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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000003844
Receipt No. 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 2010/06/29

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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
Email

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
Email

Sponsor
Institute National Defense Medical College
Institute
Department

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
Email

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 Open public recruiting
Date of protocol fixation
2010 Year 05 Month 31 Day
Date of IRB
Anticipated trial start date
2010 Year 06 Month 01 Day
Last follow-up date
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
2010 Year 06 Month 29 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000004550

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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