Zydus Lifesciences commences Phase IV clinical trial for Desidustat in patients with CKD induced anemia

30 Aug 2022 Evaluate

Zydus Lifesciences has commenced 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.

Zydus Lifesciences (formerly known as Cadila Healthcare) is an India-based pharmaceutical company. The company's subsidiaries include Zydus Wellness, Liva Pharmaceuticals, Biochem Pharmaceutical Industries, Zydus Technologies, German Remedies, Dialforhealth India, Dialforhealth Unity and Dialforhealth Greencross, among others.

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