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

July 11, 2014 updated by: Akros Pharma Inc.

Randomized, Single-blind, Placebo-controlled, Multiple Ascending Dose Study to Evaluate Safety, Tolerability, Pharmacokinetics & Pharmacodynamics of JTZ-951 Administered Once Daily for 15 Days in Anemic Subjects With End-stage Renal Disease

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

29

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Colorado
      • Lakewood, Colorado, United States
    • Florida
      • Miami, Florida, United States
      • Orlando, Florida, United States
    • Minnesota
      • Minneapolis, Minnesota, United States
      • Saint Paul, Minnesota, United States

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Subjects who have ESRD and have been receiving maintenance hemodialysis for at least 12 weeks prior to the Screening Visit
  • Body weight (post-dialysis weight) greater than 45.0 kg and a body mass index between 20.0 and 40.0 kg/m2 (inclusive) at the Screening Visit
  • Hemoglobin value as defined in the protocol
  • Meet the erythropoiesis-stimulating agent (ESA) therapy criteria at the Screening Visit as defined in the protocol

Exclusion Criteria:

  • Transferrin saturation and ferritin levels at the Screening Visit as defined in the protocol
  • Anemia due to known causes other than chronic kidney disease
  • Known history of hyporesponsiveness to ESAs
  • Acute coronary syndrome (e.g., myocardial infarction) within 1 year prior to Screening visit

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Dose 1 JTZ-951 or Placebo
Tablets, 1 dose per day for 15 days
Drug: Placebo
Drug: JTZ-951
Subjects will receive JTZ-951 or Placebo
Experimental: Dose 2 JTZ-951 or Placebo
Tablets, 1 dose per day for 15 days
Drug: Placebo
Drug: JTZ-951
Subjects will receive JTZ-951 or Placebo
Experimental: Dose 3 JTZ-951 or Placebo
Tablets, 1 dose per day for 15 days
Drug: Placebo
Drug: JTZ-951
Subjects will receive JTZ-951 or Placebo
Experimental: Dose 4 JTZ-951 or Placebo
Tablets, 1 dose per day for 15 days
Drug: Placebo
Drug: JTZ-951
Subjects will receive JTZ-951 or Placebo

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Number of subjects with adverse events
Time Frame: 15 days
15 days
Vital signs and 12 lead ECGs
Time Frame: 15 days
15 days
Cmax (maximum concentration)
Time Frame: 15 days
15 days
tmax (time to reach maximum concentration)
Time Frame: 15 days
15 days
t1/2 (elimination half-life)
Time Frame: 15 days
15 days
AUC (area under the concentration-time curve)
Time Frame: 15 days
15 days
AR (accumulation ratio)
Time Frame: 15 days
15 days
RBC (red blood cell) count
Time Frame: 15 days
15 days
Hgb (hemoglobin)
Time Frame: 15 days
15 days
TSAT (transferrin saturation)
Time Frame: 15 days
15 days
serum ferritin
Time Frame: 15 days
15 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Akros Pharma Inc.

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 1, 2013

Primary Completion (Actual)

May 1, 2014

Study Completion (Actual)

July 1, 2014

Study Registration Dates

First Submitted

October 15, 2013

First Submitted That Met QC Criteria

October 28, 2013

First Posted (Estimate)

October 29, 2013

Study Record Updates

Last Update Posted (Estimate)

July 14, 2014

Last Update Submitted That Met QC Criteria

July 11, 2014

Last Verified

July 1, 2014

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • AZ951-U-12-004

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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