UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000041608 |
|---|---|
| Receipt number | R000047289 |
| Scientific Title | A prospective observational study of the effect of kidney senescence on the prognosis of allograft in living kidney transplantation |
| Date of disclosure of the study information | 2020/08/30 |
| Last modified on | 2020/08/30 16:46:43 |
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Basic information
Public title
A prospective observational study of the effect of kidney senescence on the prognosis of allograft in living kidney transplantation
Acronym
A study of the effect of kidney senescence on the prognosis of allograft
Scientific Title
A prospective observational study of the effect of kidney senescence on the prognosis of allograft in living kidney transplantation
Scientific Title:Acronym
A study of the effect of kidney senescence on the prognosis of allograft
Region
| Japan |
Condition
Condition
renal transplant recipients
Classification by specialty
| Nephrology | Urology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To test the hypothesis that senescence of the allograft is a determining factor for calcineurin inhibitor-induced nephrotoxicity
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Effect of allograft senescence on the incidence of CNI nephrotoxicity
Key secondary outcomes
1) Effect of allograft senescence on the decline rate in allograft function
2) Effect of progression in allograft senescence on the incidence of CNI nephrotoxicity
3) Effect of progression in allograft senescence on the decline rate in allograft function
4) Exploration of clinical factors contributing to allograft senescence and progression in allograft senescence
5) The detective rate of incidence in allograft senescence and CNI Nephrotoxicity by serum soluble alpha Klotho
6) Co-staining rate with P16 and alpha Klotho in the tubules
7) Exploring the accuracy of detecting allograft senescence by urine cytology.
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
| 80 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Donor/recipient for living donor kidney transplantation or recipient for allograft biopsy
Key exclusion criteria
recipients with cadaver donor kidney and those with simultaneous pancreas and kidney transplantation
Target sample size
200
Research contact person
Name of lead principal investigator
| 1st name | Tadashi |
| Middle name | |
| Last name | SOFUE |
Organization
Kagawa University Hospital
Division name
Department of Nephrology
Zip code
761-0793
Address
1750-1 Ikenobe, Miki-cho, Kita-gun, Kagawa, Japan
TEL
087-891-2150
sofue@med.kagawa-u.ac.jp
Public contact
Name of contact person
| 1st name | Tadashi |
| Middle name | |
| Last name | SOFUE |
Organization
Kagawa University Hospital
Division name
Department of Nephrology
Zip code
7610793
Address
1750-1 Ikenobe, Miki-cho, Kita-gun, Kagawa, Japan
TEL
087-891-2150
Homepage URL
sofue@med.kagawa-u.ac.jp
Sponsor or person
Institute
Kagawa University Hospital
Institute
Department
Personal name
Funding Source
Organization
Kagawa University
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Kagawa University
Address
1750-1 Ikenobe, Miki-cho, Kita-gun, Kagawa, Japan
Tel
0878912150
chiken-b.@med.kagawa-u.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 | 08 | Month | 30 | 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 | 06 | Month | 17 | Day |
Date of IRB
Anticipated trial start date
| 2020 | Year | 09 | Month | 01 | Day |
Last follow-up date
| 2026 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
evaluation item
Patient background: patient ID, date of birth, gender, BMI, medical history, and current medical history.
(2) Donor kidney function: Cr, eGFR, and change in eGFR per year
3) General blood tests: TP, Alb, BUN, UA, Na, K, LDH, CPK, CRP, WBC, RBC, Hb, Plt, fasting blood glucose, HbA1c, and other general biochemical tests
4) General urinalysis: urine protein, urine albumin, urine NAG, urine beta2-microglobulin, urine sedimentation rate
(5) Vital signs: blood pressure (home blood pressure), pulse rate, and presence/absence of medication.
(6) Special blood tests: serum complement level, serum globulin level, serum soluble alpha Klotho
(vii) Special urine test: urinary angiotensinogen, urinary soluble alpha Klotho
(h) Urine cytology: Number of P16-positive cells in urine
(ix) Donor renal histology assessment: presence of fibrous intimal thickening in the interlobar artery, intimal thickening area, glomerular sclerosis rate, interstitial fibrosis rate, immunostaining (e.g. IgA), electron microscopy, number of glomeruli per unit area
10 Donated renal tissue special stains: p16-positive cells and alphaKlotho-positive cells
Management information
Registered date
| 2020 | Year | 08 | Month | 30 | Day |
Last modified on
| 2020 | Year | 08 | Month | 30 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000047289
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