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GlaxoSmithKline commences studies of new treatment for CKD-associated anaemia
GlaxoSmithKline has announced the commencement of a new phase III clinical trial programme assessing a promising new treatment for anaemia associated with chronic kidney disease (CKD).
The phase III development programme investigating the oral hypoxia-inducible factor prolyl hydroxylase inhibitor daprodustat will consist of two studies evaluating the drug's safety and efficacy compared to recombinant human erythropoietin.
The first, ASCEND-D will enroll approximately 3,000 dialysis dependent subjects with anaemia associated with CKD, who are switching from an erythropoietin-stimulating agent (ESA).
Meanwhile, the ASCEND-ND trial will involve around 4,500 non-dialysis-dependent subjects with anaemia associated with CKD, with these subjects having either switched from ESA or having never taken one of these therapies.
Currently, patients with chronic kidney disease who require treatment for anaemia are faced with a variety of treatment-related risks associated with cardiovascular safety and injectable administration.
Julian Jenkins, vice-president and medicine development leader responsible for the daprodustat programme, said: "The start of phase III studies of daprodustat is an important step in our work to explore whether daprodustat could address those risks and provide a potential alternative, oral treatment option."
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