UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Evaluation of microcirculation of the optic nerve head after undergoing a living donor renal transplantation.
Title of the study (Brief title)	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	Tetsushi Arimura
Organization	Toho uviversity Omori Hospital
Division name	Opthalmology
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	Tetsushi Arimura
Organization	Toho uviversity Omori Hospital
Division name	Opthalmology
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)

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

Progress
Recruitment status	Open public recruiting
Date of protocol fixation	2016 Year 11 Month 01 Day
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

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
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