Remimazolam Infusion in Kidney Transplant Patients: A Multicenter Study

Launched by QIANFOSHAN HOSPITAL · Jun 22, 2025

Keywords

ClinConnect Summary

This clinical trial is studying a medicine called remimazolam, which is used to help patients stay calm and sleepy during surgery. The goal is to understand how this medicine works in the body—how quickly it reaches the bloodstream, how long it stays active, and how it affects a person’s level of consciousness during anesthesia. This study focuses on adults with chronic kidney disease who are preparing for a kidney transplant, to see if remimazolam provides safe and reliable sedation for them.

People who might join this study are adults aged 18 to under 65 who have chronic kidney failure and are scheduled for a kidney transplant. They should be generally healthy enough for surgery and meet certain weight and health criteria. During the study, participants will receive a continuous infusion of remimazolam and have blood samples taken to measure the drug’s levels. Their sedation will be closely monitored using special scales and devices, and the research team will also check safety through physical exams and lab tests. This information will help doctors understand how best to use remimazolam safely in patients needing anesthesia, especially those with kidney problems.

Gender

ALL

Eligibility criteria

• • 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