UMIN-CTR Clinical Trial

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
Institute	Juntendo University
Institute
Department

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
URL(English)	https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000021194