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Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000026958
Receipt No. R000030768
Scientific Title Evaluation of microcirculation of the optic nerve head after undergoing a living donor renal transplantation.
Date of disclosure of the study information 2017/04/12
Last modified on 2017/04/12

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Basic information
Public title Evaluation of microcirculation of the optic nerve head after undergoing a living donor renal transplantation.
Acronym Evaluation of microcirculation of the optic nerve head after undergoing a living donor renal transplantation.
Scientific Title Evaluation of microcirculation of the optic nerve head after undergoing a living donor renal transplantation.
Scientific Title:Acronym Evaluation of microcirculation of the optic nerve head after undergoing a living donor renal transplantation.
Region
Japan

Condition
Condition Renal failure patients
Classification by specialty
Nephrology Ophthalmology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To measure the fundus blood flow using LSFG in patients with kidney disease and to clarify the relationship between the state of the kidney and fundus blood flow
Basic objectives2 Others
Basic objectives -Others In recent years, patients such as kidney disease and diabetes have been increasing in Japan, and grasp of public health is an extremely important position.
By measuring changes in blood flow etc. in the treatment of systemic diseases, it is possible to capture changes in the general state by measuring the ocular blood flow from the data.
This time we can measure the fundus blood flow of the subject under a wide range and non-invasive with time and do not use the contrast medium, so we will not put a burden on patients themselves.
In addition to grasping the quantitative fundus blood flow dynamics for the target disease, at the same time, we examine clinical usefulness and future possibilities of measuring instruments.
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes To evaluate short-term(4weeks,12weeks,24weeks) variations in the optic nerve head (ONH) circulation obtained by laser speckle flowgraphy (LSFG) after receiving a living donor renal transplant.
Key secondary outcomes Renal function evaluation by blood test
(Serum creatinine, eGFR, etc.)

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
70 years-old >=
Gender Male and Female
Key inclusion criteria Perform only for patients who understand the intent of this test well and who can receive cooperation in the examination
Key exclusion criteria Those who can not obtain consent, or when the attending physician judges that continuation of participation cooperation in this research is not medically appropriate, and also shows intention to not participate on the way.
Target sample size 50

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Tetsushi Arimura
Organization Toho uviversity Omori Hospital
Division name Opthalmology
Zip code
Address 7-5-23 Omorinishi Otaku Tokyo
TEL 03-3762-4151
Email tetsushi.arimura@med.toho-u.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Tetsushi Arimura
Organization Toho uviversity Omori Hospital
Division name Opthalmology
Zip code
Address 7-5-23OmorinishiOtakuTokyo
TEL 03-3762-4151
Homepage URL
Email tetsushi.arimura@med.toho-u.ac.jp

Sponsor
Institute Toho uviversity
Institute
Department

Funding Source
Organization None
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
Address
Tel
Email

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
2017 Year 04 Month 12 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 Open public recruiting
Date of protocol fixation
2016 Year 11 Month 01 Day
Date of IRB
Anticipated trial start date
2016 Year 11 Month 01 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information To evaluate some variations in the optic nerve head (ONH) circulation obtained by laser speckle flowgraphy (LSFG) after living renal transplantation.

Management information
Registered date
2017 Year 04 Month 12 Day
Last modified on
2017 Year 04 Month 12 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000030768

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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