niertransplantatie Transplantation
Conditions
Interventions
Description of the treatment protocol:
-Administration of Rituximab (two doses)
The first dose of rituximab (MabThera, Roche) 375 mg/m2 intravenously will be
administered five months prior to transp
if there are no adverse side
effects
increase the rate 50 mg/hour every 30 minutes, to a maximum of 400
mg/hour. Subsequent infusions: Start at 100 mg/hour
increase
the rate 100 mg/hour every 30 minutes, to a maximum of 400 mg/hour. All
recipients will be given acetaminophen (1000 mg) and Di-adresoneF (25 mg),
tavegil (2 mg), 30 min before the infusio
Sponsors
Academisch Medisch Centrum
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: -Patients older than 18 years with end stage renal failure and a current Panel Reactive Antibody level >= 80 % who are for more than two years on the waiting list for a cadaveric donor kidney, and included in the Acceptable Mismatch program of Eurotransplant. -Written informed consent
Exclusion criteria
Exclusion criteria: Complete IgA deficiency Overhydration History of anaphylaxis against blood/plasma products Significant cardiac or pulmonary disease, hepatitis C or HIV infection, or malignancy within the last 5 years
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Primary end point is achievement of a negative cross-match test with the donor kidney and transplantability. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary objectives are patient and graft survival, graft function as assessed by calculated creatinine clearance, proteinuria, the number and severity of acute (antibody mediated) rejections, blood pressure (antihypertensive treatment), monitoring of infections and the occurrence of malignancies. | — |
Countries
Netherlands
Outcome results
None listed