UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000005759 |
|---|---|
| Receipt number | R000006794 |
| Scientific Title | The protective effect for renal function of Aliskiren in hypertensive CKD patients with proteinuria |
| Date of disclosure of the study information | 2011/06/14 |
| Last modified on | 2013/06/18 22:59:57 |
* 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
The protective effect for renal function of Aliskiren in hypertensive CKD patients with proteinuria
Acronym
The protective effect of Aliskiren for CKD patients with hypertension
Scientific Title
The protective effect for renal function of Aliskiren in hypertensive CKD patients with proteinuria
Scientific Title:Acronym
The protective effect of Aliskiren for CKD patients with hypertension
Region
| Japan |
Condition
Condition
hypertensive patients with chronic kidney disease
Classification by specialty
| Nephrology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The purpose of this study is to elucidate the efficacy of Aliskiren for reduction of proteinuria in CKD patients who are treated with ARB.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
Levels of urinary protein after 12 and 24 weeks
Key secondary outcomes
Plasma aldosterone
Urinary sodium
Blood pressure
Estimation glomerulus filtration (eGFR)
Serum potassium, serum creatinine
Plasma renin activity
Serum thrombomodulin
Serum cystatin C
Fibrinolysis system marker (plasma PAI-I)
Oxidative stress marker (urinary 8-OHDG)
Harmful phenomenon
will be analyzed after 12 and 24 wekks
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -but assessor(s) are blinded
Control
Active
Stratification
YES
Dynamic allocation
YES
Institution consideration
Institution is not considered as adjustment factor.
Blocking
NO
Concealment
Pseudo-randomization
Intervention
No. of arms
3
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
Group 1: administer the Aliskiren add on ARB
Duration of study: 2011.9.1 to 2012.12.31
Duration of registration: 6 months
Obsevation period: 24 weeks after the administration
Interventions/Control_2
Group 2: increase the dose of ARB
Duration of study: 2011.9.1 to 2012.12.31
Duration of registration: 6 months
Obsevation period: 24 weeks after the administration
Interventions/Control_3
Group 3: administer the Ca-blocker add on ARB
Duration of study: 2011.9.1 to 2012.12.31
Duration of registration: 6 months
Obsevation period: 24 weeks after the administration
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 with proteinuria (more than 0.3g/g Cr)
2. In cases that systolic BP is over 130mmHg and diastolic BP is over 80mmHg who administer standard dose of ARB.
The standard dose of ARB are as below.
Valsartan 80mg, Losartan 50mg, Candesartan 8mg, Terumisartan 40mg, Olmesartan 20mg
Key exclusion criteria
1. systolic BP is over 180mmHg, or diastolic BP is over 110mmHg
2. Severe diabetic patients whose HbA1c is over 8.5%
3. In case of severe hepatic injuries
4. nephrotic syndrome
5. the patients with pregnant or possibly pregnant
6. in case with contraindication of Aliskiren
Target sample size
153
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Hitoshi Suzuki |
Organization
Juntendo University Faculty of Medicine
Division name
Department of Internal Medicine, Division of Nephrology
Zip code
Address
2-1-1 Hongo, Bunkyo-ku, Tokyo, Japan
TEL
03-3813-3111
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Hitoshi Suzuki |
Organization
Juntendo University Faculty of Medicine
Division name
Department of Internal Medicine, Division of Nephrology
Zip code
Address
2-1-1 Hongo, Bunkyo-ku, Tokyo, Japan
TEL
03-3813-3111
Homepage URL
Sponsor or person
Institute
Department of Internal Medicine, Division of Nephrology, Juntendo University Faculty of Medicine
Institute
Department
Personal name
Funding Source
Organization
Department of Internal Medicine, Division of Nephrology, Juntendo University Faculty of Medicine
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Japan
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
順天堂大学付属順天堂医院（東京都）、江東高齢者医療センター（東京都）、順天堂大学付属練馬病院（東京都）、順天堂大学付属浦安病院（千葉県）、順天堂大学付属静岡病院（静岡県）、順天堂大学付属越谷病院（埼玉県）
Other administrative information
Date of disclosure of the study information
| 2011 | Year | 06 | Month | 14 | 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 | 16 | Day |
Date of IRB
Anticipated trial start date
| 2011 | Year | 09 | Month | 01 | Day |
Last follow-up date
| 2013 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
| 2014 | Year | 03 | Month | 01 | Day |
Other
Other related information
Management information
Registered date
| 2011 | Year | 06 | Month | 12 | Day |
Last modified on
| 2013 | Year | 06 | Month | 18 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000006794
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
|---|---|
| Registered date | File name |
| Research case data | |
|---|---|
| Registered date | File name |
