Unique ID issued by UMIN | UMIN000009120 |
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Receipt number | R000010695 |
Scientific Title | A PROSPECTIVE, RANDOMIZED COMPARATIVE TRIAL OF MIZORIBINE VERSUS MYCOPHENOLATE MOFETIL IN COMBINATION THERAPY WITH TACROLIMUS AND BASILIXIMAB FOR LIVING DONOR RENAL TRANSPLANTATION. |
Date of disclosure of the study information | 2012/11/06 |
Last modified on | 2014/12/26 16:51:51 |
A PROSPECTIVE, RANDOMIZED COMPARATIVE TRIAL OF MIZORIBINE VERSUS MYCOPHENOLATE MOFETIL IN COMBINATION THERAPY WITH TACROLIMUS AND BASILIXIMAB FOR LIVING DONOR RENAL TRANSPLANTATION.
A COMPARATIVE TRIAL OF MIZORIBINE VERSUS MYCOPHENOLATE MOFETIL FOR LIVING DONOR RENAL TRANSPLANTATION.
A PROSPECTIVE, RANDOMIZED COMPARATIVE TRIAL OF MIZORIBINE VERSUS MYCOPHENOLATE MOFETIL IN COMBINATION THERAPY WITH TACROLIMUS AND BASILIXIMAB FOR LIVING DONOR RENAL TRANSPLANTATION.
A COMPARATIVE TRIAL OF MIZORIBINE VERSUS MYCOPHENOLATE MOFETIL FOR LIVING DONOR RENAL TRANSPLANTATION.
Japan |
Kidney transplantation
Urology |
Others
NO
To compare the clinical outcome of mizoribine (MZ, 12mg/kg/day) and mycophenolate mofetil (MMF, 2g/day). We will perform a prospective, randomized, comparative study of MZ versus MMF in combination therapy with tacrolimus, basiliximab and steroid for living donor kidney transplantation.
Safety,Efficacy
Rejection (incidence, types, severity)
Patient survival, graft survival, incidence of adverse effects / abnormalities in the laboratory values.
Interventional
Parallel
Randomized
Open -no one is blinded
Active
YES
Institution is considered as adjustment factor in dynamic allocation.
Central registration
2
Treatment
Medicine |
Tacrolimus + basiliximab + steroid + mizoribine
Tacrolimus + basiliximab + steroid + cellcept
Not applicable |
Not applicable |
Male and Female
1.Living donor kidney transplantation. 2.Primary kidney transplantation.
3.ABO blood type compatible (including semi-compatible).
4.Gender free, any case of uremia.
The patient or whose family has submitted (if the patient is showing disturbance of consciousness or decreased ability to understand) written consent forms based on their free choice once adequate information and understandings are obtained regarding the study upon the participation.
1.The patient who is pregnant or a female patient who is expecting to become pregnant.
2.The patient who has anti-donor antibody (anti-T antibody).
3.The patient who has severe infections.
5.The patient with whom the physician-in-charge considered inappropriate as a subject of this study.
120
1st name | |
Middle name | |
Last name | Hiroshi Toma |
Tokyo Women Medical University
professor
8-1, Kawadacho, Sinzyuku-ku, Tokyo, Japan
03-3353-8111
1st name | |
Middle name | |
Last name |
AMCT
Dep. Urology, Tokyo Women Medical University
https://www.statz.jp/aMcT200811/top.php
AMCT
none
Self funding
NO
仙台社会保険病院(宮城県)、東京女子医科大学(東京都)、虎ノ門病院(東京都)、
虎ノ門病院分院(神奈川県)、聖マリアンナ医科大学(神奈川県)、戸田中央総合病院(埼玉県)、新潟大学(新潟県)、大阪大学(大阪府)、大阪府立急性期・総合医療センター(大阪府)、大阪船員保険病院(大阪府)、兵庫県立西宮病院(兵庫県)、九州大学(福岡県)
2012 | Year | 11 | Month | 06 | Day |
Unpublished
Completed
2008 | Year | 07 | Month | 07 | Day |
2008 | Year | 08 | Month | 07 | Day |
2014 | Year | 12 | Month | 31 | Day |
2012 | Year | 10 | Month | 15 | Day |
2014 | Year | 12 | Month | 26 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000010695
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