Zydus Lifesciences Ltd on Tuesday announced the start of Phase IV clinical trials for its novel drug 'Desidustat' in patients with chronic kidney disease induced anaemia.
The phase IV trial will enrol 1,004 chronic kidney disease (CKD) patients in India, including 502 dialysis dependent, 502 dialysis independent CKD patients with anaemia, the company said in a regulatory filing.
The multicentre, post marketing surveillance study will evaluate safety of Desidustat for the treatment of anemia in subjects with chronic kidney disease over a period of 52 weeks, it said.
Besides, it will also study the secondary endpoints, including changes in hemoglobin level, lipid profile, weight and serum hepcidin, and evaluation of safety laboratory parameters, among others, the company added.
Zydus said Desidustat, sold under the Oxemia trademark, is a prescription drug approved in India for patients with CKD induced anemia, and can be taken only under the advice and guidance of a nephrologist or an internal medicine specialist.
The drug has been previously studied in randomised controlled clinical trials in over 1,200 CKD patients, it added.The company, citing Lancet data, said 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 people in Western Europe are living with CKD.