Unique ID issued by UMIN | UMIN000006309 |
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Receipt number | R000007458 |
Scientific Title | Comparison of clinical outcomes of various treatment regimens as induction and maintenance therapy for lupus nephritis |
Date of disclosure of the study information | 2011/10/01 |
Last modified on | 2013/09/19 16:51:04 |
Comparison of clinical outcomes of various treatment regimens as induction and maintenance therapy for lupus nephritis
Comparison of clinical outcomes of various treatment regimens as induction and maintenance therapy for lupus nephritis
Comparison of clinical outcomes of various treatment regimens as induction and maintenance therapy for lupus nephritis
Comparison of clinical outcomes of various treatment regimens as induction and maintenance therapy for lupus nephritis
Japan |
lupus nephritis
Clinical immunology |
Others
NO
To compare the efficacy and safety with various immunosuppressive treatment regimens as induction therapy and maintenance therapy for lupus nephritis
Safety,Efficacy
Confirmatory
Pragmatic
Not applicable
renal remission rate
relapse rate
duration to remission
duration to relapse
Interventional
Parallel
Randomized
Individual
Open -no one is blinded
Active
NO
YES
Institution is not considered as adjustment factor.
YES
Numbered container method
6
Treatment
Medicine |
moderate dose of intravenous cyclophosphamide (500-700mg/body/month) as induction therapy, tacrolimus(1-3mg/day) as maintenance therapy
moderate dose of intravenous cyclophosphamide (500-700mg/body/month) as induction therapy, azathioprine(1-3mg/kg/day) as maintenance therapy
low dose of intravenous cyclophosphamide (300mg/m2/month) and apheresis as induction therapy, tacrolimus(1-3mg/day)as maintenance therapy
low dose of intravenous cyclophosphamide (300mg/m2/month) and apheresis as induction therapy, azathioprine(1-3mg/kg/day)as maintenance therapy
multi-target therapy: tacrolimus(1-3mg/day), azathioprine(1-3mg/kg/day) as induction therapy, tacrolimus(1-3mg/day) as maintenance therapy
multi-target therapy: tacrolimus(1-3mg/day), azathioprine(1-3mg/kg/day) as induction therapy, azathioprine(1-3mg/kg/day) as maintenance therapy
Not applicable |
Not applicable |
Male and Female
patient of active lupus nephritis
patient who has contraindication of drugs including cyclophosphamide, azathioprine and tacrolimus.
patient who has contraindication of apheresis therapy
60
1st name | |
Middle name | |
Last name | Ken Yamaji |
Juntendo University School of Medicine
Department of Internal Medicine and Rheumatology
2-1-1 Hongo Bunkyo-ku, Tokyo, Japan 113-8421
03-3813-3111
k.yamaji@juntendo.ac.jp
1st name | |
Middle name | |
Last name | Ken Yamaji |
Juntendo University School of Medicine
Department of Internal Medicine and Rheumatology
2-1-1 Hongo Bunkyo-ku, Tokyo, Japan 113-8421
03-3813-3111
k.yamaji@juntendo.ac.jp
Department of Internal Medicine and Rheumatology, Juntendo University School of Medicine
None
Self funding
Japan
NO
順天堂大学医学部附属順天堂医院
2011 | Year | 10 | Month | 01 | Day |
Unpublished
Open public recruiting
2011 | Year | 08 | Month | 01 | Day |
2011 | Year | 10 | Month | 01 | Day |
2011 | Year | 09 | Month | 08 | Day |
2013 | Year | 09 | Month | 19 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000007458
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