Zydus starts phase IV trial for Desidustat
NEW DELHI: Zydus Lifesciences Ltd. (formerly known as Cadila Healthcare Ltd.), a discovery-driven, global
life sciences company announced the commencement of Phase IV clinical trial for Desidustat in
patients with Chronic Kidney Disease (CKD) induced anemia.
CKD is predicted to become one of the most common causes of premature death by 2040 globally.
It is estimated that 115.1 million people in India, 132 million in China, 38 million in the United
States, 21 million in Japan and 41 million people in Western Europe are living with Chronic
Kidney Disease (Lancet 2020; 395: 709–33).
The Phase IV DREAM-CKD trial will enrol 1004 CKD patients in India, including 502 dialysis
dependent, 502 dialysis independent CKD patients with anemia. This multicentre post marketing
surveillance study will evaluate the safety of Desidustat for the treatment of anemia in subjects
with chronic kidney disease over a period of 52 weeks, in addition to secondary endpoints
including; change in hemoglobin level, change in Lipid profile including Small dense LDL, change
in weight, change in VEGF, change in serum hepcidin and evaluation of safety laboratory
parameters [clinicaltrials.gov identifier :
Dr. Ajay K. Singh, a senior nephrologist at the Brigham and Women’s Hospital and Harvard
Medical School mentioned that “This Phase 4 DREAM-CKD study will help generate Real World
Data (RWD) in CKD patients and will add to our existing knowledge of Desidustat. Real World
Data is crucial to understanding how Desidustat works in diverse settings and will be critical to
generate real world evidence which will help formulate clinical guidelines, to further support its
use in clinical practice.”
Pankaj R. Patel, Chairman, Zydus Lifesciences Ltd. said, “Desidustat testifies our commitment to
innovation.It exemplifies our endeavour to develop novel best-in-class innovative medicines,
which is backed by robust clinical trial results and publications in peer-reviewed scientific