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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000041011
Receipt No. R000046835
Scientific Title Efficacy of preoperative nutritional guidance for living kidney transplant marginal donors
Date of disclosure of the study information 2020/07/13
Last modified on 2020/07/06

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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 3 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 3 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 Preinitiation
Date of protocol fixation
2020 Year 03 Month 27 Day
Date of IRB
Anticipated trial start date
2020 Year 06 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
2020 Year 07 Month 06 Day


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

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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