UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000008985 |
|---|---|
| Receipt number | R000010536 |
| Scientific Title | Studies on the once daily dosing immunosuppressive therapy of tacrolimus extended release and mycophenolate mofetil in maintenance kidney transplant patients |
| Date of disclosure of the study information | 2012/09/26 |
| Last modified on | 2014/09/26 10:25:39 |
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Basic information
Public title
Studies on the once daily dosing immunosuppressive therapy of tacrolimus extended release and mycophenolate mofetil in maintenance kidney transplant patients
Acronym
Studies on the once daily dosing immunosuppressive therapy of tacrolimus extended release and mycophenolate mofetil
Scientific Title
Studies on the once daily dosing immunosuppressive therapy of tacrolimus extended release and mycophenolate mofetil in maintenance kidney transplant patients
Scientific Title:Acronym
Studies on the once daily dosing immunosuppressive therapy of tacrolimus extended release and mycophenolate mofetil
Region
| Japan |
Condition
Condition
Chronic renal failure
Classification by specialty
| Nephrology | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To investigate the efficacy and safety of once daily administration of mycophenolate mofetil
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Phase IV
Assessment
Primary outcomes
acute rejection rate during 3 months before and 3months after swiching
Key secondary outcomes
serum creatinine level during 3 months before and 3months after swiching
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
once daily administration of mycophenolate mofetil
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
| 18 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
patients who underwent kidney transplant surgery more than 1 year ago
patients in stable general condition
patients who take tacrolimus, mycophenlate mofetil and steroid
patients who take 1000mg or less mycophenlate mofetil per day
patients with written informed consent
Key exclusion criteria
patiens with liver dysfunction
Target sample size
19
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Shiro Takahara |
Organization
Osaka University Graduate School of Medicine
Division name
Department of Advanced Technology for Transplantation
Zip code
Address
2-2 Yamadaoka, Suita-city, Osaka
TEL
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Naotsugu Ichimaru |
Organization
Osaka University Graduate School of Medicine
Division name
Department of Advanced Technology for Transplantation
Zip code
Address
2-2 Yamadaoka, Suita-city, Osaka
TEL
+81-6-6879-3746
Homepage URL
Sponsor or person
Institute
Department of Advanced Technology for Transplantation, Osaka University Graduate School of Medicine
Institute
Department
Personal name
Funding Source
Organization
none
Organization
Division
Category of Funding Organization
Self funding
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
10287
Org. issuing International ID_1
Osaka University
Study ID_2
173
Org. issuing International ID_2
Inoue Hospital
IND to MHLW
Institutions
Institutions
Osaka University Hospital, Inoue Hospital
Other administrative information
Date of disclosure of the study information
| 2012 | Year | 09 | Month | 26 | Day |
Related information
URL releasing protocol
Publication of results
Published
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
| 2012 | Year | 02 | Month | 14 | Day |
Date of IRB
Anticipated trial start date
| 2012 | Year | 09 | Month | 27 | 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
| 2012 | Year | 09 | Month | 26 | Day |
Last modified on
| 2014 | Year | 09 | Month | 26 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000010536
