Efficacy of Rivaroxaban for Thromboprophylaxis in Idiopathic Membranous Nephropathy: A Prospective, Single-Center, Randomized Controlled Trial
Status: Recruiting
Location: See location...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 4
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.
Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 80
Healthy Volunteers: f
View:
• 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).
Locations
Other Locations
China
Beijing Friedship Hospital
RECRUITING
Beijing
Time Frame
Start Date:2024-01-05
Estimated Completion Date:2026-12-31
Participants
Target number of participants:134
Treatments
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.
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.