NCT07045467RecruitingPhase 1
Remimazolam Infusion in Kidney Transplant Patients: A Multicenter Study
Pharmacokinetics and Pharmacodynamics of Continuous Infusion of Remimazolam in Kidney Transplant Recipients: A Multicenter Interventional Study
Source: ClinicalTrials.gov · Last updated 1 Oct 2025 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
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
- Status (registry)
- Recruiting
- Phase (registry)
- Phase 1
- Study type
- Interventional
- Enrollment
- 30 (estimated)
- First submitted
- 5 Jun 2025
- Start date
- 1 Jul 2025
- Primary completion date
- 1 Jul 2026
- Lead sponsor
- Qianfoshan Hospital
- Diseases
- Chronic kidney disease
- NCT number
- NCT07045467
What you commit to
- Study type: Interventional · Phase 1
- Planned participants: 30
- From 1 Jul 2025 to the primary completion date, 1 Jul 2026
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Participation in other drug/device trials within 3 months prior
- Positive syphilis antibody
- Use of hepatic enzyme inhibitors/inducers within 30 days prior (per Appendix 1)
- 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
- Significant bleeding history within 3 months prior
- Current anticoagulant therapy
Other illness
- Heart failure
- Respiratory failure
- Positive hepatitis B surface antigen (HBsAg)
- Positive hepatitis C antibody (HCV-Ab)
- Positive HIV antibody
- Known hypersensitivity to ≥2 substances
- Any condition deemed unsuitable by investigator
Lab values
- INR \>1.5, PT \>ULN+4 seconds, or APTT \>15×ULN
Other
- Coagulopathy
- Long-term sedative or antidepressant use
- Pregnancy or lactation
- Inability to communicate or cooperate
Who the study is looking for
- 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
Age in the registry: 18 years to 65 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Shandong First Medical University Hospital Coordinator of this site? Confirm its status | Jinan | China | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.