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Prevention of Skin Cancer in High Risk Patients After Conversion to a Sirolimus-Based Immunosuppressive Protocol

Phase 4
18 Years
Open (Enrolling)
Kidney Transplantation, Skin Cancer

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Trial Information

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

Type of Study:


Study Design:

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention

Outcome Measure:

Progression of actinic keratosis I and II to III or invasive squamous cell carcinoma (SCC) or incidence/reoccurrence of neoplastic skin tumors

Safety Issue:


Principal Investigator

Petra Reinke, Prof. Dr.

Investigator Role:

Principal Investigator

Investigator Affiliation:

Charite University, Berlin, Germany


Germany: Federal Institute for Drugs and Medical Devices

Study ID:




Start Date:

January 2007

Completion Date:

July 2011

Related Keywords:

  • Kidney Transplantation
  • Skin Cancer
  • renal transplant-patients with high-risk for skin cancer
  • Skin Neoplasms