UMIN-CTR Clinical Trial

BACK TOP
UMIN-CTR English Home Glossary (Simple) FAQ Search clinical trials

Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000002478
Receipt No. 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

* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments


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
Email 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
Email masaki4221@gmail.com

Sponsor
Institute Kure Kyousai Hospital
Institute
Department

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
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 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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000003038

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


Contact us.