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

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