UMIN-CTR Clinical Trial

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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