UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000023850 |
|---|---|
| Receipt number | R000027479 |
| Scientific Title | Effect of lubiprostone on CKD patients to protect renal function |
| Date of disclosure of the study information | 2017/01/23 |
| Last modified on | 2024/03/06 12:29:42 |
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Basic information
Public title
Effect of lubiprostone on CKD patients to protect renal function
Acronym
Double blind test of lubiprostone for CKD patients
Scientific Title
Effect of lubiprostone on CKD patients to protect renal function
Scientific Title:Acronym
Double blind test of lubiprostone for CKD patients
Region
| Japan |
Condition
Condition
chronic kidney disease
Classification by specialty
| Nephrology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Examine the effectiveness and safety of lubiprostone administration for CKD patients
Basic objectives2
Safety
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Change of concentration of serum indoxyl sulfate before and after administration
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Double blind -all involved are blinded
Control
Placebo
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
3
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
placebo, lubiprostone 8 mcg/day, lubiprostone 16 mcg/day
Interventions/Control_2
lubiprostone 8 mcg/day
Interventions/Control_3
lubiprostone 16 mcg/day
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
patient with eFGR between 25-45 mL/min/1.73m2 for 3month
Key exclusion criteria
1, inflammmatry diseases
2, oral absorbent
3, PSL more 5mg , immunosuppressant
4, oral absorbent
5, ARF
6, Drug-induced renal failure
7, renal transplant
8, RRT
9, gut obstruction
10, sensitive for lubiprostone
11, symptomatic constipation
12, diarrea
13, gut diesases
14, abdominal operation within 6 mo
15, HbA1c>9%
16, BP > 160/90
17, serious heart, liver, kidney, lung, CNS diseases
18, malignancy
19, unable for contraception
20, other clinical study enrollment within 3mo
21, exacerbation of lab data during screening
22, Can not follow instruction
23, Inadequate for trial
Target sample size
140
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | ABE Takaaki |
Organization
Tohoku University Hospital
Division name
Department of endocrinology and vascular medicine
Zip code
Address
1-1 Seiryo-cho, Aoba-ku, Sendai
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 Hospital
Division name
Clincal Research Center
Zip code
Address
1-1 Seiryo-cho, Aoba-ku, Sendai
TEL
022-717-7774
Homepage URL
jinushi@hosp.tohoku.ac.jp
Sponsor or person
Institute
Tohoku Univerisy
Institute
Department
Personal name
Funding Source
Organization
AMED
Organization
Division
Category of Funding Organization
Japanese Governmental office
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
| 2017 | Year | 01 | 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
Completed
Date of protocol fixation
| 2016 | Year | 08 | Month | 23 | Day |
Date of IRB
| 2016 | Year | 08 | Month | 23 | Day |
Anticipated trial start date
| 2016 | Year | 08 | Month | 31 | Day |
Last follow-up date
| 2019 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2016 | Year | 08 | Month | 30 | Day |
Last modified on
| 2024 | Year | 03 | Month | 06 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000027479
