Open AccessDesidustat in Anemia due to Non-Dialysis-Dependent Chronic Kidney Disease: A Phase 3 Study (DREAM-ND)
Author(s) -
D. P. Agrawal,
Deepak Varade,
Hardik Shah,
Alm Nazar,
Jayakumar Edathedathe Krishnan,
Varsha Shukla,
Chinta Ramakrishna,
Mahel Chinthana Bandara Galahitiyawa,
Sidhharth B. Mavani,
Sunil Rajanna,
Petkar Jikki,
Shamila De Silva,
Vivek Ruhela,
Parshottam Koradia,
Kevinkumar Kansagra,
Pooja Kanani,
Nitin Sharma,
Kuldipsinh Zala,
Deven Parmar
Publication year - 2022
Publication title -
american journal of nephrology
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 1.394
H-Index - 85
eISSN - 1421-9670
pISSN - 0250-8095
DOI - 10.1159/000523961
Subject(s) - medicine , kidney disease , erythropoietin , anemia , darbepoetin alfa , gastroenterology , hemoglobin , dialysis , endocrinology
Background: Desidustat, an oral hypoxia-inducible factor prolyl hydroxylase inhibitor, is being developed to treat anemia in patients with chronic kidney disease (CKD) without dialysis dependency. Methods: In total, 588 patients with a clinical diagnosis of anemia due to CKD without dialysis need and with baseline hemoglobin of 7.0–10.0 g/dL (inclusive) were randomized in a 1:1 ratio to receive either desidustat 100 mg oral tablets thrice a week for 24 weeks or biosimilar darbepoetin subcutaneous injection 0.75 μg/kg once in 2 weeks for 24 weeks. The primary outcome was the change from baseline in hemoglobin to evaluation period of Weeks 16–24. Key secondary outcomes included the number of patients with hemoglobin response, changes in the hepcidin levels, changes in the vascular endothelial growth factor (VEGF) levels, and changes in the lipid and lipoprotein profiles. Results: Hemoglobin change from baseline to Weeks 16–24 was 1.95 g/dL in the desidustat group and 1.83 g/dL in the darbepoetin group (difference: 0.11 g/dL; 95% CI: −0.12, 0.34), which met prespecified non-inferiority margin (−0.75 g/dL). The hemoglobin responders were significantly higher ( p = 0.0181) in the desidustat group (196 [77.78%]) compared to the darbepoetin group (176 [68.48%]). The difference of change in hepcidin from baseline to Week 12 and Week 24 ( p = 0.0032 at Week 12, p = 0.0016 at Week 24) and the difference of change in low-density lipoprotein from baseline to Week 24 ( p value = 0.0269) between the two groups was statistically significant. The difference of change from baseline in VEGF to Weeks 12 and 24 between the two groups was not statistically significant. Conclusion: Desidustat is non-inferior to darbepoetin in the treatment of anemia due to non-dialysis dependent CKD and it is well-tolerated.