| Trial ID: | L6576 |
| Source ID: | NCT03582878
|
| Associated Drug: |
Sirolimus Oral Product
|
| Title: |
Sirolimus vs Mycophenolate With Tacrolimus in Simultaneous Pancreas and Kidney Transplantation
|
| Acronym: |
|
| Status: |
COMPLETED
|
| Study Results: |
NO
|
| Results: |
|
| Conditions: |
Diabetes Mellitus, Type 1
|
| Interventions: |
DRUG: Sirolimus Oral Product|DRUG: Mycophenolate Mofetil
|
| Outcome Measures: |
Primary: Pancreas graft survival, Number of failed pancreatic grafts, failure is defined as graft removal, death, retransplantation or return to intensified insulin regimen., 10 years | Secondary: Recipient survival, Long-term recipient survival evaluated with Kaplan-Meyer method, 10 years|Wound healing time, The number of days from transplantation to date of completely healed wound, 1year|Kidney graft survival, Number of failed kidneys evaluated with Kaplan-Meyer method. Failure defined as return to dialysis, death, retransplantation or graft removal, 10 years
|
| Sponsor/Collaborators: |
Sponsor: Institute for Clinical and Experimental Medicine
|
| Gender: |
ALL
|
| Age: |
ADULT, OLDER_ADULT
|
| Phases: |
PHASE4
|
| Enrollment: |
238
|
| Study Type: |
INTERVENTIONAL
|
| Study Designs: |
Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: TREATMENT
|
| Start Date: |
2004-01-01
|
| Completion Date: |
2019-01-01
|
| Results First Posted: |
|
| Last Update Posted: |
2021-04-26
|
| Locations: |
Institute for Clinical and Experimental Medicine, Prague, 14021, Czechia
|
| URL: |
https://clinicaltrials.gov/show/NCT03582878
|
