UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000006686 |
|---|---|
| Receipt number | R000007743 |
| Scientific Title | Therapeutic Effect of Irbesartan, AVAPRO, on Blood Pressure and eGFR by Morning or Bedtime Administration in Chronic Kidney Disease Patients(ABPM-CKD) |
| Date of disclosure of the study information | 2011/11/08 |
| Last modified on | 2014/08/19 21:56:14 |
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Basic information
Public title
Therapeutic Effect of Irbesartan, AVAPRO, on Blood Pressure and eGFR by Morning or Bedtime Administration in Chronic Kidney Disease Patients(ABPM-CKD)
Acronym
ABPM-CKD study
Scientific Title
Therapeutic Effect of Irbesartan, AVAPRO, on Blood Pressure and eGFR by Morning or Bedtime Administration in Chronic Kidney Disease Patients(ABPM-CKD)
Scientific Title:Acronym
ABPM-CKD study
Region
| Japan |
Condition
Condition
Chronic Kidney Disease
Classification by specialty
| Nephrology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To determine therapeutic Effect of Irbesartan, AVAPRO, on Blood Pressure (Office Blood pressure,Self-monitoring at home, and ABPM) and eGFR by Morning or Bedtime Administration in Chronic Kidney Disease Patients (ABPM-CKD).
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
1.Change of blood pressure (a:Office Blood pressure, b:Self-monitoring at home, c: ABPM)
Key secondary outcomes
1.eGFR
2.Serum creatinine
3.Uric acid
4.Plasma renin activity
5.Plasma aldosterone
6.Urinary sodium concentration (daytime, sleeping time)
7. Albumin creatinine ratio of spot urine
Base
Study type
Interventional
Study design
Basic design
Cross-over
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
NO
Dynamic allocation
NO
Institution consideration
Institution is not considered as adjustment factor.
Blocking
NO
Concealment
Pseudo-randomization
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
Irbesartan 50-200mg/day
from morning to bedtime administration
Interventions/Control_2
Irbesartan 50-200mg/day
bfrom edtime to morning 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
| 20 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1)Patients treated with irbesartan eight weeks or more at the informed consent acquisition
(CKD:eGFR<60,proteinuria positive three months or more)
2)20 and over
3)Sex unquestioned
4)Inpatients and Outpatients
5)documented informed consent
Key exclusion criteria
1)Pregant or possible pregnant patients
2)Patients with bilareral renal artery stenosis and patients with unilateral and renal artery stenosis
3)Nephrotic syndrome
4)Patients whose hepatic function was over 2 times higher than normal upper limit within eight weekss before the informed consent acquisition
5)Patients received hospitalizing by onset of cardiovascular disease, myocardial infarction, cerebral apoplexy, cardiac insufficiency within eight weeks before the informed consent acquisition
6)Allergic reaction to irbesartan
7)Judged inappropriate for this study by the physicians
Target sample size
30
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Shoichi Maruyama |
Organization
Nagoya university graduate school of medicine
Division name
Department of Nephrology
Zip code
Address
65 Tsuruma-cho, Showa-ku, Nagoya, Japan
TEL
052-744-2192
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Yoshinari Yasuda |
Organization
Nagoya university graduate school of medicine
Division name
Departmrnt of CKD initiatives
Zip code
Address
65 Tsuruma-cho, Showa-ku, Nagoya, Japan
TEL
052-744-2202
Homepage URL
Sponsor or person
Institute
Department of Nephrology, Nagoya university graduate school of medicine
Institute
Department
Personal name
Funding Source
Organization
none
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
| 2011 | Year | 11 | Month | 08 | 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
Terminated
Date of protocol fixation
| 2011 | Year | 05 | Month | 31 | Day |
Date of IRB
Anticipated trial start date
| 2011 | Year | 11 | Month | 01 | Day |
Last follow-up date
| 2013 | Year | 05 | 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
| 2011 | Year | 11 | Month | 08 | Day |
Last modified on
| 2014 | Year | 08 | Month | 19 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000007743
| Research Plan | |
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| Registered date | File name |
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| Registered date | File name |
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