Remimazolam Infusion in Kidney Transplant Patients: A Multicenter Study

NCT ID: NCT07045467

Last Updated: 2025-10-01

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: PHASE1
• Total Enrollment: 30 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-07-01
• Study Completion Date: 2027-06-01

Brief Summary

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

Conditions

Chronic Kidney Diseases; Renal Transplantation

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

All enrolled participants receive Remimazolam Besylate via continuous IV infusion

All enrolled participants receive a standardized Remimazolam Besylate-based anesthesia protocol for renal transplant surgery, as follows:

1. Intervention Drug:

◦ Remimazolam Besylate (Trade name: Rymazol®), supplied as a lyophilized powder (25 mg/vial) reconstituted with sterile water.

2. Dosing Regimen:

• Induction: Continuous IV infusion at 6 mg/kg/h until loss of consciousness (defined as MOAA/S score ≤1).
• Maintenance: Titrated IV infusion (0.5-2 mg/kg/h) to maintain target anesthesia depth (Narcotrend Index: 27-60) until end of surgery.

3. Ancillary Medications (per protocol §7.2):

• Analgesia: Sufentanil (0.4-0.5 μg/kg induction; 10 μg at peritoneum closure) + Remifentanil infusion intraoperatively.
• Muscle Relaxant: Rocuronium (0.6 mg/kg induction; 0.15 mg/kg bolus PRN).
• Immunosuppression: Methylprednisolone 750 mg + Furosemide 60 mg pre-reperfusion.
• Prohibited Agents: Sevoflurane, propofol, midazolam, dexmedetomidine, or etomidate.

4. Depth Monitoring:

• Real-time Narcot

Group Type: EXPERIMENTAL

Remimazolam Besylate

Intervention Type: 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/

Interventions

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/

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

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

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Qianfoshan Hospital

OTHER

Sponsor Role: lead

Responsible Party

Guanghan Wu

Department of Anesthesiology and Perioperative Medicine

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Shandong First Medical University Hospital

Jinan, Shangdong, China

Site Status: RECRUITING

Countries

China

Central Contacts

guanghan wu

Role: CONTACT

guanghanwu2021@163.com

+8618763995357

Facility Contacts

jianbo wu

Role: primary

jianbowu@126.com

+8613805319310

Other Identifiers

YXLL-KY-2024(103)

Identifier Type: -

Identifier Source: org_study_id