A Long-term Study of JR-131 in Renal Anemia Patients With Chronic Kidney Disease (CKD)

NCT ID: NCT02912533

Last Updated: 2019-04-02

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Study Classification

INTERVENTIONAL

Study Start Date

2016-09-30

Study Completion Date

2018-03-31

Brief Summary

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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).

Detailed Description

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Conditions

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Anemia

Study Design

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Blinding Strategy

NONE

Study Groups

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JR-131

Group Type EXPERIMENTAL

JR-131

Intervention Type DRUG

Interventions

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JR-131

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Patients being treated with erythropoiesis stimulating agent.

Exclusion Criteria

* Patients having complication or history of a cardiovascular / lung / brain infarction.
* Patients having a pronounced hemorrhagic lesion.
Minimum Eligible Age

20 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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JCR Pharmaceuticals Co., Ltd.

INDUSTRY

Sponsor Role collaborator

Kissei Pharmaceutical Co., Ltd.

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Multiple Locations, , Japan

Site Status

Countries

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Japan

Other Identifiers

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JR-131-302

Identifier Type: -

Identifier Source: org_study_id

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