| Trial ID: | L1373 |
| Source ID: | NCT01653847
|
| Associated Drug: |
Tacrolimus With Mmf
|
| Title: |
Study in Recipients of Renal Transplant Allograft to Evaluate the Impact of Two Immunosuppressive Regimens
|
| Acronym: |
|
| Status: |
COMPLETED
|
| Study Results: |
YES
|
| Results: |
https://ClinicalTrials.gov/show/NCT01653847/results
|
| Conditions: |
End Stage Renal Failure With Renal Transplant
|
| Interventions: |
DRUG: Tacrolimus with MMF|DRUG: Group 2: Tacrolimus with Everolimus.
|
| Outcome Measures: |
Primary: Change in T Cell & B Cell Generation, Evaluate the change in regulatory T cell generation and review the relationship of the newly generated T cells with their function in the two maintenance immunosuppressive regimens at baseline, 3 and 12 months post-transplant., Baseline, 3 months, and 12 months post-transplant|Change in Glomerular Filtration Rate (GFR), Evaluate the change in graft function (as measured by GFR) at 12 months post-transplant from baseline., 3 months, 6 months, and 12 months post-transplant | Secondary: Patient Survival, The number of patients who were alive at 2 years post transplant, baseline - 24 months post transplant|Renal Allograft Survival, The number of subjects with renal allograft survival., 12 months post-transplant|Acute Rejection, Number of subjects who experience acute rejection of the renal allograft., 12 months post transplant
|
| Sponsor/Collaborators: |
Sponsor: Northwestern University | Collaborators: Novartis
|
| Gender: |
ALL
|
| Age: |
ADULT, OLDER_ADULT
|
| Phases: |
|
| Enrollment: |
88
|
| Study Type: |
INTERVENTIONAL
|
| Study Designs: |
Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: TREATMENT
|
| Start Date: |
2013-02
|
| Completion Date: |
2020-05
|
| Results First Posted: |
2021-03-02
|
| Last Update Posted: |
2021-03-02
|
| Locations: |
Northwestern Memorial Hospital, Chicago, Illinois, 60611, United States
|
| URL: |
https://clinicaltrials.gov/show/NCT01653847
|
