Zydus Cadila announces second Phase 3 trail of Desidustat

Zydus Cadila announced the second Phase III DREAM-D trials of Desidustat, an Investigational New Drug (IND) targeted at treating anemia in dialysis dependent CKD patients.

Desidustat is a novel, oral, HIFPH inhibitor being developed for treating anemia in CKD patients. This Phase III DREAMD study will be a multicenter (50- 60 sites in India), randomized, activecontrolled clinical trial to evaluate the efficacy and safety of Desidustat versus Epoetin for the treatment of anemia in patients with CKD who are on dialysis.

The primary end-point in Phase III DREAM-D study will be the efficacy of Desidustat tablet versus Epoetin alfa injection based on the change of hemoglobin (Hb) levels at 24 weeks. The secondary endpoints 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.

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