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RECRUITING
NCT07404436
PHASE4

Rivaroxaban in Idiopathic Membranous Nephropathy

Sponsor: Beijing Friendship Hospital

View on ClinicalTrials.gov

Summary

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.

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

Key Details

Gender

All

Age Range

18 Years - 80 Years

Study Type

INTERVENTIONAL

Enrollment

134

Start Date

2024-01-05

Completion Date

2026-12-31

Last Updated

2026-02-11

Healthy Volunteers

No

Interventions

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.

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.

Locations (1)

Beijing Friedship Hospital

Beijing, Beijing Municipality, China