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

NCT00799188 | Completed Phase 3 DMC

• 1 other identifier: 2007.489/32
• Study Type: interventional
• Target: 175
• Locations: 1 country
• Sites: 1

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 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.

Conditions

Cardiac Transplantation; Skin Cancer

Keywords

Cardiac Transplantation; Skin cancer; Everolimus

Outcome Measures

Primary Outcomes (1)

• Number of skin tumors per patients requiring surgery with histology control within 2 years

  2 years

Secondary Outcomes (10)

• New skin cancer

  2 years

• Number of patients with new skin cancers

  2 years

• Time of recurrence

  2 years

• Number and histology of other types of skin cancer

  2 years

• Graft function (including acute rejection, graft loss, death)

  2 years

Study Arms (2)

1

NO INTERVENTION

reduction of immunosuppression

2

EXPERIMENTAL

switch to Everolimus : 50% reduction of calcineurin inhibitors (ciclosporine or tacrolimus)

Drug: Everolimus

Interventions

Everolimus DRUG

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.

Also known as: Certican

2

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Hospices Civils de Lyon: lead

Study Sites (1)

HOSPICES CIVILS de LYON

Lyon, France

Location

MeSH Terms

Conditions

Skin Neoplasms

Interventions

Everolimus

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Sirolimus; Macrolides; Lactones; Organic Chemicals

Study Officials

• LAURENT SEBBAG, MD

  Hospices Civils de Lyon

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 26, 2008
• First Posted: November 27, 2008
• Study Start: October 1, 2008
• Primary Completion: August 1, 2014
• Last Updated: December 19, 2025

Record last verified: 2025-12

Locations

FR (1)