Rivaroxaban in Idiopathic Membranous Nephropathy

ConditionIdiopathic Membranous Nephropathy

Trial statusRecruiting

Trial phasePhase 4

Trial typeInterventional

Biological sexAll

Age18-80

SponsorBeijing Friendship Hospital

About this trial

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

This trial does not accept healthy volunteers

Qualifiers

None

Disqualifiers

None

Trial design

Design model

Parallel

Treatments tested in this trial

Rivaroxaban 10 MG
Drug
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.
Warfarin Sodium
Drug
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 weekly thereafter. If the INR remains outside the target range on two consecutive measurements, the dose may be increased or decreased by 20% of the current dose until the INR reaches the target range.

Treatment groups

134 Participants

are divided into 2 treatment groups

Group A: RivaroxabanExperimental treatment 1 intervention

Group B: WarfarinActive comparator 1 intervention

Trial outcomes

Primary outcomes

Primary efficacy outcome

a composite endpoint, including the incidence of pulmonary embolism, renal vein thrombosis, and lower-extremity deep vein thrombosis.

Time frame

6 months

Secondary outcomes

Secondary efficacy outcome

the incidence of pulmonary embolism, renal vein thrombosis, lower-extremity deep vein thrombosis, and other thrombotic events.

Time frame

6 months

Other outcomes

Safety events

the incidence of all bleeding events

Time frame

6 months

Sponsors and contacts

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Beijing Friendship Hospital

Lead sponsor

Source ClinicalTrials.gov

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