Anticoagulant (Apixaban Vs Warfarin) in prevention of nephrotic syndrome associated thromboembolism
Prospective, Open-Label, Randomized Control Trial on Efficacy of Highly Protein Bound New Oral Anticoagulant (Apixaban Vs Warfarin) in Prevention of Primary Nephrotic Syndrome Associated Thromboembolic Disease.
Royal Brisbane Women Hospital
270 participants
Feb 3, 2020
Interventional
Conditions
Summary
Incidence of venous thromboembolism (VTE) in adult nephrotic syndorme is 25-30% and this risk is inversely related to serum albumin (protein) level. This study will investigate whether apixaban (new oral anticoagulant) is as effective as warfarin which is prescribed routinely when patients serum albumin level is very low. Measurement of apixaban in this study will give a good insight into pharmacokinetic of the drug in nephrotic syndrome.
Eligibility
Inclusion Criteria1
- Adult Primary Nephrotic Syndrome patients with Albumin <25gL
Exclusion Criteria6
- eGFR <30
- Chronic Liver Disease
- Bleeding disorders
- Hb<10g/L
- Acute bleeding in 3 months
- Inducers and inhibitors CYP3A44 and P-gp
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Interventions
Apixaban 2.5mg tablet will be given twice a day orally for 2-6 months or until serum albumin is improved >25g/L with specific therapy (ie. immunosuppressant) for nephrotic syndrome, whichever occurs first . Type, dose and duration of immunosuppressants (steroid, calcineurin inhibitor, mycophenolate, rituximab) will depend on a cause of nephrotic syndrome as guided by a clinical guideline (https://kdigo.org/guidelines/gn/) and patients' tolerability of the drug. Type, dose and duration of immunosuppressants and changes of the treatment plan will be chosen by a primary specialist or in-charge clinician after receiving an informed consent from the patient. Renal pharmacist will contact patient and chemist to make sure that patient is compliant with medications.
Locations(1)
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ACTRN12619001193167