UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000002478 |
|---|---|
| Receipt number | R000003038 |
| Scientific Title | Examination of the effect of renal protection of aliskiren in chronic renal failure patient with hypertension (preservation period) |
| Date of disclosure of the study information | 2009/10/01 |
| Last modified on | 2015/09/10 09:25:39 |
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Basic information
Public title
Examination of the effect of renal protection of aliskiren in chronic renal failure patient with hypertension (preservation period)
Acronym
The Effect of Renal protection of Aliskiren in CRF with HT (preservation period)
(ERA-CRF HT trial)
Scientific Title
Examination of the effect of renal protection of aliskiren in chronic renal failure patient with hypertension (preservation period)
Scientific Title:Acronym
The Effect of Renal protection of Aliskiren in CRF with HT (preservation period)
(ERA-CRF HT trial)
Region
| Japan |
Condition
Condition
Chronic renal failure patient with hypertension under going rennin-angiotensin treatment (ARB/ACE-inhibitor) (preservation period)
Classification by specialty
| Medicine in general | Nephrology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The chronic renal failure patients with hypertension (preservation period) under going ARB/ACE-inhibitor treatment are rondomized to two arms (Aliskiren and non-aliskiren group) , and the target of blood pressure for each groups is 125/75mmHg , and it makes comparative study of the effectiveness of renal protection besed on the urine protein decrease and serum Cr value.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Explanatory
Developmental phase
Not applicable
Assessment
Primary outcomes
(1)Comparison with urinary protein and serum Cr between aliskiren group and non-aliskiren group.
(2)Comparison with urinary protein and serum Cr before and after administering aliskiren in aliskiren group.
Key secondary outcomes
(1)Office blood pressure(BP)
(2)Estimated glomerular filtration rate(eGFR)calculated using the modified MDRD formula in the Japanese Society of Nephrology:eGFR(ml/min/1.73m2)=194 x age -0.287 x serum Cr -1.094(multiply by 0.739 in female)
(3)CCr
(4)Dialysis shift rate
(5)Cardiovascular events (Stroke or transient ischaemic attack,New or recurrent acute myocardial infection,New occurrence or exacerbation of angina pectoris needing hospitalization,New occurrence or exacerbation of heart failure needing hospitalization,All-cause mortality)
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
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
Another antihypertensive agents (aliskiren is excluded) are oral-administrating or ARB/ACE inhibitor is increased in patients under the treatment of ARB/ACE inhibitor.
If BP dose not reach to lower than 125/75mmHg, other antihypertensive drug is added.
Interventions/Control_2
Aliskiren150mg-300mg/day is administrating in patients under the treatment of ARB/ACE inhibitor.
If BP dose not reach to lower than 125/75mmHg, other antihypertensive drug is added.
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
| 80 | years-old | > |
Gender
Male and Female
Key inclusion criteria
Fulfill all the following requirements at the time of the examination beginning.
(1) Chronic renal failure patient with hypertension (preservation period), eGFR <60ml/min/1.73m2,and urinary protein is positive.
(2) Patients under the treatment with ARB or ACE inhibitor (administrating for 6 months at the time of the examination beginnig at least.)
(3)Patients who can acquire agreement with document when participating in research
Key exclusion criteria
Patient who much as one of the following items excludes from the examination object.
(1)Active artery disease(within 6months of the clinical research beginning, patients who have unstable AP,MI,TIA,cerebrovascular disease,coronary bypass)
(2)Patients administrating with Cyclosporin
(3) Woman who has pregnant or possibility of pregnancy.
(4) Patients who is important or unstable physically or mentally, and who is considerd to ruin a safety of patient and a participation to clinical research by the research doctor.
(5)Additionally, patients who thought that doctor is improper.
Target sample size
200
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Takao Masaki |
Organization
Hiroshima University Hospital
Division name
Department of Nephrology
Zip code
Address
1-2-3 Kasumi Minami-Ku Hiroshimacity, Hiroshima 734-8551, Japan
TEL
082-257-1506
masakit@hiroshima-u.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Takao Masaki |
Organization
Kure Kyousai Hospital
Division name
Hiroshima University Hospital
Zip code
Address
1-2-3 Kasumi Minami-Ku Hiroshimacity, Hiroshima 734-8551, Japan
TEL
082-257-1506
Homepage URL
masaki4221@gmail.com
Sponsor or person
Institute
Kure Kyousai Hospital
Institute
Department
Personal name
Funding Source
Organization
none
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Chuo Naika Clinic
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
呉共済病院（広島県）
Other administrative information
Date of disclosure of the study information
| 2009 | Year | 10 | Month | 01 | 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
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
| 2009 | Year | 10 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2009 | Year | 11 | Month | 01 | Day |
Last follow-up date
| 2014 | Year | 06 | 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
| 2009 | Year | 09 | Month | 10 | Day |
Last modified on
| 2015 | Year | 09 | Month | 10 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000003038
| Research Plan | |
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| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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