Rivaroxaban in Idiopathic Membranous Nephropathy

Efficacy of Rivaroxaban for Thromboprophylaxis in Idiopathic Membranous Nephropathy: A Prospective, Single-Center, Randomized Controlled Trial

Through a prospective, single-center, randomized controlled trial, we aim to determine the thromboprophylactic efficacy of rivaroxaban in patients with idiopathic membranous nephropathy (IMN). IMN patients at high risk of thrombosis and low risk of bleeding will be enrolled and randomly assigned to a rivaroxaban group or a control group (receiving warfarin). Prophylactic anticoagulation will be administered with rivaroxaban or warfarin accordingly. Over the 6 months following initiation of prophylactic anticoagulation, the incidence of the primary efficacy endpoint (a composite of pulmonary embolism, deep vein thrombosis, and lower-extremity deep vein thrombosis) and the safety endpoint (bleeding events) will be compared between the two groups.

Study Overview

• Status: Recruiting
• Conditions: Idiopathic Membranous Nephropathy
• Intervention / Treatment: Drug: Rivaroxaban 10 MG; Drug: Warfarin Sodium

• Study Type: Interventional
• Enrollment (Estimated): 134
• Phase: Phase 4

Contacts and Locations

Study Locations

• China
  • Beijing Municipality
    • Beijing, Beijing Municipality, China, 100050
      • Recruiting
      • Beijing Friedship Hospital
      • Contact: Wenhu Liu, Doctor; Phone Number: +86-01-63139144; Email: liuwh0211@126.com
      • Sub-Investigator: Zongli Diao, Master

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

Age 18-80 years, either sex. Kidney biopsy findings on both light microscopy and electron microscopy consistent with idiopathic membranous nephropathy (IMN).

IMN patients at high risk of thrombosis: meeting the diagnostic criteria for nephrotic syndrome and having serum albumin <25 g/L. Normal renal function (normal creatinine clearance).

Exclusion Criteria:

Prior thrombotic events, such as pulmonary embolism, renal vein thrombosis, or lower-extremity deep vein thrombosis.

Pulmonary diseases that may affect the accuracy of ventilation-perfusion (V/Q) scanning for diagnosing pulmonary embolism, such as pulmonary infection/inflammation, lung tumors, or chronic obstructive pulmonary disease.

Inability to undergo V/Q scanning, e.g., right-to-left congenital cardiac shunt, prior allergy to radiopharmaceuticals, or inability to cooperate with the examination.

Clinically significant active bleeding. Pregnant or breastfeeding women. Acute myocardial infarction and/or acute stroke, or atrial fibrillation. Active infection or active malignancy. Coagulation abnormalities; hepatic dysfunction (aminotransferases ≥3× the upper limit of normal); or thrombocytopenia (platelet count <100×10^9/L).

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Rivaroxaban; At present, an established rivaroxaban dosing regimen for thromboprophylaxis in IMN is lacking. In this study, we will adopt the dosing regimen used for postoperative venous thromboembolism prophylaxis (N Engl J Med, 2020, 382(20):1916-1925), administering rivaroxaban 10 mg orally once daily.	Drug: Rivaroxaban 10 MG; At present, an established rivaroxaban dosing regimen for thromboprophylaxis in IMN is lacking. In this study, we will adopt the dosing regimen used for postoperative venous thromboembolism prophylaxis (N Engl J Med, 2020, 382(20):1916-1925), administering rivaroxaban 10 mg orally once daily.
Active Comparator: Warfarin; According to the Chinese Expert Consensus on Warfarin Anticoagulation Therapy (Chinese Journal of Internal Medicine, 2013, 52(1):76-82) and the recommendations in UpToDate (Hypercoagulability in patients with nephrotic syndrome), the protocol is as follows: Anticoagulation intensity: the target INR is 1.5-2.5. Dosing regimen: the initial warfarin dose is 1.5 mg orally once daily. INR will be measured after 3 days of treatment for inpatients or after 1 week for outpatients, and then monitored weekly thereafter. If the INR remains outside the target range on two consecutive measurements, the dose may be increased or decreased by 20% of the current dose until the INR reaches the target range.	Drug: Warfarin Sodium; According to the Chinese Expert Consensus on Warfarin Anticoagulation Therapy (Chinese Journal of Internal Medicine, 2013, 52(1):76-82) and the recommendations in UpToDate (Hypercoagulability in patients with nephrotic syndrome), the protocol is as follows: Anticoagulation intensity: the target INR is 1.5-2.5. Dosing regimen: the initial warfarin dose is 1.5 mg orally once daily. INR will be measured after 3 days of treatment for inpatients or after 1 week for outpatients, and then monitored weekly thereafter. If the INR remains outside the target range on two consecutive measurements, the dose may be increased or decreased by 20% of the current dose until the INR reaches the target range.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Primary efficacy outcome	a composite endpoint, including the incidence of pulmonary embolism, renal vein thrombosis, and lower-extremity deep vein thrombosis.	6 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Secondary efficacy outcome	the incidence of pulmonary embolism, renal vein thrombosis, lower-extremity deep vein thrombosis, and other thrombotic events.	6 months

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Safety events	the incidence of all bleeding events	6 months

Collaborators and Investigators

• Sponsor: Beijing Friendship Hospital

Study record dates

Study Major Dates

• Study Start (Actual): January 5, 2024
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): December 31, 2026

Study Registration Dates

• First Submitted: February 5, 2026
• First Submitted That Met QC Criteria: February 5, 2026
• First Posted (Actual): February 11, 2026

Study Record Updates

• Last Update Posted (Actual): February 11, 2026
• Last Update Submitted That Met QC Criteria: February 5, 2026
• Last Verified: February 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Urogenital Diseases; Male Urogenital Diseases; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Autoimmune Diseases; Immune System Diseases; Glomerulonephritis; Nephritis; Glomerulonephritis, Membranous; Sulfur Compounds; Organic Chemicals; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Pyrans; Morpholines; Oxazines; Thiophenes; Coumarins; Benzopyrans; 4-Hydroxycoumarins; Rivaroxaban; Warfarin
• Other Study ID Numbers: 2023-P2-369-01

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No