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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.
 
ClinicalTrials.gov Identifier: NCT02912494
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.

Tracking Information
First Submitted Date  ICMJE September 21, 2016
First Posted Date  ICMJE September 23, 2016
Last Update Posted Date April 2, 2019
Actual Study Start Date  ICMJE September 2016
Actual Primary Completion Date September 2017   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: September¬†21,¬†2016)
Change from baseline in Hemoglobin level [ Time Frame: 24 weeks ]
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE A Phase III Study of JR-131 in Renal Anemia Patients With Chronic Kidney Disease (CKD)
Official Title  ICMJE Not Provided
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).
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Masking: Double (Participant, Investigator)
Condition  ICMJE Anemia
Intervention  ICMJE
  • Drug: JR-131
  • Drug: Darbepoetin alfa
Study Arms  ICMJE
  • Experimental: JR-131
    Intervention: Drug: JR-131
  • Active Comparator: Darbepoetin alfa
    Intervention: Drug: Darbepoetin alfa
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Enrollment  ICMJE Not Provided
Original Enrollment  ICMJE Not Provided
Actual Study Completion Date  ICMJE September 2017
Actual Primary Completion Date September 2017   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 20 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Not Provided
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Japan
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02912494
Other Study ID Numbers  ICMJE JR-131-301
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Kissei Pharmaceutical Co., Ltd.
Study Sponsor  ICMJE Kissei Pharmaceutical Co., Ltd.
Collaborators  ICMJE JCR Pharmaceuticals Co., Ltd.
Investigators  ICMJE Not Provided
PRS Account Kissei Pharmaceutical Co., Ltd.
Verification Date March 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP