UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000046648 |
|---|---|
| Receipt number | R000053155 |
| Scientific Title | Kidney transplantation for elderly patients with CKD: Systematic review and meta-analysis |
| Date of disclosure of the study information | 2022/01/16 |
| Last modified on | 2023/01/16 11:18:33 |
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Basic information
Public title
Does kidney transplantation recommend for the elderly patients with chronic kidney disease: Systematic review and meta-analysis
Acronym
Kidney transplantation for elderly patients with CKD
Scientific Title
Kidney transplantation for elderly patients with CKD: Systematic review and meta-analysis
Scientific Title:Acronym
Kidney transplantation for elderly patients with CKD: Systematic review and meta-analysis
Region
| Japan |
Condition
Condition
Those who are aged 65 years or older with treating dialysis therapy, initiating dialysis therapy, or undergoing kidney transplantation
Classification by specialty
| Medicine in general | Nephrology | Surgery in general |
| Urology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To investigate whether kidney transplantation is superior compared to dialysis therapy as a renal replacement therapy among elderly patients with chronic kidney disease.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Mortality
Key secondary outcomes
Quality of life, Cardiovascular disease, and activity of daily living/frailty/physical function
Base
Study type
Others,meta-analysis etc
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
| 65 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Those who are on maintenance dialysis therapy, initiating dialysis therapy, or undergoing kidney transplantation
Key exclusion criteria
Those who are aged 65 years or less
Target sample size
Research contact person
Name of lead principal investigator
| 1st name | Masahiko |
| Middle name | |
| Last name | Yazawa |
Organization
St. Marianna University School of Medicine
Division name
Department of Nephrology and Hypertension
Zip code
216-8511
Address
2-16-1, Sugao, Miyamae-ku, Kawasaki, Kanagawa, Japan
TEL
044-977-8111
masahikoyazawa@gmail.com
Public contact
Name of contact person
| 1st name | Masahiko |
| Middle name | |
| Last name | Yazawa |
Organization
St. Marianna University School of Medicine
Division name
Department of Nephrology and Hypertension
Zip code
216-8511
Address
2-16-1, Sugao, Miyamae-ku, Kawasaki, Kanagawa, Japan
TEL
044-977-8111
Homepage URL
masahikoyazawa@gmail.com
Sponsor or person
Institute
Department of Nephrology and Hypertension, St. Marianna University School of Medicine
Institute
Department
Personal name
Funding Source
Organization
Japanese Society of Nephrology
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
Department of Nephrology and Hypertension, St. Marianna University School of Medicine
Address
2-16-1, Sugao, Miyamae-ku, Kawasaki, Kanagawa, Japan
Tel
044-977-8111
masahikoyazawa@gmail.com
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
| 2022 | Year | 01 | Month | 16 | Day |
Related information
URL releasing protocol
N/A
Publication of results
Unpublished
Result
URL related to results and publications
N/A
Number of participants that the trial has enrolled
12284
Results
In preparation.
Results date posted
| 2023 | Year | 01 | Month | 16 | Day |
Results Delayed
| Delay expected |
Results Delay Reason
We are writing the manuscript now.
Date of the first journal publication of results
Baseline Characteristics
Those who were initiated dialysis or kidney transplantation aged over 65 years old.
Participant flow
Any related manuscripts were extracted according to the guideline of systematic review (MINDs and GRADE).
Adverse events
N/A
Outcome measures
All-cause mortality
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
No longer recruiting
Date of protocol fixation
| 2021 | Year | 09 | Month | 01 | Day |
Date of IRB
| 2021 | Year | 09 | Month | 01 | Day |
Anticipated trial start date
| 2021 | Year | 09 | Month | 01 | Day |
Last follow-up date
| 2022 | Year | 01 | Month | 10 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
This is a systematic review (SR) and meta-analysis (MA) for the clinical question "Does kidney transplantation recommend for elderly patients with chronic kidney disease. The effort of this SR and MA is for creating "CKD clinical guideline for 2023" organized by the Japanese Society of Nephrology.
Management information
Registered date
| 2022 | Year | 01 | Month | 15 | Day |
Last modified on
| 2023 | Year | 01 | Month | 16 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000053155
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
