Status:
COMPLETED
CERTICOEUR: A Secondary Prevention Study of Skin Cancers in Heart Transplant Patients. Everolimus Versus Calcineurin Inhibitors Multicenter Trial
Lead Sponsor:
Hospices Civils de Lyon
Conditions:
Cardiac Transplantation
Skin Cancer
Eligibility:
All Genders
18-65 years
Phase:
PHASE3
Brief 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 ...
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) *...
Eligibility Criteria
Inclusion
- First orthotopic heart transplant after 1st year
- No rejection within previous 6 Months
- Occurrence of squamous cell carcinoma, basal cell carcinoma, in situ carcinoma, Bowen disease, premalignant keratosis
- Recurrence of skin cancers leading to immunosuppressive regimen modifications
- Removal of a skin lesion in the past three years
- Above 18 yrs and under contraceptive drugs if applicable
- Informed consent given
- Health coverage ongoing
Exclusion
- Other non simultaneously transplanted organ
- recent biopsy proven acute rejection
- Proteinuria \> 1g/l
- Ongoing infectious disease
- HIV positivity, Chronic active Hepatitis B or C.
- Abnormal blood tests: transaminases \>= 3UNL, Bilirubin \> 34 mmol.l, albumin\<35 g/l, spontaneous INR \>1,3
- Hemoglobin \>= 8 g/dl, White Blood Count\<= 2 giga/l, platelet count \<= 50 giga/l
- Hypercholesterolemia\>= 9 mmol/l, hypertriglyceridemia \>= 8,5 mmol/l despite treatment
- History of macrolid or mTor inhibitor intolerance
- Previous cancer other than skin in the year prior to enrollment
- Medical or surgical condition unsuitable for the trial
- Breast feeding
- Positive pregnancy test
- Severe psychiatric disorder
- Communication or language disability
Key Trial Info
Start Date :
October 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
Estimated Enrollment :
175 Patients enrolled
Trial Details
Trial ID
NCT00799188
Start Date
October 1 2008
Last Update
December 19 2025
Active Locations (1)
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1
HOSPICES CIVILS de LYON
Lyon, France