Chronic Kidney DiseasesPhase 1NCT07045467
Remimazolam Infusion in Kidney Transplant Patients: A Multicenter Study
A Phase 1 study testing Remimazolam Besylate in people with Chronic Kidney Diseases and Renal Transplantation, run by Qianfoshan Hospital at 1 site in China.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Chronic Kidney Diseases, Renal Transplantation
- What is being tested?
- Remimazolam Besylate
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteChina
- Study dates
- 1 Jul 2025to 1 Jun 2027
- Phase
- Phase 1
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Show all 30Show fewer
- 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
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Shandong First Medical University Hospital
Jinan, Shangdong, 250014
jianbo wu, +8613805319310, jianbowu@126.com
Chengjie Gao
About this study
Official title: Pharmacokinetics and Pharmacodynamics of Continuous Infusion of Remimazolam in Kidney Transplant Recipients: A Multicenter Interventional 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.
Read more
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
- Conditions
- Chronic Kidney Diseases, Renal Transplantation
- Being tested
- Remimazolam Besylate
- Medical subject headings
- Renal Insufficiency, Chronic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Remimazolam BesylateDrug
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/
| Study group | Role | What they receive |
|---|---|---|
| All enrolled participants receive Remimazolam Besylate via continuous IV infusion | Experimental | All enrolled participants receive a standardized Remimazolam Besylate-based anesthesia protocol for renal transplant surgery, as follows:
1. Intervention Drug:
◦ Remimazolam Besylate (Trade name: Rymazol®), supplied as a lyophilized powder (25 mg/vial) reconstituted with sterile water.
2. Dosing Regimen:
* Induction: Continuous IV infusion at 6 mg/kg/h until loss of consciousness (defined as MOAA/S score ≤1).
* Maintenance: Titrated IV infusion (0.5-2 mg/kg/h) to maintain target anesthesia depth (Narcotrend Index: 27-60) until end of surgery.
3. Ancillary Medications (per protocol §7.2):
* Analgesia: Sufentanil (0.4-0.5 μg/kg induction; 10 μg at peritoneum closure) + Remifentanil infusion intraoperatively.
* Muscle Relaxant: Rocuronium (0.6 mg/kg induction; 0.15 mg/kg bolus PRN).
* Immunosuppression: Methylprednisolone 750 mg + Furosemide 60 mg pre-reperfusion.
* Prohibited Agents: Sevoflurane, propofol, midazolam, dexmedetomidine, or etomidate.
4. Depth Monitoring:
* Real-time Narcot Receives: Drug: Remimazolam Besylate |
What is being measured
The primary outcome is the main question the study is designed to answer.
Remimazolam Plasma Concentration
Blood concentration (ng/mL) of Remimazolam
Measured: 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.
Remimazolam PK Parameters
Maximum Plasma Concentration
Measured: 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.
Remimazolam PK Parameters
Area Under the Curve (0 to last measurable t)
Measured: 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
Remimazolam PK Parameters
Area Under the Curve (0 to infinity)
Measured: 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
Remimazolam PK Parameters
Time to Cmax
Measured: 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
Remimazolam PK Parameters
Terminal Elimination Half-Life
Measured: 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
Remimazolam PK Parameters
Total Body Clearance
Measured: 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
Remimazolam PK Parameters
Renal Clearance
Measured: 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
Remimazolam PK Parameters
Apparent Volume of Distribution (Terminal)
Measured: 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
Remimazolam PK Parameters
Mean Residence Time
Measured: 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
Remimazolam PK Parameters
Percentage of AUC Extrapolated
Measured: 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
CNS 7054 (Metabolite) PK Parameters
Maximum Plasma Concentration
Measured: 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.
CNS 7054 (Metabolite) PK Parameters
Area Under the Curve (0 to last measurable t)
Measured: 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.
CNS 7054 (Metabolite) PK Parameters
Area Under the Curve (0 to infinity)
Measured: 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.
CNS 7054 (Metabolite) PK Parameters
Time to Cmax
Measured: 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.
CNS 7054 (Metabolite) PK Parameters
Terminal Elimination Half-Life
Measured: 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.
CNS 7054 (Metabolite) PK Parameters
Mean Residence Time
Measured: 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.
CNS 7054 (Metabolite) PK Parameters
Percentage of AUC Extrapolated
Measured: 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.
Sedation Depth (PD)
MOAA/S score (0 to 5) + Narcotrend Index (NCI 0 to 100)
Measured: Induction: every 1minutes until MOAA/S≤1; Maintenance: every 10 minutes; Recovery: every 2 minutes until 3 consecutive MOAA/S=5.
Time to Loss of Consciousness (MOAA/S ≤1)
Time from infusion start to first MOAA/S score ≤1
Measured: 0 to 10 minutes after infusion start
Time to Full Alertness (3 consecutive MOAA/S=5)
Time from infusion stop to sustained alertness
Measured: Time from infusion stop to sustained alertness
Narcotrend Index (NCI) Values
Anesthesia depth index (0-100 scale)
Measured: Continuous monitoring during infusion + 30 min post-stop
Secondary outcomes (10)
Postoperative Urine Output
24-hour urine volume
Measured: Postoperation Days 1 to 6
Serum Creatinine Level
Blood creatinine concentration
Measured: Preoperation, Postoperation Days 1 to 6
Estimated Glomerular Filtration Rate
Kidney filtration rate
Measured: Preoperation, Postoperation Days 1 to 6
Intraoperative Hypotension Incidence
MAP <65 mmHg for >1 minute
Measured: Intra-operative period
Intraoperative Bradycardia Incidence
HR <45 bpm for >1 min
Measured: Intra-operative period
Injection Pain Incidence
Participant-reported pain during drug administration
Measured: During induction (0 to 10 minutes)
Postoperative Nausea/Vomiting Incidence
Postoperative Nausea/Vomiting occurrence
Measured: PACU admission to Postoperation Day 6
Postoperative Agitation Incidence
RASS score ≥2
Measured: PACU stay (0 to 2 hours)
Delayed Recovery Incidence
Extubation time >30 min post-surgery
Measured: End of surgery to PACU discharge
Intraoperative Awareness Incidence
Positive Brice questionnaire response
Measured: Upon PACU discharge (Day 1)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Jul 2025
- Study start1 Jul 2025
- Primary completion1 Jul 2026 (estimated)
- Study completion1 Jun 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Kidney DiseasesStudies of the same condition, open and under way.
- More trials run by Qianfoshan HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Qianfoshan Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Guanghan Wu, Qianfoshan Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07045467
- Sponsor's protocol ID
- YXLL-KY-2024(103)
- Status last verified
- Sep 2025
- First submitted
- 5 Jun 2025
- Last updated
- 1 Oct 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Oct 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pharmacokinetics and Pharmacodynamics of Continuous Infusion of Remimazolam in Kidney Transplant Recipients: A Multicenter Interventional Study
- ClinicalTrials.gov ID
- NCT07045467
- Acronym / sponsor ID
- YXLL-KY-2024(103)
- Conditions
- Chronic Kidney Diseases, Renal Transplantation
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Qianfoshan HospitalUniversity, hospital or other
- Study start
- 1 Jul 2025 (actual)
- Primary completion
- 1 Jul 2026 (estimated)
- Study completion
- 1 Jun 2027 (estimated)
- First posted
- 1 Jul 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| All enrolled participants receive Remimazolam Besylate via continuous IV infusion | Experimental | Drug: Remimazolam BesylateAll enrolled participants receive a standardized Remimazolam Besylate-based anesthesia protocol for renal transplant surgery, as follows: 1. Intervention Drug: ◦ Remimazolam Besylate (Trade name: Rymazol®), supplied as a lyophilized powder (25 mg/vial) reconstituted with sterile water. 2. Dosing Regimen: * Induction: Continuous IV infusion at 6 mg/kg/h until loss of consciousness (defined as MOAA/S score ≤1). * Maintenance: Titrated IV infusion (0.5-2 mg/kg/h) to maintain target anesthesia depth (Narcotrend Index: 27-60) until end of surgery. 3. Ancillary Medications (per protocol §7.2): * Analgesia: Sufentanil (0.4-0.5 μg/kg induction; 10 μg at peritoneum closure) + Remifentanil infusion intraoperatively. * Muscle Relaxant: Rocuronium (0.6 mg/kg induction; 0.15 mg/kg bolus PRN). * Immunosuppression: Methylprednisolone 750 mg + Furosemide 60 mg pre-reperfusion. * Prohibited Agents: Sevoflurane, propofol, midazolam, dexmedetomidine, or etomidate. 4. Depth Monitoring: * Real-time Narcot |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (30 listed)
- 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
Key exclusion criteria (0 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Remimazolam BesylateThis 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/ | Drug | All enrolled participants receive Remimazolam Besylate via continuous IV infusion |
Primary outcome
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
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
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)
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)
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
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
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
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
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)
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
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
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
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)
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)
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
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
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
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
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)
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
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
Narcotrend Index (NCI) Values
Time frame: Continuous monitoring during infusion + 30 min post-stop
Anesthesia depth index (0-100 scale)
10 secondary outcomes
Postoperative Urine Output
Time frame: Postoperation Days 1 to 6
Serum Creatinine Level
Time frame: Preoperation, Postoperation Days 1 to 6
Estimated Glomerular Filtration Rate
Time frame: Preoperation, Postoperation Days 1 to 6
Intraoperative Hypotension Incidence
Time frame: Intra-operative period
Intraoperative Bradycardia Incidence
Time frame: Intra-operative period
Injection Pain Incidence
Time frame: During induction (0 to 10 minutes)
Postoperative Nausea/Vomiting Incidence
Time frame: PACU admission to Postoperation Day 6
Postoperative Agitation Incidence
Time frame: PACU stay (0 to 2 hours)
Delayed Recovery Incidence
Time frame: End of surgery to PACU discharge
Intraoperative Awareness Incidence
Time frame: Upon PACU discharge (Day 1)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Oct 2025.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Remimazolam Besylate in people with Chronic Kidney Diseases and Renal Transplantation, run by Qianfoshan Hospital at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 30 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 1 Oct 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact guanghan wu (+8618763995357, guanghanwu2021@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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.). The study lists 22 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Oct 2025.