Zydus Lifesciences Ltd has commenced Phase IV clinical trial for Desidustat in patients with chronic kidney disease (CKD)-induced anaemia.
The Phase IV DREAM-CKD trial will enrol 1,004 patients in India, including 502 dialysis-dependent and 502 dialysis-independent CKD patients with anaemia, a company statement said. Zydus Lifesciences shares traded flat on Tuesday at ₹377.70 on BSE.
The multicentre post-marketing surveillance study will evaluate the safety of Desidustat over a period of 52 weeks.
Notably, in November 2021, Zydus had submitted a new drug application (NDA) to the Drug Controller General of India for Desidustat.
The study will also cover secondary endpoints including change in haemoglobin level, change in lipid profile including small dense low-density lipoprotein (LDL), change in weight, change in vascular endothelial growth factor (VEGF), change in serum hepcidin, and evaluation of safety laboratory parameters.
Pankaj Patel, chairman, Zydus Lifesciences Ltd, commented, "Desidustat 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 anaemia."
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 US, 21 million in Japan, and 41 million in western Europe are living with CKD, according to a 2020 report in Lancet.
Real-world data
Dr Ajay Singh, a senior nephrologist at the Brigham and Women’s Hospital and Harvard Medical School said, "This Phase IV DREAM-CKD study will help generate real-world data in CKD patients and 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 the real-world evidence, which will help formulate clinical guidelines, to further support its use in clinical practice," he said.
Desidustat’s development was based on the Nobel Prize-winning discovery of the oxygen-sensing mechanism of cells through hypoxia-inducible factor (HIF), a Zydus statement said.
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 American Journal of Nephrology.