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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Page 1 of 1 (1 locations)

1

Department of Internal Medicine, University of Giessen

Giessen, Germany