Rivaroxaban to prevent blood clots in idiopathic membranous nephropathy

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

This trial will test whether daily rivaroxaban prevents dangerous blood clots better than warfarin in adults with idiopathic membranous nephropathy who have nephrotic syndrome and very low albumin.

Quick facts

• Phase: PHASE4
• Study type: Interventional
• Enrollment: 134 (estimated)
• Ages: 18 Years to 80 Years
• Sex: All
• Sponsor: Beijing Friendship Hospital (other)
• Locations: 1 site (Beijing, Beijing Municipality)
• Trial ID: NCT07404436 on ClinicalTrials.gov

What this trial studies

This is a prospective, single-center, randomized controlled trial enrolling adults with biopsy-confirmed idiopathic membranous nephropathy at high risk of thrombosis. Eligible participants with nephrotic syndrome and serum albumin under 25 g/L and normal renal function will be randomized to receive prophylactic rivaroxaban 10 mg daily or warfarin. Participants will be followed for six months to compare the incidence of a composite efficacy endpoint (pulmonary embolism and deep vein thrombosis) and the rate of bleeding events. Patients with prior thrombotic events, active clinically significant bleeding, pregnancy, or pulmonary conditions that preclude V/Q scanning are excluded.

Who should consider this trial

Good fit: Adults 18–80 with biopsy-confirmed idiopathic membranous nephropathy who meet nephrotic syndrome criteria, have serum albumin <25 g/L, normal renal function, and low bleeding risk are the ideal candidates.

Not a fit: Patients with prior thrombotic events, active significant bleeding, pregnancy or breastfeeding, inability to undergo V/Q scanning, significant pulmonary disease, or impaired renal function may not receive benefit from this trial.

Why it matters

Potential benefit: If successful, rivaroxaban could provide a simpler, fixed-dose option that lowers the risk of pulmonary embolism and deep vein thrombosis in high-risk IMN patients with less routine monitoring than warfarin.

How similar studies have performed: Rivaroxaban has proven effective for thromboprophylaxis in other settings, but its use specifically for preventing clots in idiopathic membranous nephropathy is relatively novel with limited prior trial data.

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).

Where this trial is running

Beijing, Beijing Municipality

• Beijing Friedship Hospital — Beijing, Beijing Municipality, China (RECRUITING)

Conditions: Idiopathic Membranous Nephropathy