Comparison of safety and efficacy of desidustat with erythropoietin in newly diagnosed patient of anemia in chronic kidney disease: a prospective, open label, randomized controlled trial

Background: Anemia is a frequent complication of chronic kidney disease (CKD), affecting quality of life and increasing cardiovascular risks. Erythropoiesis-stimulating agents (ESAs) like erythropoietin are standard treatments but raise concerns about safety and long-term outcomes. Hypoxia-inducible factor prolyl hydroxylase inhibitors (HIF-PHIs), such as desidustat, have emerged as potential alternatives. This study compared the safety and efficacy of desidustat with erythropoietin in adults with CKD-associated anemia. Methods: A randomized controlled trial was conducted in the Departments of Nephrology and Pharmacology at Dr. R.P.G.M.C. Kangra at Tanda. Adult CKD patients (>18 years) with anemia, whether on dialysis or not, were enrolled. Participants received either oral desidustat (50 mg thrice weekly) or subcutaneous erythropoietin alfa (50 IU/kg two to three times weekly). Doses were adjusted to maintain haemoglobin (Hb) between 10-11 g/dl. Hematological and biochemical parameters were assessed at baseline, one month and three months. Results: A total of 109 patients were randomized: 54 to desidustat and 55 to erythropoietin. Baseline characteristics, including age, weight and BMI, were comparable. Both groups showed a significant increase in haemoglobin from baseline to follow-ups (p<0.001). At three months, mean Hb rose by 1.65 g/dl in the desidustat group and by 1.31 g/dl in the erythropoietin group. Conclusions: Desidustat demonstrated efficacy and safety comparable to erythropoietin in managing CKD-associated anemia. Its oral administration offers practical advantages, supporting its role as a promising alternative pending further large-scale studies.