prophylaxis of acute rejection after renal transplantation
Conditions
Interventions
Trade Name: MabThera
Pharmaceutical Form: Concentrate for solution for infusion
Pharmaceutical form of the placebo: Intravenous infusion
Route of administration of the placebo: Intravenous use
Sponsors
Radboud University Nijmegen Medical Center
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. All renal transplant recipients older than 18 years 2. All female patients at risk for pregnancy must have a negative serum pregnancy test before randomization. Female patients at risk for pregnancy must agree to use a medically acceptable method of contraception throughout the treatment period and for 12 weeks after discontinuation of study medication. 3. Signed, dated, and witnessed institutional review board (IRB) approved informed consent before screening and before any tests are performed that are specific to the protocol. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: 1. Recipients of a kidney from a living donor, who is HLA identical. 2. Patients with hemolytic uremic syndrome as original kidney disease. 3. Patients with focal segmental glomerulosclerosis that had recurred in a previous graft 4. Recipients with more than two previously failed grafts and/or PRA > 85% 5. Previous treatment with anti-CD20 antibodies. 6. Diabetes mellitus that is currently not treated with insulin 7. Total white blood cell count <3,000/mm3 or platelet count <75,000/mm3. 8. Active infection with hepatitis B, hepatitis C, or HIV. 9. History of tuberculosis.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To determine the incidence and severity of biopsy-confirmed acute rejection within the first six months after transplantation.;Secondary Objective: To analyze: -Renal function as estimated by the endogenous creatinine clearance at 6 months -Occurrence of chronic allograft nephropathy at 6 months -Cumulative incidence of infections and malignancies at 6 months -Medical costs during the first 6 months after transplantation -Patient and graft survival ;Primary end point(s): The incidence and severity of biopsy-confirmed acute rejections within the first six months after transplantation. | — |
Countries
Netherlands
Outcome results
None listed