NCT00799188

CERTICOEUR: A Secondary Prevention Study of Skin Cancers in Heart Transplant Patients. Everolimus Versus Calcineurin Inhibitors Multicenter Trial

CERTICOEUR a Secondary Prevention Study of Skin Cancers in Heart Transplant Patients. An Open Labelled Randomized Everolimus vs Calcineurin Inhibitors Multicenter Trial

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 175 (actual)
• Sponsor: Hospices Civils de Lyon · Academic / Other
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

Summary

Heart transplant is a recognized therapeutic strategy in refractory heart failure. Its success is however hampered by severe cancer occurrence and recurrence. The new m-tor inhibiting drugs Sirolimus and Everolimus have shown potential for reducing the incidence of cancer in animal models. They are potent immunosuppressant, antiproliferative and antiangiogenic drugs. This open labelled randomized multicenter study aims at evaluating the beneficial antineoplastic effect of Everolimus in 159 heart transplant patients suffering of recurrent skin cancer. Primary objective is to demonstrate a reduction in the number of new skin cancers. Secondary end point will be time of recurrence, incidence of non skin cancer, graft function following switch (including death), renal function evolution following calcineurin inhibitors reduction or withdrawal, Everolimus tolerance profile, schemes of calcineurin inhibitors reduction management in centers.

Detailed description

* 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 Cockcroft 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 immunosuppression switch

Conditions

• Cardiac Transplantation
• Skin Cancer

Interventions

Type	Name	Description
DRUG	Everolimus	50% reduction of calcineurin inhibitors daily dose followed by further decrease or withdrawal. Everolimus will be introduced and tapered to a trough level of 6 to 10 microg/l.

Timeline

• Start date: 2008-10-01
• Primary completion: 2014-08-01
• First posted: 2008-11-27
• Last updated: 2025-12-19

Locations

1 site across 1 country: France