UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000017430 |
|---|---|
| Receipt number | R000020212 |
| Scientific Title | Effect of a Laxative on progression of CKD |
| Date of disclosure of the study information | 2015/05/06 |
| Last modified on | 2018/11/07 10:03:23 |
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Basic information
Public title
Effect of a Laxative on progression of CKD
Acronym
J-LUBIC
Scientific Title
Effect of a Laxative on progression of CKD
Scientific Title:Acronym
J-LUBIC
Region
| Japan |
Condition
Condition
Chronic Kidney Disease (CKD)
Classification by specialty
| Medicine in general |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The study aim is to establish the efficiency of lubiprostone as a novel CKD drug.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Explanatory
Developmental phase
Not applicable
Assessment
Primary outcomes
constipation
Concentration of uremic toxins
Renal funcitons
Key secondary outcomes
gutmicrobiota
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
Administration of lubiprostone to CKD patients
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 with constipation
Key exclusion criteria
ileus
Target sample size
50
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Takaaki ABE |
Organization
Tohoku University Graduate School of Biomedical Engineering
Division name
Division of Medical Science
Zip code
Address
1-1 Seiryo-cho, Aoba, Sendai,Japan
TEL
022-717-7163
takaabe@med.tohoku.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Takaaki ABE |
Organization
Tohoku University Graduate School of Biomedical Engineering
Division name
Division of Medical Science
Zip code
Address
1-1 Seiryo-cho, Aoba, Sendai,Japan
TEL
022-717-7163
Homepage URL
takaabe@med.tohoku.ac.jp
Sponsor or person
Institute
Tohoku University Hospital
Institute
Department
Personal name
Funding Source
Organization
Tohoku University Hospital
Organization
Division
Category of Funding Organization
Government offices of other countries
Nationality of Funding Organization
Japan
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
| 2015 | Year | 05 | Month | 06 | 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
Open public recruiting
Date of protocol fixation
| 2014 | Year | 02 | Month | 18 | Day |
Date of IRB
Anticipated trial start date
| 2014 | Year | 02 | Month | 18 | Day |
Last follow-up date
| 2018 | Year | 02 | Month | 28 | Day |
Date of closure to data entry
| 2020 | Year | 02 | Month | 28 | Day |
Date trial data considered complete
| 2020 | Year | 02 | Month | 28 | Day |
Date analysis concluded
| 2020 | Year | 03 | Month | 01 | Day |
Other
Other related information
Management information
Registered date
| 2015 | Year | 05 | Month | 06 | Day |
Last modified on
| 2018 | Year | 11 | Month | 07 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000020212
