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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN C000000380
Receipt No. R000000441
Scientific Title The renoprotective effects of ARB in patients with IgA nephropathy : multicenter,radomized trial
Date of disclosure of the study information 2006/03/31
Last modified on 2014/04/01

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Basic information
Public title The renoprotective effects of ARB in patients with IgA nephropathy : multicenter,radomized trial
Acronym ARB and IgA nephropathy
Scientific Title The renoprotective effects of ARB in patients with IgA nephropathy : multicenter,radomized trial
Scientific Title:Acronym ARB and IgA nephropathy
Region
Japan

Condition
Condition IgA nephropathy
Classification by specialty
Nephrology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 The aim is to compare a clinical difference of renoprotective effects and an influence on renin-angiotensin-aldosterone system with valsartan and enalapril in IgA nephropathy patients with hypertensin.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1 Exploratory
Trial characteristics_2
Developmental phase Phase IV

Assessment
Primary outcomes 1)change in Ccr,2)inverse of inclination of serum Cr value, 3)change in urinary protein excretion, 4)inidence of events (doubling of serum creatinine concentration, 50% decrease in Ccr from the baseline value, dialysis)
Key secondary outcomes 1)change in PRA and PCA, 2)hyperkalemia, 3)tolerability (drug discontinuation rate)

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 YES
Institution consideration Institution is considered as adjustment factor in dynamic allocation.
Blocking NO
Concealment Central registration

Intervention
No. of arms 2
Purpose of intervention Treatment
Type of intervention
Medicine
Interventions/Control_1 ARB valsartan
Interventions/Control_2 ACE-I enalapril
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)patients with IgA nephropathy proven by renal biopsy
2)patients aged over 16 years and 75 years or less
3)patients who have urinary protein of over 0.5g/day
4)Patients with a serum creatinine value of 3mg/dL or less.
5)IgA nephropathy patients with hypertension (over 140 mmHg in SBP and over 90 mmHg in DBP) treated with or without antihypertensive agents except ARBs and ACE-Is.
Key exclusion criteria 1)patients with nephrotic syndorome.
2)patients who administered steroid or discontinuted within 6 months prior to enrolment in the study.
3)patients with serious liver dysfunction.
4)pregnant women or women of child bearing potential and nursing women.
5)patients with hypersensitivity to angiotensin II receptor blocker and angiotensin convertig enzyme inhibitor.
6)Other patients who are judged to be inappropriate for the study by the investigator or subinvestigator.
Target sample size 400

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Testuya Kawamura
Organization The Jikei University School of Medicine
Division name Department of Internal Medicine
Zip code
Address 3-25-8 Nishi-shinbashi, Minato-ku, Tokyo, 105-8461, Japan
TEL 03-3433-1111
Email kawatetu@coral.ocn.ne.jp

Public contact
Name of contact person
1st name
Middle name
Last name Yoichi Miyazaki
Organization The Jikei University School of Medicine
Division name Department of Internal Medicine
Zip code
Address 3-25-8 Nishi-shinbashi, Minato-ku, Tokyo, 105-8461, Japan
TEL 03-3433-1111
Homepage URL
Email yoichimiyazaki@jikei.ac.jp

Sponsor
Institute ARB therapeutic society of IgA nephropathy
Institute
Department

Funding Source
Organization The Kidney Foundation,Japan
Organization
Division
Category of Funding Organization Self funding
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 Unpublished

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
2003 Year 02 Month 01 Day
Date of IRB
Anticipated trial start date
2003 Year 04 Month 01 Day
Last follow-up date
2011 Year 03 Month 01 Day
Date of closure to data entry
2012 Year 03 Month 01 Day
Date trial data considered complete
2012 Year 08 Month 01 Day
Date analysis concluded
2012 Year 12 Month 01 Day

Other
Other related information

Management information
Registered date
2006 Year 03 Month 29 Day
Last modified on
2014 Year 04 Month 01 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000000441

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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