Prevention of Skin Cancer in High Risk Patients After Conversion to a Sirolimus-based Immunosuppressive Protocol
NCT ID: NCT00866684
Last Updated: 2025-03-14
Study Results
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View full resultsBasic Information
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TERMINATED
PHASE4
44 participants
INTERVENTIONAL
2007-01-01
2011-04-19
Brief Summary
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This study was designed to assess whether a switch to a SRL-immunosuppressive therapy decreases the incidence/reoccurrence of skin neoplasm.
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
NONE
Study Groups
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1 Sirolimus
Patients will receive Sirolimus in addition to their previous immunosuppressive therapy.
Sirolimus
Treatment arm Dosage: 4-8 micrograms/litre; Route of administration: oral use; Frequency: one tablet per day
2 Standard
Patients will stay on their previous immunosuppressive regimen.
Azathioprine
control arm Dosage form: Coated tablet; dosage: 1-4 milligrams/kilogram; Frequency: daily; Duration: 24 month
Mycophenolate
Control arm Dosage form: Tablet; dosage: 2 gram; Frequency: daily; Duration: 24 month
Ciclosporin
Control arm Dosage form: Capsule; Dosage: 50-80 micrograms/litre; Frequency: daily; Duration: 24 month
Tacrolimus
Control arm Dosage form: Capsule; dosage: 3-5 micrograms/litre; Frequency: daily; Duration: 24 month
Interventions
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Sirolimus
Treatment arm Dosage: 4-8 micrograms/litre; Route of administration: oral use; Frequency: one tablet per day
Azathioprine
control arm Dosage form: Coated tablet; dosage: 1-4 milligrams/kilogram; Frequency: daily; Duration: 24 month
Mycophenolate
Control arm Dosage form: Tablet; dosage: 2 gram; Frequency: daily; Duration: 24 month
Ciclosporin
Control arm Dosage form: Capsule; Dosage: 50-80 micrograms/litre; Frequency: daily; Duration: 24 month
Tacrolimus
Control arm Dosage form: Capsule; dosage: 3-5 micrograms/litre; Frequency: daily; Duration: 24 month
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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)
* All contraindications to SRL (see package insert, appendix)
* Persons who are detained officially or legally to an official institute
Exclusion Criteria
* 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
18 Years
ALL
No
Sponsors
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Charite University, Berlin, Germany
OTHER
Responsible Party
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Prof. Dr. Petra Reinke
Prof. Dr. med.
Principal Investigators
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Petra Reinke, Prof. Dr.
Role: PRINCIPAL_INVESTIGATOR
Charite University, Berlin, Germany
Locations
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Universitätsklinikum Erlangen, Hautklinik
Erlangen, Bavaria, Germany
Universitätsklinikum Erlangen, Medizinische Klinik IV
Erlangen, Bavaria, Germany
Klinikum der LMU München, Medizinische Poliklinik Innenstadt
München, Bavaria, Germany
Klinikum der LMU München, Klinik und Poliklinik für Dermatologie
München, Bavaria, Germany
Klinikum rechts der Isar, Klinik und Poliklinik für Dermatologie und Allergologie
München, Bavaria, Germany
Klinikum rechts der Isar, II. Medizinische Klinik und Poliklinik
München, Bavaria, Germany
Universität Regensburg, Dermatologie
Regensburg, Bavaria, Germany
Universität Regensburg, Nephrologie Innere Medizin II
Regensburg, Bavaria, Germany
Kliniken der Stadt Köln, Medizinische Klinik I
Cologne, North Rhine-Westphalia, Germany
Universitätsklinikum Münster, Klinik und Poliklinik für Hautkrankheiten
Münster, North Rhine-Westphalia, Germany
Universitätsklinikum Münster, Med. Klinik und Poliklinik D
Münster, North Rhine-Westphalia, Germany
HELIOS Klinikum Wuppertal, Zentrum für Dermatologie, Allergologie und Umweltmedizin
Wuppertal, North Rhine-Westphalia, Germany
Universitätsklinikum Schleswig-Holstein, Klinik für Dermatologie, Venerologie und Allergologie
Kiel, Schleswig-Holstein, Germany
Universitätsklinikum Schleswig-Holstein, Klinik für Nieren- und Hochdruckkrankheiten
Kiel, Schleswig-Holstein, Germany
Charité Universitätsmedizin, Klinik für Dermatologie, Venerologie und Allergologie
Berlin, , Germany
Countries
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Other Identifiers
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PROSKIN 01
Identifier Type: -
Identifier Source: org_study_id
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