NCT01971164

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
29

participants targeted

Target at P25-P50 for phase_1

Timeline
Completed

Started May 2013

Geographic Reach
1 country

5 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2013

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

October 15, 2013

Completed
14 days until next milestone

First Posted

Study publicly available on registry

October 29, 2013

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2014

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2014

Completed
Last Updated

July 14, 2014

Status Verified

July 1, 2014

Enrollment Period

1 year

First QC Date

October 15, 2013

Last Update Submit

July 11, 2014

Conditions

Anemia of Chronic Kidney Disease

Keywords

anemiachronic kidney diseasehemodialysis

Outcome Measures

Primary Outcomes (11)

  • Number of subjects with adverse events

    15 days

  • Vital signs and 12 lead ECGs

    15 days

  • Cmax (maximum concentration)

    15 days

  • tmax (time to reach maximum concentration)

    15 days

  • t1/2 (elimination half-life)

    15 days

  • AUC (area under the concentration-time curve)

    15 days

  • AR (accumulation ratio)

    15 days

  • RBC (red blood cell) count

    15 days

  • Hgb (hemoglobin)

    15 days

  • TSAT (transferrin saturation)

    15 days

  • serum ferritin

    15 days

Study Arms (4)

Dose 1 JTZ-951 or Placebo

EXPERIMENTAL

Tablets, 1 dose per day for 15 days

Drug: JTZ-951Drug: Placebo

Dose 2 JTZ-951 or Placebo

EXPERIMENTAL

Tablets, 1 dose per day for 15 days

Drug: JTZ-951Drug: Placebo

Dose 3 JTZ-951 or Placebo

EXPERIMENTAL

Tablets, 1 dose per day for 15 days

Drug: JTZ-951Drug: Placebo

Dose 4 JTZ-951 or Placebo

EXPERIMENTAL

Tablets, 1 dose per day for 15 days

Drug: JTZ-951Drug: Placebo

Interventions

JTZ-951DRUG

Subjects will receive JTZ-951 or Placebo

Dose 1 JTZ-951 or PlaceboDose 2 JTZ-951 or PlaceboDose 3 JTZ-951 or PlaceboDose 4 JTZ-951 or Placebo
PlaceboDRUG
Dose 1 JTZ-951 or PlaceboDose 2 JTZ-951 or PlaceboDose 3 JTZ-951 or PlaceboDose 4 JTZ-951 or Placebo

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (5)

Unknown Facility

Lakewood, Colorado, United States

Location

Unknown Facility

Miami, Florida, United States

Location

Unknown Facility

Orlando, Florida, United States

Location

Unknown Facility

Minneapolis, Minnesota, United States

Location

Unknown Facility

Saint Paul, Minnesota, United States

Location

Related Publications (1)

  • Natale P, Palmer SC, Jaure A, Hodson EM, Ruospo M, Cooper TE, Hahn D, Saglimbene VM, Craig JC, Strippoli GF. Hypoxia-inducible factor stabilisers for the anaemia of chronic kidney disease. Cochrane Database Syst Rev. 2022 Aug 25;8(8):CD013751. doi: 10.1002/14651858.CD013751.pub2.

    PMID: 36005278DERIVED

MeSH Terms

Conditions

AnemiaRenal Insufficiency, Chronic

Interventions

enarodustat

Condition Hierarchy (Ancestors)

Hematologic DiseasesHemic and Lymphatic DiseasesRenal InsufficiencyKidney DiseasesUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital DiseasesChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Hideyuki Yamamoto

    Akros Pharma Inc.

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 15, 2013

First Posted

October 29, 2013

Study Start

May 1, 2013

Primary Completion

May 1, 2014

Study Completion

July 1, 2014

Last Updated

July 14, 2014

Record last verified: 2014-07

Locations

US(5)