UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000013464
Receipt number 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 12:13:07

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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 or person

Institute

Niigata University Graduate School of Medical & Dental Sciences

Institute

Department

Personal name



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

Value
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