| Trial ID: | L0864 |
| Source ID: | NCT02432833
|
| Associated Drug: |
Envarsus®
|
| Title: |
Multicentre, Open Label, Randomized, Two-arm, Parallel-group Study to Assess Efficacy and Safety of ENVARSUS® Compared With Tacrolimus Used as Per Current Clinical Practice in the Initial Maintenance Setting in de Novo Kidney Transplant Patients
|
| Acronym: |
STEADY
|
| Status: |
COMPLETED
|
| Study Results: |
NO
|
| Results: |
|
| Conditions: |
End Stage Renal Disease
|
| Interventions: |
DRUG: ENVARSUS®|DRUG: PROGRAF®|DRUG: ADVAGRAF®
|
| Outcome Measures: |
Primary: Tacrolimus total daily dose (TDD) from week 3 to month 6, from week 3 to month 6 | Secondary: Tacrolimus blood trough level (TL)., from screening to months 6|number of dose adjustment, from screening to months 6|Occurrence of treatment failure, from screening to months 6|Delayed graft function, from screening to months 6|Acute rejection requiring treatment, from screening to months 6|Consumption of concomitant immunosuppressant medications, from screening to months 6|Treatment discontinuation, from screening to months 6
|
| Sponsor/Collaborators: |
Sponsor: Chiesi Farmaceutici S.p.A.
|
| Gender: |
ALL
|
| Age: |
ADULT, OLDER_ADULT
|
| Phases: |
PHASE4
|
| Enrollment: |
428
|
| Study Type: |
INTERVENTIONAL
|
| Study Designs: |
Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: TREATMENT
|
| Start Date: |
2015-05
|
| Completion Date: |
2017-01-24
|
| Results First Posted: |
|
| Last Update Posted: |
2018-04-13
|
| Locations: |
Chiesi farmaceutici Spa, Parma, 43123, Italy
|
| URL: |
https://clinicaltrials.gov/show/NCT02432833
|
