UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | C000000368 |
|---|---|
| Receipt number | R000000462 |
| Scientific Title | Multicenter study for combined therapy of prednisolone and mizoribine in idiopathic membranous nephropathy with refractory nephrotic syndrome |
| Date of disclosure of the study information | 2006/03/27 |
| Last modified on | 2015/03/18 14:16:40 |
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Basic information
Public title
Multicenter study for combined therapy of prednisolone and mizoribine in idiopathic membranous nephropathy with refractory nephrotic syndrome
Acronym
Combined therapy of prednisolone and mizoribine in membranous nephropathy with refractory nephrotic syndrome
Scientific Title
Multicenter study for combined therapy of prednisolone and mizoribine in idiopathic membranous nephropathy with refractory nephrotic syndrome
Scientific Title:Acronym
Combined therapy of prednisolone and mizoribine in membranous nephropathy with refractory nephrotic syndrome
Region
| Japan |
Condition
Condition
membranous nephropathy with primary steroid resistant nephrotic syndrome
Classification by specialty
| Medicine in general | Nephrology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
We prospectively and randomizedly compare the efficacy and safety of combined therapy using mizoribine between once a day administration at 150mg and 3 times a day administration at 50mg each for membranous nephropathy with primary steroid resistant nephrotic syndrome in adults.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
urine protein excretion (g/day)
remission status of nephrotic syndrome
Key secondary outcomes
renal function (creatinine clearance (Ccr))
serum total protein and albumin levels
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
mizoribine once a day per os administration (150mg) after breakfast for 2years.
Interventions/Control_2
mizoribine 3 times a day per os administration (50mg each) after meals for 2years.
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
| 16 | years-old | <= |
Age-upper limit
| 75 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
1) Membranous nephropathy is diagnosed by renal biopsy.
2) The subject's urine protein excretion is more than 3.5g/day and serum albumin level is less than 3.0/dL before the treatment. In addition, corticosteroids treatment for more than 4 weeks has not reduced the subject's urine protein excretion less than 1g/day before the study commencement.
3) The subject is a male or female between 16 and 75 years of age.
4) The subject has voluntarily signed a document of the informed consent.
Key exclusion criteria
1) The subject presents with renal dysfunction (Ccr less than 50mL/min or serum creatinine more than 2mg/dL.
2) The subject previously had serious hypersensitivity to mizoribine.
3) The subject's white blood cells are under 3000/mm3.
4) The subject is currently pregnant, is supposed to be pregnant, plans to become pregnant during the study period, or is nursing.
5) The subject has serious complications.
6) The subject has serious infections by bacteria, fungus or virus.
7) The subject has already been treated with mizoribine at the study commencement.
8) The subject is inappropriate for participation in the study as determined by an investigator.
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Takao Saito |
Organization
Project team for treatment of refractory nephrotic syndrome
Division name
Division of Nephrology and Rheumatology, Department of Internal Medicine, Fukuoka University School of Medicine
Zip code
Address
7-45-1 Nanakuma, Jonan-ku, Fukuoka 814-0180, Japan
TEL
092-801-1011
tsaito@fukuoka-u.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Takao Saito |
Organization
Project team for refractory nephrotic syndrome
Division name
Division of Nephrology and Rheumatology, Fukuoka University Hospital
Zip code
Address
7-45-1 Nanakuma, Jonan-ku, Fukuoka 814-0180, Japan
TEL
092-801-1011ext.3374
Homepage URL
https://www.wan.jp/mhlw/
tsaito@fukuoka-u.ac.jp
Sponsor or person
Institute
Project team for treatment of refractory nephrotic syndrome
Institute
Department
Personal name
Funding Source
Organization
Japan Kidney Foundation
Organization
Division
Category of Funding Organization
Non profit foundation
Nationality of Funding Organization
Other related organizations
Co-sponsor
The Progressive Renal Disease Research Projects in the Ministry of Health, Labor and Welfare, Japan
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
| 2006 | Year | 03 | Month | 27 | 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
Completed
Date of protocol fixation
| 2004 | Year | 01 | Month | 24 | Day |
Date of IRB
Anticipated trial start date
| 2004 | Year | 04 | Month | 01 | Day |
Last follow-up date
| 2009 | Year | 12 | Month | 01 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
| 2015 | Year | 03 | Month | 18 | Day |
Other
Other related information
Management information
Registered date
| 2006 | Year | 03 | Month | 25 | Day |
Last modified on
| 2015 | Year | 03 | Month | 18 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000000462
