UMIN-CTR Clinical Trial

Basic information
Public title	Comparison of different dialysis modality (conventional hemodialysis and on-line hemodiafiltration) on coronary and lower limbs' arterial calcification. ~Multicenter interventional study.
Acronym	Effect of hemodialysis and online hemodialysis on vascular calcification
Scientific Title	Comparison of different dialysis modality (conventional hemodialysis and on-line hemodiafiltration) on coronary and lower limbs' arterial calcification. ~Multicenter interventional study.
Scientific Title:Acronym	Effect of hemodialysis and online hemodialysis on vascular calcification
Region	Japan

Condition
Condition	chronic renal failure
Classification by specialty	Nephrology
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To compare the effect of conventional hemodialysis and online-hemodialfiltration on the progression of vascular calcification (coronary artery calcification and lower limbs' arterial calcification).
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Coronary artery calcification score and lower limbs' arterial calcification at study entry, 26 weeks, and 52 weeks, and compare them between hemodialysis and online hemodiafiltration.
Key secondary outcomes	change of serum phosphate, calcium, intact parathyroid hormone, C reactive protein, albumin, beta2 microglobulin, ankle brachial pressure index, toe brachial pressure index, skin perfusion pressure, cardiac ultrasonography in hemodialysis and online hemodiafiltration.

Base
Study type	Interventional

Study design
Basic design	Single arm
Randomization	Non-randomized
Randomization unit
Blinding	Open -no one is blinded
Control	Self control
Stratification	NO
Dynamic allocation	NO
Institution consideration
Blocking
Concealment

Intervention
No. of arms	1
Purpose of intervention	Treatment
Type of intervention	Device,equipment
Interventions/Control_1	switch from 6 months' hemodialysys treatment to 6 months' online hemodialysis treatment, and compare the progression of coronary artery and lower limbs' calcification score.
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	85 years-old >=
Gender	Male and Female
Key inclusion criteria	patients with more than 12 weeks of hemodialysis vintage who gave written informed consent
Key exclusion criteria	1)in hospital treatment within prior 12 weeks 2)have some infection or fever 3)atrial fibrillation 4)stent implanted in coornary artery or lower Limbs' artery 5)planned major amputation of lower limbs 6)severe cardiac failure with EF < 25% 7)warfarin user 8)involuntary movement of lower limbs 9)could not hold breath 10) pregnancy
Target sample size	100

Research contact person
Name of lead principal investigator	1st name Shuzo Middle name Last name Kobayashi
Organization	Shonan Kamakura General Hospital
Division name	Kidney and Dialysis Center
Zip code	247-8533
Address	1370-1 Okamoto, kmakura, Japan
TEL	+81-467-46-1717
Email	shuzo@shonankamakura.or.jp

Public contact
Name of contact person	1st name Takayasu Middle name Last name Ohtake
Organization	Shonan Kamakura General Hospital
Division name	Kidney and Dialysis Center
Zip code	247-8533
Address	1370-1 Okamoto, Kamakura, Japan
TEL	+81-467-46-1717
Homepage URL
Email	ohtake@shonankamakura.or.jp

Sponsor
Institute	Shonan Kamakura General Hospital
Institute
Department

Funding Source
Organization	none
Organization
Division
Category of Funding Organization	Self funding
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization	Ethical Committee in Tokushukai Group
Address	1-8-7 Kojimachi, Tokyo
Tel	03-3263-4801
Email	utada@mirai-iryo.com

Secondary IDs
Secondary IDs	YES
Study ID_1	TGE00673-024
Org. issuing International ID_1	Ethical committee in Tokushukai Group
Study ID_2
Org. issuing International ID_2
IND to MHLW

Institutions
Institutions

Other administrative information
Date of disclosure of the study information	2016 Year 10 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	No longer recruiting
Date of protocol fixation	2016 Year 07 Month 19 Day
Date of IRB	2016 Year 07 Month 29 Day
Anticipated trial start date	2016 Year 10 Month 01 Day
Last follow-up date	2018 Year 03 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date	2016 Year 09 Month 30 Day
Last modified on	2019 Year 10 Month 04 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000027913

Research Plan
Registered date	File name
2019/10/04	切替のみ_大竹石灰化　実施計画書_条件付修正20160719r.docx

Research case data specifications
Registered date	File name

Research case data
Registered date	File name
2017/04/01	切替のみ_大竹石灰化　実施計画書_条件付修正20160719r.docx

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