Single-Centre Prospective Study of Indigenously Developed Hypoxia-Inducible Factor-Prolyl Hydroxylase Inhibitor (HIF-PHI) (Desidustat) for Treatment of Renal Anemia

Background: Anemia in dialysis patients impairs quality of life and leads to adverse cardiovascular outcomes. Standard treatments for CKD-associated anemia include EPO analogues and iron supplementation. Desidustat, a hypoxia-inducible factor prolyl hydroxylase inhibitor (HIF-PHI), was recently approved in India for treating anemia in CKD patients. This study aims to evaluate the efficacy and safety of Desidustat in patients with dialysis-dependent CKD anemia. Methods: This single-center, prospective study enrolled 68 dialysis-dependent CKD patients with anemia. Patients received Desidustat (Oxemia®) either twice or thrice weekly, depending on their hemoglobin (Hb) levels, and were monitored monthly. Supplemental treatments included iron, vitamin B12, and folic acid as needed. The primary endpoint was the efficacy of Desidustat in increasing Hb levels, while the secondary endpoint assessed its safety profile. Results: The study cohort consisted of 68 patients, 47 (69.11%) male, with a mean age of 56 ± 11.5 years. The majority, 66 (97%), were on maintenance hemodialysis (MHD) twice weekly, while 2 (3%) were on thrice weekly schedules. Desidustat was administered to 35 (51.4%) patients thrice weekly and to 31 (45.6%) patients twice weekly. Among the participants, 40 (58.8%) were EPO-naïve, and 28 (42.8%) had switched from EPO therapy. Significant improvements in Hb levels were observed following Desidustat treatment (p<0.05). Pre-treatment Hb was 7.78 gm/dl, increasing to 8.27 gm/dl after 1 month, 8.71 gm/dl after 2 months, 9.22 gm/dl after 3 months, and 9.94 gm/dl after more than 3 months, with a mean treatment duration of 11.8 ± 6.7 months. Both EPO-naïve patients and those who switched from EPO showed comparable increases in Hb levels. Background therapy included oral iron for 12 (17.6%) patients, intravenous (IV) iron for 52 (76.4%) patients, and vitamin B12 supplementation. Adverse events included mild hyperkalemia in 6 patients and vomiting in 2 patients, both managed appropriately. Conclusion: This study demonstrates that Desidustat is an effective and safe alternative for treating anemia in dialysis-dependent CKD patients. Given its oral administration Desidustat offers a convenient alternative to injectable EPO therapies Funding: Commercial Support - Zydus Pharmaceutical, India