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NCT Number: NCT07045467

Remimazolam Infusion in Kidney Transplant Patients: A Multicenter Study

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

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Key information

Conditions

Chronic Kidney Diseases Chronic Disease Disease Attributes Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Kidney Diseases Male Urogenital Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms Renal Insufficiency Renal Insufficiency, Chronic Renal Transplantation Urogenital Diseases Urologic Diseases

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Shandong First Medical University Hospital

Jinan, Shangdong, 250014, China

Location status: Recruiting

Location contact

Chengjie Gao

SUB_INVESTIGATOR

Zhaoyang Xiao

SUB_INVESTIGATOR

jianbo wu

CONTACT

[email protected]

+8613805319310

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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/

Primary outcomes

  1. Remimazolam 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.

    Blood concentration (ng/mL) of Remimazolam

  2. Remimazolam PK Parameters

    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.

    Maximum Plasma Concentration

  3. Remimazolam PK Parameters

    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

    Area Under the Curve (0 to last measurable t)

  4. Remimazolam PK Parameters

    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

    Area Under the Curve (0 to infinity)

  5. Remimazolam PK Parameters

    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

    Time to Cmax

  6. Remimazolam PK Parameters

    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

    Terminal Elimination Half-Life

  7. Remimazolam PK Parameters

    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

    Total Body Clearance

  8. Remimazolam PK Parameters

    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

    Renal Clearance

  9. Remimazolam PK Parameters

    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

    Apparent Volume of Distribution (Terminal)

  10. Remimazolam PK Parameters

    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

    Mean Residence Time

  11. Remimazolam PK Parameters

    Time frame: 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

    Percentage of AUC Extrapolated

  12. CNS 7054 (Metabolite) PK Parameters

    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.

    Maximum Plasma Concentration

  13. CNS 7054 (Metabolite) PK Parameters

    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.

    Area Under the Curve (0 to last measurable t)

  14. CNS 7054 (Metabolite) PK Parameters

    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.

    Area Under the Curve (0 to infinity)

  15. CNS 7054 (Metabolite) PK Parameters

    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.

    Time to Cmax

  16. CNS 7054 (Metabolite) PK Parameters

    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.

    Terminal Elimination Half-Life

  17. CNS 7054 (Metabolite) PK Parameters

    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.

    Mean Residence Time

  18. CNS 7054 (Metabolite) PK Parameters

    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.

    Percentage of AUC Extrapolated

  19. Sedation Depth (PD)

    Time frame: Induction: every 1minutes until MOAA/S≤1; Maintenance: every 10 minutes; Recovery: every 2 minutes until 3 consecutive MOAA/S=5.

    MOAA/S score (0 to 5) + Narcotrend Index (NCI 0 to 100)

  20. Time to Loss of Consciousness (MOAA/S ≤1)

    Time frame: 0 to 10 minutes after infusion start

    Time from infusion start to first MOAA/S score ≤1

  21. Time to Full Alertness (3 consecutive MOAA/S=5)

    Time frame: Time from infusion stop to sustained alertness

    Time from infusion stop to sustained alertness

  22. Narcotrend Index (NCI) Values

    Time frame: Continuous monitoring during infusion + 30 min post-stop

    Anesthesia depth index (0-100 scale)

Secondary outcomes

  1. Postoperative Urine Output

    Time frame: Postoperation Days 1 to 6

    24-hour urine volume

  2. Serum Creatinine Level

    Time frame: Preoperation, Postoperation Days 1 to 6

    Blood creatinine concentration

  3. Estimated Glomerular Filtration Rate

    Time frame: Preoperation, Postoperation Days 1 to 6

    Kidney filtration rate

  4. Intraoperative Hypotension Incidence

    Time frame: Intra-operative period

    MAP <65 mmHg for >1 minute

  5. Intraoperative Bradycardia Incidence

    Time frame: Intra-operative period

    HR <45 bpm for >1 min

  6. Injection Pain Incidence

    Time frame: During induction (0 to 10 minutes)

    Participant-reported pain during drug administration

  7. Postoperative Nausea/Vomiting Incidence

    Time frame: PACU admission to Postoperation Day 6

    Postoperative Nausea/Vomiting occurrence

  8. Postoperative Agitation Incidence

    Time frame: PACU stay (0 to 2 hours)

    RASS score ≥2

  9. Delayed Recovery Incidence

    Time frame: End of surgery to PACU discharge

    Extubation time >30 min post-surgery

  10. Intraoperative Awareness Incidence

    Time frame: Upon PACU discharge (Day 1)

    Positive Brice questionnaire response

Other outcomes

  1. VDR Genotype Effect on Remimazolam Maximum Plasma Concentration

    Time frame: Pre-dose (Day 1)

    Correlation of VDR polymorphisms with peak concentration

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

    Time frame: Pre-dose (Day 1)

    Correlation of CYP3A polymorphisms with total exposure

  3. POR Genotype Effect on Remimazolam Clearance

    Time frame: Pre-dose (Day 1)

    Correlation of POR polymorphisms with systemic clearance

  4. VDR Genotype Effect on CNS 7054 Terminal Elimination Half-Life

    Time frame: Pre-dose (Day 1)

    Correlation of VDR polymorphisms with metabolite half-life

Study contacts

Contact information is provided by the study sponsor or research team.

guanghan wu

CONTACT

[email protected]

+8618763995357

Sponsors and collaborators

Lead sponsor

Qianfoshan Hospital

Other

Registry information

Official study title

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

Important dates

Study start
2025
Primary completion
2026
Study completion
2027
First posted
Jul 1, 2025
Registry last updated
Oct 1, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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