NCT02912533

Brief Summary

The purpose of this study is to investigate the safety and efficacy for 52-week dosing of JR-131 in renal anemia patients with chronic kidney disease (CKD).

Trial Health

87
On Track

Trial Health Score

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

Timeline
Completed

Started Sep 2016

Geographic Reach
1 country

1 active site

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

September 1, 2016

Completed
20 days until next milestone

First Submitted

Initial submission to the registry

September 21, 2016

Completed
2 days until next milestone

First Posted

Study publicly available on registry

September 23, 2016

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2018

Completed
Last Updated

April 2, 2019

Status Verified

March 1, 2019

Enrollment Period

1.5 years

First QC Date

September 21, 2016

Last Update Submit

March 29, 2019

Conditions

Anemia

Outcome Measures

Primary Outcomes (1)

  • Measure adverse events

    52 weeks

Secondary Outcomes (1)

  • Hemoglobin level

    52 weeks

Study Arms (1)

JR-131

EXPERIMENTAL
Drug: JR-131

Interventions

JR-131DRUG
JR-131

Eligibility Criteria

Age20 Years+
Sexall
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patients being treated with erythropoiesis stimulating agent.

You may not qualify if:

  • Patients having complication or history of a cardiovascular / lung / brain infarction.
  • Patients having a pronounced hemorrhagic lesion.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Unknown Facility

Multiple Locations, Japan

Location

MeSH Terms

Conditions

Anemia

Condition Hierarchy (Ancestors)

Hematologic DiseasesHemic and Lymphatic Diseases

Study Design

Study Type
interventional
Phase
phase 3
Masking
NONE
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 21, 2016

First Posted

September 23, 2016

Study Start

September 1, 2016

Primary Completion

March 1, 2018

Study Completion

March 1, 2018

Last Updated

April 2, 2019

Record last verified: 2019-03

Locations

JP(1)