UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000039173
Receipt number R000044602
Scientific Title Serum soluble (pro) renin receptor values and analysis in patients with lower limb amputees
Date of disclosure of the study information 2020/03/01
Last modified on 2020/01/16 12:11:52

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Basic information

Public title

Serum soluble (pro) renin receptor values and analysis in patients with lower limb amputees

Acronym

Serum soluble (pro) renin receptor values and analysis in patients with lower limb amputees

Scientific Title

Serum soluble (pro) renin receptor values and analysis in patients with lower limb amputees

Scientific Title:Acronym

Serum soluble (pro) renin receptor values and analysis in patients with lower limb amputees

Region

Japan


Condition

Condition

patients with lower limb amputees

Classification by specialty

Medicine in general

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

To examine the characteristics of sPRR values in lower extremity amputation cases

Basic objectives2

Bio-availability

Basic objectives -Others


Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

Changes in sPRR values before and after surgery

Key secondary outcomes

Changes in sPRR values before and after surgery


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

100 years-old >

Gender

Male and Female

Key inclusion criteria

patients with lower limb amputaion

Key exclusion criteria

Patients who do not undergo amputation

Target sample size

20


Research contact person

Name of lead principal investigator

1st name satoshi
Middle name
Last name morimoto

Organization

Tokyo Women's Medical University

Division name

Department of Endocrinology and Hypertension

Zip code

162-8666

Address

8-1 Kawada-cho, Shinjuku-ku, Tokyo

TEL

03-3353-8111

Email

morimoto.satoshi@twmu.ac.jp


Public contact

Name of contact person

1st name yoshifumi
Middle name
Last name amari

Organization

Moriguchi Keijinkai Hospital

Division name

Department of Nephrology

Zip code

570-0021

Address

2-47-12, yagumo-higashi-machi, moriguchi city, osaka

TEL

06-6906-9000

Homepage URL


Email

yoshifumi.0315@gmail.com


Sponsor or person

Institute

Department of Endocrinology and Hypertension, Tokyo Women's Medical University, Tokyo, Japan

Institute

Department

Personal name



Funding Source

Organization

Department of Endocrinology and Hypertension, Tokyo Women's Medical University, Tokyo, Japan

Organization

Division

Category of Funding Organization

Other

Nationality of Funding Organization



Other related organizations

Co-sponsor


Name of secondary funder(s)



IRB Contact (For public release)

Organization

Department of Endocrinology and Hypertension, Tokyo Women's Medical University, Tokyo, Japan

Address

8-1 Kawada-cho, Shinjuku-ku, Tokyo

Tel

03-3353-8111

Email

morimoto.satoshi@twmu.ac.jp


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



Other administrative information

Date of disclosure of the study information

2020 Year 03 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

Preinitiation

Date of protocol fixation

2019 Year 02 Month 01 Day

Date of IRB


Anticipated trial start date

2020 Year 03 Month 01 Day

Last follow-up date

2021 Year 12 Month 31 Day

Date of closure to data entry


Date trial data considered complete


Date analysis concluded



Other

Other related information

none


Management information

Registered date

2020 Year 01 Month 16 Day

Last modified on

2020 Year 01 Month 16 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000044602


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name