Status:
COMPLETED
Immunoregulatory Effects of Immunoglobulin Induction Therapy in Renal Transplant Recipients
Lead Sponsor:
University of Giessen
Collaborating Sponsors:
Heidelberg University
Astellas Pharma Inc
Conditions:
Renal Failure, Chronic
Renal Transplantation
Eligibility:
All Genders
14+ years
Phase:
EARLY_PHASE1
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 (p...
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...
Eligibility Criteria
Inclusion
- renal transplant recipients of the Giessen renal transplant unit
- cadaveric and living renal transplants
- first and retransplants
Exclusion
- 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
Key Trial Info
Start Date :
October 1 2001
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 1 2006
Estimated Enrollment :
50 Patients enrolled
Trial Details
Trial ID
NCT00176059
Start Date
October 1 2001
End Date
May 1 2006
Last Update
May 10 2007
Active Locations (1)
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1
Department of Internal Medicine, University of Giessen
Giessen, Germany