV polymerase chain reaction \\[PCR\\] will be allowed), or antibodies to HIV-1 and\u002For HIV-2.\n9. Newly diagnosed malignancy (participants with basal cell carcinoma that was completely resected or curatively treated cervical carcinoma in situ or low-risk prostate cancer (i.e., Gleason score \\\u003C 7 and prostate specific antigen \\\u003C 10 ng\u002FmL) are eligible for the study).\n10. Pregnancy or breastfeeding or intent to become pregnant or to donate sperm during the study period and until 24 weeks after last dose.\n11. History or evidence of any other clinically significant medical or psychiatric disorder, condition, disease, or laboratory finding that, in the discretion of the Investigator, constitutes an uncertain or unfavorable benefit-risk for continued long-term therapy with zigakibart.\n12. Confirmed IgG levels \\\u003C 3 g\u002FL prior to first study treatment administration in the OLE study.\n13. Women of child-bearing potential, defined as all women physiologically capable of becoming pregnant, from menarche until becoming post-menopausal unless they are using highly effective methods of contraception (failure rate \\\u003C 1% per year) while taking study treatment and for 24 weeks after stopping study treatment. Women are considered post-menopausal if they have had 12 months of natural (spontaneous) amenorrhea with an appropriate clinical profile (e.g., hormonal profile confirming menopause and\u002For age-appropriate history of vasomotor symptoms).\n14. Sexually active males unwilling to use a highly effective methods of contraception during intercourse while taking study treatment and for 24 weeks after stopping study treatment. In addition, male participants must not donate sperm for the time period specified above.\n\nHighly effective contraception methods for both women and men include:\n\n* Total abstinence (when this is in line with the preferred and usual lifestyle of the participant). Note that periodic abstinence (e.g., calendar, ovulation, symptothermal, post-ovulation methods) and withdrawal are not acceptable methods of contraception.\n* Bilateral oophorectomy with or without hysterectomy, total hysterectomy or bilateral salpingectomy at least six weeks before taking study treatment. In case of oophorectomy alone, only when the reproductive status of the woman has been confirmed by follow up hormone level assessment are they considered to be not of childbearing potential.\n* Bilateral tubal occlusion, bilateral tubal ligation (at least six weeks before taking study treatment).\n* Sterilization (vasectomy) of male partner(s) of the female participant at least 6 months prior to first study treatment provided partner(s) has(have) received medical confirmation of surgical success.\n* Use of hormonal contraception methods:\n* Combined (estrogen and progestogen containing) hormonal contraception associated with inhibition of ovulation; oral, intravaginal or transdermal.\n* Progestogen-only hormonal contraception (where inhibition of ovulation is not the primary or only mode of action): oral, injectable or implantable.\n* Intrauterine device (IUD) or intrauterine hormone-releasing system (IUS). In case of use of hormonal contraception, women should have been stable on the same method for a minimum of 3 months before taking study treatment.","100 Years",{"count":55,"type":22},220,[57],"PHASE3","The purpose of this study is to determine if zigakibart is safe and effective for long-term use in patients with immunoglobulin A nephropathy (IgAN). This is an extension study for patients who have already completed an another zigakibart study.",[60,29,61,62,63,64,65,66],"Kidney Diseases","Urological Diseases","Glomerulonephritis","Glomerular Disease","Glomerulonephritis, IGA","Glomerulopathy","Immunoglobulin Disease",[68,69,70,71,72,62,73,74,75,60,64,76,77,78,79,80],"Urologic Diseases","Female Urogenital Diseases","Female Urogenital Diseases and Pregnancy Complications","Urogenital Diseases","Male Urogenital Diseases","Nephritis","Autoimmune Diseases","Immune System Diseases","Primary IgA \u002F Immunoglobulin A nephropathy","eGFR","UPCR","UACR","FUB523","RECRUITING","2026-05-28",{"date":84,"type":38},"2026-06-01",{"date":86,"type":38},"2025-07-28",{"date":88,"type":22},"2031-06-25",{"name":90,"class":91},"Novartis Pharmaceuticals","INDUSTRY",18,{"id":94,"slug":95,"hasResults":11,"nctId":96,"briefTitle":97,"officialTitle":98,"acronym":99,"eligibilityCriteria":100,"healthyVolunteers":101,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":102,"targetDuration":4,"studyType":104,"phases":4,"briefSummary":105,"conditions":106,"keywords":4,"overallStatus":81,"whyStopped":4,"lastUpdateSubmitDate":111,"lastUpdatePostDateStruct":112,"startDateStruct":114,"completionDateStruct":115,"leadSponsor":117,"locationsCount":119},"100609665","rutgers-university-study-of-the-genetics-of-kidney-disease-100609665","NCT07217535","Rutgers University Study of the Genetics of Kidney Disease","The Rutgers University Study of the Genetics of Kidney Disease","rugcc-kd","Inclusion Criteria:\n\n* age 18 years or older\n* currently living in the United States\n* able to understand and follow written instructions in English\n* have access to the internet and a computer, laptop, tablet or smart phone\n* willing to provide written informed consent for participation\n* willing to provide DNA via a saliva sample using a collection kit mailed to the study participant's home\n* willing to complete a survey with questions about health related to the study of kidney disease\n\nExclusion Criteria:\n\n* Not able to meet or fulfill any of the inclusion criter",true,{"count":103,"type":22},50000,"OBSERVATIONAL","The goal of this observational study is to learn more about how genes impact the risk of kidney disease. Anyone 18 or older living in the US is eligible, and a diagnosis of kidney disease is NOT required. Study participation is online, and it takes about 20 minutes to complete health surveys and request a saliva collection kit sent through US mail. In return, study participants may opt to receive information about their genetic ancestry at no cost.",[107,108,109,60,29,110],"Kidney Disease","Kidney Disease, Chronic","Kidney Disease, End-Stage","Kidney Diseases,Cystic","2026-04-23",{"date":113,"type":38},"2026-04-24",{"date":111,"type":38},{"date":116,"type":22},"2028-10-31",{"name":118,"class":45},"Rutgers, The State University of New Jersey",1]