Edoxaban Steady-State PK/PD in Adults With Nephrotic Syndrome

Inclusion Criteria: 1. Nephrotic syndrome Group: * Age between 18-70 years old * Diagnosed with nephrotic syndrome: proteinuria≥3.5 g/24h or morning urine protein/creatinine ratio ≥3.0g/g), with serum albumin \<30g/L present at the time of enrollment, with or without edema or hyperlipidemia * Calculated creatinine clearance (CrCl) \>50ml/min using the Cockcroft-Gault formula * Actual body weight \>60kg, and body mass index within the range of 18.5-28kg/m2 * Signed informed consent form 2. Healthy volunteer Group: * Age between 18-70 years old * Serum albumin ≥40g/L * Calculated CrCl \>50ml/min using the Cockcroft-Gault formula * Actual body weight \>60kg, and body mass index within the range of 18.5-28kg/m2 * Signed informed consent form Exclusion Criteria: * Serun albumin \<30 g/L for other reasons in patients with nephrotic syndrome as judged by the investigator * Prolonged PT, INR, APTT at baseline (defined as greater than the upper limit of normal values) * Platelet count \<100×109/L or ≥300×109/L due to hematological diseases confirmed by laboratory tests * History of: gastrointestinal bleeding, intracranial hemorrhage, hemoptysis, or other clinically documented bleeding from internal organs within the last 3 months; surgery (except \>3 days after renal biopsy without bleeding complications) or trauma. Bleeding complications after renal biopsy are defined as: ① bleeding (hematuria, perirenal hematoma, or arteriovenous fistula) that occur after renal biopsy requiring transfusion, resulting in altered hemodynamics, or requiring surgery or interventional treatment; ② symptomatic perirenal hematoma; and ③visible hematuria that persist for \>3 days postoperatively. * A lesion or condition with a significant risk of major bleeding, such as current or recent gastrointestinal ulcer, malignant tumors with a high risk of bleeding, esophageal varices, arteriovenous malformations, vascular aneurysms, or major intravertebral or intracerebral vascular malformations. * Serious bleeding disorders as judged by the investigator * Systemic lupus erythematosus with or without renal damage * Bleeding or thrombophilia disorders as judged by the investigator * History of stroke * History of congestive heart failure (New York grade II or above) at the time of screening * Liver dysfunction (cirrhosis or bilirubin \>2×, and serum transaminases \>3×, upper limit of normal) * Use of (but not limited to) the prescription medications that are inhibitors or inducers of CYP3A4 and/or P-gp within the past 14 days: * CYP3A4 inducers (e.g., rifampicin, carbamazepine, phenytoin, etc.) ②CYP3A4 inhibitors (e.g., ketoconazole, ritonavir, clarithromycin, etc.) * P-gp inducers (e.g., apalutamide, rifampicin, etc.) ④ P-gp inhibitors (e.g., dronedarone, cyclosporine, erythromycin, ketoconazole, quinidine, verapamil, amiodarone, etc.) ⑤Selective serotonin reuptake inhibitors (SSRI) or serotonin-norepinephrine reuptake inhibitors (SNRI) * Use of antiplatelet and/ or anticoagulant agents within 5 half-lives (at least 7 days): including but not limited to heparin, heparin derivatives, aspirin, clopidogrel, prasugrel, nonsteroidal anti-inflammatory drugs, warfarin, rivaroxaban, dabigatran, apixaban, etc. * Pregnant or breastfeeding women or women of childbearing age without contraception * Uncontrolled severe hypertension (SBP≥180mmHg, DBP≥110mmHg) * Conditions considered unsuitable for inclusion in this study, judged by investigator * Patients with hypersensitivity to the active ingredient or other excipients of the Edoxaban and enoxaparin sodium * History of immune-mediated heparin-induced thrombocytopenia (HIT) or presence of circulating antibodies within the previous 100 days. * Spinal or epidural anesthesia or local anesthesia within 24 hours prior to the administration of enoxaparin sodium and Edoxaban