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

NCT ID: NCT07116239

Last Updated: 2025-08-11

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 60 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-09-30
• Study Completion Date: 2026-02-28

Brief Summary

A study to evaluate the impact of nephrotic syndrome on the steady state pharmacokinetics and pharmacodynamics of edoxaban compared to health volunteers, and whether edoxaban can provide an equivalent anticoagulant effect to enoxaparin sodium.

Conditions

Nephrotic Syndrome; Hypoalbuminemia

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

Edoxaban NS Group 1

Patients with mild hypoalbuminemia (serum albumin \>25g/L and \<30g/L), taking edoxaban 60mg orally once daily

Group Type: EXPERIMENTAL

Edoxaban 60 mg

Intervention Type: DRUG

film-coated tablet, manufactured by Daiichi Sankyo Europe GmbH

Edoxaban NS Group 2

Patients with severe hypoalbuminemia (serum albumin ≤25g/L), taking edoxaban 60mg orally once daily

Group Type: EXPERIMENTAL

Edoxaban 60 mg

Intervention Type: DRUG

film-coated tablet, manufactured by Daiichi Sankyo Europe GmbH

LMWH NS Group 1

Patients with mild hypoalbuminemia (serum albumin \>25g/L and \<30g/L), injecting enoxaparin sodium 0.4ml subcutaneously once daily

Group Type: ACTIVE_COMPARATOR

Enoxaparin 40 mg

Intervention Type: DRUG

enoxaparin sodium, prefilled syringe of 0.4mL injectable solution, manufactured by SANOFI WINTHROP INDUSTRIE

LMWH NS Group 2

Patients with severe hypoalbuminemia (serum albumin ≤25g/L), injecting enoxaparin sodium 0.4ml subcutaneously once daily

Group Type: ACTIVE_COMPARATOR

Enoxaparin 40 mg

Intervention Type: DRUG

enoxaparin sodium, prefilled syringe of 0.4mL injectable solution, manufactured by SANOFI WINTHROP INDUSTRIE

Healthy Volunteer Group

Healthy volunteers, taking edoxaban 60mg orally once daily

Group Type: OTHER

Edoxaban 60 mg

Intervention Type: DRUG

film-coated tablet, manufactured by Daiichi Sankyo Europe GmbH

Interventions

Edoxaban 60 mg

film-coated tablet, manufactured by Daiichi Sankyo Europe GmbH

Intervention Type: DRUG

Enoxaparin 40 mg

enoxaparin sodium, prefilled syringe of 0.4mL injectable solution, manufactured by SANOFI WINTHROP INDUSTRIE

Intervention Type: DRUG

Other Intervention Names

LIXIANAN; CLEXANE

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Chinese Academy of Medical Sciences, Fuwai Hospital

OTHER

Sponsor Role: collaborator

Peking University People's Hospital

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Other Identifiers

2025-h009

Identifier Type: -

Identifier Source: org_study_id