Immunoregulatory Effects of Immunoglobulin Induction Therapy in Renal Transplant Recipients
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|ClinicalTrials.gov Identifier: NCT00176059|
Recruitment Status : Completed
First Posted : September 15, 2005
Last Update Posted : May 10, 2007
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.
|Condition or disease||Intervention/treatment||Phase|
|Renal Failure, Chronic Renal Transplantation||Drug: intravenous immunoglobulins (IVIG) Procedure: kidney transplantation||Early Phase 1|
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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||50 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|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|
|Study Start Date :||October 2001|
|Actual Study Completion Date :||May 2006|
- patient survival [ Time Frame: 1 year / 3 years / 5 years posttransplant ]
- graft survival [ Time Frame: 1 year / 3 years / 5 years posttransplant ]
- acute rejection [ Time Frame: 1 year ]
- chronic allograft nephropathy [ Time Frame: 3 years / 5 years posttransplant ]
- graft function [ Time Frame: 1 year / 3 years / 5 years ]
- infectious complications [ Time Frame: 1 year ]
- immunoglobulin levels [ Time Frame: 1 year ]
- regulatory autoantibody levels [ Time Frame: 1 year / 3 years / 5 years ]
- Th1 and Th2 responses [ Time Frame: 1 year / 3 years ]
- B-cell/monocyte responses [ Time Frame: 1 year / 3 years ]
- Expression of adhesion molecules, costimulatory molecules and cytokine receptors [ Time Frame: 1 year / 3 years ]
- proteinuria (quantitative assessment) [ Time Frame: 1 year / 3 years ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00176059
|Department of Internal Medicine, University of Giessen|
|Principal Investigator:||Rolf Weimer, Prof. Dr.||Department of Internal Medicine, University of Giessen, Giessen, Germany|