UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000000593 |
|---|---|
| Receipt number | R000000675 |
| Scientific Title | Randomized controlled trial of mizoribine for progressive IgA nephropathy |
| Date of disclosure of the study information | 2007/02/05 |
| Last modified on | 2018/09/21 08:13:59 |
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Basic information
Public title
Randomized controlled trial of
mizoribine for progressive IgA
nephropathy
Acronym
Randomized controlled trial of mizoribine for progressive IgA nephropathy
Scientific Title
Randomized controlled trial of
mizoribine for progressive IgA
nephropathy
Scientific Title:Acronym
Randomized controlled trial of mizoribine for progressive IgA nephropathy
Region
| Japan |
Condition
Condition
IgA nephropathy with moderate to severe histological alterations
Classification by specialty
| Medicine in general | Cardiology | Endocrinology and Metabolism |
| Nephrology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Investigation of efficacy and safety of mizoribine for IgA nephropathy with moderate to severe histological alterations
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Altered amounts of proteinuria
Key secondary outcomes
Alteration of serum creatinine (SCr) and the slope of reciprocal SCr
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Central registration
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
Methylprednisolone pulse therapy followed by oral prednisolone administration
Interventions/Control_2
Methylprednisolone pulse therapy followed by oral prednisolone and mizoribine administration
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
| 60 | years-old | > |
Gender
Male and Female
Key inclusion criteria
Patients with IgA nephropathy who underwent renal biopsy and provided a written informed consent prior to study by reading and signing the form.
1) Patients who have 5 or more of glomerular score*.
2) Patients who are between 15 and 60 years of age.
3) Patients who have potential to receive methylprednisolone pulse therapy on inpatient basis, and thereafter to receive routine medical treatment as outpatients.
*(Katafuchi R et al.Clin Nephrol 49,1998)
Key exclusion criteria
1) Patients who have been treated with corticosteroids or mizoribine already
2) Patients who suffered infectious diseases such as pneumonia
3) Patients whose white blood cells count is under 3,000/mm3
4) Patients who are demonstrated to have another renal disease on renal biopsy
5) Patients who have diabetes mellitus
6) Patients who are have severe heart or liver disease
7) Patients who have malignant tumors
8) Patients who are currently pregnant or are supposed to be pregnant
9) Patients who are judged to be inappropriate for participation in this study by an physician
Target sample size
120
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Kazuhiko Tsuruya |
Organization
Graduate School of Medical Sciences, Kyushu University
Division name
Department of Integrated Therapy for Chronic Kidney Disease
Zip code
Address
Maidashi 3-1-1, Higashi-ku, Fukuoka
TEL
092-642-5843
tsuruya@intmed2.med.kyushu-u.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Kosuke Masutani |
Organization
West Japan Study Group for Therapy of IgA Nephropathy
Division name
Kidney Care Unit, Kyushu University Hospital
Zip code
Address
Maidashi 3-1-1, Higashi-ku, Fukuoka
TEL
092-642-5843
Homepage URL
masutani@kcu.med.kyushu-u.ac.jp
Sponsor or person
Institute
West Japan Study Group for Therapy of IgA Nephropathy
Institute
Department
Personal name
Funding Source
Organization
The Kidney Foundation, Japan
Organization
Division
Category of Funding Organization
Non profit foundation
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
| 2007 | Year | 02 | Month | 05 | Day |
Related information
URL releasing protocol
Publication of results
Published
Result
URL related to results and publications
https://www.ncbi.nlm.nih.gov/pubmed/26758039
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
| 2006 | Year | 10 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2006 | Year | 11 | Month | 01 | Day |
Last follow-up date
| 2010 | Year | 10 | Month | 01 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2007 | Year | 02 | Month | 05 | Day |
Last modified on
| 2018 | Year | 09 | Month | 21 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000000675
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
