| Trial ID: | L1035 |
| Source ID: | NCT00176059
|
| Associated Drug: |
Intravenous Immunoglobulins (Ivig)
|
| Title: |
Immunoregulatory Effects of Immunoglobulin Induction Therapy in Renal Transplant Recipients
|
| Acronym: |
|
| Status: |
COMPLETED
|
| Study Results: |
NO
|
| Results: |
|
| Conditions: |
Renal Failure, Chronic|Renal Transplantation
|
| Interventions: |
DRUG: intravenous immunoglobulins (IVIG)|PROCEDURE: kidney transplantation
|
| Outcome Measures: |
Primary: patient survival, 1 year / 3 years / 5 years posttransplant|graft survival, 1 year / 3 years / 5 years posttransplant|acute rejection, 1 year|chronic allograft nephropathy, 3 years / 5 years posttransplant | Secondary: graft function, 1 year / 3 years / 5 years|infectious complications, 1 year|immunoglobulin levels, 1 year|regulatory autoantibody levels, 1 year / 3 years / 5 years|Th1 and Th2 responses, 1 year / 3 years|B-cell/monocyte responses, 1 year / 3 years|Expression of adhesion molecules, costimulatory molecules and cytokine receptors, 1 year / 3 years|proteinuria (quantitative assessment), 1 year / 3 years
|
| Sponsor/Collaborators: |
Sponsor: University of Giessen | Collaborators: Heidelberg University|Astellas Pharma Inc|Hoffmann-La Roche|Aventis Pharmaceuticals
|
| Gender: |
ALL
|
| Age: |
CHILD, ADULT, OLDER_ADULT
|
| Phases: |
EARLY_PHASE1
|
| Enrollment: |
50
|
| Study Type: |
INTERVENTIONAL
|
| Study Designs: |
Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: TREATMENT
|
| Start Date: |
2001-10
|
| Completion Date: |
2006-05
|
| Results First Posted: |
|
| Last Update Posted: |
2007-05-10
|
| Locations: |
Department of Internal Medicine, University of Giessen, Giessen, Germany
|
| URL: |
https://clinicaltrials.gov/show/NCT00176059
|
