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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02912494
Other study ID # JR-131-301
Secondary ID
Status Completed
Phase Phase 3
First received
Last updated
Start date September 2016
Est. completion date September 2017

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 equivalence of JR-131 to Darbepoetin alfa and evaluate the safety of JR-131 in renal anemia patients with chronic kidney disease (CKD).


Recruitment information / eligibility

Status Completed
Enrollment 0
Est. completion date September 2017
Est. primary completion date September 2017
Accepts healthy volunteers
Gender All
Age group 20 Years and older
Eligibility Inclusion Criteria:

- Patients being treated with Darbepoetin alfa.

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

Darbepoetin alfa


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 Change from baseline in Hemoglobin level 24 weeks
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