Immunoregulatory Effects of Immunoglobulin Induction Therapy in Renal Transplant Recipients

• Status: Completed
• Trial end date: 2006-05-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Early Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University of Giessen
• Collaborators: Astellas Pharma Inc; Aventis Pharmaceuticals; Heidelberg University; Hoffmann-La Roche
• Treatments: Antibodies; Autoantibodies; gamma-Globulins; Immunoglobulins; Immunoglobulins, Intravenous; Rho(D) Immune Globulin

Criteria

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