Unique ID issued by UMIN | UMIN000018625 |
---|---|
Receipt number | R000021552 |
Scientific Title | The intervention trial of the effect of the double induction therapy with basiliximab and rituximab on the production of donor specific antibody after kidney transprantation. |
Date of disclosure of the study information | 2015/08/10 |
Last modified on | 2015/08/10 14:52:29 |
The intervention trial of the effect of the double induction therapy with basiliximab and rituximab on the production of donor specific antibody after kidney transprantation.
Double induction therapy with basiliximab and rituximab.
The intervention trial of the effect of the double induction therapy with basiliximab and rituximab on the production of donor specific antibody after kidney transprantation.
Double induction therapy with basiliximab and rituximab.
Japan |
Chronic kidney disease
Surgery in general |
Others
NO
Effectiveness of the double induction therapy with basiliximab and rituximab on de novo DSA production.
Safety,Efficacy
Confirmatory
Pragmatic
Phase II,III
Production of donor specific antibody at two years after kidney transplantation.
Serum creatinine,eGFR,an incidence of infection,rejection and adverse events at two years after kidney transplantation.
Interventional
Single arm
Non-randomized
Open -no one is blinded
Historical
1
Treatment
Medicine |
ABO blood type compatibile transplant
The day of transplantation,administered the rituximab 200mg/body before kidney blood flow resumes.
Other immunosuppressive therapy is,
Basiliximab:20mg/body(0POD and 4POD)
Mycophenolate Mofetil:1500mg/body(from 1POD)
Tacrolimus:0.15mg/kg(-3POD)
Steroids:methylprednisolon 500mg/body(in the pancreas transplantation 250mg/body) on 0POD,in subsequent,take orally Medrol 40mg(in the pancreas transplantation, prednisolone 50mg) and be increased or decreased as appropriate.
ABO blood type incompatible transplant or preexisting DSA
Similarly to the conventional,administered the rituximab 200mg/body two weeks prior to transplantation.
From a week ago before surgery,it enforces plasma exchange, double filtration plasma exchange as appropriate.
Other immunosuppressive therapy is,
Basiliximab:20mg/body(0POD and 4POD)
Mycophenolate Mofetil:1500mg/body(from -14POD)
Tacrolimus:0.15mg/kg(-10POD)
Steroids:methylprednisolon 500mg / body on 0POD,in subsequent,take orally Medrol 40mg and be increased or decreased as appropriate.
Not applicable |
Not applicable |
Male and Female
Renal transplant patient to be enforced in our hospital obtained the consent.
Patient with a history of hypersensitivity to rituximab.
Patient whom doctor has determined that there is not appropriate participation in this study.
100
1st name | |
Middle name | |
Last name | Takashi Kenmochi |
Fujita Health University Hospital
Department of Organ Transplant Surgery
1-98 Dengakugakubo, Kutsukake-cho, Toyoake-city, Aichi, Japan
0562-93-9043
kenmochi@fujita-hu.ac.jp
1st name | |
Middle name | |
Last name | Taihei Ito |
Fujita Health University Hospital
Department of Organ Transplant Surgery
1-98 Dengakugakubo, Kutsukake-cho, Toyoake-city, Aichi, Japan
0562-93-2380
i-taihei@fujita-hu.ac.jp
Fujita Health University Hospital
None
Self funding
NO
藤田保健衛生大学病院(愛知県)/Fujita Health University Hospital(Aichi)
2015 | Year | 08 | Month | 10 | Day |
Unpublished
Open public recruiting
2015 | Year | 08 | Month | 05 | Day |
2015 | Year | 08 | Month | 10 | Day |
2015 | Year | 08 | Month | 10 | Day |
2015 | Year | 08 | Month | 10 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000021552
Research Plan | |
---|---|
Registered date | File name |
Research case data specifications | |
---|---|
Registered date | File name |
Research case data | |
---|---|
Registered date | File name |