Remimazolam Infusion in Kidney Transplant Patients: A Multicenter Study
Key facts
- Where
- Jinan, ChinaSee the site
- Phase
- Phase 1
Could this be for you?
Answer for yourself. This is not a decision: only the study team can say whether you can take part.
- Are you between 18 and 65 years old?
Source: NCT07045467, who can take part
Where in China
- Shandong First Medical University HospitalJinan, ChinaTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Qianfoshan Hospital
- Trial code
- NCT07045467
- Record updated
- 1 October 2025
- Original description
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:Read full original descriptionShow less
Pharmacokinetics and Pharmacodynamics of Continuous Infusion of Remimazolam in Kidney Transplant Recipients: A Multicenter Interventional Study
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
Inclusion: 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: Participation in other drug/device trials within 3 months prior; Positive syphilis antibody; Use of hepatic enzyme inhibitors/inducers within 30 days prior (per Appendix 1); 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; Significant bleeding history within 3 months prior; Current anticoagulant therapy; Heart failure; Respiratory failure; Positive hepatitis B surface antigen (HBsAg); Positive hepatitis C antibody (HCV-Ab); Positive HIV antibody; Known hypersensitivity to ≥2 substances; Any condition deemed unsuitable by investigator; INR >1.5, PT >ULN+4 seconds, or APTT >15×ULN; Coagulopathy; Long-term sedative or antidepressant use; Pregnancy or lactation; Inability to communicate or cooperate.