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Name:
UMIN ID:

Recruitment status No longer recruiting
Unique ID issued by UMIN UMIN000024241
Receipt No. R000027913
Scientific Title Comparison of different dialysis modality (conventional hemodialysis and on-line hemodiafiltration) on coronary and lower limbs' arterial calcification. ~Multicenter interventional study.
Date of disclosure of the study information 2016/10/01
Last modified on 2019/04/10

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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
Middle name
Last name Shuzo Kobayashi
Organization Shonan Kamakura General Hospital
Division name Kidney and Dialysis Center
Zip code
Address 1370-1 Okamoto, kmakura, Japan
TEL +81-467-46-1717
Email shuzo@shonankamakura.or.jp

Public contact
Name of contact person
1st name
Middle name
Last name Takayasu Ohtake
Organization Shonan Kamakura General Hospital
Division name Kidney and Dialysis Center
Zip code
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
Address
Tel
Email

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 04 Month 10 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
2017/04/01 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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