UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000004182 |
|---|---|
| Receipt number | R000005024 |
| Scientific Title | efficacy and safety of tacrolimus for mild/modelate flare in patients with systemic lupus erythematosus |
| Date of disclosure of the study information | 2010/09/30 |
| Last modified on | 2012/03/12 07:43:11 |
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Basic information
Public title
efficacy and safety of tacrolimus for mild/modelate flare in patients with systemic lupus erythematosus
Acronym
FK for SLE Flare
Scientific Title
efficacy and safety of tacrolimus for mild/modelate flare in patients with systemic lupus erythematosus
Scientific Title:Acronym
FK for SLE Flare
Region
| Japan |
Condition
Condition
systemic lupus erythematosus
Classification by specialty
| Clinical immunology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the efficacy and safety of Tacrolimus for mild/modelate flare in patients with SLE
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
Time to discontinuation of treatment
Time to flare rate
Dose of prednisolone
Key secondary outcomes
SLE Disease Activity Index (SLEDAI)
Anti-double-stranded DNA antibody titer
Serum complement titer
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Historical
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
Administration of Tacrolimus
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
| 20 | years-old | <= |
Age-upper limit
| 80 | years-old | > |
Gender
Male and Female
Key inclusion criteria
1 Patients with diagnosed according to the American College of Rheumatology criteria of SLE
2 Patients has complicated lupus nephritis
3 Patients maintained with prednisolone less than 10 mg/day for at least 3 months before the entry.
4 Patients with mild/modelate flare during treatment with prednisolone alone or prednisolone concomitant with immunosuppressant (except for TAC or CsA)
Key exclusion criteria
1 A renal failure
Cr more than 1.2mg/dl or
Ccr less than 30ml/min or dialysis
2 Previous treatment with TAC
3 Pregnancy or lactation
4 Present uncontrolled infections
5 A history of cancer
6 Non-compliance
Target sample size
30
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Hirofumi Makino |
Organization
Okayama University Graduate School of Medicine, Dentistry and Pharmaceutical Sciences
Division name
Department of Medicine and Clinical Science
Zip code
Address
2-5-1 Shikata-cho, Kitaku, Okayama
TEL
086-235-7235
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Ken-ei Sada |
Organization
Okayama University Graduate School of Medicine, Dentistry and Pharmaceutical Sciences
Division name
Department of Medicine and Clinical Science
Zip code
Address
2-5-1 Shikata-cho, Kitaku, Okayama
TEL
086-235-7235
Homepage URL
sadakenn@md.okayama-u.ac.jp
Sponsor or person
Institute
Department of Medicine and Clinical Science, Okayama University Graduate School of Medicine, Dentistry and Pharmaceutical Sciences
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
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
| 2010 | Year | 09 | Month | 30 | 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
Enrolling by invitation
Date of protocol fixation
| 2010 | Year | 09 | Month | 30 | Day |
Date of IRB
Anticipated trial start date
| 2010 | Year | 10 | Month | 01 | Day |
Last follow-up date
| 2014 | Year | 12 | Month | 01 | Day |
Date of closure to data entry
| 2015 | Year | 03 | Month | 01 | Day |
Date trial data considered complete
| 2015 | Year | 06 | Month | 01 | Day |
Date analysis concluded
| 2015 | Year | 12 | Month | 01 | Day |
Other
Other related information
Management information
Registered date
| 2010 | Year | 09 | Month | 09 | Day |
Last modified on
| 2012 | Year | 03 | Month | 12 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000005024
