NCT07404436 Rivaroxaban in Idiopathic Membranous Nephropathy
| NCT ID | NCT07404436 |
| Status | Recruiting |
| Phase | Phase 4 |
| Sponsor | Beijing Friendship Hospital |
| Condition | Idiopathic Membranous Nephropathy |
| Study Type | INTERVENTIONAL |
| Enrollment | 134 participants |
| Start Date | 2024-01-05 |
| Primary Completion | 2026-12-31 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 4 studies follow an already-approved treatment in real-world conditions to monitor long-term safety and effectiveness.
This trial targets 134 participants in total. It began in 2024-01-05 with a primary completion date of 2026-12-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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.
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).
Frequently Asked Questions
Who can join the NCT07404436 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 80 Years, studying Idiopathic Membranous Nephropathy. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT07404436 trial and what does that mean for participants?
Phase 4 studies are conducted after a treatment has been approved. They monitor long-term safety and real-world effectiveness in a broader patient population.
Is NCT07404436 currently recruiting?
Yes, NCT07404436 is actively recruiting participants. Visit ClinicalTrials.gov or contact Beijing Friendship Hospital to inquire about joining.
Where is the NCT07404436 trial being conducted?
This trial is being conducted at Beijing, China.
Who is sponsoring the NCT07404436 clinical trial?
NCT07404436 is sponsored by Beijing Friendship Hospital. The trial plans to enroll 134 participants.