UMIN-CTR Clinical Trial

Basic information
Public title	Efficacy of preoperative nutritional guidance for living kidney transplant marginal donors
Acronym	Efficacy of preoperative nutritional guidance for living kidney transplant marginal donors
Scientific Title	Efficacy of preoperative nutritional guidance for living kidney transplant marginal donors
Scientific Title:Acronym	Efficacy of preoperative nutritional guidance for living kidney transplant marginal donors
Region	Japan

Condition
Condition	Bio-Renal Transplantation Marginaldner
Classification by specialty	Nephrology Surgery in general
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	The purpose of the study is to evaluate the effectiveness of nutritional guidance 1 months prior to surgery in patients who meet the Marginaldner criteria and who, among other things, are obese (BMI less than 32 kg/m2) or hypertensive (blood pressure strictly controlled to less than 130/80 mmHg with the use of antihypertensive medication and urinary albumin excretion less than 30 mg/gCr and no organ damage such as myocardial hypertrophy or renal dysfunction due to hypertension).
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1	Confirmatory
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Decline in weight and BMI at 3 months post-operatively, fluctuations in blood biochemistry data, blood pressure trends, and antihypertensive medication doses. transition
Key secondary outcomes	Six months post-operatively, weight and BMI decline, blood biochemistry data variation, blood pressure trends, and antihypertensive medication intake.

Base
Study type	Interventional

Study design
Basic design	Single arm
Randomization	Non-randomized
Randomization unit
Blinding	Open -no one is blinded
Control	Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	1
Purpose of intervention	Treatment
Type of intervention	Food Behavior,custom
Interventions/Control_1	Nutritional guidance and assessments are provided 1 months prior to surgery after the decision to transplant the kidney, and 3 and 6 months after kidney transplantation. to provide nutritional guidance and evaluation. Preoperative nutritional guidance includes guidance on blood pressure and weight control, salt reduction and evaluation of nutritional status. Postoperatively, the changes in blood pressure and weight control and the change in the amount of antihypertensive medication are checked and the nutritional status is evaluated. Guidance on blood pressure, weight control, and salt reduction is provided as needed.
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	80 years-old >=
Gender	Male and Female
Key inclusion criteria	(1) Patients who are 80 years of age or younger at the time of obtaining consent (2) Patients who meet the Marginal Donor Criteria of the Japanese Society for Transplantation's Living Donor Guidelines for Kidney Transplantation (3) Patients diagnosed as obese (BMI 32 kg/m2 or less) Hypertension [strictly controlled to 130/80 mmHg with antihypertensive medication and urinary albumin The amount of excretion. Less than 30 mg/gCr and organ damage due to hypertension (myocardial hypertrophy, fundus changes, aortic advanced stone Patients diagnosed with [no ashing, etc.] (5) Outpatients (6) Patients who have given written consent to participate in this study
Key exclusion criteria	(1) Patients who are unable to continue to quit smoking (2) Patients who deviated from the Marginaldner criteria prior to kidney transplantation. (3) Other patients who are deemed by the physician in charge to be inappropriate for the subject
Target sample size	15

Research contact person
Name of lead principal investigator	1st name yurie Middle name Last name kurosaka
Organization	Asahikawa Medical University Hospital
Division name	Nutritional Management Department
Zip code	078-8510
Address	Midorigaoka Higashi 2-1-1-1,Asahikawa,Hokkaido
TEL	0166-69-3085
Email	kurosaka@asahikawa-med.ac.jp

Public contact
Name of contact person	1st name yurie Middle name Last name kurosaka
Organization	Asahikawa Medical University Hospital
Division name	Nutritional Management Department
Zip code	078-8510
Address	Midorigaoka Higashi 2-1-1-1,Asahikawa,Hokkaido
TEL	0166-69-3085
Homepage URL
Email	kurosaka@asahikawa-med.ac.jp

Sponsor
Institute	Asahikawa Medical University Hospital
Institute
Department

Funding Source
Organization	No research funding
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	Asahikawa Medical University Hospital
Address	Midorigaoka Higashi 2-1-1-1,Asahikawa,Hokkaido
Tel	0166-69-3085
Email	kurosaka@asahikawa-med.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 07 Month 13 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	2020 Year 03 Month 27 Day
Date of IRB	2020 Year 07 Month 07 Day
Anticipated trial start date	2020 Year 10 Month 01 Day
Last follow-up date	2025 Year 03 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date	2020 Year 07 Month 06 Day
Last modified on	2021 Year 01 Month 05 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000046835