Renal Failure, Chronic, Renal Transplantation
Conditions
Keywords
immunoglobulins, intravenous, kidney transplantation, acute rejection, chronic rejection, regulatory autoantibodies, Th1, Th2, B Cell, Monokines, Cytokine promoter gene polymorphisms
Brief summary
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.
Detailed description
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.
Interventions
PROCEDUREkidney transplantation
Sponsors
Heidelberg University
Astellas Pharma Inc
Hoffmann-La Roche
Aventis Pharmaceuticals
University of Giessen
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
14 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* renal transplant recipients of the Giessen renal transplant unit * cadaveric and living renal transplants * first and retransplants
Exclusion criteria
* Contraindications against blood-taking (anaemia with hemoglobin \< 9,5 g/l, hypotension) * intravenous immunoglobulin therapy in the last half year before study entry * Hyperimmunoglobulin therapy for severe CMV infection * Pregnancy
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| patient survival | 1 year / 3 years / 5 years posttransplant |
| graft survival | 1 year / 3 years / 5 years posttransplant |
| acute rejection | 1 year |
| chronic allograft nephropathy | 3 years / 5 years posttransplant |
Secondary
| Measure | Time frame |
|---|---|
| Expression of adhesion molecules, costimulatory molecules and cytokine receptors | 1 year / 3 years |
| regulatory autoantibody levels | 1 year / 3 years / 5 years |
| Th1 and Th2 responses | 1 year / 3 years |
| B-cell/monocyte responses | 1 year / 3 years |
| proteinuria (quantitative assessment) | 1 year / 3 years |
| graft function | 1 year / 3 years / 5 years |
| infectious complications | 1 year |
| immunoglobulin levels | 1 year |
Countries
Germany
Outcome results
None listed