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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN C000000341
Receipt No. R000000440
Scientific Title Randomised controlled trial of multiple drugs combined therapy for diffuse IgA nephropathy
Date of disclosure of the study information 2006/03/31
Last modified on 2015/02/22

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Basic information
Public title Randomised controlled trial of multiple drugs combined therapy for diffuse IgA nephropathy
Acronym Randomised controlled trial of multiple drugs combined therapy for diffuse IgA nephropathy
Scientific Title Randomised controlled trial of multiple drugs combined therapy for diffuse IgA nephropathy
Scientific Title:Acronym Randomised controlled trial of multiple drugs combined therapy for diffuse IgA nephropathy
Region
Japan

Condition
Condition Refractory IgA nephropathy
Classification by specialty
Medicine in general Cardiology Endocrinology and Metabolism
Nephrology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 We investigate efficacy and safty of mizoribine, prednisolone anti-platelet drug and ARB or ACE inhibitor: four drug combined therapy for refractory IgA nephropathy
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Changing percentage of Ccr and urinary protein.
Key secondary outcomes

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 Prednisolone and anti-thrombocyte and angiotensin II receptor blocker or angiotensin converting enzyme inhibitor
inhibitor
Interventions/Control_2 mizoribine and Prednisolone and anti thrombocyte and angiotensin II receptor blocker or angiotensin-converting enzyme
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 IgA nephropathy patients who underwent renal biopsy.
Patients who diagnosed to have diffuse IgA nephropathy
Age 16-75 years
Urine protein excretion of over 0.5g daily
Key exclusion criteria patients who's Ccr. Are Under 50ml/min or s-Cr. are over 2.0 mg/dl
patients who have severe liver dysfunction
pregnant or nursing women
patients with a hypersensitivity to each thrapy drugs
Judged inapproopriate for the physicians
Target sample size 60

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Tetsuya Mitarai
Organization Saitama Medical Center, Saitama Medical School
Division name Department of Nephrology and Hypertension
Zip code
Address 1981- Kamoda, Kawagoeshi, SAITAMA 350-8550, JAPAN
TEL 049-228-3604
Email mitarai@saitama-med.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Tetsuya Mitarai
Organization Japanese Study Group of Multiple drug therapy for IgAN
Division name Department of Nephrology and Hypertension, Saitama Medical Center, Saitama Medical School
Zip code
Address 1981-Kamoda, Kawagoeshi, Saitama
TEL 049-228-3604
Homepage URL
Email mitarai@saitama-med.ac.jp

Sponsor
Institute Japanese Study Group of Multiple drug therapy for IgAN
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
2006 Year 03 Month 31 Day

Related information
URL releasing protocol
Publication of results Published

Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Forty five patients, 20 for Group A (corticosteroid, ARB/ACEI, anti-platelet agents) and 25 for Group B (same medications of Group A plus MZB), were analyzed. The baseline characteristics of patients between two groups did not significantly differ.The rate of clinical remission at 12M was significantly higher in group B(40%) than in Group A(7%)(P=0.049), but the difference was no-longer significant at 24M. Multiple-drug combind therapy using MZB may be a useful option for adult patients with intermediate-severrity IgAN.
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 03 Month 01 Day
Date of IRB
Anticipated trial start date
2004 Year 04 Month 01 Day
Last follow-up date
2009 Year 09 Month 01 Day
Date of closure to data entry
2010 Year 12 Month 31 Day
Date trial data considered complete
2011 Year 03 Month 31 Day
Date analysis concluded
2013 Year 03 Month 31 Day

Other
Other related information

Management information
Registered date
2006 Year 02 Month 28 Day
Last modified on
2015 Year 02 Month 22 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000000440

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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