CERTICOEUR a Secondary Prevention Study of Skin Cancers in Heart Transplant Patients. An Open Labelled Randomized Everolimus vs Calcineurin Inhibitors Multicenter Trial
- Open labelled randomized Everolimus vs reduction of calcineurin inhibitors trial. 2:1
randomization design
- October 10, 2008
- 159 patients (106 everolimus vs 53 calcineurin inhibitors reduction)
- 175 patients (117 vs 58)
- X Not yet recruiting 0 recruiting 0 no longer recruiting
- Number of skin tumors per patients requiring surgery with histology control within 2
years
Within 2 years of Follow up:
- New skin cancer
- Number of patients with new skin cancers
- Time of recurrence
- Number and histology of other types of skin cancer
- Graft function (including acute rejection, graft loss, death)
- Renal function evolution as assessed using cockroft creatinine clearance and
proteinuria
- Adverse events and serious adverse events
- Non skin cancer (Number and diagnostic)
- Schemes of calcineurin inhibitors reduction/withdrawal
- Immune response assessment through regulatory or effector function of blood and in situ
T lymphocytes at baseline and following immusuppression switch
Interventional
Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Number of skin tumors per patients requiring surgery with histology control within 2 years
2 years
No
LAURENT SEBBAG, MD
Principal Investigator
Hospices Civils de Lyon
France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
2007.489/32
NCT00799188
October 2008
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