Efficacy of Rivaroxaban for Thromboprophylaxis in Idiopathic Membranous Nephropathy: A Prospective, Single-Center, Randomized Controlled Trial
试验速览
- 阶段
- 4 期
- 状态
- 招募中
- 入组人数
- 134
- 试验地点
- 1
- 主要终点
- Primary efficacy outcome
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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).
排除标准
- •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).
研究组 & 干预措施
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.
干预措施: Rivaroxaban 10 MG (Drug)
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.
干预措施: Warfarin Sodium (Drug)
结局指标
主要结局
Primary efficacy outcome
时间窗: 6 months
a composite endpoint, including the incidence of pulmonary embolism, renal vein thrombosis, and lower-extremity deep vein thrombosis.
次要结局
- Secondary efficacy outcome(6 months)
研究者
Diao Zongli
Pro
Beijing Friendship Hospital