UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000008211 |
|---|---|
| Receipt number | R000009667 |
| Scientific Title | Kremezin Adherence Supporting Program for hundred days(KRASP-study) |
| Date of disclosure of the study information | 2012/06/26 |
| Last modified on | 2013/01/21 09:19:48 |
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Basic information
Public title
Kremezin Adherence Supporting Program for hundred days(KRASP-study)
Acronym
Kremezin Adherence Supporting Program for hundred days
Scientific Title
Kremezin Adherence Supporting Program for hundred days(KRASP-study)
Scientific Title:Acronym
Kremezin Adherence Supporting Program for hundred days
Region
| Japan |
Condition
Condition
Chronic Kidney Disease
Classification by specialty
| Nephrology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The emprical study to prove effectiveness of medication adherence support program among CKD patients
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
-The ratio of failure in taking medication by forgetfulness
-The ratio of taken drugs in total amont of prescription proved by pill count
Key secondary outcomes
-Serum creatinine level, Glomerular filtration rate (GFR), urinary protein, Serum Indoxyl Sulfate
-Patient behavioral stage according to transtheoretical model
-Influence factors on medcation adherence
-Satisfaction with adherence support programe
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
Educational,Counseling,Training
Type of intervention
| Behavior,custom |
Interventions/Control_1
Intervention program by using telephon call, letters, patient education materials(DVDs, Text books)
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
-CKD Patients who newly prescribed Kremezin.
-Male/female age over 20 who speak Japanese fluently
-Ambulatory patients who are in stable condition and show no risk to be hospitalized.
-Patient who sign agreement of this clinical study.
Key exclusion criteria
-Hospitalized patinets
-Patients who Plannded to undergo artificial dialysis
-Patients who have alergic history to Kremezin
-Patients who need to pay physician's or nurces's close attention to their illness conditition.
-Patients who have cognitive impairment, perceptual disfunction, alcohol addiction, or any other illnesses which incure problems to complete this clinical study.
-Patients who have severe heart, liver, or lung disease, mental disorder, or malignant neoplasm progression
Target sample size
25
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Yasuhiko Tomino |
Organization
Juntendo University. Faculty of Medicine
Division name
Department of Nephrology
Zip code
Address
3-1-3, Hongo, Bunkyo-Ku, Tokyo, 113-8431, Japan
TEL
03-3813-3111
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Chieko Hamada |
Organization
Juntendo University. Faculty of Medicine
Division name
Department of Nephrology
Zip code
Address
3-1-3, Hongo, Bunkyo-Ku, Tokyo, 113-8431, Japan
TEL
03-3813-3111
Homepage URL
Sponsor or person
Institute
Juntendo University. Faculty of Medicine
Department of Nephrology
Institute
Department
Personal name
Funding Source
Organization
None
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
IML Corporation
Name of secondary funder(s)
IML Corporation
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
順天堂大学医学部附属順天堂医院（東京都）
Other administrative information
Date of disclosure of the study information
| 2012 | Year | 06 | Month | 26 | 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
No longer recruiting
Date of protocol fixation
| 2012 | Year | 06 | Month | 04 | Day |
Date of IRB
Anticipated trial start date
| 2012 | Year | 07 | Month | 01 | Day |
Last follow-up date
| 2013 | Year | 06 | Month | 30 | Day |
Date of closure to data entry
| 2013 | Year | 07 | Month | 31 | Day |
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2012 | Year | 06 | Month | 19 | Day |
Last modified on
| 2013 | Year | 01 | Month | 21 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000009667
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
