[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100596439":3},{"organization":4,"armGroups":7,"interventions":14,"overallOfficials":20,"centralContacts":21,"locations":27,"responsibleParty":52,"collaborators":20,"id":56,"slug":57,"hasResults":58,"nctId":59,"briefTitle":60,"officialTitle":61,"acronym":20,"eligibilityCriteria":62,"healthyVolunteers":58,"sex":63,"minAge":64,"maxAge":65,"enrollmentInfo":66,"targetDuration":20,"studyType":69,"phases":70,"briefSummary":72,"conditions":73,"keywords":20,"overallStatus":30,"whyStopped":20,"lastUpdateSubmitDate":76,"lastUpdatePostDateStruct":77,"startDateStruct":80,"completionDateStruct":82,"leadSponsor":84,"locationsCount":85},{"fullName":5,"class":6},"Qianfoshan Hospital","OTHER",[8],{"label":9,"type":10,"description":11,"interventionNames":12},"All enrolled participants receive Remimazolam Besylate via continuous IV infusion","EXPERIMENTAL","All enrolled participants receive a standardized Remimazolam Besylate-based anesthesia protocol for renal transplant surgery, as follows:\n\n1. Intervention Drug:\n\n   ◦ Remimazolam Besylate (Trade name: Rymazol®), supplied as a lyophilized powder (25 mg\u002Fvial) reconstituted with sterile water.\n2. Dosing Regimen:\n\n   * Induction: Continuous IV infusion at 6 mg\u002Fkg\u002Fh until loss of consciousness (defined as MOAA\u002FS score ≤1).\n   * Maintenance: Titrated IV infusion (0.5-2 mg\u002Fkg\u002Fh) to maintain target anesthesia depth (Narcotrend Index: 27-60) until end of surgery.\n3. Ancillary Medications (per protocol §7.2):\n\n   * Analgesia: Sufentanil (0.4-0.5 μg\u002Fkg induction; 10 μg at peritoneum closure) + Remifentanil infusion intraoperatively.\n   * Muscle Relaxant: Rocuronium (0.6 mg\u002Fkg induction; 0.15 mg\u002Fkg bolus PRN).\n   * Immunosuppression: Methylprednisolone 750 mg + Furosemide 60 mg pre-reperfusion.\n   * Prohibited Agents: Sevoflurane, propofol, midazolam, dexmedetomidine, or etomidate.\n4. Depth Monitoring:\n\n   * Real-time Narcot",[13],"Drug: Remimazolam Besylate",[15],{"type":16,"name":17,"description":18,"armGroupLabels":19,"otherNames":20},"DRUG","Remimazolam Besylate","This is the first clinical trial evaluating Remimazolam's pharmacokinetics (PK), pharmacodynamics (PD), and safety in renal transplant recipients-a population with unique physiological alterations due to end-stage renal disease and graft reperfusion. Key differentiators include:\n\nPopulation-Specific Dosing Protocol:\n\nInduction: 6 mg\u002Fkg\u002Fh until MOAA\u002FS ≤1 (vs. 5-12 mg\u002Fkg\u002Fh in general surgery).\n\nMaintenance: Titrated (0.5-2 mg\u002Fkg\u002Fh) to Narcotrend Index 27-60 (lower than typical BIS 40-60 targets), accounting for altered drug metabolism post-transplant.\n\nTransplant-Specific Context:\n\nAdministered alongside standard immunosuppressants (methylprednisolone 750 mg + furosemide 60 mg at reperfusion) but prohibits common sedatives (midazolam\u002Fpropofol) to isolate Remimazolam's effects.\n\nPK\u002FPD sampling accounts for graft function dynamics (e.g., blood draws during reperfusion and post-op days 1-6).\n\nExploratory Genetic Analysis:\n\nFirst study linking VDR\u002F",[9],null,[22],{"name":23,"role":24,"phone":25,"phoneExt":20,"email":26},"guanghan wu","CONTACT","+8618763995357","guanghanwu2021@163.com",[28],{"facility":29,"status":30,"city":31,"state":32,"zip":33,"country":34,"countryCode":35,"cosmosGeoPoint":36,"geoPoint":41,"contacts":42},"Shandong First Medical University Hospital","RECRUITING","Jinan","Shangdong","250014","China","CN",{"type":37,"coordinates":38},"Point",[39,40],116.99722,36.66833,{"lat":40,"lon":39},[43,47,50],{"name":44,"role":24,"phone":45,"phoneExt":20,"email":46},"jianbo wu","+8613805319310","jianbowu@126.com",{"name":48,"role":49,"phone":20,"phoneExt":20,"email":20},"Chengjie Gao","SUB_INVESTIGATOR",{"name":51,"role":49,"phone":20,"phoneExt":20,"email":20},"Zhaoyang Xiao",{"type":53,"investigatorFullName":54,"investigatorTitle":55,"investigatorAffiliation":5,"oldNameTitle":20,"oldOrganization":20},"PRINCIPAL_INVESTIGATOR","Guanghan Wu","Department of Anesthesiology and Perioperative Medicine","100596439","phase-1-remimazolam-infusion-in-kidney-transplant-patients-a-multicenter-study-100596439",false,"NCT07045467","Remimazolam Infusion in Kidney Transplant Patients: A Multicenter Study","Pharmacokinetics and Pharmacodynamics of Continuous Infusion of Remimazolam in Kidney Transplant Recipients: A Multicenter Interventional Study","Inclusion Criteria Signed informed consent\n\nAge ≥18 years and \\\u003C65 years\n\nChronic renal failure scheduled for renal transplantation\n\nBody mass index (BMI) 18-30 kg\u002Fm² (inclusive)\n\nWeight ≥50 kg (males) or ≥45 kg (females)\n\nASA physical status classification III or IV\n\nExclusion Criteria Hepatic, psychiatric, or neurological disorders\n\nCoagulopathy\n\nHeart failure\n\nRespiratory failure\n\nLong-term sedative or antidepressant use\n\nPregnancy or lactation\n\nInability to communicate or cooperate\n\nParticipation in other drug\u002Fdevice trials within 3 months prior\n\nPositive hepatitis B surface antigen (HBsAg)\n\nPositive hepatitis C antibody (HCV-Ab)\n\nPositive HIV antibody\n\nPositive syphilis antibody\n\nUse of hepatic enzyme inhibitors\u002Finducers within 30 days prior (per Appendix 1)\n\nKnown hypersensitivity to ≥2 substances\n\nAlcohol consumption \\>14 units\u002Fweek within 6 months prior\\*\n\nDrug abuse history within 3 months prior\n\nMajor infection\u002Ftrauma within 1 month prior\n\nGastrointestinal surgery affecting drug absorption within 1 month prior\n\nVaccination within 1 month prior or planned during study\n\nBlood loss\u002Fdonation \\>400 mL within 3 months prior\n\nBlood transfusion within 1 month prior\n\nINR \\>1.5, PT \\>ULN+4 seconds, or APTT \\>15×ULN\n\nSignificant bleeding history within 3 months prior\n\nCurrent anticoagulant therapy\n\nAny condition deemed unsuitable by investigator","ALL","18 Years","65 Years",{"count":67,"type":68},30,"ESTIMATED","INTERVENTIONAL",[71],"PHASE1","The goal of this clinical trial is to evaluate the pharmacokinetics (PK) and pharmacodynamics (PD) of remimazolam (CNS 70754) in healthy adult participants. The main questions it aims to answer are:\n\nWhat are the key pharmacokinetic parameters of remimazolam, including peak concentration (Cmax), time to peak concentration (Tmax), area under the curve (AUC), and elimination half-life (T1\u002F2)? What is the effect of remimazolam on consciousness, as measured by the MOAA\u002FS scale and Narcotrend monitoring during anesthesia? Researchers will compare the pharmacokinetic and pharmacodynamic effects of remimazolam to see if the drug provides consistent and predictable sedation without significant adverse effects.\n\nParticipants will:\n\nReceive continuous Infusion of Remimazolam. Have blood samples taken at various time points to measure plasma concentrations and calculate PK parameters.\n\nBe monitored for consciousness and sedation levels using the MOAA\u002FS scale and Narcotrend.\n\nUndergo safety assessments, including laboratory tests, vital signs monitoring, and physical examinations throughout the study.\n\nThis study will help determine the drug's behavior in the body and its impact on sedation, providing valuable information for its future clinical use in anesthesia and other medical applications.\n\nLast updated on December 22, 2024",[74,75],"Chronic Kidney Diseases","Renal Transplantation","2025-09-25",{"date":78,"type":79},"2025-10-01","ACTUAL",{"date":81,"type":79},"2025-07-01",{"date":83,"type":68},"2027-06-01",{"name":5,"class":6},1]