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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000023850
Receipt No. 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 2017/03/01

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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
Email 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
Email jinushi@hosp.tohoku.ac.jp

Sponsor
Institute Tohoku Univerisy
Institute
Department

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
Email

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 Open public recruiting
Date of protocol fixation
2016 Year 08 Month 23 Day
Date of IRB
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
2017 Year 03 Month 01 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000027479

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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