UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000003678 |
|---|---|
| Receipt number | R000004460 |
| Scientific Title | An Open label multi- facilities cooperation randomized control trial to verify renoprotective effects of Aliskiren treatment in the chronic kidney disease (CKD). |
| Date of disclosure of the study information | 2010/07/01 |
| Last modified on | 2022/04/06 10:25:27 |
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Basic information
Public title
An Open label multi- facilities cooperation randomized control trial to verify renoprotective effects of Aliskiren treatment in the chronic kidney disease (CKD).
Acronym
Aliskiren prevents the estimated glomerular filtration rate (eGFR) decrease in Japanese hypertensive patients with chronic kidney disease. (Al pen-Glow Study)
Scientific Title
An Open label multi- facilities cooperation randomized control trial to verify renoprotective effects of Aliskiren treatment in the chronic kidney disease (CKD).
Scientific Title:Acronym
Aliskiren prevents the estimated glomerular filtration rate (eGFR) decrease in Japanese hypertensive patients with chronic kidney disease. (Al pen-Glow Study)
Region
| Japan |
Condition
Condition
Japanese hypertensive patients with CKD.
Classification by specialty
| Medicine in general | Nephrology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To clarify the renoprotective effects of Aliskiren treatment in hypertensive patients with CKD.The purpose of this study was to investigate whether Aliskiren prevents the eGFR decrease more than other anti-hypertensive agents under ACEI and/or ARB treatments.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Assessment
Primary outcomes
percent change of eGFR
Key secondary outcomes
Percent changes of the urinary albumin, MCP-1, 8-OHdG, NAG and beta2-microgloburin excretions.
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Cluster
Blinding
Open -but assessor(s) are blinded
Control
Active
Stratification
YES
Dynamic allocation
NO
Institution consideration
Blocking
NO
Concealment
No need to know
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
This study is a prospective randomized control trial. The entry period of this study is two years. Study subjects are hypertensive patients with CKD, taking RAS inhibitors (ACEI and/or ARB). These patients are randomly assigned to two groups, an Aliskiren treatment group (Aliskiren 150mg/day) and other anti-hypertensive agents treatment group. The dose of Aliskiren can be properly increased to 300 mg/day when the anti-hypertensive effect is insufficient.
Interventions/Control_2
Their height, body weight, blood pressure, serum creatinine (e GFR), and urinary excretions of albumin, MCP-1, 8-OHdG, NAG and beta2 microgloburin are determined before (baseline) and after the treatment for two months. We collect fasting blood and first urine samples in early morning.
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
The subjects enrolled in the present study are hypertensive out-patients with CKD, who fulfill the following criteria; 1) Mild or moderate hypertension defined as the blood pressure of 130 / 90 – 160 / 110 mmHg. 2) Taking of RAS inhibitors such as ACEI and/or ARB, for at least six months. 3) Corresponding to the second stage – the fourth stage of CKD (eGFR=15-89 ml/min). 4) The participation agreement of this study is obtained.
Key exclusion criteria
1) Corresponding to the CKD 5th stage (eGFR < 15 ml/min, or receiving continuous dialysis). 2) Woman who has pregnancy or possibility of pregnancy and suckling. 3) To have other serious and active diseases such as severe hyperglycemia (HbA1c > 10%), liver dysfunction, cardiovascular disease and so on). 4) Severe hypertensive subjects (> 160 / 110 mmHg). 5) The patient that corresponds to contraindication of Aliskiren treatment. 6) Patient from whom physician in charge of treatment judged this study participation to be improper.
Target sample size
300
Research contact person
Name of lead principal investigator
| 1st name | Sadayoshi |
| Middle name | |
| Last name | Ito |
Organization
Tohoku University Graduate School of Medicine
Division name
Division of Nephrology, Rndocrinology and Vascular Medicine Department of Internal Medicine
Zip code
980-8574
Address
1-1 Seiryo-machi, Aoba-ku, Sendai, Miyagi, 980-8574, Japan
TEL
022-717-7166
ogawa-s@hosp.tohoku.ac.jp
Public contact
Name of contact person
| 1st name | Susumu |
| Middle name | |
| Last name | Ogawa |
Organization
Tohoku University Hospital
Division name
Division of Nephrology, Endocrinology and Hypertension
Zip code
980-8574
Address
1-1 Seiryo-machi, Aoba-ku, Sendai, Miyagi, 980-8574, Japan
TEL
022-717-7166
Homepage URL
ogawa-s@hosp.tohoku.ac.jp
Sponsor or person
Institute
Graduate School of Medicine, Tohoku University
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
Ethics Committee Tohoku University Graduate School of Medicine
Address
2-1 Seiryo-machi, Aoba-ku, Sendai, Miyagi, 980-8574, Japan
Tel
022-717-8007
med-kenkyo@grp.tohoku.ac.jp
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
| 2010 | Year | 07 | Month | 01 | 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
| 2010 | Year | 06 | Month | 30 | Day |
Date of IRB
Anticipated trial start date
| 2011 | Year | 07 | Month | 01 | Day |
Last follow-up date
| 2012 | Year | 11 | Month | 01 | Day |
Date of closure to data entry
| 2013 | Year | 01 | Month | 01 | Day |
Date trial data considered complete
| 2013 | Year | 01 | Month | 01 | Day |
Date analysis concluded
| 2013 | Year | 03 | Month | 01 | Day |
Other
Other related information
Management information
Registered date
| 2010 | Year | 05 | Month | 31 | Day |
Last modified on
| 2022 | Year | 04 | Month | 06 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000004460
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