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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000032031
Receipt No. R000036551
Scientific Title The steroid internal use method for patients with IgA nephropathy
Date of disclosure of the study information 2018/04/01
Last modified on 2020/04/01

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Basic information
Public title The steroid internal use method for patients with IgA nephropathy
Acronym The steroid internal use method for patients with IgA nephropathy
Scientific Title The steroid internal use method for patients with IgA nephropathy
Scientific Title:Acronym The steroid internal use method for patients with IgA nephropathy
Region
Japan

Condition
Condition IgA nephropathy
Classification by specialty
Nephrology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 The tonsillectomy pulse therapy is effective for proteinuria decrease and preservation of renal function in comparison with the steroid pulse monotherapy. However, about the oral adrenocorticosteroid medicine of the after care, the study that compared 0.25 mg/kg/day of everyday medication without the difference of the full dose with 0.5mg/kg/day of alternate-day administration is not reported. Therefore we tect an effect and a side effect in each prospectively this time and review protocol of the current steroid-pulse therapy for IgA nephropathy.
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes In-urine proteine quantity, Urinary sediment finding, eGFR, IgA/C3 rate, Steroid side effect
Key secondary outcomes

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit Cluster
Blinding Double blind -all involved are blinded
Control Dose comparison
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 2
Purpose of intervention Treatment
Type of intervention
Medicine
Interventions/Control_1 Prednisolone 0.5mg/kg/every other day group
Interventions/Control_2 Prednisolone 0.25mg/kg/everyday group
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
20 years-old <=
Age-upper limit
100 years-old >
Gender Male and Female
Key inclusion criteria 1. The patients who proved IgA nephropathy by renal biopsy
2. Indication of steroid therapy
Key exclusion criteria Patients desided by the doctor to be unsuitable to use the study other than above
Target sample size 100

Research contact person
Name of lead principal investigator
1st name Hitoshi
Middle name
Last name Suzuki
Organization Juntendo University
Division name Department of Nephrology
Zip code 113-8421
Address 2-1-1, Hongo, Bunkyo-ku, Tokyo, 113-8421, Japan
TEL 03-5802-1065
Email shitoshi@juntendo.ac.jp

Public contact
Name of contact person
1st name Hitoshi
Middle name
Last name Suzuki
Organization Juntendo University
Division name Department of Nephrology
Zip code 113-8421
Address 2-1-1, Hongo, Bunkyo-ku, Tokyo, 113-8421, Japan
TEL 03-5802-1065
Homepage URL
Email shitoshi@juntendo.ac.jp

Sponsor
Institute Juntendo University
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 Juntendo University
Address 3-1-3 Hongo, Bunkyo-ku
Tel 03-3813-3111
Email kenkyu5858@juntendo.ac.jp

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
2018 Year 04 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 Open public recruiting
Date of protocol fixation
2018 Year 04 Month 01 Day
Date of IRB
2018 Year 03 Month 22 Day
Anticipated trial start date
2018 Year 04 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

Management information
Registered date
2018 Year 03 Month 31 Day
Last modified on
2020 Year 04 Month 01 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000036551

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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