Now Available for Public Comment: Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

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

September 9, 2005
May 8, 2007
October 2001
Not Provided
  • 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 ]
  • patient survival
  • graft survival
  • acute rejection
  • chronic rejection
Complete list of historical versions of study NCT00176059 on ClinicalTrials.gov Archive Site
  • 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 ]
  • graft function
  • infectious complications
  • immunoglobulin levels
  • regulatory autoantibody levels
  • Th1 and Th2 responses
  • B-cell/monocyte responses
  • Expression of adhesion molecules, costimulatory factors and cytokine receptors
Not Provided
Not Provided
 
Immunoregulatory Effects of Immunoglobulin Induction Therapy in Renal Transplant Recipients
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

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.

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.

Interventional
Phase 0
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
  • Renal Failure, Chronic
  • Renal Transplantation
  • Drug: intravenous immunoglobulins (IVIG)
  • Procedure: kidney transplantation
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
50
May 2006
Not Provided

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
Both
14 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Germany
 
NCT00176059
NTx-Ig-003
No
Not Provided
University of Giessen
  • Heidelberg University
  • Astellas Pharma Inc
  • Hoffmann-La Roche
  • Aventis Pharmaceuticals
Principal Investigator: Rolf Weimer, Prof. Dr. Department of Internal Medicine, University of Giessen, Giessen, Germany
University of Giessen
May 2007

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP