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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000003678
Receipt No. 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 2015/06/08

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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 &#8211; 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 &#8211; 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
Middle name
Last name Sadayoshi Ito MD, PhD
Organization Tohoku University Graduate School of Medicine
Division name Division of Nephrology, Rndocrinology and Vascular Medicine Department of Internal Medicine
Zip code
Address 1-1 Seiryo-cho Aoba-ku, Sendai, 980-8574 Japan
TEL 022-717-7166
Email

Public contact
Name of contact person
1st name
Middle name
Last name Susummu Ogawa MD, PhD
Organization Tohoku University Hospital
Division name Division of Nephrology, Endocrinology and Hypertension
Zip code
Address 1-1 Seiryo-cho Aoba-ku, Sendai, 980-8574 Japan
TEL 022-717-7166
Homepage URL
Email ogawa-s@hosp.tohoku.ac.jp

Sponsor
Institute Graduate School of Medicine, Tohoku University
Institute
Department

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
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

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
2015 Year 06 Month 08 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000004460

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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