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UMIN-CTR Clinical Trial |
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Name: | UMIN ID: |
Recruitment status | Terminated |
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 | 2020/04/30 |
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 |
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Condition | ||
Condition | chronic renal failure | |
Classification by specialty |
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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 |
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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 |
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Age-upper limit |
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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 |
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Target sample size | 100 |
Research contact person | |||||||
Name of lead principal investigator |
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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 |
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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 | |
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 |
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 |
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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 |
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Date of IRB |
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Anticipated trial start date |
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Last follow-up date |
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Date of closure to data entry | |||||||
Date trial data considered complete | |||||||
Date analysis concluded |
Other | |
Other related information |
Management information | |||||||
Registered date |
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Last modified on |
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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 |