Remimazolam Infusion in Kidney Transplant Patients: A Multicenter Study

ConditionsChronic Kidney Diseases Renal Transplantation

Trial statusRecruiting

Trial phasePhase 1

Trial typeInterventional

Biological sexAll

Age18-65

SponsorQianfoshan Hospital

About this trial

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 criteria

This trial does not accept healthy volunteers

Qualifiers

None

Disqualifiers

None

Trial design

Design model

Single group

Treatments tested in this trial

Remimazolam Besylate
Drug
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/

Treatment groups

30 Participants

are divided into 1 treatment group

Group A: All enrolled participants receive Remimazolam Besylate via continuous IV infusionExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

Remimazolam Plasma Concentration

Blood concentration (ng/mL) of Remimazolam

Time frame

During surgery: Pre-infusion, 2/5/10/20/30/45/60/120 minutes, hourly until infusion stop; Post-infusion: 0/5/15/30/60/90/120/240 minutes.

Remimazolam PK Parameters

Maximum Plasma Concentration

Time frame

During surgery: Pre-infusion, 2/5/10/20/30/45/60/120 minutes, hourly until infusion stop; Post-infusion: 0/5/15/30/60/90/120/240 minutes.

Remimazolam PK Parameters

Area Under the Curve (0 to last measurable t)

Time frame

During surgery: Pre-infusion, 2/5/10/20/30/45/60/120 minutes , hourly until infusion stop; Post-infusion: 0/5/15/30/60/90/120/240 minutes

Remimazolam PK Parameters

Area Under the Curve (0 to infinity)

Time frame

During surgery: Pre-infusion, 2/5/10/20/30/45/60/120 minutes , hourly until infusion stop; Post-infusion: 0/5/15/30/60/90/120/240 minutes

Secondary outcomes

Postoperative Urine Output

24-hour urine volume

Time frame

Postoperation Days 1 to 6

Serum Creatinine Level

Blood creatinine concentration

Time frame

Preoperation, Postoperation Days 1 to 6

Estimated Glomerular Filtration Rate

Kidney filtration rate

Time frame

Preoperation, Postoperation Days 1 to 6

Intraoperative Hypotension Incidence

MAP \<65 mmHg for \>1 minute

Time frame

Intra-operative period

Other outcomes

VDR Genotype Effect on Remimazolam Maximum Plasma Concentration

Correlation of VDR polymorphisms with peak concentration

Time frame

Pre-dose (Day 1)

CYP3A Genotype Effect on Remimazolam Area Under the Curve (0 to last measurable t)

Correlation of CYP3A polymorphisms with total exposure

Time frame

Pre-dose (Day 1)

POR Genotype Effect on Remimazolam Clearance

Correlation of POR polymorphisms with systemic clearance

Time frame

Pre-dose (Day 1)

VDR Genotype Effect on CNS 7054 Terminal Elimination Half-Life

Correlation of VDR polymorphisms with metabolite half-life

Time frame

Pre-dose (Day 1)

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Qianfoshan Hospital

Lead sponsor

Source ClinicalTrials.gov

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