Remimazolam Infusion in Kidney Transplant Patients: A Multicenter Study

PHASE1RecruitingINTERVENTIONAL
Enrollment

30

Participants

Timeline

Start Date

July 1, 2025

Primary Completion Date

July 1, 2026

Study Completion Date

June 1, 2027

Conditions
Chronic Kidney DiseasesRenal Transplantation
Interventions
DRUG

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/"

Trial Locations (1)

250014

RECRUITING

Shandong First Medical University Hospital, Jinan

All Listed Sponsors
lead

Qianfoshan Hospital

OTHER