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Clinical Trials in China / NCT07045467
Recruiting Phase 1

Remimazolam Infusion in Kidney Transplant Patients: A Multicenter Study

NCT07045467 · tracked via the Priya Life Science China tracker
Sponsor
Qianfoshan Hospital
Phase
Phase 1
Started
2025-07-01
Last updated
2025-10-01

Condition(s) studied

Chronic Kidney DiseasesRenal Transplantation

Investigational drug(s) / intervention(s)

Remimazolam Besylate

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: 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/

Study 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

Sex
ALL
Min age
18 Years
Max age
65 Years
Healthy volunteers
No
Inclusion Criteria Signed informed consent 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 Criteria Hepatic, psychiatric, or neurological disorders 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

Primary outcome measure(s)

Trial sites (1)

FacilityCityRegionStatus
Shandong First Medical University Hospital Jinan Shangdong Recruiting

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07045467 on ClinicalTrials.gov ↗ ← All trials in China