| Trial ID: | L0383 |
| Source ID: | NCT00812123
|
| Associated Drug: |
Sirolimus
|
| Title: |
Calcineurin Free Immunosuppression in Renal Transplant Recipients
|
| Acronym: |
|
| Status: |
COMPLETED
|
| Study Results: |
NO
|
| Results: |
|
| Conditions: |
Kidney Transplantation|Chronic Kidney Disease
|
| Interventions: |
DRUG: Sirolimus|DRUG: Cyclosporine A|DRUG: Prednisone|DRUG: Mycophenolate mofetil|PROCEDURE: Protocol biopsies
|
| Outcome Measures: |
Primary: Plasma Creatinine, 6 months | Secondary: Graft survival, 6 months|Patient survival, 6 months|Incidence of first acute rejections and number of total rejections, 6 months|Total number of anti-rejection treatments, 6 months
|
| Sponsor/Collaborators: |
Sponsor: University Hospital, Basel, Switzerland | Collaborators: Wyeth is now a wholly owned subsidiary of Pfizer
|
| Gender: |
ALL
|
| Age: |
CHILD, ADULT, OLDER_ADULT
|
| Phases: |
PHASE4
|
| Enrollment: |
127
|
| Study Type: |
INTERVENTIONAL
|
| Study Designs: |
Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: TREATMENT
|
| Start Date: |
2001-01
|
| Completion Date: |
2005-07
|
| Results First Posted: |
|
| Last Update Posted: |
2008-12-19
|
| Locations: |
University Hospital Basel, Clinic for Transplantation Immunology and Nephrology, Basel, 4031, Switzerland
|
| URL: |
https://clinicaltrials.gov/show/NCT00812123
|
