Unique ID issued by UMIN | UMIN000008751 |
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Receipt number | R000010280 |
Scientific Title | Multicenter study of combination therapy using calcineurin inhibitor, basiliximab, mizoribine and steroids in kidney transplantation. |
Date of disclosure of the study information | 2012/08/31 |
Last modified on | 2015/01/06 14:32:10 |
Multicenter study of combination therapy using calcineurin inhibitor, basiliximab, mizoribine and steroids in kidney transplantation.
Multi-drug combination therapy in kidney transplantation.
Multicenter study of combination therapy using calcineurin inhibitor, basiliximab, mizoribine and steroids in kidney transplantation.
Multi-drug combination therapy in kidney transplantation.
Japan |
Kidney transplantation
Surgery in general | Urology |
Others
NO
To Compare the clinical outcome of mizoribine(MZ) and mycophenolate mofetil(MMF). We will perform the study of combination therapy in kidney transplantation, combined with MZ, calcineurin inhibitor (CNI), basiliximab and steroids, in compareson with historyical data with MMF, CNI, basiliximab and steroids.
Safety,Efficacy
Rejection (incidence, types, severity)
CMV and BKV infection
Patient survival, graft survival, incidence of adverse effects / abnormalities in the laboratory values.
Interventional
Single arm
Non-randomized
Open -no one is blinded
Historical
1
Treatment
Medicine |
Calcineurin inhibitor + basiliximab + steroid + mizoribine
16 | years-old | <= |
70 | years-old | > |
Male and Female
1.Kidney transplantation.
2.Gender free, any case of uremia.
3. Aged 16 years to 70 years.
4.ABO blood type compatible (including semi-compatible).
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 has a history of hypersensitivity against components of either one of this study drugs.
2. The patient who has leucopenia.
3. The patient who is pregnant or a female patient who is expecting to become pregnant.
4. The patients who showed a positive result with cross match test.
5. The patient who recived ABO incompatible donor.
6. The patient with whom the physician-in-charge considered inappropriate as a subject of this study.
200
1st name | |
Middle name | |
Last name | Norio Yoshimura |
Kyoto Prefectural University of Medicine
Department of Organ Transplantation and General Surgery
465 Hirokoji, Kawaramachi, Kamikyo-ku, Kyoto, Japan.
1st name | |
Middle name | |
Last name |
Study group on a multi-drug combination therapy for renal transplantation
Department of Organ Transplantation and General Surgery, Kyoto Prefectural University of Medicine
0752515532
Study group on a multi-drug combination therapy for renal transplantation
The Kidney Foundation, Japan.
Non profit foundation
NO
2012 | Year | 08 | Month | 31 | Day |
Partially published
Completed
2008 | Year | 09 | Month | 04 | Day |
2009 | Year | 01 | Month | 01 | Day |
2014 | Year | 10 | Month | 31 | Day |
2014 | Year | 10 | Month | 31 | Day |
2014 | Year | 10 | Month | 31 | Day |
2014 | Year | 10 | Month | 31 | Day |
2012 | Year | 08 | Month | 22 | Day |
2015 | Year | 01 | Month | 06 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000010280
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