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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN C000000368
Receipt No. 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

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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
Email 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/
Email tsaito@fukuoka-u.ac.jp

Sponsor
Institute Project team for treatment of refractory nephrotic syndrome
Institute
Department

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
Email

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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000000462

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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