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Name
UMIN ID

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000013546
Receipt No. R000015741
Scientific Title The effect ofgrepefruit juice on the patients with autoimmune diseases taking tacrolimus
Date of disclosure of the study information 2014/03/31
Last modified on 2014/03/28

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Basic information
Public title The effect ofgrepefruit juice on the patients with autoimmune diseases taking tacrolimus
Acronym Effect of grapefruit juice with Tacrolimus
Scientific Title The effect ofgrepefruit juice on the patients with autoimmune diseases taking tacrolimus
Scientific Title:Acronym Effect of grapefruit juice with Tacrolimus
Region
Japan

Condition
Condition rheumatoid arthritis, lupus nephritis, polymyositis/dermatomyositis with interstitial pneumonia, ulcerative colitis
Classification by specialty
Medicine in general
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To investigate the effect of grapefruit juice intake for the patients with tacrolimus whose tacrolimus blood concentrations do not reach the effective range (5-15 ng/ml).
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1 Confirmatory
Trial characteristics_2 Pragmatic
Developmental phase Not applicable

Assessment
Primary outcomes Increase of tacrolimus blood concentration
Key secondary outcomes

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Non-randomized
Randomization unit
Blinding Open -no one is blinded
Control No treatment
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 2
Purpose of intervention Treatment
Type of intervention
Food
Interventions/Control_1 take a glass of grapefruit juice every day
Interventions/Control_2 do not take grapefruit juice
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
16 years-old <=
Age-upper limit
80 years-old >
Gender Male and Female
Key inclusion criteria Autoimmune Disease Patients (with rheumatoid arthritis, systemic lupus erythematosus, dermatomyositis / polymyositis, mixed connective tissue disease or ulcerative colitis) who are taking Tacrolimus with 3mg/day or more but the trough levels of serum tacrolimus concentration did not reach the minimal effecive range.
Key exclusion criteria patients who do not satisfy the classification criteria of each disease and those who do not wish to perticipate in this clinical test.
Target sample size 20

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Koichiro Ohmura
Organization Kyoto University
Division name Department of Rheumatology and Clinical Immunology
Zip code
Address 54 Kawahara-cho, Shogoin, Sakyo-ku, Kyoto
TEL 075-751-4380
Email ohmurako@kuhp.kyoto-u.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Hideki Tsuji
Organization Kyoto University
Division name Department of Rheumatology and Clinical Immunology
Zip code
Address 54 Kawahara-cho, Shogoin, Sakyo-ku, Kyoto
TEL 075-751-3124
Homepage URL
Email htsuji@kuhp.kyoto-u.ac.jp

Sponsor
Institute Department of Rheumatology and Clinical Immunology, Kyoto University Hospital
Institute
Department

Funding Source
Organization Management Expenses Grants (Educational Research Grants)
Organization
Division
Category of Funding Organization Other
Nationality of Funding Organization

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
2014 Year 03 Month 31 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 Preinitiation
Date of protocol fixation
2014 Year 04 Month 14 Day
Date of IRB
Anticipated trial start date
2014 Year 06 Month 01 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
2014 Year 03 Month 28 Day
Last modified on
2014 Year 03 Month 28 Day


Link to view the page
URL(English) https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000015741

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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