Abstract: TH-PO1196
Phase 4, 52-Week, Single-Arm, Post-Marketing Surveillance to Evaluate Safety of Desidustat for Treatment of Anemia in Patients with CKD
Session Information
- Late-Breaking Research Posters
November 06, 2025 | Location: Exhibit Hall, Convention Center
Abstract Time: 10:00 AM - 12:00 PM
Category: Anemia and Iron Metabolism
- 200 Anemia and Iron Metabolism
Authors
- Kansagra, Kevinkumar Ashokbhai, Zydus Research Center, Ahmedabad, GJ, India
- Parmar, Deven, Zydus Research Center, Ahmedabad, GJ, India
- Shah, Suchi, Zydus Research Center, Ahmedabad, GJ, India
- Khetan, Prakash, Shravan Hospital and Kidney Institute, Nagpur, Maharashtra, India
- Shah, Hardik Kirit, Shree Ashirwad Hospital, Mumbai, Maharashtra, India
- Khanna, Umesh, Lancelot Medical Center, Mumbai, Maharashtra, India
- Singh, Rana Gopal, Shubham Sudbhawana Super Specialty Hospital, Uttarpradesh, India
- Mavani, Siddharth, Mavani Research Center, Ahmedabad, GJ, India
Background
Anemia is a common complication in Chronic Kidney Disease (CKD) patients, with prevalence of 14% to 79% globally and 40% in India. Desidustat, a hypoxia-inducible factor prolyl hydroxylase inhibitor (HIF-PHI), promotes erythropoiesis by activating the body’s natural response to hypoxia through the HIF pathway. This report presents interim data (cut off date:08/20/2025) from 669 (Dialysis dependent (DD), 297; Non-dialysis dependent (ND), 372) patients who completed 24 weeks of treatment, out of planned 1004 patients.
Methods
Men or women aged ≥18 years with anemia (baseline hemoglobin:7 to 11 g/dL) due to CKD were enrolled. The trial included a screening period of 4 weeks, a 52-week treatment period and a safety assessment visit. Subjects received Desidustat three times a week; 100 mg for ND subjects and for DD subjects, dose was 100 mg (ESA naïve) or 100/125/150 mg (based on previous ESA dose). The primary endpoint was proportion of subjects experiencing treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs). Secondary endpoints included mean change in hemoglobin, serum hepcidin and vascular endothelial growth factor (VEGF).
Results
The mean (±SD) age was 52 ± 14 years. Total 368 TEAEs were observed with 226 patients reporting at least one AE. Most common AEs (>10) were thrombocytopenia, pyrexia, hyperkalemia, AV fistula creation, cough and low WBC count. Most AEs were mild to moderate in severity, unrelated to the study drug, and resolved without sequelae. Total 27 SAEs were reported, including 10 deaths (in line with phase 3 data), 1 life threatening and 16 hospitalizations (all recovered). None were related to Desidustat. Treatment with Desidustat led to an increase in hemoglobin, a reduction in serum hepcidin, and no significant change in VEGF.
Conclusion
This, phase-4 study showed favourable safety and efficacy of desidustat over 24-weeks for anemia in CKD patients.