Renal Transplantation Clinical Trial
Official title:
Immunoglobulin Induction Therapy in Renal Transplant Recipients on Tacrolimus/Azathioprine or Tacrolimus/MMF: Effects on Th1, Th2, B Cell-/Monokine Responses and Immunoregulatory Autoantibody Levels
The aim of this randomized prospective study in renal transplant recipients is to
investigate immunological short and long-term effects of an IVIG induction therapy.
Furthermore clinical endpoints (patient and graft survival, incidence of acute and chronic
rejection, infectious diseases and graft function) up to three years posttransplant will be
analyzed.
Intravenous immunoglobulin (IVIG) preparations are known to be effective in the treatment of
various autoimmune and inflammatory disorders due to their immunomodulatory and
antiinflammatory properties. It has been demonstrated that IVIG is effective in the
treatment of acute vascular rejection and steroid resistant cellular rejection. Furthermore,
IVIG has been used to inhibit production of lymphocytotoxic antibodies in highly sensitized
patients so that successful cadaveric or living renal transplantation could be performed.
The aim of this randomized prospective study in renal transplant recipients is to
investigate immunological short and long-term effects of an IVIG induction therapy on Th1,
Th2 and B-cell/monocyte responses, expression of adhesion molecules, costimulatory factors
and cytokine receptors and on secretion of immunoregulatory autoantibodies (anti-F(ab)-,
anti-F(ab')2G-, anti-hinge autoantibodies). These autoantibodies have been shown to
significantly affect the risk of chronic rejection and graft loss.
Furthermore, clinical endpoints (patient and gaft survival, incidence of acute and chronic
rejection, infectious diseases and graft function) up to 3 years will be analyzed.
;
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
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