February 5, 2021- Zydus Cadila,today announced that it has completed patient enrolment in DREAM-ND and DREAM-D Phase III trials of Desidustat, an oral small molecule hypoxia-inducible factor prolyl hydroxylase (HIF-PH) inhibitor for treatment of anaemia in patients with Chronic Kidney Disease (CKD).
The DREAM-ND Phase III trial has now enrolled 588 CKD patients not-on-dialysis . This Phase III study is a multicentre (68 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.
The DREAM-D Phase III trial is being conducted in 392 CKD patients on Dialysis. The primary end-point in Phase III DREAM-D multicentre study (44 sites) will be the efficacy of Desidustat tablet versus Epoetin alfa injection based on the change of hemoglobin (Hb) levels. The secondary end-points will include number of hemoglobin (Hb) responders, time to achieve target range Hb level, percentage of time spent in target Hb range, serum hepcidin levels, serum potassium (K+) levels, vascular endothelial growth factor (VEGF) levels, lipid profile and lipoproteins.
“The completion of patient enrolment into the DREAM-D and DREAM-ND Phase III trials is a major milestone in the development program of Desidustat, and we are thankful to all the patients and investigators who have persisted in this scientific research in the midst of this COVID-19 pandemic to develop novel therapies for patients with Chronic Kidney Disease.”, said, Pankaj R. Patel, Chairman, Zydus Group. “Desidustat has the potential to bring about a paradigm shift in the management of CKD patients with anaemia as it could provide an oral, safer lternative to currently available injectable erythropoietin-stimulating agents (ESAs), by additionally reducing hepcidin, reducing triglycerides, reducing inflammation, and better iron mobilisation.”Desidustat had previously met its primary endpoints in the Phase II clinical studies and showed good safety profile, endogenous production of erythropoietin, downregulation of hepcidin, improved iron mobilization and reduced triglycerides in CKD patients. The Phase I trials were earlier completed in Australia. Zydus has recently reported that Desidustat in Phase 2(b) POC study conducted in Mexico showed the potential to help prevent acute respiratory distress syndrome (ARDS) in COVID-19 patients and also reduced anti-inflammatory markers including CRP and IL-6.
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