| Trial ID: | L1275 |
| Source ID: | NCT00189202
|
| Associated Drug: |
Sirolimus
|
| Title: |
Efficacy of Sirolimus-Based, Steroid Avoidance Immunosuppression African Americans
|
| Acronym: |
|
| Status: |
COMPLETED
|
| Study Results: |
YES
|
| Results: |
https://ClinicalTrials.gov/show/NCT00189202/results
|
| Conditions: |
End Stage Renal Disease|Kidney Transplantation
|
| Interventions: |
DRUG: Sirolimus
|
| Outcome Measures: |
Primary: Cumulative One-year Acute Rejection Rates, To test the efficacy of Sirolimus (SRL)-based steroid avoidance regimen in high risk de novo renal allograft recipients. Efficacy endpoints for this objective is: cumulative one-year acute rejection rates of the transplant, 12 months|One-year Graft Survival, To test the efficacy of SRL-based steroid avoidance regimen in high risk de novo renal allograft recipients. Efficacy endpoints for this objective is: one-year graft survival, 12 months|One-year Patient Survival, To test the efficacy of SRL-based steroid avoidance regimen in high risk de novo renal allograft recipients. Efficacy endpoints for this objective is: one-year patient survival, 12 months | Secondary: Incidence of Post Transplant Diabetes, To determine whether SRL-based steroid avoidance maintenance regimen is associated with decreased rates of metabolic complications. Endpoint is incidence of posttransplant diabetes mellitus, 12 months|Drug-treated Dyslipidemic Syndrome, To determine whether SRL-based steroid avoidance maintenance regimen is associated with decreased rates of metabolic complications. Endpoint is drug-treated dyslipidemic syndrome, 12 months|Blood Pressure Control, To determine whether SRL-based steroid avoidance maintenance regimen is associated with decreased rates of metabolic complications. Endpoint is number of people who had their blood pressure in the target control range with or without medication, 12 months
|
| Sponsor/Collaborators: |
Sponsor: University of Michigan | Collaborators: Wyeth is now a wholly owned subsidiary of Pfizer
|
| Gender: |
ALL
|
| Age: |
ADULT, OLDER_ADULT
|
| Phases: |
PHASE2|PHASE3
|
| Enrollment: |
49
|
| Study Type: |
INTERVENTIONAL
|
| Study Designs: |
Allocation: NA|Intervention Model: SINGLE_GROUP|Masking: NONE|Primary Purpose: TREATMENT
|
| Start Date: |
2004-08
|
| Completion Date: |
2008-07-01
|
| Results First Posted: |
2017-04-05
|
| Last Update Posted: |
2018-03-27
|
| Locations: |
University of Michigan Health Center, Ann Arbor, Michigan, 48109, United States
|
| URL: |
https://clinicaltrials.gov/show/NCT00189202
|
