UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000043727
Receipt number 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 2023/10/01 18:08:17

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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 or person

Institute

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

Institute

Department

Personal name



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

2023 Year 12 Month 31 Day

Date of closure to data entry


Date trial data considered complete


Date analysis concluded

2024 Year 12 Month 31 Day


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

2023 Year 10 Month 01 Day



Link to view the page

Value
https://center6.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