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
Sponsor study identifier
Secondary identifiers
EUDRACT_NUMBER
NIH
interventional
31
2 countries
3
Study Start
November 2014
Date type not reportedThis date has not been verified as actual or estimated.
Primary Completion
May 2015
Actual (reported)Study Completion
May 2015
Actual (reported)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.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
May 2015
Actual (reported)Click on a node to explore related trials.
Some registry-reported names shown below are not yet linked in this graph.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
November 2014
Date type not reportedThis date has not been verified as actual or estimated.
November 18, 2014
Actual (reported)November 24, 2014
Actual (reported)May 2015
Actual (reported)May 2015
Actual (reported)Plasma concentrations of DS-1093a
Plasma concentrations of DS-1093a and derived PK parameters up to 28 days post-dose.
28 days
Change in serum erythropoietin concentrations
Change in serum erythropoietin concentrations compared to baseline, and derived EPO parameters, up to 6 days post-dose
6 days
Change from baseline for composite haematology parameters
28 days
Change from baseline for composite iron metabolism parameters
7 days
Change from baseline for serum concentrations of vascular endothelial growth factor
7 days
Number and severity of adverse events
28 days
DS-1093a, single oral dose of 7.5 mg
DS-1093a, single oral dose of 25 mg
DS-1093a, single oral dose of 50 mg
DS-1093a, single oral doses up to 50 mg
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
: Hemodialysis Center, Teaching Hospital Hradec Králove
Hradec Králové, 500 05, Czechia
PRA Clinical Pharmacology Unit
Prague, 170 00 Prague 7, Czechia
PRA Clinical Pharmacology Unit
Budapest, H-1077, Hungary
Mendel Jansen, BSc
Daiichi Sankyo Development
31 participants (actual enrollment reported by the registry).
First Submitted
November 18, 2014
First Posted
November 24, 2014
Study Start
November 2014
Date type not reportedThis date has not been verified as actual or estimated.
A Study of LY3113593 in Participants With Chronic Kidney Disease
Contact the study team to confirm eligibility.
Primary Completion
May 2015
Actual (reported)Study Completion
May 2015
Actual (reported)Last Updated
December 24, 2018
Record last verified: 2015-06
De-identified individual participant data (IPD) and applicable supporting clinical trial documents may be available upon request at https://vivli.org/. In cases where clinical trial data and supporting documents are provided pursuant to our company policies and procedures, Daiichi Sankyo will continue to protect the privacy of our clinical trial participants. Details on data sharing criteria and the procedure for requesting access can be found at this web address: https://vivli.org/ourmember/daiichi-sankyo/
Download the complete ClinicalTrials.gov record imported by Syfrah, including fields not shown in this page. The registry may contain a newer revision.
Source: ClinicalTrials.gov.
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