Zydus Lifecsciences begins Desidustat Phase IV trial in patients with CKD induced anemia
Desidustat is currently approved in India as Oxemia for the treatment of anemia in Chronic Kidney Disease (CKD) patients.
Ahmedabad: 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.
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 journals. This novel medicine will meet the needs of millions of patients living with Chronic Kidney Disease induced anemia."
Desidustat's development was based on the Nobel Prize in Medicine winning science on discoveries of the oxygen sensing mechanism of cells through hypoxia-inducible factor (HIF). Desidustat has been previously studied in randomised controlled clinical trials in over 1200 CKD patients, and is currently approved in India as Oxemia for the treatment of anemia in Chronic Kidney Disease (CKD) patients.
Earlier the two Phase 3 trial results of Desidustat in CKD patients not-on-dialysis [DREAM-ND], and in CKD patients on-dialysis [DREAM-D] have been published in the prestigious American Journal of Nephrology.
Read also: Zydus bags USFDA nod for Prochlorperazine Maleate Tablets
