UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000008919 |
|---|---|
| Receipt number | R000009274 |
| Scientific Title | The prospective multi-center study on the efficacy and safety of mizoribine for the treatment of aged nephrotic patients with primary membranous nephropathy. |
| Date of disclosure of the study information | 2012/09/14 |
| Last modified on | 2017/03/21 20:36:52 |
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Basic information
Public title
The prospective multi-center study on the efficacy and safety of mizoribine for the treatment of aged nephrotic patients with primary membranous nephropathy.
Acronym
The study on efficacy and safety of mizoribine for the aged patients with membranous nephropathy.
Scientific Title
The prospective multi-center study on the efficacy and safety of mizoribine for the treatment of aged nephrotic patients with primary membranous nephropathy.
Scientific Title:Acronym
The study on efficacy and safety of mizoribine for the aged patients with membranous nephropathy.
Region
| Japan |
Condition
Condition
The patients with nephrotic syndrome due to primary membranous nephropathy.
Classification by specialty
| Nephrology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The purpose of this study is to clarify the efficacy and safety of mizoribine for aged nephrotic patient with membranous nephropathy.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
Rate of remission from nephrotic syndrome
Key secondary outcomes
1.Rate of continuity of the selected treatment.
2. The reduction of the degree of proteinuria.
3.Frequency of adverse complication derived from drug use.
4.Total dose of corticosteroid for treatment of nephrotic syndrome.
5. Changes in the renal function.
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
Active
Stratification
NO
Dynamic allocation
NO
Institution consideration
Institution is not considered as adjustment factor.
Blocking
NO
Concealment
Central registration
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
Treatment with a combination of mizoribine plus steroid therapy
Interventions/Control_2
Treatment with steroid monotherapy
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
| 65 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Patient whose age is more than 65 years old, and who clears all of the following entry-criterion can enroll in this study.
1) The patient is established the diagnosis of nephrotic syndrome.
2) The diagnosis of membranous nephropathy is also histologically established.
3)The eGFR is more than 45ml/min.
Key exclusion criteria
Case that showed at least one of the following terms should be excluded.
1) Patient who have the allergy for mizoribine.
2) Data of WBC count before entry showed less than 3000/microL.
3) Patient who has the severe disease, such as heart and liver diseases.
4) Patient who has the severe bacterial, fungal or viral infection.
5) Patient who has the relapsed nephrotic syndrome.
6) Patient who experienced kidney transplantation.
7) The doctor decides that the patient is inappropriate to enroll in this study.
Target sample size
200
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Tetsuya Mitarai |
Organization
Saitama Medical Center, Saitama Medical University
Division name
Department of Hypertension and kidney disease
Zip code
Address
1981 Kamoda, Kawagoe-shi, Saitama 350-8550, Japan
TEL
049-228-3710
mitarai@saitama-med.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Hajime Hasegawa |
Organization
The study group of treatment for aged patients with nephrotic syndrome.
Division name
Affair
Zip code
Address
1981 Kamoda, Kawagoe-shi, Saitama 350-8550, Japan
TEL
049-228-3604
Homepage URL
hase2126@saitama-med.ac.jp
Sponsor or person
Institute
The study group of treatment for aged patients with nephrotic syndrome.
Institute
Department
Personal name
Funding Source
Organization
The Kindney Foundation, Japan
Organization
Division
Category of Funding Organization
Non profit foundation
Nationality of Funding Organization
Japan
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
| 2012 | Year | 09 | Month | 14 | 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
Thirty six patients were enroled in this study. There was no difference about primary outcome, the rate of compleat and partial remission after one year observation, between two groups,that consisted with steroid alone group and steroid with mizoribine group.
More detail analysis are on going.
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
| 2012 | Year | 09 | Month | 14 | Day |
Date of IRB
Anticipated trial start date
| 2012 | Year | 09 | Month | 15 | Day |
Last follow-up date
| 2015 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
| 2016 | Year | 03 | Month | 31 | Day |
Date trial data considered complete
| 2016 | Year | 04 | Month | 30 | Day |
Date analysis concluded
| 2016 | Year | 06 | Month | 30 | Day |
Other
Other related information
Anti-PLA2 antibody at observational point were evaluated in 14 patients.
Management information
Registered date
| 2012 | Year | 09 | Month | 14 | Day |
Last modified on
| 2017 | Year | 03 | Month | 21 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000009274
