NCT07045467 Remimazolam Infusion in Kidney Transplant Patients: A Multicenter Study
| NCT ID | NCT07045467 |
| Status | Recruiting |
| Phase | Phase 1 |
| Sponsor | Qianfoshan Hospital |
| Condition | Chronic Kidney Diseases |
| Study Type | INTERVENTIONAL |
| Enrollment | 30 participants |
| Start Date | 2025-07-01 |
| Primary Completion | 2026-07-01 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 1 is the earliest stage of human testing — safety and dosage are the primary focus. Visits are frequent and medical supervision is intensive. You will be among the first people to receive this treatment.
This trial targets 30 participants in total. It began in 2025-07-01 with a primary completion date of 2026-07-01.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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
Eligibility Criteria
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
Contact & Investigator
Frequently Asked Questions
Who can join the NCT07045467 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 65 Years, studying Chronic Kidney Diseases. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT07045467 trial and what does that mean for participants?
Phase 1 trials are the first stage of human testing. The primary goal is to assess safety and determine appropriate dosage levels. Participants are closely monitored. These trials typically involve a small number of volunteers.
Is NCT07045467 currently recruiting?
Yes, NCT07045467 is actively recruiting participants. Contact the research team at guanghanwu2021@163.com for enrollment information.
Where is the NCT07045467 trial being conducted?
This trial is being conducted at Jinan, China.
Who is sponsoring the NCT07045467 clinical trial?
NCT07045467 is sponsored by Qianfoshan Hospital. The trial plans to enroll 30 participants.
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