UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000010789 |
|---|---|
| Receipt number | R000012626 |
| Scientific Title | Effects of eplerenon in chronik kidney disease with hypertension |
| Date of disclosure of the study information | 2013/05/23 |
| Last modified on | 2015/06/19 13:45:28 |
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Basic information
Public title
Effects of eplerenon in chronik kidney disease with hypertension
Acronym
Eplerenon in chronik kidney disease
Scientific Title
Effects of eplerenon in chronik kidney disease with hypertension
Scientific Title:Acronym
Eplerenon in chronik kidney disease
Region
| Japan |
Condition
Condition
chronick kidney disease with hypertension
Classification by specialty
| Medicine in general |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Investigation the efficacy and safety of eplerenone in chronick kideny disease patinets with hypertension
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Phase IV
Assessment
Primary outcomes
The change of blood pressure, heart function, renal function
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
eplerenone 50-100mg/day
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
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1) >=20 years old
2)chronic kidney disease patients whose eGFR is over 60ml/min/1.73m2
3)hypertension(140/90 mmHg) irrespected of antihypertensive therapy
Key exclusion criteria
1)diabetes mellitus with microalbuminuria or proteinuria
2)patinets who have allegry for eplerenon
3)hyperkalemia (> 5.5 mEq/ml)
4)chronic kidney disease patients whose eGFR is under 50ml/min/1.73m2
5)severe liver dysfunction
6)patinets who are taking potassiums or potassium-sparing diuretics
7)pregnant women
8)patinets who are taking itraconazole, ritonavir or nelfinavir
9)patinets who will not give informed concent
Target sample size
30
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Yoshiyuki Morishita |
Organization
Jichi Medical University
Division name
Division of Nephrology, Department of Internal medicine
Zip code
Address
3311-1, Yakushiji, Shimotsuke-city, Tochigi 329-0498, Japan
TEL
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Yoshiyuki Morishita |
Organization
Jichi Medical University
Division name
Division of Nephrology, Department of Internal medicine
Zip code
Address
3311-1, Yakushiji, Shimotsuke-city, Tochigi 329-0498, Japan
TEL
Homepage URL
Sponsor or person
Institute
Division of Nephrology, Department of Internal medicine, Jichi Medical University
Institute
Department
Personal name
Funding Source
Organization
Division of Nephrology, Department of Internal medicine, Jichi Medical University
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
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
| 2013 | Year | 05 | Month | 23 | 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
| 2013 | Year | 04 | Month | 24 | Day |
Date of IRB
Anticipated trial start date
| 2013 | Year | 05 | Month | 23 | 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
| 2013 | Year | 05 | Month | 23 | Day |
Last modified on
| 2015 | Year | 06 | Month | 19 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000012626
