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

NCT02299661 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 31

Last updated 2018-12-24

No results posted yet for this study

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

DRUG

DS-1093a

DS-1093a, single oral doses up to 50 mg

Sponsors & Collaborators

  • PRA Health Sciences

    collaborator INDUSTRY

  • Daiichi Sankyo

    lead INDUSTRY

Principal Investigators

  • Mendel Jansen, BSc · Daiichi Sankyo Development

Study Design

Allocation
RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
70 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2014-11-30
Primary Completion
2015-05-31
Completion
2015-05-31

Countries

  • Czechia
  • Hungary

Study Locations

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Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02299661 on ClinicalTrials.gov