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Immunoregulatory Effects of Immunoglobulin Induction Therapy in Renal Transplant Recipients

This study has been completed.
Sponsor:
Collaborators:
Heidelberg University
Astellas Pharma Inc
Hoffmann-La Roche
Aventis Pharmaceuticals
Information provided by:
University of Giessen
ClinicalTrials.gov Identifier:
NCT00176059
First received: September 9, 2005
Last updated: May 8, 2007
Last verified: May 2007
  Purpose

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 Intervention Phase
Renal Failure, Chronic
Renal Transplantation
Drug: intravenous immunoglobulins (IVIG)
Procedure: kidney transplantation
Phase 0

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
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

Resource links provided by NLM:


Further study details as provided by University of Giessen:

Primary Outcome Measures:
  • 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 ]

Secondary Outcome Measures:
  • 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 ]

Enrollment: 50
Study Start Date: October 2001
Study Completion Date: May 2006
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.

  Eligibility

Ages Eligible for Study:   14 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00176059

Locations
Germany
Department of Internal Medicine, University of Giessen
Giessen, Germany
Sponsors and Collaborators
University of Giessen
Heidelberg University
Astellas Pharma Inc
Hoffmann-La Roche
Aventis Pharmaceuticals
Investigators
Principal Investigator: Rolf Weimer, Prof. Dr. Department of Internal Medicine, University of Giessen, Giessen, Germany
  More Information

Publications:

ClinicalTrials.gov Identifier: NCT00176059     History of Changes
Other Study ID Numbers: NTx-Ig-003
Study First Received: September 9, 2005
Last Updated: May 8, 2007
Health Authority: Germany: Federal Institute for Drugs and Medical Devices

Keywords provided by University of Giessen:
immunoglobulins, intravenous
kidney transplantation
acute rejection
chronic rejection
regulatory autoantibodies
Th1
Th2
B Cell
Monokines
Cytokine promoter gene polymorphisms

Additional relevant MeSH terms:
Kidney Failure, Chronic
Renal Insufficiency
Kidney Diseases
Renal Insufficiency, Chronic
Urologic Diseases
Antibodies
Immunoglobulins
Immunoglobulins, Intravenous
Rho(D) Immune Globulin
Immunologic Factors
Pharmacologic Actions
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on November 24, 2014