Rivaroxaban to prevent blood clots in idiopathic membranous nephropathy

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• Beijing Friedship Hospital
  Beijing, Beijing Municipality, China Recruiting

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.