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Safety, Tolerability, PK & PD Study of JTZ-951 in Anemic Subjects With End-stage Renal Disease

NCT01971164 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 29

Last updated 2014-07-14

No results posted yet for this study

Summary

The purpose of this study is to determine the safety, tolerability, pharmacokinetics (PK), and pharmacodynamics (PD) of sequential ascending doses of JTZ-951 administered for 15 days in anemic subjects with end-stage renal disease (ESRD) receiving hemodialysis.

Conditions

  • Anemia of Chronic Kidney Disease

Interventions

DRUG

JTZ-951

Subjects will receive JTZ-951 or Placebo

DRUG

Placebo

Sponsors & Collaborators

  • Akros Pharma Inc.

    lead INDUSTRY

Principal Investigators

  • Hideyuki Yamamoto · Akros Pharma Inc.

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2013-05-31
Primary Completion
2014-05-31
Completion
2014-07-31

Countries

  • United States

Study Locations

More Related Trials

Entities

Drugs

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 NCT01971164 on ClinicalTrials.gov