Chronic renal failure patients who are receiving a kidney transplant. Different immunosuppressive protocls are awailable. However, current strategies for the medical management of transplant patients are largely focused on the prevention and treatment of T-cell mediated processes. However, there is an increasing evidence that B cells may significantly contribute to post-transplant morbidity in addition to their role in acute humoral rejection.
Conditions
Interventions
Trade Name: MabThera
Product Name: Mabthera
Product Code: RO 45-2294/V02
Pharmaceutical Form: Concentrate for solution for infusion
Pharmaceutical form of the placebo: Solution for infusion
Route of a
Sponsors
Dept of Transplantation Surgery B 56, Karolinska University Hospital, Huddinge
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Patients aged 18 years or above Recipients of first or second renal transplant Recipients from living or cadaveric donors Single organ recipients (kidney only) Patients providing written informed consent Patients cooperative and able to complete all the assessment procedures 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: HLA-identical siblings Patients receiving immunosuppressive therapy within the preceding 28 days PRA >50% within 6 months prior to enrolment Previous exposure to murine antibodies History of malignancy (except localised non-melanotic skin cancer) or the presence of any active malignancy at the time of transplant Active infection (HCV, HBV, HIV) Pregnant or lactating females Women of child bearing potential not willing to use reliable form of contraception
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The primary objective of the study is to determine the effect of one dose of rituximab as induction therapy together with a conventional tacrolimus, mycophenolate mofetil, prednisolone immunosuppressive protocol on the incidence of treatment failure (biopsy-proven acute rejection, graft loss or death) at 6 months post transplant. ;Secondary Objective: To assess the effect of rituximab induction on renal function at 6 months post transplant, measured as creatinine clearance. To assess the incidence and severity of infections (CMV, BKV, fungal and bacterial) in the two groups. Creatinine clearance determined by the iohexol technique at 6 months Incidence of opportunistic infections (CMV, BK, fungus) Incidence of urinary tract infections and septicemia Incidence of rituximab-related adverse events Incidence of malignancies All adverse events including clinically significant abnormalities and clinical and laboratory parameters Additional parameters to be assessed peroperatively and at 6 months Number of CD19+, CD20+ lymphocytes in blood Immunoglobulin G and M levels Anti-tetanus IgG Anti-CMV IgG Cystatin C Iohexol clearance (at 6 months only) Transplant biopsy ;Primary end point(s): The primary endpoint will be a composite endpoint defined as treatment failure, including the occurrence of any of the following: biopsy-proven acute rejection, graft loss or death during the first 6 months following transplantation. | — |
Countries
Sweden
Outcome results
None listed