| Trial ID: | L1486 |
| Source ID: | NCT00493194
|
| Associated Drug: |
Sirolimus
|
| Title: |
Fibrosis in Renal Allografts
|
| Acronym: |
|
| Status: |
UNKNOWN
|
| Study Results: |
NO
|
| Results: |
|
| Conditions: |
Kidney Failure, Chronic|Transplantation|Immunosuppression|Interstitial Fibrosis
|
| Interventions: |
DRUG: sirolimus|DRUG: cyclosporine|DRUG: daclizumab
|
| Outcome Measures: |
Primary: The primary end-point of this study will be the cortical fractional interstitial fibrosis volume (V IntFib) in protocol biopsies at 6 months. The V IntFib will be determined on Sirius red stained slides by means of a computerized image analysis program, | Secondary: Secundary end-points:|-Patient and graft-survival at one year.|-The serum creatinine and the estimated creatinine|clearance at 6 and 12 months.|-The 24 hour proteinuria at 6 and 12 months.|-The intimal area and arterial wall thickness in protocol|biopsies at 6 months.|-The glomerular volume in protocol biopsies at 6 months.|-The incidence of acute rejection episodes during the|first year.|-The severity of acute rejection episodes according to|the Banffâ 97 classification.|-The incidence of infectious complications.|-The incidence of hematological adverse effects.|-The number of antihypertensive and lipid-lowering drugs|at 6 and 12 months.|-The incidence of treatment failure.
|
| Sponsor/Collaborators: |
Sponsor: University Hospital, Antwerp | Collaborators: Wyeth is now a wholly owned subsidiary of Pfizer|Hoffmann-La Roche
|
| Gender: |
ALL
|
| Age: |
ADULT, OLDER_ADULT
|
| Phases: |
PHASE4
|
| Enrollment: |
100
|
| Study Type: |
INTERVENTIONAL
|
| Study Designs: |
Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: TREATMENT
|
| Start Date: |
2005-05
|
| Completion Date: |
2007-07
|
| Results First Posted: |
|
| Last Update Posted: |
2008-11-26
|
| Locations: |
University Hospital Antwerp, Edegem, Antwerp, 9260, Belgium|University Hospital Brussels, Brussels (Jette), Brabant, 1090, Belgium|University Hospital Gent, Gent, Oost-Vlaanderen, 9000, Belgium
|
| URL: |
https://clinicaltrials.gov/show/NCT00493194
|
