UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000032031 |
|---|---|
| Receipt number | 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 | 2023/04/04 19:56:43 |
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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
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
shitoshi@juntendo.ac.jp
Sponsor or person
Institute
Juntendo University
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
Juntendo University
Address
3-1-3 Hongo, Bunkyo-ku
Tel
03-3813-3111
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
Completed
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
| 2022 | 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
| 2023 | Year | 04 | Month | 04 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000036551
