Pilot PK/PD Study of DS-1093a in Patients With Chronic Kidney Disease
Status:
Completed
Trial end date:
2015-05-01
Target enrollment:
Participant gender:
Summary
DS-1093a is an inhibitor of hypoxia-inducible factor prolyl hydroxylases, and is expected to
produce transient dose / exposure dependent increases in erythropoietin levels in subjects
with chronic kidney disease (CKD). This study will be conducted in 2 parts. Part A will
involve subjects with stage 3b or 4 CKD, and will be an open, non-controlled parallel group
investigation of three single doses of DS-1093a (6 subjects/dose), in which allocation to
dose will be randomised. On completion of this part of the study an optional fourth dose may
be tested to gain a more complete understanding of the PK/PD behaviour of DS-1093a. Part B
will be an open, non-controlled investigation of a single dose of DS-1093a in CKD subjects
(n=6) receiving haemodialysis. The dose for Part B will be determined based on the data from
Part A.