UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000015773 |
|---|---|
| Receipt number | R000018347 |
| Scientific Title | A biomarker investigation for the recurrence and/or activity of recurrent glomerulonephritis in renal transplant recipients |
| Date of disclosure of the study information | 2014/12/01 |
| Last modified on | 2023/10/06 11:59:13 |
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Basic information
Public title
A biomarker investigation for the recurrence and/or activity of recurrent glomerulonephritis in renal transplant recipients
Acronym
A biomarker investigation for the recurrence and/or activity of recurrent glomerulonephritis in renal transplant recipients
Scientific Title
A biomarker investigation for the recurrence and/or activity of recurrent glomerulonephritis in renal transplant recipients
Scientific Title:Acronym
A biomarker investigation for the recurrence and/or activity of recurrent glomerulonephritis in renal transplant recipients
Region
| Japan |
Condition
Condition
kidney transplant recipients
Classification by specialty
| Nephrology | Urology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To establish the biomarkers for the detection of the recurrence and/or activity of recurrent glomerulonephritis in renal transplant recipients
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Developmental phase
Not applicable
Assessment
Primary outcomes
Pathological diagnosis of post-transplant IgA deposition in the allograft and its activity (Oxford classification, pathological severity score of Japanese Society of Nephrology, and the existence/ absence of crescent formation)
: At the time of allograft biopsy
Key secondary outcomes
1) Serological IgA activity (galactose-deficient IgA1, galactose-deficient IgA1-specific IgA, galactose-deficient IgA1-specific IgG, and immune complex of galactose-deficient IgA1 and galactose-deficient IgA1-specific IgA/IgG)
2) Urinary WT1-positive cells and CD68-positive cells
3) Type of the original disease for end stage renal disease
4) Pathological expression of CD71 (IgA receptor) in the mesangial cells
5) Banff classification score, the existence of fibrous intimal thickening of interlobular artery, and glomerular sclerosis index
6) Urinary angiotensinogen
7) The type, dose, blood concentration and AUC of immunosuppressants
8) Allograft function (eGFRCr and eGFRCys)
9) Urinary protein excretion, urinary albumin excretion, urinary occult blood, urinary NAG and microscopic urinalysis
10) Blood pressure and the type and dose of antihypertensive drug(s)
11) Blood biochemical test
1~7: at the time of allograft biopsy
8~11: at the time of allograft biopsy, and 1 and 2 years after allograft biopsy
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
| 16 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Recipients who are scheduled allograft biopsy and agreed with the study
Key exclusion criteria
1) Patients without agreement
2) Patients who are under 16 years-old
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Tadashi Sofue |
Organization
Kagawa University Hospital
Division name
Department of Nephrology
Zip code
Address
1750-1 Ikenobe, Miki-cho, Kita-gun, Kagawa, Japan
TEL
087-891-2149
sofue@med.kagawa-u.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Tadashi Sofue |
Organization
Kagawa University Hospital
Division name
Department of Nephrology
Zip code
Address
1750-1 Ikenobe, Miki-cho, Kita-gun, Kagawa, Japan
TEL
087-891-2149
Homepage URL
sofue@med.kagawa-u.ac.jp
Sponsor or person
Institute
Kagawa University, Faculty of Medicine
Institute
Department
Personal name
Funding Source
Organization
None
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
Address
Tel
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
香川大学医学部附属病院, 東京女子医科大学八千代医療センター
Other administrative information
Date of disclosure of the study information
| 2014 | Year | 12 | Month | 01 | 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
Main results already published
Date of protocol fixation
| 2014 | Year | 11 | Month | 14 | Day |
Date of IRB
| 2010 | Year | 10 | Month | 14 | Day |
Anticipated trial start date
| 2014 | Year | 12 | Month | 01 | Day |
Last follow-up date
| 2021 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Prospective cohort study
Predictive variable: biomarkers (serological IgA activity and urinary WT1-positive cells)
Outcome variable: pathological diagnosis of post-transplant IgA deposition in the allograft and its activity
Management information
Registered date
| 2014 | Year | 11 | Month | 28 | Day |
Last modified on
| 2023 | Year | 10 | Month | 06 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000018347
| Research Plan | |
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| Registered date | File name |
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