Evaluating Therapeutic Potential and Safety Profile of Desidustat for Anaemia Management in Patients with CKD: A Prospective, Open-Label, Single-Centre Study

Background: Anemia is one of the common, most prevalent and challenging complications of chronic kidney disease (CKD). Desidustat (Oxemia®), a hypoxia-inducible factor prolyl hydroxylase inhibitor (HIF-PHI), is a promising oral alternative to injectable erythropoiesis-stimulating agents (ESAs) for the treatment of anaemia in patients with CKD. Desidustat is approved in India for adults with CKD who are either not on dialysis or on dialysis. Here we aim to evaluate the real life effectiveness and safety profile of Desidustat in managing anemia among patients with chronic kidney disease (CKD). Methods: This is a prospective single center analysis of Patient suffering from CKD –Anemia treated with Newer HIF PHIv-Desidustat. In this study Patients were on 100 mg Desidustat three times in a week. Primary end point was to observe rise in Hb from baseline to 24 weeks. Other secondary were safety and rise of Hb between different subgroup. Dose adjustments based on the haemoglobin levels at each follow up. Results: Sixty four (n=64) patients median (IQR) age 60(18.5) years, n=37(57.8%) were female. Majority of the patients were suffering from CIN (21, 32.8%), DKD (15, 23.4%) and CGN (13, 20.3%). 33 (51.5%) were on HD, one patients on PD and 30 (46.8%) were Pre Dialysis patients. Out of 64 Patients, 43(67.2%) patients were EpO switched and 21(32.8%) were EpO naïve patients. There was statistically significant improvement in mean Hb (figure 1). In different category of EpO naïve Switched from EpO, DD vs ND rise of Hb was comparable. Among the safety parameters, the change in serum potassium value from baseline to the end of 24 weeks was within the normal range, with minimal change (p=0.856). The adverse events were observed in (n=5, 7.8%) patients; including VA stenosis(n= 1,1.6%), MGUS(n= 1,1.6%), Vascular Thrombosis(n= 1,1.6%), IE(n= 1,1.6%), and MACE death(n= 1,1.6%). Conclusion: The study shows desidustat is significantly effective in improvement of Hb levels in both EPO exposed and naïve patients with CKD anaemia.The oral administration further improves the compliance of the patients.