Phase I Study to Evaluate the Pharmacokinetics of Roxadustat
Research type
Research Study
Full title
A phase 1 study to evaluate the pharmacokinetics of roxadustat in subjects with different degrees of renal function
IRAS ID
214708
Contact name
Asad Ullah
Contact email
Sponsor organisation
Astellas Pharma Europe B.V. (APEB)
Eudract number
2015-002565-28
Duration of Study in the UK
0 years, 8 months, 0 days
Research summary
Chronic kidney disease (CKD) is a growing worldwide public health problem, characterised by progressive loss of kidney function, resulting in premature death or requirement for renal replacement therapy (kidney transplant or dialysis). Anemia is a common complication in patients with CKD and the prevalence increases as CKD progresses. Because the main impact of anemia on organ function is reduced oxygen delivery to tissues, it affects almost every organ system. Therefore, the severity of anemia correlates directly with risk of hospitalisation, cardiovascular disease, and death. Patients with CKD are considered to be in the highest risk group for subsequent cardiovascular disease events. This supports the importance of developing medications for patients with CKD and end-stage renal disease (ESRD). Roxadustat is a new, investigational drug. it is a potent and reversible hypoxia-inducible factor (HIF) - prolyl hydroxylase inhibitor (HIF-PHI) that transiently induces HIF stabilization and leads to a functional HIF transcriptional response. This study will investigate the pharmacokinetic and metabolic profile of roxadustat in subjects with severely impaired renal function, or ESRD, subjects requiring dialysis and subjects with normal renal function. The study is being conducted at 2 anticipated study centres; 1 in the United Kingdom and 1 in Germany. The study is sponsored by the pharmaceutical company Astellas. All subjects will have 1 single dose of roxadustat, except for ESRD subjects on HD or HDF who will receive a single dose of roxadustat twice (once after and once before dialysis) to evaluate the effect of HD on the pharmacokinetics of roxadustat and its main metabolites. The study may involve up to 7 study visits over a period of 8 weeks and will include blood tests, vital sign meaurements, ECGs, 24 continuous heart rate monitoring and urine sample collections.
REC name
East of England - Cambridge East Research Ethics Committee
REC reference
16/EE/0453
Date of REC Opinion
20 Jan 2017
REC opinion
Further Information Favourable Opinion