Kidney Transplantation, Skin Cancer
Conditions
Keywords
Squamous cell carcinoma, kidney transplant recipients, rapamycin, Skin cancers in kidney transplant recipients
Brief summary
In a population of kidney transplant recipients having developed a first squamous cell carcinoma, the aim of the study is to assess the incidence of subsequent skin cancers over 2 years in patients who are switched to rapamycin as compared to patients who are maintained under calcineurin inhibitors.
Interventions
DRUGrapamycin
3 to 5 mg/day
DRUGciclosporine
Blood residual level \< or = to 125 ng/ml
DRUGtacrolimus
Blood residual level \< or = to 8 ng/ml
Sponsors
Hospices Civils de Lyon
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
* First post-transplant squamous cell carcinoma in a kidney transplant recipient under calcineurin inhibitors
Exclusion criteria
* Other squamous cell carcinomas in the past history * More than 2 transplantations * Patients not under calcineurin inhibitors * Unstable graft function * Non controlled hyperlipidemia (cholesterol \> 7.8 mmol/l or triglycerides \> 3.95 mmol/l) * Leucopenia \< 3000/mm3 * Thrombocytopenia \< 100,000/mm3 * Liver dysfunction * Pregnancy * Allergy to macrolides
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To assess the incidence of new squamous cell carcinoma in kidney transplant recipients | during 5 years |
Secondary
| Measure | Time frame |
|---|---|
| To assess the incidence of other non skin cancer in kidney transplant recipients | during 5 years |
| To assess the graft survival | during 5 years |
| To assess the tolerance of rapamycin | during 5 years |
Countries
France
Outcome results
None listed