UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000018312
Receipt number R000021194
Scientific Title Impact of evaluation for cardio-vascular examination especially for anemia treatment for left ventricular remodeling during before initiation of dialysis in chronic kidney disease patients
Date of disclosure of the study information 2015/07/21
Last modified on 2022/04/15 17:54:18

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Basic information

Public title

Impact of evaluation for cardio-vascular examination especially for anemia treatment for left ventricular remodeling during before initiation of dialysis in chronic kidney disease patients

Acronym

Impact of cardio-vascular examination especially anemia treatment for LVH in CKD patients

Scientific Title

Impact of evaluation for cardio-vascular examination especially for anemia treatment for left ventricular remodeling during before initiation of dialysis in chronic kidney disease patients

Scientific Title:Acronym

Impact of cardio-vascular examination especially anemia treatment for LVH in CKD patients

Region

Japan


Condition

Condition

chronic kidney disease patients

Classification by specialty

Nephrology

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

whether the evaluation for cardio-vascular examination and anemia treatment is independently associated with LV remodeling during before initiation of dialysis in CKD patients.

Basic objectives2

Efficacy

Basic objectives -Others


Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

left ventricular remodeling

Key secondary outcomes

cardio-vascular events
patency of arterio-venus fistula


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

90 years-old >=

Gender

Male and Female

Key inclusion criteria

More than following up 120 days with CKD before initiation of dialysis
The left ventricular mass index (LVMI) evaluated by echocardiography were performed twice (baseline and follow-up at initiation of dialysis period)

Key exclusion criteria

not inclusion criteria

Target sample size

80


Research contact person

Name of lead principal investigator

1st name Hiroaki
Middle name
Last name Io

Organization

Juntendo University Hospital

Division name

Nephrology

Zip code

113-0033

Address

2-1-1 Hongo, Bunkyo-ku, Tokyo, Japan

TEL

03-5802-1065

Email

hiroaki@juntendo.ac.jp


Public contact

Name of contact person

1st name Hiroaki
Middle name
Last name Io

Organization

Juntendo University Hospital

Division name

Nephrology

Zip code

112-0033

Address

2-1-1 Hongo, Bunkyo-ku, Tokyo, Japan

TEL

03-5802-1065

Homepage URL


Email

hiroaki@juntendo.ac.jp


Sponsor or person

Institute

Juntendo University

Institute

Department

Personal name



Funding Source

Organization

The Kidney Foundation, Japan (JKFB11-29)

Organization

Division

Category of Funding Organization

Non profit foundation

Nationality of Funding Organization



Other related organizations

Co-sponsor


Name of secondary funder(s)



IRB Contact (For public release)

Organization

Juntendo University

Address

2-1-1 Hongo, Bunkyo-ku, Tokyo, Japan

Tel

03-3813-3176

Email

hongo-rinri@juntendo.ac.jp


Secondary IDs

Secondary IDs

NO

Study ID_1


Org. issuing International ID_1


Study ID_2


Org. issuing International ID_2


IND to MHLW



Institutions

Institutions



Other administrative information

Date of disclosure of the study information

2015 Year 07 Month 21 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

No longer recruiting

Date of protocol fixation

2015 Year 07 Month 13 Day

Date of IRB


Anticipated trial start date

2015 Year 07 Month 13 Day

Last follow-up date


Date of closure to data entry


Date trial data considered complete


Date analysis concluded



Other

Other related information

Measurements of biochemical and physical values, and LVMI evaluated by echocardiography were performed twice (baseline and follow-up at initiation of dialysis period) from 1998 to 2015.
we retrospective examined whether the long acting erythropoietin stimulating agents is the efficacy and stability for treating anemia and LV remodeling.
And we evaluated the factors associated with progression ofCKD,cardiovascular events, patency of arterio-venus fistula.


Management information

Registered date

2015 Year 07 Month 14 Day

Last modified on

2022 Year 04 Month 15 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000021194


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name