Rivaroxaban in Idiopathic Membranous Nephropathy
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Rivaroxaban 10 MG, Warfarin Sodium.
- Who it may be relevant to
- Registry conditions: Idiopathic Membranous Nephropathy. Basic parameters: 18 years — 80 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- China
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Efficacy of Rivaroxaban for Thromboprophylaxis in Idiopathic Membranous Nephropathy: A Prospective, Single-Center, Randomized Controlled Trial
Overview
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.
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 wee
Primary outcome measures
- Primary efficacy outcome [Time frame: 6 months]
Secondary outcome measures (1)
- Secondary efficacy outcome [Time frame: 6 months]
Eligibility criteria
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).
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
China · 1 center
- Beijing Friedship Hospital — Beijing
Identifiers
NCT: NCT07404436 · 2023-P2-369-01