Remimazolam infusion for adults undergoing kidney transplant

Pharmacokinetics and Pharmacodynamics of Continuous Infusion of Remimazolam in Kidney Transplant Recipients: A Multicenter Interventional Study

This will test whether a continuous remimazolam infusion gives consistent sedation and predictable blood levels in adults having kidney transplants.

Quick facts

• Phase: PHASE1
• Study type: Interventional
• Enrollment: 30 (estimated)
• Ages: 18 Years to 65 Years
• Sex: All
• Sponsor: Qianfoshan Hospital (other)
• Locations: 1 site (Jinan, Shangdong)
• Trial ID: NCT07045467 on ClinicalTrials.gov

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.

Who should consider this trial

Good fit: Adults aged 18–64 with chronic renal failure scheduled for renal transplantation, BMI 18–30 kg/m², meeting the weight and ASA III–IV criteria and able to give informed consent are ideal candidates.

Not a fit: Patients with significant hepatic, psychiatric, or neurological disease, coagulopathy, heart or respiratory failure, pregnancy/lactation, positive viral serologies, recent substance abuse, or use of interacting hepatic enzyme modifiers are unlikely to benefit or be eligible.

Why it matters

Potential benefit: If successful, the study could enable more predictable, titratable sedation with dosing guidance tailored for kidney transplant patients, potentially reducing side effects and recovery time.

How similar studies have performed: Remimazolam has shown predictable PK/PD and effective procedural sedation in healthy volunteers and other surgical settings, but its specific use and dosing in end-stage renal disease patients undergoing transplant are less well studied.

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

Where this trial is running

Jinan, Shangdong

• Shandong First Medical University Hospital — Jinan, Shangdong, China (RECRUITING)

Study contacts

• Study coordinator: guanghan wu

Conditions: Chronic Kidney Diseases, Renal Transplantation