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Name:
UMIN ID:

Recruitment status No longer recruiting
Unique ID issued by UMIN UMIN000043727
Receipt No. R000049605
Scientific Title Retrospective cohort study on prevention of lower limb amputation in chronic dialysis patients.
Date of disclosure of the study information 2021/04/01
Last modified on 2021/03/24

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Basic information
Public title Retrospective cohort study on prevention of lower limb amputation in chronic dialysis patients.
Acronym Retrospective cohort study on prevention of lower limb amputation in chronic dialysis patients.
Scientific Title Retrospective cohort study on prevention of lower limb amputation in chronic dialysis patients.
Scientific Title:Acronym Retrospective cohort study on prevention of lower limb amputation in chronic dialysis patients.
Region
Japan

Condition
Condition chronic renal failure
Classification by specialty
Endocrinology and Metabolism Plastic surgery
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 For chronic dialysis patients, the effect of preventing major amputation and its cost-effectiveness of guidance/management fee for peripheral arterial disease of lower limb will be evaluated.
Basic objectives2 Others
Basic objectives -Others Using a database consisting of receipts and DPCs, we will compare the rate of major amputations between patients with chronic dialysis patients who have calculated guidance/management fee for peripheral arterial disease of lower limb and those who have not.
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Major amputation rate
Key secondary outcomes 1.Cost-effectiveness of guidance/management fee for peripheral arterial disease
2. Patients rate undergoing major amputation, minor amputation, EVT and bypass surgery
3. Major amputation rate with and without minor amputation
4. Major amputation rate with or without ischemic limbs
5. Major amputation rate in patients with a history of major amputations
6. Major amputation rate in patients undergoing renal rehabilitation
7.Major amputation rate in patients with chronic renal failure due to diabetic nephropathy
8.Major amputation rate in patients with chronic renal failure due to nephrosclerosis
9.Major amputation rate in patients with chronic renal failure due to glomerulonephritis

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
75 years-old >
Gender Male and Female
Key inclusion criteria Index date(t0) is March 2016, when guidance/management fee for peripheral arterial disease of lower limb can be calculated. Patients who meet the following conditions starting from Index Date (t0).
(1) Patient receiving dialysis at t0
(2) Patients aged 20 to 75 years at t0
Key exclusion criteria (1) Patients who have undergone major amputation due to trauma or malignant tumors within the evaluation period
(2) Patients with a history of malignant tumors (Treatment for malignant tumors has been performed before t0)
(3) Patients who started to calculate the guidance/management fee for peripheral arterial disease of lower limb during the evaluation period
(4) Dementia patients(Dementia treatment has been performed before t0)
(5) Patients with mental disease(mental disease treatment has been performed before t0)
(6) Patients who underwent kidney transplantation during the study period (April 2012-June 2019)
(7) Patients with collagen disease, vasculitis, etc. (including rare diseases) (collagen disease, vasculitis, etc. treatment have been performed before t0)
(8) Patients who started dialysis from January to March 2016
(9) Patients using a auxiliary artificial heart (using a auxiliary artificial heart before t0)
(10) Patients undergoing EVT or bypass surgery (undergoing EVT or bypass surgery before t0)
Target sample size 2000

Research contact person
Name of lead principal investigator
1st name Tomoyuki
Middle name
Last name Takura
Organization The University of Tokyo
Division name Department of Healthcare Economics and Health Policy, Graduate School of Medicine
Zip code 133-8655
Address 7-3-1, Hongo, Bunkyoku, Tokyo, 113-8655, Japan
TEL +81-3-5800-9523
Email ttakura@m.u-tokyo.ac.jp

Public contact
Name of contact person
1st name Tomoyuki
Middle name
Last name Takura
Organization The University of Tokyo
Division name Department of Healthcare Economics and Health Policy, Graduate School of Medicine
Zip code 133-8655
Address 7-3-1, Hongo, Bunkyoku, Tokyo, 113-8655, Japan
TEL +81-3-5800-9523
Homepage URL http://plaza.unin.ac.jp/hehp/thebd.html
Email acishea@gmail.com

Sponsor
Institute Department of Healthcare Economics and Health Policy, Graduate School of Medicine, The University of Tokyo
Institute
Department

Funding Source
Organization The University of Tokyo
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 Tokyo Hospital IRB
Address 7-3-1, Hongo, Bunkyo-ku, Tokyo
Tel 03-5841-0818
Email acishea@gmail.com

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 東京大学附属病院

Other administrative information
Date of disclosure of the study information
2021 Year 04 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 2000
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
2020 Year 07 Month 02 Day
Date of IRB
2019 Year 03 Month 26 Day
Anticipated trial start date
2021 Year 02 Month 24 Day
Last follow-up date
2021 Year 03 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information This study is a retrospective cohort study utilizing the medical information database collected from April 2012 to June 2019. Patients undergoing chronic dialysis therapy are identified, and the rate of major amputation and cost-effectiveness are calculated and evaluated between the two groups of patients who have calculated guidance/management fee for peripheral arterial disease of the lower limb and those who have not.

Management information
Registered date
2021 Year 03 Month 24 Day
Last modified on
2021 Year 03 Month 24 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000049605

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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