| Trial ID: | L1231 |
| Source ID: | NCT00005113
|
| Associated Drug: |
Cyclosporine
|
| Title: |
A Study to Compare Treatment With Sirolimus Versus Standard Treatment in Patients Who Have Received a Kidney Transplant
|
| Acronym: |
|
| Status: |
TERMINATED
|
| Study Results: |
NO
|
| Results: |
|
| Conditions: |
End-Stage Renal Disease|Kidney Transplantation
|
| Interventions: |
DRUG: Cyclosporine|DRUG: Sirolimus|DRUG: Tacrolimus
|
| Outcome Measures: |
Primary: Safety and efficacy of sirolimus, Throughout study | Secondary: Composite endpoint of biopsy proven acute rejection, graft loss, or death, At Months 6, 12, and 24|Rate of clinically diagnosed acute rejection, At months 6, 12, 24, and 36|Rate of change in glomerular filtration rate, At Month 18|Mean change in volume of allograft fibrosis, At Months 6 and 18|Intragraft expression of cytokines, Throughout study|Cytokine expression and subsequent development of chronic allograft nephropathy, Throughout study
|
| Sponsor/Collaborators: |
Sponsor: Boston Children's Hospital
|
| Gender: |
ALL
|
| Age: |
CHILD, ADULT
|
| Phases: |
PHASE3
|
| Enrollment: |
102
|
| Study Type: |
INTERVENTIONAL
|
| Study Designs: |
Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: TREATMENT
|
| Start Date: |
1999-07
|
| Completion Date: |
2006-03
|
| Results First Posted: |
|
| Last Update Posted: |
2012-03-13
|
| Locations: |
Children's Hospital Boston, Boston, Massachusetts, 02115, United States
|
| URL: |
https://clinicaltrials.gov/show/NCT00005113
|
