Ignite Creation Date:
2025-12-25 @ 12:34 AM
Ignite Modification Date:
2025-12-26 @ 8:50 PM
Study NCT ID:
NCT07045467
Status:
RECRUITING
Last Update Posted:
2025-10-01
First Post:
2025-06-05
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Remimazolam Infusion in Kidney Transplant Patients: A Multicenter Study
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D051436', 'term': 'Renal Insufficiency, Chronic'}], 'ancestors': [{'id': 'D051437', 'term': 'Renal Insufficiency'}, {'id': 'D007674', 'term': 'Kidney Diseases'}, {'id': 'D014570', 'term': 'Urologic Diseases'}, {'id': 'D052776', 'term': 'Female Urogenital Diseases'}, {'id': 'D005261', 'term': 'Female Urogenital Diseases and Pregnancy Complications'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}, {'id': 'D052801', 'term': 'Male Urogenital Diseases'}, {'id': 'D002908', 'term': 'Chronic Disease'}, {'id': 'D020969', 'term': 'Disease Attributes'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 30}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2025-07-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-09', 'completionDateStruct': {'date': '2027-06-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-09-25', 'studyFirstSubmitDate': '2025-06-05', 'studyFirstSubmitQcDate': '2025-06-22', 'lastUpdatePostDateStruct': {'date': '2025-10-01', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2025-07-01', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-07-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'VDR Genotype Effect on Remimazolam Maximum Plasma Concentration', 'timeFrame': 'Pre-dose (Day 1)', 'description': 'Correlation of VDR polymorphisms with peak concentration'}, {'measure': 'CYP3A Genotype Effect on Remimazolam Area Under the Curve (0 to last measurable t)', 'timeFrame': 'Pre-dose (Day 1)', 'description': 'Correlation of CYP3A polymorphisms with total exposure'}, {'measure': 'POR Genotype Effect on Remimazolam Clearance', 'timeFrame': 'Pre-dose (Day 1)', 'description': 'Correlation of POR polymorphisms with systemic clearance'}, {'measure': 'VDR Genotype Effect on CNS 7054 Terminal Elimination Half-Life', 'timeFrame': 'Pre-dose (Day 1)', 'description': 'Correlation of VDR polymorphisms with metabolite half-life'}], 'primaryOutcomes': [{'measure': 'Remimazolam Plasma Concentration', 'timeFrame': 'During surgery: Pre-infusion, 2/5/10/20/30/45/60/120 minutes, hourly until infusion stop; Post-infusion: 0/5/15/30/60/90/120/240 minutes.', 'description': 'Blood concentration (ng/mL) of Remimazolam'}, {'measure': 'Remimazolam PK Parameters', 'timeFrame': 'During surgery: Pre-infusion, 2/5/10/20/30/45/60/120 minutes, hourly until infusion stop; Post-infusion: 0/5/15/30/60/90/120/240 minutes.', 'description': 'Maximum Plasma Concentration'}, {'measure': 'Remimazolam PK Parameters', 'timeFrame': 'During surgery: Pre-infusion, 2/5/10/20/30/45/60/120 minutes , hourly until infusion stop; Post-infusion: 0/5/15/30/60/90/120/240 minutes', 'description': 'Area Under the Curve (0 to last measurable t)'}, {'measure': 'Remimazolam PK Parameters', 'timeFrame': 'During surgery: Pre-infusion, 2/5/10/20/30/45/60/120 minutes , hourly until infusion stop; Post-infusion: 0/5/15/30/60/90/120/240 minutes', 'description': 'Area Under the Curve (0 to infinity)'}, {'measure': 'Remimazolam PK Parameters', 'timeFrame': 'During surgery: Pre-infusion, 2/5/10/20/30/45/60/120 minutes , hourly until infusion stop; Post-infusion: 0/5/15/30/60/90/120/240 minutes', 'description': 'Time to Cmax'}, {'measure': 'Remimazolam PK Parameters', 'timeFrame': 'During surgery: Pre-infusion, 2/5/10/20/30/45/60/120 minutes , hourly until infusion stop; Post-infusion: 0/5/15/30/60/90/120/240 minutes', 'description': 'Terminal Elimination Half-Life'}, {'measure': 'Remimazolam PK Parameters', 'timeFrame': 'During surgery: Pre-infusion, 2/5/10/20/30/45/60/120 minutes , hourly until infusion stop; Post-infusion: 0/5/15/30/60/90/120/240 minutes', 'description': 'Total Body Clearance'}, {'measure': 'Remimazolam PK Parameters', 'timeFrame': 'During surgery: Pre-infusion, 2/5/10/20/30/45/60/120 minutes , hourly until infusion stop; Post-infusion: 0/5/15/30/60/90/120/240 minutes', 'description': 'Renal Clearance'}, {'measure': 'Remimazolam PK Parameters', 'timeFrame': 'During surgery: Pre-infusion, 2/5/10/20/30/45/60/120 minutes , hourly until infusion stop; Post-infusion: 0/5/15/30/60/90/120/240 minutes', 'description': 'Apparent Volume of Distribution (Terminal)'}, {'measure': 'Remimazolam PK Parameters', 'timeFrame': 'During surgery: Pre-infusion, 2/5/10/20/30/45/60/120 minutes , hourly until infusion stop; Post-infusion: 0/5/15/30/60/90/120/240 minutes', 'description': 'Mean Residence Time'}, {'measure': 'Remimazolam PK Parameters', 'timeFrame': 'Pre-infusion, 2/5/10/20/30/45/60/120 minutes , hourly until infusion stop; Post-infusion: 0/5/15/30/60/90/120/240 minutes', 'description': 'Percentage of AUC Extrapolated'}, {'measure': 'CNS 7054 (Metabolite) PK Parameters', 'timeFrame': 'During surgery: Pre-infusion, 2/5/10/20/30/45/60/120 minutes, hourly until infusion stop; Post-infusion: 0/5/15/30/60/90/120/240 minutes.', 'description': 'Maximum Plasma Concentration'}, {'measure': 'CNS 7054 (Metabolite) PK Parameters', 'timeFrame': 'During surgery: Pre-infusion, 2/5/10/20/30/45/60/120 minutes, hourly until infusion stop; Post-infusion: 0/5/15/30/60/90/120/240 minutes.', 'description': 'Area Under the Curve (0 to last measurable t)'}, {'measure': 'CNS 7054 (Metabolite) PK Parameters', 'timeFrame': 'During surgery: Pre-infusion, 2/5/10/20/30/45/60/120 minutes, hourly until infusion stop; Post-infusion: 0/5/15/30/60/90/120/240 minutes.', 'description': 'Area Under the Curve (0 to infinity)'}, {'measure': 'CNS 7054 (Metabolite) PK Parameters', 'timeFrame': 'During surgery: Pre-infusion, 2/5/10/20/30/45/60/120 minutes, hourly until infusion stop; Post-infusion: 0/5/15/30/60/90/120/240 minutes.', 'description': 'Time to Cmax'}, {'measure': 'CNS 7054 (Metabolite) PK Parameters', 'timeFrame': 'During surgery: Pre-infusion, 2/5/10/20/30/45/60/120 minutes, hourly until infusion stop; Post-infusion: 0/5/15/30/60/90/120/240 minutes.', 'description': 'Terminal Elimination Half-Life'}, {'measure': 'CNS 7054 (Metabolite) PK Parameters', 'timeFrame': 'During surgery: Pre-infusion, 2/5/10/20/30/45/60/120 minutes, hourly until infusion stop; Post-infusion: 0/5/15/30/60/90/120/240 minutes.', 'description': 'Mean Residence Time'}, {'measure': 'CNS 7054 (Metabolite) PK Parameters', 'timeFrame': 'During surgery: Pre-infusion, 2/5/10/20/30/45/60/120 minutes, hourly until infusion stop; Post-infusion: 0/5/15/30/60/90/120/240 minutes.', 'description': 'Percentage of AUC Extrapolated'}, {'measure': 'Sedation Depth (PD)', 'timeFrame': 'Induction: every 1minutes until MOAA/S≤1; Maintenance: every 10 minutes; Recovery: every 2 minutes until 3 consecutive MOAA/S=5.', 'description': 'MOAA/S score (0 to 5) + Narcotrend Index (NCI 0 to 100)'}, {'measure': 'Time to Loss of Consciousness (MOAA/S ≤1)', 'timeFrame': '0 to 10 minutes after infusion start', 'description': 'Time from infusion start to first MOAA/S score ≤1'}, {'measure': 'Time to Full Alertness (3 consecutive MOAA/S=5)', 'timeFrame': 'Time from infusion stop to sustained alertness', 'description': 'Time from infusion stop to sustained alertness'}, {'measure': 'Narcotrend Index (NCI) Values', 'timeFrame': 'Continuous monitoring during infusion + 30 min post-stop', 'description': 'Anesthesia depth index (0-100 scale)'}], 'secondaryOutcomes': [{'measure': 'Postoperative Urine Output', 'timeFrame': 'Postoperation Days 1 to 6', 'description': '24-hour urine volume'}, {'measure': 'Serum Creatinine Level', 'timeFrame': 'Preoperation, Postoperation Days 1 to 6', 'description': 'Blood creatinine concentration'}, {'measure': 'Estimated Glomerular Filtration Rate', 'timeFrame': 'Preoperation, Postoperation Days 1 to 6', 'description': 'Kidney filtration rate'}, {'measure': 'Intraoperative Hypotension Incidence', 'timeFrame': 'Intra-operative period', 'description': 'MAP \\<65 mmHg for \\>1 minute'}, {'measure': 'Intraoperative Bradycardia Incidence', 'timeFrame': 'Intra-operative period', 'description': 'HR \\<45 bpm for \\>1 min'}, {'measure': 'Injection Pain Incidence', 'timeFrame': 'During induction (0 to 10 minutes)', 'description': 'Participant-reported pain during drug administration'}, {'measure': 'Postoperative Nausea/Vomiting Incidence', 'timeFrame': 'PACU admission to Postoperation Day 6', 'description': 'Postoperative Nausea/Vomiting occurrence'}, {'measure': 'Postoperative Agitation Incidence', 'timeFrame': 'PACU stay (0 to 2 hours)', 'description': 'RASS score ≥2'}, {'measure': 'Delayed Recovery Incidence', 'timeFrame': 'End of surgery to PACU discharge', 'description': 'Extubation time \\>30 min post-surgery'}, {'measure': 'Intraoperative Awareness Incidence', 'timeFrame': 'Upon PACU discharge (Day 1)', 'description': 'Positive Brice questionnaire response'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Chronic Kidney Diseases', 'Renal Transplantation']}, 'descriptionModule': {'briefSummary': "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 (T1/2)? What is the effect of remimazolam on consciousness, as measured by the MOAA/S 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/S 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"}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria Signed informed consent\n\nAge ≥18 years and \\<65 years\n\nChronic renal failure scheduled for renal transplantation\n\nBody mass index (BMI) 18-30 kg/m² (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/device 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/inducers within 30 days prior (per Appendix 1)\n\nKnown hypersensitivity to ≥2 substances\n\nAlcohol consumption \\>14 units/week within 6 months prior\\*\n\nDrug abuse history within 3 months prior\n\nMajor infection/trauma 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/donation \\>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'}, 'identificationModule': {'nctId': 'NCT07045467', 'briefTitle': 'Remimazolam Infusion in Kidney Transplant Patients: A Multicenter Study', 'organization': {'class': 'OTHER', 'fullName': 'Qianfoshan Hospital'}, 'officialTitle': 'Pharmacokinetics and Pharmacodynamics of Continuous Infusion of Remimazolam in Kidney Transplant Recipients: A Multicenter Interventional Study', 'orgStudyIdInfo': {'id': 'YXLL-KY-2024(103)'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'All enrolled participants receive Remimazolam Besylate via continuous IV infusion', 'description': '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/vial) reconstituted with sterile water.\n2. Dosing Regimen:\n\n * Induction: Continuous IV infusion at 6 mg/kg/h until loss of consciousness (defined as MOAA/S score ≤1).\n * Maintenance: Titrated IV infusion (0.5-2 mg/kg/h) 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/kg induction; 10 μg at peritoneum closure) + Remifentanil infusion intraoperatively.\n * Muscle Relaxant: Rocuronium (0.6 mg/kg induction; 0.15 mg/kg 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', 'interventionNames': ['Drug: Remimazolam Besylate']}], 'interventions': [{'name': 'Remimazolam Besylate', 'type': 'DRUG', 'description': "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/kg/h until MOAA/S ≤1 (vs. 5-12 mg/kg/h in general surgery).\n\nMaintenance: Titrated (0.5-2 mg/kg/h) 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/propofol) to isolate Remimazolam's effects.\n\nPK/PD 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/", 'armGroupLabels': ['All enrolled participants receive Remimazolam Besylate via continuous IV infusion']}]}, 'contactsLocationsModule': {'locations': [{'zip': '250014', 'city': 'Jinan', 'state': 'Shangdong', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'jianbo wu', 'role': 'CONTACT', 'email': 'jianbowu@126.com', 'phone': '+8613805319310'}, {'name': 'Chengjie Gao', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Zhaoyang Xiao', 'role': 'SUB_INVESTIGATOR'}], 'facility': 'Shandong First Medical University Hospital', 'geoPoint': {'lat': 36.66833, 'lon': 116.99722}}], 'centralContacts': [{'name': 'guanghan wu', 'role': 'CONTACT', 'email': 'guanghanwu2021@163.com', 'phone': '+8618763995357'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Qianfoshan Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Department of Anesthesiology and Perioperative Medicine', 'investigatorFullName': 'Guanghan Wu', 'investigatorAffiliation': 'Qianfoshan Hospital'}}}}