UMIN-CTR Clinical Trial

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Name
UMIN ID

Recruitment status Completed
Unique ID issued by UMIN UMIN000013464
Receipt No. R000015164
Scientific Title oBservational clinical Research In chronic kidney disease patients with renal anemia :renal proGnosis in patients with Hyporesponsive anemia To Erythropoiesis stimulating agents,darbepoetiN alfa
Date of disclosure of the study information 2014/04/01
Last modified on 2019/09/26

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Basic information
Public title oBservational clinical Research In chronic kidney disease patients with renal anemia :renal proGnosis in patients with Hyporesponsive anemia To Erythropoiesis stimulating agents,darbepoetiN alfa
Acronym BRIGHTEN
Scientific Title oBservational clinical Research In chronic kidney disease patients with renal anemia :renal proGnosis in patients with Hyporesponsive anemia To Erythropoiesis stimulating agents,darbepoetiN alfa
Scientific Title:Acronym BRIGHTEN
Region
Japan

Condition
Condition Renal anemia in chronic kidney disease
Classification by specialty
Nephrology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 This is an observational clinical research on patients with chronic kidney disease who are not on hemodialysis and receiving darbepoetin alfa to treat diagnosed renal anemia; the major objective is to explore novel erythropoiesis stimulating agent (ESA) response index in association with deterioration of renal function as well as occurrence of cardiovascular disease events.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Deterioration of renal function,
Cardiovascular disease events
Key secondary outcomes

Base
Study type Observational

Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
Interventions/Control_2
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10

Eligibility
Age-lower limit
20 years-old <=
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria 1) Patients who are planning to start treatment with darbepoetin alfa within
8 weeks after enrollment;
2) Patients with eGFR <60 mL/min/1.73m2 at the latest examination performed within 8 weeks before enrollment;
3) Patients with a hemoglobin level <11.0 g/dL at the latest examination performed within 8 weeks before enrollment;
4) Patients aged at least 20 years or older at the time of providing informed consent;
5) Patients who voluntarily provided written informed consent to participate in the study.
Key exclusion criteria 1) Patients who are planning to start hemodialysis or renal transplantation within 24 weeks after enrolment;
2) Patients with a history of treatment with ESA except the ones who were
treated temporarily more than 12 weeks before the enrollment;
3)Patients with malignant tumor, hematological disease, or hemorrhagic lesions;
4) Patients with hypersensitivity to ESA or any ingredient thereof;
5) Pregnant, lactating or possibly pregnant women or those who wish to be pregnant during the study period;
6) Patients who are participating in other clinical study;
7) Patients who are assessed as not eligible for the study by the investigator.
Target sample size 2000

Research contact person
Name of lead principal investigator
1st name Ichiei
Middle name
Last name Narita
Organization Niigata University Graduate School of Medical & Dental Sciences
Division name Division of Clinical Nephrology & Rheumatology
Zip code 951-8510
Address 1-757 Asahimachi-dori, Chuo-ku, Niigata, Niigata, Japan
TEL 025-227-2200
Email naritai@med.niigata-u.ac.jp

Public contact
Name of contact person
1st name Tomoko
Middle name
Last name Usui
Organization The University of Tokyo Hospital
Division name Division of Nephrology and Endocrinology
Zip code 113-8655
Address 7-3-1 Hongo, Bunkyo-ku, Tokyo, Japan
TEL 03-3815-5411
Homepage URL
Email usu-tky@umin.ac.jp

Sponsor
Institute Niigata University Graduate School of Medical & Dental Sciences
Institute
Department

Funding Source
Organization Kyowa Kirin Co., Ltd.
Organization
Division
Category of Funding Organization Profit organization
Nationality of Funding Organization

Other related organizations
Co-sponsor Foundation for Biomedical Research and Innov
ation at Kobe
Name of secondary funder(s)

IRB Contact (For public release)
Organization Niigata University Medical & Dental Hospital IRB
Address 1-757 Asahimachi-dori, Chuo-ku, Niigata, Niigata, Japan
Tel 025-227-2436
Email chiken@med.niigata-u.ac.jp

Secondary IDs
Secondary IDs NO
Study ID_1 NCT02136563
Org. issuing International ID_1 ClinicalTrials.gov
Study ID_2
Org. issuing International ID_2
IND to MHLW

Institutions
Institutions

Other administrative information
Date of disclosure of the study information
2014 Year 04 Month 01 Day

Related information
URL releasing protocol
Publication of results Unpublished

Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description

Progress
Recruitment status Completed
Date of protocol fixation
2014 Year 05 Month 02 Day
Date of IRB
2014 Year 05 Month 02 Day
Anticipated trial start date
2014 Year 05 Month 02 Day
Last follow-up date
2018 Year 09 Month 30 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information prospective, multicenter, observational study

Management information
Registered date
2014 Year 03 Month 19 Day
Last modified on
2019 Year 09 Month 26 Day


Link to view the page
URL(English) https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000015164

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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