UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000041011 |
|---|---|
| Receipt number | 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 | 2021/01/05 10:43:05 |
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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 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
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
kurosaka@asahikawa-med.ac.jp
Sponsor or person
Institute
Asahikawa Medical University Hospital
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000046835
