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
Qianfoshan Hospital
30 participants
Jul 1, 2025
INTERVENTIONAL
Conditions
Summary
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: What 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. Participants will: Receive continuous Infusion of Remimazolam. Have blood samples taken at various time points to measure plasma concentrations and calculate PK parameters. Be monitored for consciousness and sedation levels using the MOAA/S scale and Narcotrend. Undergo safety assessments, including laboratory tests, vital signs monitoring, and physical examinations throughout the study. This 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. Last updated on December 22, 2024
Eligibility
Inclusion Criteria5
- Age ≥18 years and \<65 years
- Chronic renal failure scheduled for renal transplantation
- Body mass index (BMI) 18-30 kg/m² (inclusive)
- Weight ≥50 kg (males) or ≥45 kg (females)
- ASA physical status classification III or IV
Exclusion Criteria24
- Coagulopathy
- Heart failure
- Respiratory failure
- Long-term sedative or antidepressant use
- Pregnancy or lactation
- Inability to communicate or cooperate
- Participation in other drug/device trials within 3 months prior
- Positive hepatitis B surface antigen (HBsAg)
- Positive hepatitis C antibody (HCV-Ab)
- Positive HIV antibody
- Positive syphilis antibody
- Use of hepatic enzyme inhibitors/inducers within 30 days prior (per Appendix 1)
- Known hypersensitivity to ≥2 substances
- Alcohol consumption \>14 units/week within 6 months prior\*
- Drug abuse history within 3 months prior
- Major infection/trauma within 1 month prior
- Gastrointestinal surgery affecting drug absorption within 1 month prior
- Vaccination within 1 month prior or planned during study
- Blood loss/donation \>400 mL within 3 months prior
- Blood transfusion within 1 month prior
- INR \>1.5, PT \>ULN+4 seconds, or APTT \>15×ULN
- Significant bleeding history within 3 months prior
- Current anticoagulant therapy
- Any condition deemed unsuitable by investigator
Interventions
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: Population-Specific Dosing Protocol: Induction: 6 mg/kg/h until MOAA/S ≤1 (vs. 5-12 mg/kg/h in general surgery). Maintenance: 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. Transplant-Specific Context: Administered alongside standard immunosuppressants (methylprednisolone 750 mg + furosemide 60 mg at reperfusion) but prohibits common sedatives (midazolam/propofol) to isolate Remimazolam's effects. PK/PD sampling accounts for graft function dynamics (e.g., blood draws during reperfusion and post-op days 1-6). Exploratory Genetic Analysis: First study linking VDR/
Locations(1)
View Full Details on ClinicalTrials.gov
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NCT07045467