Unique ID issued by UMIN | UMIN000011562 |
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Receipt number | R000013526 |
Scientific Title | Efficacy and safety of everolimus (Certican) plus once-daily prolonged-release tacrolimus (Graceptor) combination therapy in living donor kidney transplantation: Open-label, multicenter, randomized controlled trial. |
Date of disclosure of the study information | 2013/10/01 |
Last modified on | 2013/08/23 11:59:49 |
Efficacy and safety of everolimus (Certican) plus once-daily prolonged-release tacrolimus (Graceptor) combination therapy in living donor kidney transplantation: Open-label, multicenter, randomized controlled trial.
Efficacy and safety of everolimus plus once-daily prolonged-release tacrolimus combination therapy in living donor kidney transplantation: Open-label, multicenter, randomized controlled trial.
Efficacy and safety of everolimus (Certican) plus once-daily prolonged-release tacrolimus (Graceptor) combination therapy in living donor kidney transplantation: Open-label, multicenter, randomized controlled trial.
Efficacy and safety of everolimus plus once-daily prolonged-release tacrolimus combination therapy in living donor kidney transplantation: Open-label, multicenter, randomized controlled trial.
Japan |
Kidney transplantation
Urology |
Others
NO
Aim of this multicenter, randomized controlled trial is to compare the efficacy and safety of once-daily prolonged-release tacrolimus plus everolimus to once-daily prolonged-release tacrolimus plus mycophenolate mofetil immunosuppressive regimen in cytomegalovirus high-risk transplant recipients.
Safety,Efficacy
Rejection
Graft survival, patient survival
CMV infection
Incidence of adverse effects/abnormalities in the laboratory values.
Kidney function(eGFR)
Anti-HLA antibodies
Chronic allograft nephropathy
BKV infection
Interventional
Parallel
Randomized
Individual
Open -no one is blinded
Active
NO
NO
Institution is not considered as adjustment factor.
NO
Central registration
2
Treatment
Medicine |
everolimus
mycophenolate mofetil
20 | years-old | <= |
Not applicable |
Male and Female
1. Subject over 20 years old.
2.Living donor kidney transplantation
3.CMV-seropositive recipient/seropositive donor
4. Patients who had a detailed briefing of the trial with explanatory documents prior to the enrollment, and voluntarily signed a consent form.
1. Inability or un willingness to sign a consent form.
2. Subject under 20 years old.
3.ABO blood incompatible kidney transplantation
4.Unable to outpatient treatment in study period
5.Pregnancy or possible to pregnant
6.Serious digestive disease
7.Active infectious disease
8. Cancer
9. Hypersensibility to sirolimus or everolimus
10. Investigator considered inappropriate as a subject of this study.
120
1st name | |
Middle name | |
Last name | Kazunari Tanabe |
Tokyo Women's Medical University
Dep. Urology
8-1, Kawadacho, Sinzyuku-ku, Tokyo, Japan
0333538111
tanabe@kc.twmu.ac.jp
1st name | |
Middle name | |
Last name | Hideki Ishida |
Tokyo Women's Medical University
Dep. Urology
8-1, Kawadacho, Sinzyuku-ku, Tokyo, Japan
03-3353-8111
tgphide@gol.com
Tokyo Women's Medical University,
Dep. Urology
none
Self funding
NO
2013 | Year | 10 | Month | 01 | Day |
Unpublished
Open public recruiting
2013 | Year | 08 | Month | 01 | Day |
2013 | Year | 10 | Month | 01 | Day |
2013 | Year | 08 | Month | 23 | Day |
2013 | Year | 08 | Month | 23 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000013526
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