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NCT02912533 Clinical Trial

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

Anemia Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT02912533
Other study ID # JR-131-302
Secondary ID
Status Completed
Phase Phase 3
First received
Last updated
Start date September 2016
Est. completion date March 2018

Study information
Verified date March 2019
Source Kissei Pharmaceutical Co., Ltd.
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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).

Recruitment information / eligibility
Status Completed
Enrollment 0
Est. completion date March 2018
Est. primary completion date March 2018
Accepts healthy volunteers
Gender All
Age group 20 Years and older
Eligibility 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.

Study Design

Related Conditions & MeSH terms

Intervention

Drug:
• JR-131

Locations
Country Name City State
n/a

Sponsors (2)
Lead Sponsor Collaborator
Kissei Pharmaceutical Co., Ltd. JCR Pharmaceuticals Co., Ltd.

Country where clinical trial is conducted

Japan, 

Outcome
Type Measure Description Time frame Safety issue
Primary Measure adverse events 52 weeks
Secondary Hemoglobin level 52 weeks
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