Lead Investigator: Yuya Matsue, Juntendo University School of Medicine Graduate School of Medicine
Title of Proposal Research: Impact of serum hepcidin levels on the efficacy of daprodustat treatment in patients with chronic kidney disease
Vivli Data Request: 9835
Funding Source: None
Potential Conflicts of Interest: Yuya Matsue received an honorarium from Otsuka Pharmaceutical Co., Novartis Pharma K.K., Bayer Inc., and AstraZeneca, and research grants from Pfizer Japan Inc., Otsuka Pharmaceutical Co., EN Otsuka Pharmaceutical Co., Ltd., and Nippon Boehringer Ingelheim Co., Ltd. We will declare any conflicts of interest in any subsequent publication. Kentaro Sakamaki received an honorarium from Kowa Co., Ono Pharmaceutical Co., and Nippon Boehringer Ingelheim Co., Ltd. We will declare any conflicts of interest in any subsequent publication.
Summary of the Proposed Research:
Chronic Kidney Disease (CKD) has been recognized as a leading public health problem worldwide, and affects 10-15% of all the global population. It is characterized by a long-term condition which often brings along other health problems, like anemia (where the blood has lower-than-normal levels of healthy red blood cells), which can make people sicker and increase the risk of death as it significantly increases the risk of major adverse cardiovascular events (MACE), such as heart failure.
Daprodustat is a new kind of medicine that might help treat anemia in people with chronic kidney disease. It works by targeting a hormone called hepcidin, which plays a big role in how our bodies use iron. If there is too much hepcidin in the body, this can stop the body absorbing iron from the bloodstream and cause anemia.
However, we don’t yet fully understand how the levels of hepcidin in the body can affect health outcomes or how daprodustat works in relation to hepcidin levels.
Two randomized controlled trials (RCTs) looking at anemia in CKD, known as ASCEND-ND and ASCEND-D, demonstrated that hepcidin levels were lower in the group of patients taking daprodustat versus those in the control group.
However, little is known about the prognostic implications of baseline hepcidin levels to predict MACE in patients with CKD. Moreover, the association between baseline hepcidin levels and the efficacy of daprodustat remains poorly understood.
Our study aims to use the data from the ASCEND-ND and ASCEND-D trials to find out two main things: how hepcidin levels and their changes over time might predict health outcomes, and how these levels might influence how well daprodustat works for people with kidney disease.
This study will provide invaluable information regarding the target population who should receive daprodustat, and the clinical implications of hepcidin levels, leading to change in the clinical decision making in patients with CKD.
Requested Studies:
A Phase 3 Randomized, Open-label (Sponsor-blind), Active-controlled, Parallel-group, Multi-center, Event Driven Study in Non-dialysis Subjects With Anemia Associated With Chronic Kidney Disease to Evaluate the Safety and Efficacy of Daprodustat Compared to Darbepoetin Alfa
Data Contributor: GlaxoSmithKline
Study ID: NCT02876835
Sponsor ID: 200808
A Phase 3 Randomized, Open-label (Sponsor-blind), Active-controlled, Parallel-group, Multi-center, Event Driven Study in Dialysis Subjects With Anemia Associated With Chronic Kidney Disease to Evaluate the Safety and Efficacy of Daprodustat Compared to Recombinant Human Erythropoietin, Following a Switch From Erythropoietin-stimulating Agents
Data Contributor: GlaxoSmithKline
Study ID: NCT02879305
Sponsor ID: 200807