UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | C000000380 |
|---|---|
| Receipt number | 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 11:16:05 |
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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
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
yoichimiyazaki@jikei.ac.jp
Sponsor or person
Institute
ARB therapeutic society of IgA nephropathy
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000000441
