UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000026958 |
|---|---|
| Receipt number | 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 10:51:14 |
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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
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
tetsushi.arimura@med.toho-u.ac.jp
Sponsor or person
Institute
Toho uviversity
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000030768
