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A Long-term 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.
 
ClinicalTrials.gov Identifier: NCT02912533
Recruitment Status : Completed
First Posted : September 23, 2016
Last Update Posted : April 2, 2019
Sponsor:
Collaborator:
JCR Pharmaceuticals Co., Ltd.
Information provided by (Responsible Party):
Kissei Pharmaceutical Co., Ltd.

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).

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

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Study Type : Interventional  (Clinical Trial)
Masking: None (Open Label)
Actual Study Start Date : September 2016
Actual Primary Completion Date : March 2018
Actual Study Completion Date : March 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Anemia

Arm Intervention/treatment
Experimental: JR-131 Drug: JR-131



Primary Outcome Measures :
  1. Measure adverse events [ Time Frame: 52 weeks ]

Secondary Outcome Measures :
  1. Hemoglobin level [ Time Frame: 52 weeks ]


Information from the National Library of Medicine

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

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.

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 ClinicalTrials.gov identifier (NCT number): NCT02912533


Locations
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Japan
Multiple Locations, Japan
Sponsors and Collaborators
Kissei Pharmaceutical Co., Ltd.
JCR Pharmaceuticals Co., Ltd.
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Responsible Party: Kissei Pharmaceutical Co., Ltd.
ClinicalTrials.gov Identifier: NCT02912533    
Other Study ID Numbers: JR-131-302
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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Anemia
Hematologic Diseases