Status:
TERMINATED
Prevention of Skin Cancer in High Risk Patients After Conversion to a Sirolimus-based Immunosuppressive Protocol
Lead Sponsor:
Charite University, Berlin, Germany
Conditions:
Skin Cancer
Eligibility:
All Genders
18+ years
Phase:
PHASE4
Brief Summary
Transplant recipients have a high risk to develop skin malignancies. This effect depends on the one hand on the immunosuppressive drugs themselves (i.e., azathioprine) and relates on the other hand on...
Detailed Description
Patients who meet all inclusion criteria will be included into the study and randomised. If converted to SRL, patients will take SRL according to the investigator's instructions and medication label, ...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
January 1 2007
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 19 2011
Estimated Enrollment :
44 Patients enrolled
Trial Details
Trial ID
NCT00866684
Start Date
January 1 2007
End Date
April 19 2011
Last Update
March 14 2025
Active Locations (15)
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1
Universitätsklinikum Erlangen, Hautklinik
Erlangen, Bavaria, Germany, 91052
2
Universitätsklinikum Erlangen, Medizinische Klinik IV
Erlangen, Bavaria, Germany, 91054
3
Klinikum der LMU München, Medizinische Poliklinik Innenstadt
München, Bavaria, Germany, 80336
4
Klinikum der LMU München, Klinik und Poliklinik für Dermatologie
München, Bavaria, Germany, 80337