| Trial ID: | L3392 |
| Source ID: | NCT00784966
|
| Associated Drug: |
Etanercept
|
| Title: |
Islet After Kidney Transplant for Type 1 Diabetes
|
| Acronym: |
|
| Status: |
WITHDRAWN
|
| Study Results: |
NO
|
| Results: |
|
| Conditions: |
Type 1 Diabetes Mellitus
|
| Interventions: |
DRUG: etanercept|DRUG: etanercept
|
| Outcome Measures: |
Primary: The functional capability of the islet allograft to normalize glucose metabolism in the absence of insulin therapy., Outcome measures will be assessed at protocol prescribed intervals. Long term outcomes assessment will be measured at 5 years post transplant or all evidence of islet function has ceased plus six months. | Secondary: Reduction in insulin requirements in those patients who do not achieve insulin independence with improved metabolic control., Outcome measures will be assessed at protocol prescribed intervals.
|
| Sponsor/Collaborators: |
Sponsor: Virginia Commonwealth University | Collaborators: University of Miami
|
| Gender: |
ALL
|
| Age: |
ADULT
|
| Phases: |
PHASE1|PHASE2
|
| Enrollment: |
0
|
| Study Type: |
INTERVENTIONAL
|
| Study Designs: |
Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: TREATMENT
|
| Start Date: |
2011-08
|
| Completion Date: |
2017-09
|
| Results First Posted: |
|
| Last Update Posted: |
2014-09-16
|
| Locations: |
Virginia Commonwealth University Health System, Richmond, Virginia, 23298, United States
|
| URL: |
https://clinicaltrials.gov/show/NCT00784966
|
