UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000013546 |
|---|---|
| Receipt number | 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 14:19:01 |
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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
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
htsuji@kuhp.kyoto-u.ac.jp
Sponsor or person
Institute
Department of Rheumatology and Clinical Immunology, Kyoto University Hospital
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000015741
