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.

Status

Not yet recruiting

Phases

Phase 3

Study type

Interventional

Source

ANZCTR

Registry ID

ACTRN12619001193167

Acronym

No acronym

Enrollment

270

Registered

2019-08-27

Start date

2020-02-03

Completion date

Unknown

Last updated

2019-09-16

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Brief 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.

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.

Study design

Allocation

Randomised controlled trial

Intervention model

Parallel

Primary purpose

Prevention

Masking

Open (masking not used)

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Healthy volunteers

Inclusion criteria

Adult Primary Nephrotic Syndrome patients with Albumin <25gL

Exclusion criteria

eGFR <30 Chronic Liver Disease Bleeding disorders Hb<10g/L Acute bleeding in 3 months Inducers and inhibitors CYP3A44 and P-gp

Outcome results