Medical condition: renal transplant-patients at high-risk for skin cancer Transplant 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.
Conditions
Interventions
Trade Name: Rapamune
Product Name: Rapamune
Product Code: Sirolimus
Pharmaceutical Form: Coated tablet
INN or Proposed INN: Sirolimus
CAS Number: 104987-11-3
Concentration unit: mg milligram(s)
Conce
Sponsors
Charité Universitätsmedizin Berlin
Eligibility
Sex/Gender
All
Inclusion criteria
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
Exclusion criteria: •Current Sirolimus- or Everolimus- intake •Instable graft function (creatinine clearance 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The primary objective of this study is to determine the incidence/reoccurence of skin cancer after patients are converted to a SRL including therapy regime. ;Secondary Objective: Secondary Endpoints: •Patient and graft survival rates •Incidence of non-cutaneous cancers •Development of renal function, expressed as the calculated glomerular filtration rate according to the Cockroft-Gault formula •Renal biopsy changes (CADI score) •Incidence of selected adverse events (opportunistic infections, cardiovascular events, hyperlipidemia, diabetes mellitus, hypertension) •Development of proteinuria after conversation to SRL based IS •Incidence of acute rejection after conversation to SRL based IS •Incidence and development of actinic keratosis I and II ;Primary end point(s): Primary Endpoints: •Progression of actinic keratosis I and II to III or invasive squamous cell carcinoma (SCC) or incidence/reoccurrence of neoplastic skin tumors (namely SCC, basal cell carcinoma, keratoacanthoma, Bowen’s disease, precancerous keratoses, actinic keratoses III) | — |
Countries
Germany
Outcome results
None listed