Dr Shaun Chandler1,2, Mr Steven Wallis3, Ms Tanu Taylor1, Ms Shih-Han Tseng1, MS Jue Wang1, Dr Thin Han6,7, Dr Monica Ng1,2,5, Professor Jason Roberts3,4, Dr Zaw Thet6,7,8,9, Professor Dwarakanathan Ranganathan1,2,9
1Kidney Health Service, Royal Brisbane and Women’s Hospital, Herston, Australia, 2Faculty of Medicine, University of Queensland, Herston, Australia, 3University of Queensland Centre for Clinical Research, Herston, Australia, 4Herston Infectious Diseases Institute (HeIDI), Metro North Health, Brisbane, Australia, 5Conjoint Internal Medicine Laboratory, Chemical Pathology, Pathology Queensland,, Brisbane, Australia, 6Kidney Health Service, Central Queensland Hospital and Health Service, Rockhampton, Australia, 7Rural Clinical School, University of Queensland, Rockhampton, Australia, 8Kidney Health Service, West Moreton Hospital and Health Service, Queensland, Ipswich, Australia, 9School of Medicine and Dentistry, Griffith University, Gold Coast, Australia
Biography:
Shaun is an early career nephrologist with an interest in glomerular disorders and kidney transplantation.
Aim:
To assess the feasibility, safety, and pharmacokinetics of apixaban compared to warfarin in patients with nephrotic syndrome.
Background:
Severe hypoalbuminemia in nephrotic syndrome is associated with increased risks of venous thromboembolism (VTE). Direct oral anticoagulants (DOACs), offer potential advantages over warfarin (standard of care) in terms of monitoring and safety. There is limited data supporting DOACs use for VTE prophylaxis in people with nephrotic syndrome and severe hypoalbuminaemia.
Methods:
This multi-centre, open label, randomized controlled trial, enrolled patients with nephrotic syndrome and serum albumin <25g/L or confirmed VTE. Exclusion criteria included eGFR <15mL/min, dual antiplatelet therapy, significant hepatic dysfunction, solid organ malignancy, pregnancy, or anticoagulation for unrelated indications. Participants were randomised to receive apixaban 2.5mg twice daily or warfarin with a target INR of 1.7–2.7. The primary efficacy outcome was breakthrough VTE.
Results:
Ten patients were screened (1 excluded; 9 randomised: 5 warfarin, 4 apixaban). No participants had active VTE. Median participant age was 60 (IQR 47-70), and 56% were female. Underlying diagnosis included membranous nephropathy (66.6%) and focal segmental glomerulosclerosis (22.2%). Median serum albumin was 19 g/L (IQR 14.5-22.8g/L), and median treatment duration was 7.7 weeks (IQR 3.6-17.3). Two patients in the warfarin group withdrew due to burden of INR testing and anticoagulation risks in general, at 3.5 weeks and 3 days respectively. DOAC prophylaxis was taken up by one patient external to trial. No VTE events or bleeding complications were observed.
Conclusion:
This study demonstrates comparable short-term safety and efficacy between apixaban and warfarin in nephrotic syndrome. Apixaban pharmacokinetics will be analysed in the next phase of the study. Larger clinical trials are required to confirm results of this study.