Zydus Cadila, an innovation-driven, global pharmaceutical company, announced the Phase III trials of Desidustat, an investigational New Drug targeted at treating anemia in non-dialysis dependent chronic kidney disease (NDD-CKD) patients. This Phase III study will be a multicenter (50- 60 sites), randomized, active-controlled clinical trial to evaluate the efficacy and safety of Desidustat versus Darbepoetin for the treatment of anaemia in patients with chronic kidney disease (CKD) who are not on dialysis.
Speaking on the development, Mr. Pankaj R. Patel, Chairman, Zydus Group said, “This innovation has the potential to bring about a paradigm shift in the management of CKD patients with anemia. An HlF-PH inhibitor could provide an oral, safer alternative to currently available erythropoietin stimulating agents (ESAs), which are associated with increased risk of cardiovascular events and have to be given via injections and a cold chain has to be maintained. This is a significant milestone in our research journey.”
Earlier, Desidustat had met its primary endpoints in the Phase II clinical study of Non-dialysis dependent Chronic Kidney Disease (NDD-CKD) patients suffering from anemia. The Phase II NDD-CKD study was a randomized, double-blind, placebo-controlled study of the efficacy and safety of Desidustat for the treatment of anemia in CKD patients not on dialysis. Desidustat demonstrated superiority in efficacy versus placebo in terms of hemoglobin (Hb) response rate at all doses tested when compared to placebo over six weeks. This result was supported by the efficacy demonstrated across multiple secondary endpoints. The Phase I trials were earlier completed in Australia. Detailed data from this NDD-CKD Phase II study will be published in the peer-reviewed scientific journal ‘American Journal of Nephrology’.