Remimazolam infusion for adults undergoing kidney transplant

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This Phase 1 interventional trial gives continuous remimazolam infusion to adults with chronic renal failure who are scheduled for kidney transplantation and measures drug levels and sedation depth. Blood samples are taken at multiple time points to calculate pharmacokinetic parameters (Cmax, Tmax, AUC, T1/2) while sedation is monitored with the MOAA/S scale and Narcotrend. Safety and adverse events are recorded throughout the perioperative period. The goal is to characterize pharmacokinetic/pharmacodynamic relationships and identify dosing considerations specific to this patient population.

Why it matters

Who can join: the full rules

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

Where it's running

• Shandong First Medical University Hospital
  Jinan, Shangdong, China Recruiting

Study contacts

• Study coordinator: guanghan wu
• Email: guanghanwu2021@163.com
• Phone: +8618763995357

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.