PK/PD Properties and Safety of Remazolam Besylate for Injection in ICU Patients With Impaired Renal Function

A Randomized Study of the PK/PD Properties and Safety of Remazolam Besylate for Injection in ICU Patients With Impaired Renal Function

Pharmacokinetic/pharmacodynamic profiles of remazolam besylate were compared in patients with impaired and normal renal function in the ICU, and safety was assessed by recording hemodynamic parameters and adverse events.

Study Overview

• Status: Completed
• Conditions: Mechanically Ventilated Patients
• Intervention / Treatment: Drug: Remimazolam besylate

• Study Type: Interventional
• Enrollment (Actual): 36
• Phase: Not Applicable

Contacts and Locations

Study Locations

• China
  • Hubei
    • Wuhan, Hubei, China, 430022
      • Wuhan Union Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Age ≥18 and ≤80 years, regardless of gender;
• Anticipated requirement for mechanical ventilation and sedation ≥24 hours;
• arget sedation level within RASS score range of -3 to 0 (inclusive);

Patients with renal impairment were defined as having a glomerular filtration rate (GFR) <90 mL/min/1.73m². Patients with normal renal function were defined as having a glomerular filtration rate of 90 to 120 ml/min/1.73m2

Exclusion Criteria:

• BMI<18 or >30kg/m2;
• Hypersensitivity to study drugs/opioids/reversal agents;
• Life expectancy <48 hours;
• Scheduled surgery requiring general anesthesia within 24h;
• Myasthenia gravis;
• Moderate-severe hepatic impairment (Child-Pugh ≥B);
• Severe CKD (eGFR <30 mL/min/1.73m²) or renal replacement therapy within 3 days;
• Recent benzodiazepine use (≤1 week) or chronic benzodiazepine dependence;
• Hemodynamic instability (≥2 vasopressors to maintain SBP >90 mmHg);
• Inability to perform RASS assessment (e.g., major neuropsychiatric disorders, coma);
• Pregnancy/lactation;
• Acute coronary syndrome or severe cardiac dysfunction (LVEF ≤30%, advanced heart block, HR<50 bpm without pacing);
• Active ECMO/IABP support; Substance abuse history (≤2 years)。

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Normal renal function group	Drug: Remimazolam besylate; After a loading dose of 0.05mg/kg, a maintaining dose of 0.2mg/kg/h is given; It is recommended to adjust the infusion rate of Remazolam besylate for injection at a amplitude of 0.05mg/kg/h, mainly based on the RASS score of the subjects (the adjustment range is 0-1.0 mg/kg/h, and the maximum infusion rate is not more than 1.0mg/kg/h) until the subjects reach the optimal sedation level (-3≤RASS≤0).
Experimental: Renal injury group	Drug: Remimazolam besylate; After a loading dose of 0.05mg/kg, a maintaining dose of 0.2mg/kg/h is given; It is recommended to adjust the infusion rate of Remazolam besylate for injection at a amplitude of 0.05mg/kg/h, mainly based on the RASS score of the subjects (the adjustment range is 0-1.0 mg/kg/h, and the maximum infusion rate is not more than 1.0mg/kg/h) until the subjects reach the optimal sedation level (-3≤RASS≤0).

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Cmax	peak plasma concentration	Within 24 hours while receiving the study drug
The area under the plasma drug concentration-time curve	The area under the plasma drug concentration-time curve (AUC)	Within 24 hours while receiving the study drug
t1/2	half-life	Within 24 hours while receiving the study drug

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
The percentage of time in the target sedation range without rescue sedation	The percentage of time in the target sedation range without rescue sedation	Within 24 hours while receiving the study drug
The number and severity of treatment emergent adverse events (TEAEs)	The number and severity of treatment emergent adverse events (TEAEs)	Within 24 hours while receiving the study drug

Collaborators and Investigators

• Sponsor: Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
• Collaborators: Yichang Humanwell Pharmaceutical Co., Ltd., China

Study record dates

Study Major Dates

• Study Start (Actual): November 4, 2023
• Primary Completion (Actual): December 13, 2024
• Study Completion (Actual): December 13, 2024

Study Registration Dates

• First Submitted: November 23, 2023
• First Submitted That Met QC Criteria: November 23, 2023
• First Posted (Actual): December 1, 2023

Study Record Updates

• Last Update Posted (Actual): August 10, 2026
• Last Update Submitted That Met QC Criteria: August 6, 2026
• Last Verified: August 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Renal Insufficiency
• Other Study ID Numbers: WHUICU202203

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No