UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000024241 |
|---|---|
| Receipt number | 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 | 2020/04/30 08:23:10 |
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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 | 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
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
ohtake@shonankamakura.or.jp
Sponsor or person
Institute
Shonan Kamakura General Hospital
Institute
Department
Personal name
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
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
Terminated
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
| 2020 | Year | 04 | Month | 30 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000027913
