| Trial ID: | L0753 |
| Source ID: | NCT00717379
|
| Associated Drug: |
Tacrolimus
|
| Title: |
Study of Tacrolimus Immunosuppressive Therapy After Kidney Transplantation
|
| Acronym: |
|
| Status: |
COMPLETED
|
| Study Results: |
NO
|
| Results: |
|
| Conditions: |
Kidney Transplantation|Kidney Failure, Chronic|Renal Insufficiency, Chronic
|
| Interventions: |
DRUG: Tacrolimus|DRUG: Mycophenolate Mofetil|DRUG: Methylprednisolone or equivalent|DRUG: Prednisone
|
| Outcome Measures: |
Primary: Incidence and time to first biopsy-proven acute rejection, 6 months | Secondary: Overall frequency of acute rejection episodes within 6 months post transplantation, 6 months|Severity of biopsy proven acute rejections (BANFF criteria) within 6 months post transplantation, 6 months|Incidence of and time to first corticosteroid-resistant acute rejection, 6 months|Subject and graft survival, 6 months
|
| Sponsor/Collaborators: |
Sponsor: Astellas Pharma Inc
|
| Gender: |
ALL
|
| Age: |
ADULT, OLDER_ADULT
|
| Phases: |
PHASE4
|
| Enrollment: |
50
|
| Study Type: |
INTERVENTIONAL
|
| Study Designs: |
Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: TREATMENT
|
| Start Date: |
2007-05
|
| Completion Date: |
2008-10
|
| Results First Posted: |
|
| Last Update Posted: |
2009-04-15
|
| Locations: |
Moscow, 115446, Russian Federation|Moscow, 119992, Russian Federation|Moscow, 123182, Russian Federation|Omsk, 644112, Russian Federation|St. Petersburg, 197110, Russian Federation|Volzskii, 404120, Russian Federation
|
| URL: |
https://clinicaltrials.gov/show/NCT00717379
|
