NCT02299661

Pilot PK/PD Study of DS-1093a in Patients With Chronic Kidney Disease

An Open-Label, Randomised, Parallel Group Pilot Study to Assess the Pharmacokinetics, Pharmacodynamics, Safety and Tolerability of Single Doses of DS-1093a in Patients With Chronic Kidney Disease

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 31 (actual)
• Sponsor: Daiichi Sankyo · Industry
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Chronic Renal Disease
• Renal Anemia

Interventions

Type	Name	Description
DRUG	DS-1093a	DS-1093a, single oral doses up to 50 mg

Timeline

• Start date: 2014-11-01
• Primary completion: 2015-05-01
• Completion: 2015-05-01
• First posted: 2014-11-24
• Last updated: 2018-12-24

Locations

3 sites across 2 countries: Czechia, Hungary