Actively Recruiting
Efficacy of Rivaroxaban for Thromboprophylaxis in Idiopathic Membranous Nephropathy: A Prospective, Single-Center, Randomized Controlled Trial
Led by Beijing Friendship Hospital · Updated on 2026-02-11
134
Participants Needed
1
Research Sites
N/A
Total Duration
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AI-Summary
What this Trial Is About
Researchers are evaluating the use of rivaroxaban for preventing blood clots in patients with idiopathic membranous nephropathy (IMN), a kidney condition associated with a high risk of thrombosis. This prospective, single-center, randomized controlled trial compares rivaroxaban to warfarin in patients at high risk of thrombosis but low risk of bleeding. The study aims to determine which drug is more effective in reducing blood clot events in this population over six months. Participants are randomly assigned to receive either rivaroxaban 10 mg orally once daily, based on a dosing schedule used for post-surgical clot prevention, or warfarin starting at 1.5 mg once daily with dose adjustments to maintain a target INR between 1.5 and 2.5. Warfarin dosing is carefully monitored with regular INR tests, initially after 3 days or 1 week, then weekly. Both drugs are given as preventive blood thinners to reduce the risk of blood clots during the study period. Throughout the six months, participants will be monitored for the occurrence of blood clots such as pulmonary embolism and deep vein thrombosis, as well as any bleeding events. Researchers will collect data on these outcomes to compare the safety and effectiveness of the two treatments. The trial includes regular blood tests and clinical assessments to ensure participant safety and to measure study endpoints. Total participation lasts six months from the start of prophylactic anticoagulation.
CONDITIONS
Brief Title
Rivaroxaban in Idiopathic Membranous Nephropathy
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 18 to 80 years, any sex
- Kidney biopsy confirming idiopathic membranous nephropathy on light and electron microscopy
- High risk of thrombosis with nephrotic syndrome diagnosis and serum albumin below 25 g/L
- Normal kidney function with normal creatinine clearance
You will not qualify if you...
- History of blood clots such as pulmonary embolism, renal vein thrombosis, or lower-extremity deep vein thrombosis
- Lung diseases affecting ventilation-perfusion scans, including infections, tumors, or chronic obstructive pulmonary disease
- Unable to undergo ventilation-perfusion scanning due to heart shunts, allergies, or cooperation difficulties
- Active significant bleeding
- Pregnant or breastfeeding women
- Recent heart attack, stroke, or atrial fibrillation
- Active infection or cancer
- Blood clotting disorders, liver dysfunction with elevated liver enzymes, or low platelet counts
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 6 months
Participants receive either rivaroxaban 10 mg orally once daily or warfarin sodium with dose adjustments to maintain target INR levels for thromboprophylaxis in idiopathic membranous nephropathy.
Weekly visits for INR monitoring and dose adjustment for warfarin participants; rivaroxaban participants attend visits as scheduled for treatment follow-up
Trial Site Locations
Total: 1 location
1
Beijing Friedship Hospital
Beijing, Beijing Municipality, China, 100050
Actively Recruiting
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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