UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000006479 |
|---|---|
| Receipt number | R000007691 |
| Scientific Title | Evaluation of plasma angiotensinogen(AGT) and the effect of DRI on AGT and RAAS in hemodialysis patients |
| Date of disclosure of the study information | 2011/10/05 |
| Last modified on | 2011/10/05 13:43:41 |
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Basic information
Public title
Evaluation of plasma angiotensinogen(AGT) and the effect of DRI on AGT and RAAS in hemodialysis patients
Acronym
Evaluation of plasma AGT and effect of DRI in hemodiarysis patients.
Scientific Title
Evaluation of plasma angiotensinogen(AGT) and the effect of DRI on AGT and RAAS in hemodialysis patients
Scientific Title:Acronym
Evaluation of plasma AGT and effect of DRI in hemodiarysis patients.
Region
| Japan |
Condition
Condition
Hemodialysis patients
Hypertension
Classification by specialty
| Cardiology | Nephrology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To evaluate plasma AGT and RAAS in the hemodialysis patients and to determine the relationship between them. To examine the effect of DRI on AGT and RAAS and the usefulness of DRI on cardiac function in these patients.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Plasma AGT:0,2D,4D,7D,9D,11D,2,3,4,6,8W
Key secondary outcomes
1)BP:0,2D,4D,7D,9D,11D,2,3,4,6,8W
2)Plasma renin activity:
0,2D,4D,7D,9D,11D,2,3,4,6,8W
Plasma renin concentration: 0,2D,4D,7D,9D,11D,2,3,4,6,8W
3)Plasma aldosterone:0,8W
4)proBNP:0,8W
5)Body Weight: 0,2D,4D,7D,9D,11D,2,3,4,6,8W
6)BUN, Cr:0,1,2,4,6,8W
7)Na, K, Cl, Ca, P:0,1,2,4,6,8W
8)CBC:0,1,2,4,6,8W
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Historical
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
Aliskiren(150mg/day)8weeks
Interventions/Control_2
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
Hemodialysis patients
1. who have been under regular sessions for more than three months since the introduction of hemoddialysis.
2. with sBP>140mmHg or dBP>90mmHg at the beginning of the first hemodialysis session of the week.
Key exclusion criteria
1.Pregnancy
2.Severe hepatic or gallbladder disease (GOT > 150 IU or GPT > 150 IU)
3.Hyper potassium(k > 5.5 mEq/L)
4.Malignant tumor
5.Allergy to Aliskiren
6.During administration of itraconazole or ciclosporin
7.Other inadequacies
Target sample size
40
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Masakazu Kohono |
Organization
Kagawa University, Faculty of Medicine
Division name
Department of Cardiorenal and Cerebrovascular Medicine
Zip code
Address
1750-1 Ikenobe, Miki-cho, Kita-gun, Kagawa, Japan
TEL
087-891-5111
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Kumiko Kaifu |
Organization
Kagawa University, Faculty of Medicine
Division name
Department of Cardiorenal and Cerebrovascular Medicine
Zip code
Address
1750-1 Ikenobe, Miki-cho, Kita-gun, Kagawa, Japan
TEL
087-891-2149
Homepage URL
http://www.kms.ac.jp/~yakuzaib/CTMcenter/research/index2.html
kumi-kai@med.kagawa-u.ac.jp
Sponsor or person
Institute
Kagawa University, Faculty of Medicine
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
Kaifu Hospital
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
香川大学医学部附属病院（香川県）、海部医院（香川県）
Other administrative information
Date of disclosure of the study information
| 2011 | Year | 10 | Month | 05 | 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
Enrolling by invitation
Date of protocol fixation
| 2011 | Year | 08 | Month | 30 | Day |
Date of IRB
Anticipated trial start date
| 2011 | Year | 10 | Month | 01 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2011 | Year | 10 | Month | 05 | Day |
Last modified on
| 2011 | Year | 10 | Month | 05 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000007691
