UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000003311 |
|---|---|
| Receipt number | R000004007 |
| Scientific Title | Clinical evaluation of tonsillectomy with modified high-dose intravenous methylprednisolone therapy in patients with IgA nephropathy |
| Date of disclosure of the study information | 2010/03/10 |
| Last modified on | 2011/09/16 06:45:35 |
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Basic information
Public title
Clinical evaluation of tonsillectomy with modified high-dose intravenous methylprednisolone therapy
in patients with IgA nephropathy
Acronym
Clinical evaluation of tonsillectomy with modified high-dose intravenous methylprednisolone therapy
in patients with IgA nephropathy
Scientific Title
Clinical evaluation of tonsillectomy with modified high-dose intravenous methylprednisolone therapy
in patients with IgA nephropathy
Scientific Title:Acronym
Clinical evaluation of tonsillectomy with modified high-dose intravenous methylprednisolone therapy
in patients with IgA nephropathy
Region
| Japan |
Condition
Condition
IgA nephropathy
Classification by specialty
| Medicine in general | Nephrology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the efficacy of tonsillectomy and high-dose mPSL pulse therapies for patients of IgA nephropaty, and the improvement of renal function and prognosis.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Improvement of renal dysfunctions and renal prognosis
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
Administration of intravenous mPSL pulse therapy (1g/day) after the tonsillectomy.
Administration of anti-hypertensive drugs for hypertension as long as in the absence of adverse effect
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
| Not applicable |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
The enrolled patients have history of hamaturia and has been diagnosed as IgA nephropaty by biopsy specimen.
Key exclusion criteria
These patients were excluded who has other hematuric or proteinuric kidney disease.
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Kazuhito Takeda |
Organization
Aso Iizuka hospital
Division name
The department of nephrology
Zip code
Address
Yoshiomachi 3-83,Iizuka,Fukuoka,Japan
TEL
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name |
Organization
Aso Iizuka hospital
Division name
The department of nephrology
Zip code
Address
Yoshiomachi 3-83,Iizuka,Fukuoka,Japan
TEL
Homepage URL
Sponsor or person
Institute
Aso Iizuka hospital
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 | 03 | Month | 10 | Day |
Related information
URL releasing protocol
Publication of results
Partially published
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
| 2002 | Year | 08 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2002 | Year | 08 | 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
Management information
Registered date
| 2010 | Year | 03 | Month | 10 | Day |
Last modified on
| 2011 | Year | 09 | Month | 16 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000004007
