| Trial ID: | L5305 |
| Source ID: | NCT00533442
|
| Associated Drug: |
Rapamycin
|
| Title: |
Rapamycin Versus Mycophenolate Mofetil in Kidney-Pancreas Recipients
|
| Acronym: |
|
| Status: |
COMPLETED
|
| Study Results: |
YES
|
| Results: |
https://ClinicalTrials.gov/show/NCT00533442/results
|
| Conditions: |
Type 1 Diabetes
|
| Interventions: |
DRUG: Rapamycin|DRUG: Mycophenolate Mofetil|DRUG: Tacrolimus|DRUG: Steroids
|
| Outcome Measures: |
Primary: Event-Specific Survival Comparisons, Freedom from biopsy-proven acute rejection of the kidney allograft; Freedom from biopsy-proven acute rejection of the pancreas allograft; Death-censored kidney graft survival; Death-censored pancreas graft survival; Death-uncensored graft (kidney and pancreas) survival; and Patient survival., over 1-10 years post-transplant | Secondary: Overall Kidney Transplant Function at 12, 36, and 60 Months Post-transplant., Comparisons of renal function (eGFR, measured in mL/min/1.73 m\^2) at 12, 36, and 60 months post-transplant., at 1-5 years post-transplant|Overall Pancreas Transplant Function at 12, 36, and 60 Months Post-transplant., Comparisons of pancreas function (C-peptide in ng/mL) at 12, 36, and 60 months post-transplant., at 1-5 years post-transplant
|
| Sponsor/Collaborators: |
Sponsor: University of Miami | Collaborators: Astellas Pharma Inc
|
| Gender: |
ALL
|
| Age: |
ADULT, OLDER_ADULT
|
| Phases: |
PHASE2
|
| Enrollment: |
170
|
| Study Type: |
INTERVENTIONAL
|
| Study Designs: |
Allocation: RANDOMIZED|Intervention Model: SINGLE_GROUP|Masking: NONE|Primary Purpose: PREVENTION
|
| Start Date: |
2000-09
|
| Completion Date: |
2016-05
|
| Results First Posted: |
2017-07-12
|
| Last Update Posted: |
2017-07-12
|
| Locations: |
University of Miami, Miller School of Medicine, Miami, Florida, 33136, United States
|
| URL: |
https://clinicaltrials.gov/show/NCT00533442
|
