Prevention of skin cancer in high risk patients after conversion a to Sirolimus-based immunosuppressive - PROSKI

Conditions: Medical condition: renal transplant-patients at high-risk for skin cancerTransplant recipients have a high risk to develop skin malignancies. This depends on the immunosuppressive drugs and is related to the dosage. This study assesses whether a switch to a SRL-immunosuppressive therapy decreases the incidence/reoccurence of skin neoplasm.

Registration Number: EUCTR2006-001528-38-DE

Lead Sponsor: Charité Universitätsmedizin Berlin

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: ot Recruiting

Sex: All

Target Recruitment: Not specified

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)

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range

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