Prevention of Skin Cancer in High Risk Patients After Conversion to a Sirolimus-Based Immunosuppressive Protocol
Inclusion Criteria:
- Recipients of renal allograft with current actinic keratosis I or II or successfully
treated actinic keratosis III (inclusion possible immediately after completed wound
healing from surgical excision), invasive squamous cell carcinoma (SCC), basal cell
carcinoma and/or premalignant neoplastic skin lesions
- Age 18 years and older
- Minimum period of 6 month after renal transplantation
- Stable renal function and a calculated creatinine clearance of at least 40 ml/min
- Written informed consent
- Proteinuria ≤ 800 mg/d at time of enrolment
- Successfully treated solid tumor (no recurrence or metastasis in the last 2 years)
Exclusion Criteria:
- Current Sirolimus- or Everolimus- intake
- Instable graft function (creatinine clearance < 40 ml/min)
- Graft rejection within the 3 previous months
- Proteinuria > 800 mg/d
- Non-controlled hyperlipidemia (Cholesterol >7,8 mmol/l, Triglycerides > 4)
- Leucopenia < 2500/nl
- Thrombocytopenia < 90/nl
- Pregnancy or breastfeeding
- Women of childbearing age without highly effective contraception (= defined as those
which result in a low failure rate (i.e. less than 1 % per year))
- Known allergy to macrolides
- Current participation in other studies
- Refusal to sign informed consent form
- Neoplasm other than defined as inclusion criteria
- All contraindications to SRL (see package insert, appendix)
- Persons who are detained officially or legally to an official institute