Renal insufficiency
Conditions
Interventions
Experiment Group A: Mild renal insufficiency:Adamgammadex 8mg/kg
Experiment Group B: Moderate renal insufficiency:Adamgammadex 8mg/kg
Experiment Group C: Healthy subjects:Adamgammadex 8mg/kg
Sponsors
Deyang People's Hospital
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: Participants with mild and moderate renal insufficiency must meet all of the following criteria to enter the study: (1) Aged between 18 and 75 on the date of signing the informed consent; (2) Body mass index (BMI) beatween 18.0 kg/m2 and 30.0 kg/m2, and weight =50.0kg for male, weight =45.0kg for female; (3) Subjects with renal insufficiency of different degrees were divided according to glomerular filtration rate (eGFR) (eGFR was calculated by referring to CKD-EPI 2021 in Appendix II) : Subjects with mild renal insufficiency: 60=eGFR < 90 mL/min/1.73m2; Subjects with moderate renal insufficiency: 30=eGFR < 60 mL/min/1.73m2; (4) Subjects with renal insufficiency are those who have chronic kidney disease (CKD) and have any abnormal indicators of kidney injury (including abnormal blood or urine components, renal pathology or imaging examination, etc.) lasting for more than 3 months with stable renal function (defined as two eGFR tests within the same CKD stage within three months before administration of drug, and the interval between the two tests should be at least 3 days); (5) Fertile subjects (male or female) should agree to use a medically approved contraceptive method during the trial period and within 3 months after the final dosing (see Appendix I), and have no plans to donate sperm/eggs during the trial period and within 3 months after the trial; (6) Subjects have a detailed understanding of the nature, significance, possible benefits and inconvenience and potential dangers of the trial before the trial, and is voluntary to participate in this clinical trial, is able to communicate well with the investigator, comply with the requirements of the entire study, and have signed a written informed consent. Healthy subjects with normal renal function must meet all of the following criteria to enter this study: (1) Aged between 18 and 75 on the date of signing the informed consent; (2) Body mass index (BMI) between 18.0 kg/m2 and 30.0 kg/m2, and weight =50.0kg for male, weight =45.0kg for female ; (3) Glomerular filtration rate (eGFR) =90 mL/min/1.73m2 (eGFR was calculated by referring to CKD-EPI 2021 formula in Appendix II); (4) Fertile subjects (male or female) should agree to use a medically approved contraceptive method during the trial period and within 3 months after the final dosing (see Appendix I), and have no plans to donate sperm/eggs during the trial period and within 3 months after the trial; (5) Subjects have a detailed understanding of the nature, significance, possible benefits and inconvenience and potential dangers of the trial before the trial, and is voluntary to participate in this clinical trial, is able to communicate well with the investigator, comply with the requirements of the entire study, and have signed a written informed consent.
Exclusion criteria
Exclusion criteria: Subjects with mild or moderate renal insufficiency will not be admitted to the study if they meet any of the following criteria: 1) Those who have previously received a kidney transplant and/or required kidney dialysis during the study period; 2) Subjects with incontinence or no urine (24-hour urine volume 2× upper limit of normal (ULN) value and/or aspartate aminotransferase (AST) > 2×ULN and/or total bilirubin (TBIL) > 1.5×ULN; hemoglobin (Hb) 1.5); 6) Subjects have poor blood pressure control (systolic =160 mmHg and/or diastolic =100 mmHg); 7) Subjects who were judged by the investigators to have unstable kidney disease and are likely to have significant changes in glomerular filtration rate from screening to the end of the study; 8) Patients who have no stable treatment plan (such as type, dosage or frequency of medication) for renal insufficiency and/or other concomitant diseases within 1 month before screening; 9) Subjects who are known to be allergic to two or more drugs, foods such as milk and pollen, especially those who are allergic to adamgammadex sodium or its excipients (including cyclodextrins such as sugammadex sodium); 10) Subject who are positive in human immunodeficiency virus antigen + antibody (HIVAg+Ab) or active syphilis tests during screening; 11) Subjects with active viral hepatitis B (defined as HBsAg positive with HBV DNA=2000cps or 500IU/ml) or active viral hepatitis C (defined as anti-HCV antibody positive with HCV RNA positive) during screening; 12) Subjects who had undergone major surgery or the surgical incision had not completely healed within 3 months prior to screening and were deemed unsuitable for the trial by the investigator; 13) Subjects who have used prohibited drugs for this trial, including fusidic acid, toremifene citrate, tamoxifen citrate, Clomiphene citrate, progesterone, norethisterone, testosterone, prednisone and other steroid hormones, as well a
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| PK index: Main pharmacokinetic parameters of adamgammadex sodium in plasma are Cmax, AUC0-T, AUC0-8; | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary pharmacokinetic parameters of adamgammadex sodium are Tmax, t1/2, CL/F, Vz/F, etc.;Cumulative excretion rate (Ae), urinary excretion fraction (fe) and renal clearance rate (CLr) of adamgammadex sodium;Safety measures: Safety measures include adverse events, vital signs, physical examination, laboratory examination and 12-lead electrocardiogram; | — |
Countries
China
Contacts
Public ContactFan Lianlian
Deyang People's Hospital
Outcome results
None listed