Unique ID issued by UMIN | UMIN000017572 |
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Receipt number | R000020342 |
Scientific Title | Multi-center study about an early steroid withdrawal immunosuppression in kidney transplant patients receiving everolimus |
Date of disclosure of the study information | 2015/05/14 |
Last modified on | 2015/05/14 20:42:57 |
Multi-center study about an early steroid withdrawal immunosuppression in kidney transplant patients receiving everolimus
An early steroid withdrawal immunosuppression in kidney transplant patients receiving everolimus
Multi-center study about an early steroid withdrawal immunosuppression in kidney transplant patients receiving everolimus
An early steroid withdrawal immunosuppression in kidney transplant patients receiving everolimus
Japan |
Kidney transplant recipients
Urology |
Others
NO
To investigate the efficacy and safety for an early steroid withdrawal immunosuppression in kidney transplant patients receiving everolimus
Safety,Efficacy
Confirmatory
Pragmatic
Not applicable
The incidence rate of acute rejection, The rate of kidney graft survival, The rate of patients survival, and the successful rate of steroid withdrawal
The incidence rate of cytomegalovirus infection, kidney graft function (e.g. eGFR or serum creatinine), The rate of adverse events, and the rate of biopsy-proven chronic allograft nephropathy
Single arm
Non-randomized
Open -no one is blinded
Historical
1
Treatment
Medicine | Maneuver |
Everolimus intake, kidney transplantation, 3 years, Set trough level between 3 to 8 ng/ml
16 | years-old | <= |
70 | years-old | >= |
Male and Female
Living related kidney transplant patients who is between 16 and 70 years old age.
Who can make informed consent properly.
The patients who cannot make informed consent properly.
Who is unable to visit hospitals on scheduled dates.
Who is pregnant.
Who has an allergy to everolimus.
100
1st name | |
Middle name | |
Last name | Oya Mototsugu |
Keio University School of Medicine
Department of Urology
Shinanomachi 35, Shinjyuku-ku, Tokyo
03-5363-3825
moto-oya@z3.keio.jp
1st name | |
Middle name | |
Last name | Morita Shinya |
Keio University School of Medicine
Department of Urology
Shinanomachi 35, Shinjuku-ku, Tokyo
03-5363-3825
morishin75@yahoo.co.jp
Keio University School of Medicine
Not applicable
Self funding
Department of Nephrology, Toho University School of Medicine, Department of Urology, Fujita Health University Hospital
NO
慶應義塾大学病院(東京都)、東邦大学大森病院(東京都)、藤田保健衛生大学病院(愛知県)
2015 | Year | 05 | Month | 14 | Day |
Unpublished
Enrolling by invitation
2012 | Year | 11 | Month | 26 | Day |
2012 | Year | 11 | Month | 26 | Day |
2020 | Year | 10 | Month | 31 | Day |
2020 | Year | 10 | Month | 31 | Day |
2020 | Year | 10 | Month | 31 | Day |
2020 | Year | 10 | Month | 31 | Day |
2015 | Year | 05 | Month | 14 | Day |
2015 | Year | 05 | Month | 14 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000020342
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