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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT02912494
Recruitment Status : Completed
First Posted : September 23, 2016
Last Update Posted : April 2, 2019
JCR Pharmaceuticals Co., Ltd.
Information provided by (Responsible Party):
Kissei Pharmaceutical Co., Ltd.

Brief 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).

Condition or disease Intervention/treatment Phase
Anemia Drug: JR-131 Drug: Darbepoetin alfa Phase 3

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Study Type : Interventional  (Clinical Trial)
Masking: Double (Participant, Investigator)
Actual Study Start Date : September 2016
Actual Primary Completion Date : September 2017
Actual Study Completion Date : September 2017

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Anemia

Arm Intervention/treatment
Experimental: JR-131 Drug: JR-131
Active Comparator: Darbepoetin alfa Drug: Darbepoetin alfa

Primary Outcome Measures :
  1. Change from baseline in Hemoglobin level [ Time Frame: 24 weeks ]

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   20 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT02912494

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Multiple Locations, Japan
Sponsors and Collaborators
Kissei Pharmaceutical Co., Ltd.
JCR Pharmaceuticals Co., Ltd.
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Responsible Party: Kissei Pharmaceutical Co., Ltd. Identifier: NCT02912494    
Other Study ID Numbers: JR-131-301
First Posted: September 23, 2016    Key Record Dates
Last Update Posted: April 2, 2019
Last Verified: March 2019
Additional relevant MeSH terms:
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Hematologic Diseases
Darbepoetin alfa