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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000000593
Receipt No. 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

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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
Email 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
Email masutani@kcu.med.kyushu-u.ac.jp

Sponsor
Institute West Japan Study Group for Therapy of IgA Nephropathy
Institute
Department

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
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
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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000000675

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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