Abstract: TH-PO979
Efficacy and Safety of Desidustat for the Treatment of Anaemia in Patients with CKD: A Retrospective, Open-Label, Single-Centre Study
Session Information
- Anemia in CKD: Risk Factors, Practice Patterns, Therapies
November 02, 2023 | Location: Exhibit Hall, Pennsylvania Convention Center
Abstract Time: 10:00 AM - 12:00 PM
Category: Anemia and Iron Metabolism
- 200 Anemia and Iron Metabolism
Author
- Khandekar, Ashwinikumar, Kingsway Hospitals, Nagpur, India
Background
CKD is associated with an increased risk of anaemia,significantly impacting patients' quality of life.Current therapy includes injectable erythropoiesis-stimulating agents which have limitations and safety concerns. Desidustat has shown promise in stimulating endogenous erythropoiesis and addressing anaemia in CKD. This study assesses the real-world clinical efficacy & safety of the desidustat treatment in CKD patients with anaemia.
Methods
This is a retrospective, observational, open-label, single-centre, single-arm study of CKD anaemic patients. Patients were administered with desidustat 100mg orally thrice a week for a period of 24 weeks. 83.3% of patients received 300mg/ week dose of desidustat as starting dose. Dose adjustment was done every 4 weeks as per the Hb level of the patients.The primary outcome was to assess the change in the Hb from baseline to the end of 24 weeks and the secondary outcome was the evaluation of AEs if occur.
Results
Out of 84 patients,51.2% were previously on ESA therapy, 48.8% were treatment naïve,38.1% were on dialysis and 56% non-dialysis patients.The results show statistically significant improvement in mean Hb level at the end of 24 weeks (1.306g/dL; p<0.01). Within groups including - treatment naïve patients, patients previously on ESA, non-dialysis and on dialysis patients improvement in mean Hb from baseline to end of 24 weeks was statistically significant,with most significant improvement seen in treatment naïve patients (p<0.01) and non-dialysis patients (p<0.01), the improvement in mean Hb values being 9.5±0.91 to 11.3±0.87, 9.7±1.16 to 11.2±0.87 respectively. The serum potassium showed mild variation from a mean of 4.7±0.80 to 4.8±0.47. AEs were observed in 13.1% patients, including AV Fistula failures (4.8%), LVF (2.4%), Arterial thrombosis ( 1. 2%), DVT ( 1.2%), Acute Pancreatitis (1.2%), Haemorrhagic stroke (1.2%) and Transaminitis (1.2%).
Conclusion
The short-term desidustat treatment demonstrated statistically significant improvement in Hb levels in patients. Therefore, making it a viable alternative to current treatment options. Since the present study was retrospective in nature the causality assessment was not assessed. Hence, further research is needed to gather long-term data and compare the cardiovascular safety of desidustat with the injectable ESAs.