Zydus Lifesciences yesterday announced the commencement of the phase-IV clinical trial for Desidustat in patients with Chronic Kidney Disease (CKD)-induced anaemia, a company statement said.
The phase-IV Dream-CKD trial will enrol 1,004 CKD patients in India, including 502 dialysis-dependent and 502 dialysis-independent CKD patients with anaemia. This multi-centre post-marketing surveillance study will evaluate the safety of Desidustat for the treatment of anaemia in subjects with CKD over a period of 52 weeks, in addition to secondary endpoints including change in haemoglobin 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, senior nephrologist, Brigham and Women’s Hospital and Harvard Medical School mentioned in the statement, “This phase-IV 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.”
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 1,200 CKD patients, and is currently approved in India as Oxemia for the treatment of anaemia in CKD patients. Earlier, the two phase-III 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.