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
• •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)
• •All contraindications to SRL (see package insert, appendix)
• •Persons who are detained officially or legally to an official institute
• •Acute infections (mycotic, viral or bacterial)
• •Current intake of other substances with known nephrotoxicity
• •Severe liver dysfunction
• •Current intake of CY3A4-inhibitors (e.g. ketoconazole, voriconazole, itraconazole, telithromycin or clarithromycin) or CY3A4-inductors (rifampicin, rifabutin)
• •sucrose-isomaltase deficiency, fructose intolerance, glucose-galactose intolerance
• •azathioprine: known allergy to azathioprine or 6-mercaptopurine, severe bone marrow dysfunction, pancreatitis, vaccination with live vaccine
• •tacrolimus: known allergy to tacrolimus
• •mycophenolatmofetil: known allergy to mycophenolatmofetil, neutropenia, severe active gastrointestinal tract disease, Lesch-Nyhan syndrome or Kelley-Seegmiller syndrome, current intake of azathioprine
• •cyclosporine: known allergy to cyclosporine, increased intracranial pressure