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)
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 (300 mg/dl), Triglycerides > 4
mmol/l (350 mg/dl)
- Leucopenia < 2500/nl
- Thrombocytopenia < 90/nl
- Pregnancy or breastfeeding
- Women of childbearing age without highly effective contraception
- 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
- 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