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New treatment option for Chronic Kidney Diseases
Official title Remimazolam Infusion in Kidney Transplant Patients: A Multicenter Study
ClinicalTrials.gov ID: NCT07045467
What this study is testing
What is Remimazolam Besylate?
Remimazolam Besylate is an investigational medicine, given as an infusion into a vein, being studied as a potential treatment for chronic kidney diseases.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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)?
- Phase 1: an early, usually small safety study
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 65
You may be able to join if
- 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)
You likely can't join if
- Hepatic, psychiatric, or neurological disorders
- Coagulopathy
- Heart failure
- Respiratory failure
- Long-term sedative or antidepressant use
- Pregnancy or lactation
See the full eligibility 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
- 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
The study team makes the final eligibility decision.
Where it's taking place
- Jinan, Shangdong, China
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 65 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Jinan, Shangdong, China. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.