Impact of Rituximab (RTx) Induction and Living Donation on Immunoregulation and Virus Control in Renal Transplantation
Kidney Transplantation, Rituximab (RTx), Living Donors
About this trial
This is an interventional treatment trial for Kidney Transplantation focused on measuring Kidney Transplantation, Rituximab, Living Donor, ABO Incompatible (ABOi) Transplantation, Immunology, Cytomegalovirus (CMV), Epstein Barr virus (EBV), Polyomavirus
Eligibility Criteria
Inclusion Criteria:
- De-novo kidney transplantation
- Deceased donors (blood group compatible) and living donors (blood group incompatible / blood group compatible)
- First, second and third renal transplants
- Immunized and non-immunized graft recipients
- Age of recipients 18 years or older
- Negative pregnancy test before transplantation
Exclusion Criteria:
- Contra-indications to use Tacr and MPS, respectively
- Contra-indications to use Rtx in the group of ABOi LD transplants
- Chronic hepatitis B, C or HIV infection
- Recurrent infectious disease
- Previous hepatitis B, if no prophylactic antiviral therapy is used
- Previous tuberculosis
- Hemoglobin<8,5g/dl, thrombocytes<80.000/ul or leucocytes<3000/ul
- Previous vaccination with a living vaccine <4 weeks pretransplant
- Significant enterogastric disease such as diverticulitis (contra-indicates MPS treatment)
- Children and adolescents (age less than 18 years)
- Pregnancy and breast-feeding women
- Refusal of an effective contraception in women capable of bearing children
- Combined transplantations such as simultaneous islet/kidney transplants
Sites / Locations
- Department of Internal Medicine, University of Giessen
Arms of the Study
Arm 1
Arm 2
Arm 3
Active Comparator
Active Comparator
Active Comparator
LD kidney transplantation, ABOi
LD kidney transplantation, ABOc
DD kidney transplantation
Living donor (LD) kidney transplantation, ABO incompatible (ABOi); Immunosuppressive treatment: Tacrolimus (Tacr)/ Mycophenolate sodium (MPS), Basiliximab induction, Rtx induction
Living donor (LD) kidney transplantation, ABO compatible (ABOc); Immunosuppressive treatment: Tacr/MPS, Basiliximab induction
Deceased donor (DD) kidney transplantation, ABO compatible; Immunosuppressive treatment: Tacr/MPS, Basiliximab induction