UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000021922 |
|---|---|
| Receipt number | R000024853 |
| Scientific Title | A multicenter prospective observational study for the purpose of non-invasive diagnosis of post-transplant IgA nephropathy in the renal transplant recipients |
| Date of disclosure of the study information | 2016/04/30 |
| Last modified on | 2023/10/06 11:56:38 |
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Basic information
Public title
A multicenter prospective observational study for the purpose of non-invasive diagnosis of post-transplant IgA nephropathy in the renal transplant recipients
Acronym
A multicenter prospective observational study for the purpose of non-invasive diagnosis of post-transplant IgA nephropathy in the renal transplant recipients
Scientific Title
A multicenter prospective observational study for the purpose of non-invasive diagnosis of post-transplant IgA nephropathy in the renal transplant recipients
Scientific Title:Acronym
A multicenter prospective observational study for the purpose of non-invasive diagnosis of post-transplant IgA nephropathy in the renal transplant recipients
Region
| Japan |
Condition
Condition
renal transplant recipients
Classification by specialty
| Nephrology | Urology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To establish the optimum scoring method for the detection of the post-transplant IgA nephropathy in the renal transplant recipients
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
The sensitivity and specificity of the scoring method for the diagnosis of post-transplant IgA nephropathy
Key secondary outcomes
1. The difference of serological IgA activity between the presence or absence of urinary abnormality in the recipient with IgA deposition
2. The prognostic value of serological IgA activity for urinary abnormality or allograft function at 1 year after allograft biopsy in the recipient with IgA deposition
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
200
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 Hospital
Institute
Department
Personal name
Funding Source
Organization
Japanese society for clinical renal transplantation
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Japanese Red Cross Kumamoto Hospital, Kyushu University Hospital, Kobe University Hospital, St. Marianna University School of Medicine hospital, St. Luke's International Hospital, Tokyo Womens Medical University Yachiyo Medical center, Toho University Omori Medical Center, Tomishiro Central Hospital, Japanese Red Cross Nagoya Daini Hospital.
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
Other administrative information
Date of disclosure of the study information
| 2016 | Year | 04 | 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
Main results already published
Date of protocol fixation
| 2016 | Year | 03 | Month | 31 | Day |
Date of IRB
| 2016 | Year | 03 | Month | 31 | Day |
Anticipated trial start date
| 2016 | Year | 05 | 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
| 2023 | Year | 03 | Month | 31 | Day |
Other
Other related information
Prospective multicenter cohort study
Primary outcome: Detection for post-transplant IgA deposition/ nephropathy by using biological IgA activity
Management information
Registered date
| 2016 | Year | 04 | Month | 15 | 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=R000024853
| 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 |
