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Remimazolam Infusion in Kidney Transplant Patients: A Multicenter Study

RecruitingPhase 1Ages 18 Years - 65 YearsAllQianfoshan Hospital
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In plain words

What the trial is, and whether it could suit you

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

Sign in to get the eligibility rules as simple questions to take to your doctor.

๐Ÿ“‹ Eligibility rules (as published)
Inclusion Criteria Signed informed consent Age โ‰ฅ18 years and \<65 years Chronic renal failure scheduled for renal transplantation Body mass index (BMI) 18-30 kg/mยฒ (inclusive) Weight โ‰ฅ50 kg (males) or โ‰ฅ45 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 โ‰ฅ2 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 \>15ร—ULN Significant bleeding history within 3 months prior Current anticoagulant therapy Any condition deemed unsuitable by investigator
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What it tests

  • Remimazolam Besylate
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Where

1 site
Shandong First Medical University Hospital
Jinan, China
๐Ÿค Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible โ€” always decide together with your own doctor.
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