| Trial ID: | L0092 |
| Source ID: | NCT00716573
|
| Associated Drug: |
Everolimus
|
| Title: |
Efficacy Study of Everolimus on Renal Function in Heart Transplant Recipients With Established Chronic Renal Failure
|
| Acronym: |
COREV
|
| Status: |
COMPLETED
|
| Study Results: |
NO
|
| Results: |
|
| Conditions: |
Cardiac Transplantation|Chronic Renal Insufficiency
|
| Interventions: |
DRUG: everolimus
|
| Outcome Measures: |
Primary: Evaluation of the renal function, at 12 months after everolimus introduction and doses of anticalcineurins decrease., 12 months | Secondary: Evaluation of the benefit of everolimus introduction on renal function at 24 months, 24 months|Evaluation of the benefit of everolimus introduction on incidence of Major Adverse Cardiac Events (MACEs), 24 months|Evaluation of the benefit of everolimus introduction on incidence of cardiovascular risk factor (Arterial Tension, diabetes, dyslipidemia, proteinuria), 24 months|Evaluation of the benefit of everolimus introduction on incidence of treatment withdrawals, 24 months|Evaluation of the benefit of everolimus introduction on incidence of treated acute rejection, 24 months|Evaluation of the benefit of everolimus introduction on safety, 24 months
|
| Sponsor/Collaborators: |
Sponsor: Hospices Civils de Lyon
|
| Gender: |
ALL
|
| Age: |
ADULT, OLDER_ADULT
|
| Phases: |
PHASE4
|
| Enrollment: |
120
|
| Study Type: |
INTERVENTIONAL
|
| Study Designs: |
Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: TREATMENT
|
| Start Date: |
2008-09-16
|
| Completion Date: |
2014-04-17
|
| Results First Posted: |
|
| Last Update Posted: |
2017-06-20
|
| Locations: |
Hospices Civils de Lyon, Lyon, France
|
| URL: |
https://clinicaltrials.gov/show/NCT00716573
|
