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Desidustat in anemia due to Non-Dialysis-Dependent Chronic Kidney Disease: A phase 3 study (DREAM-ND)

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dc.contributor.author Agrawal, D.
dc.contributor.author Varade, D.
dc.contributor.author Shah, H.
dc.contributor.author Nazar, A.
dc.contributor.author Krishnan, J.
dc.contributor.author Shukla, V.
dc.contributor.author Ramakrishna, C.
dc.contributor.author Bandara, G.M.C.
dc.contributor.author Mavani, S.B.
dc.contributor.author Rajanna, S.
dc.contributor.author Jikki, P.
dc.contributor.author de Silva, S.
dc.contributor.author Ruhela, V.
dc.contributor.author Koradia, P.
dc.contributor.author Kansagra, K.
dc.contributor.author Kanani, P.
dc.contributor.author Sharma, N.
dc.contributor.author Zala, K.
dc.contributor.author Parmar, D.
dc.date.accessioned 2022-04-27T07:33:48Z
dc.date.available 2022-04-27T07:33:48Z
dc.date.issued 2022
dc.identifier.citation American Journal of Nephrology.2022;53(5):352-360. [Epub 2022 Apr 22] en_US
dc.identifier.issn 0250-8095
dc.identifier.uri http://repository.kln.ac.lk/handle/123456789/24570
dc.description indexed in MEDLINE. en_US
dc.description.abstract 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. en_US
dc.language.iso en en_US
dc.publisher Karger,New York en_US
dc.subject Anemia en_US
dc.subject Chronic kidney disease en_US
dc.title Desidustat in anemia due to Non-Dialysis-Dependent Chronic Kidney Disease: A phase 3 study (DREAM-ND) en_US
dc.type Article en_US


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