UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000003844 |
|---|---|
| Receipt number | R000004550 |
| Scientific Title | Supplemental diagnostic methods of IgA nephropathy using morphological studies of urinary erythrocytes and tonsil biopsies in the patients with isolated hematuria. |
| Date of disclosure of the study information | 2010/06/30 |
| Last modified on | 2025/03/25 12:03:10 |
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Basic information
Public title
Supplemental diagnostic methods of IgA nephropathy using morphological studies of urinary erythrocytes and tonsil biopsies in the patients with isolated hematuria.
Acronym
Suuplemental diagnostic methods of IgA nephropathy using morphological studies of urinary erythrocytes and tonsil biopsies.
Scientific Title
Supplemental diagnostic methods of IgA nephropathy using morphological studies of urinary erythrocytes and tonsil biopsies in the patients with isolated hematuria.
Scientific Title:Acronym
Suuplemental diagnostic methods of IgA nephropathy using morphological studies of urinary erythrocytes and tonsil biopsies.
Region
| Japan |
Condition
Condition
hematuria
Classification by specialty
| Nephrology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To examine whether the combined examination of morphological study of urinary erythrocytes and tonsil biopsy is useful as supplemental diagnosis of IgA nephropathy patients presenting with isolated hematuria.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
The correspondence of diagnosis of IgA nephropathy by renal biopsy to the result of supplemental diagnostic methods using morphological study of urinary erythrocytes and tonsil biopsy
Key secondary outcomes
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
| 15 | years-old | <= |
Age-upper limit
| 70 | years-old | > |
Gender
Male and Female
Key inclusion criteria
continuous hematuria (URBC 5-9/HPF or more)
Key exclusion criteria
1. proteinuria of 0.3g/gCr and/or 0.3g/day (1+ by test tape) or more
2. renal biopsy was already done
3. presence of urological abnormalities by abdominal X-ray, abdominal echo, or urinary cytologic examination
4. serum creatinine 2.0mg/dl or more
Target sample size
30
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Hiroo Kumagai |
Organization
National Defense Medical College
Division name
Department of Nephrology
Zip code
Address
3-2 Namiki, Tokorozawa, Saitama
TEL
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name |
Organization
National Defense Medical College
Division name
Department of Nephrology
Zip code
Address
TEL
Homepage URL
Sponsor or person
Institute
National Defense Medical College
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
Other administrative information
Date of disclosure of the study information
| 2010 | Year | 06 | 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
Completed
Date of protocol fixation
| 2010 | Year | 05 | Month | 31 | Day |
Date of IRB
| 2010 | Year | 05 | Month | 31 | Day |
Anticipated trial start date
| 2010 | Year | 06 | Month | 01 | Day |
Last follow-up date
| 2015 | Year | 08 | Month | 01 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
In patients with isolated hematuria, IgA nephropathy was diagnosed in about 20% by renal biopsy in previous studies.
In this study, both morphological study of urinary erythrocytes and tonsil biopsy will be performed before renal biopsy for patients with isolated hematuria. The usefulness of these supplemental diagnostic methods will be evaluated by comparing the diagnostic frequency of IgA nephropathy with the previously reported data.
Management information
Registered date
| 2010 | Year | 06 | Month | 29 | Day |
Last modified on
| 2025 | Year | 03 | Month | 25 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000004550
