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Prevention of Skin Cancer in High Risk Patients After Conversion to a Sirolimus-based Immunosuppressive Protocol (PROSKIN)

This study has been terminated.
(Insufficient patient recruitment)
Information provided by (Responsible Party):
Prof. Dr. Petra Reinke, Charite University, Berlin, Germany Identifier:
First received: March 19, 2009
Last updated: September 1, 2015
Last verified: September 2015

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 the dosage (i.e., calcineurin-inhibitors). Based on the encouraging results of previous, retrospective studies on patients treated with Sirolimus (SRL), these patients should be switched to an immunosuppressive regime including SRL, decreasing the dosage of calcineurin-inhibitors or converting from former immunosuppression. A conversion to a SRL-based therapy is effective in immunosuppression and safe regarding graft and patient survival.

This study was designed to assess whether a switch to a SRL-immunosuppressive therapy decreases the incidence/reoccurrence of skin neoplasm.

Condition Intervention Phase
Kidney Transplantation
Skin Cancer
Drug: Sirolimus
Drug: Azathioprine
Drug: Mycophenolate
Drug: Ciclosporin
Drug: Tacrolimus
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
Official Title: Prevention of Skin Cancer in High Risk Patients After Conversion to a Sirolimus-based Immunosuppressive Protocol

Resource links provided by NLM:

Further study details as provided by Charite University, Berlin, Germany:

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

Secondary Outcome Measures:
  • Patient and graft survival rates, Incidence of non-cutaneous cancers and of selected AEs, Development of renal function, Renal biopsy changes, Development of proteinuria after conversation to SRL, Incidence and development of actinic keratosis I and II

Enrollment: 44
Study Start Date: January 2007
Study Completion Date: July 2011
Primary Completion Date: January 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
Patients will receive Sirolimus in addition to their previous immunosuppressive therapy.
Drug: Sirolimus
Dosage form: coated tablet; Dosage: 4-8 micrograms/litre; Route of administration: oral use; Frequency: one tablet per day; Duration: 24 month
Other Name: Rapamune, ATC code: L04AA10
Active Comparator: 2
Patients will stay on their previous immunosuppressive regimen.
Drug: Azathioprine
Dosage form: Coated tablet; dosage: 1-4 milligrams/kilogram; Frequency: daily; Duration: 24 month
Other Name: ATC code: L04AX01
Drug: Mycophenolate
Dosage form: Tablet; dosage: 2 gram; Frequency: daily; Duration: 24 month
Other Name: ATC code: L04AA06
Drug: Ciclosporin
Dosage form: Capsule; Dosage: 50-80 micrograms/litre; Frequency: daily; Duration: 24 month
Other Name: ATC code: L04AA01
Drug: Tacrolimus
Dosage form: Capsule; dosage: 3-5 micrograms/litre; Frequency: daily; Duration: 24 month
Other Name: ATC code: L04AA05


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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
  Contacts and Locations
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Please refer to this study by its identifier: NCT00866684

Universitätsklinikum Erlangen, Hautklinik
Erlangen, Bavaria, Germany, 91052
Universitätsklinikum Erlangen, Medizinische Klinik IV
Erlangen, Bavaria, Germany, 91054
Klinikum der LMU München, Medizinische Poliklinik Innenstadt
München, Bavaria, Germany, 80336
Klinikum der LMU München, Klinik und Poliklinik für Dermatologie
München, Bavaria, Germany, 80337
Klinikum rechts der Isar, Klinik und Poliklinik für Dermatologie und Allergologie
München, Bavaria, Germany, 80802
Klinikum rechts der Isar, II. Medizinische Klinik und Poliklinik
München, Bavaria, Germany, 81675
Universität Regensburg, Dermatologie
Regensburg, Bavaria, Germany, 93053
Universität Regensburg, Nephrologie Innere Medizin II
Regensburg, Bavaria, Germany, 93053
Kliniken der Stadt Köln, Medizinische Klinik I
Köln, North Rhine-Westphalia, Germany, 51109
Universitätsklinikum Münster, Klinik und Poliklinik für Hautkrankheiten
Münster, North Rhine-Westphalia, Germany, 48149
Universitätsklinikum Münster, Med. Klinik und Poliklinik D
Münster, North Rhine-Westphalia, Germany, 48149
HELIOS Klinikum Wuppertal, Zentrum für Dermatologie, Allergologie und Umweltmedizin
Wuppertal, North Rhine-Westphalia, Germany, 42283
Universitätsklinikum Schleswig-Holstein, Klinik für Dermatologie, Venerologie und Allergologie
Kiel, Schleswig-Holstein, Germany, 24105
Universitätsklinikum Schleswig-Holstein, Klinik für Nieren- und Hochdruckkrankheiten
Kiel, Schleswig-Holstein, Germany, 24105
Charité Universitätsmedizin, Klinik für Dermatologie, Venerologie und Allergologie
Berlin, Germany, 10117
Sponsors and Collaborators
Charite University, Berlin, Germany
Principal Investigator: Petra Reinke, Prof. Dr. Charite University, Berlin, Germany
  More Information

Responsible Party: Prof. Dr. Petra Reinke, Prof. Dr. med., Charite University, Berlin, Germany Identifier: NCT00866684     History of Changes
Other Study ID Numbers: PROSKIN 01
Study First Received: March 19, 2009
Last Updated: September 1, 2015

Keywords provided by Charite University, Berlin, Germany:
renal transplant-patients with high-risk for skin cancer

Additional relevant MeSH terms:
Skin Neoplasms
Neoplasms by Site
Skin Diseases
Immunosuppressive Agents
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Immunologic Factors
Physiological Effects of Drugs
Antifungal Agents
Anti-Infective Agents
Dermatologic Agents
Antirheumatic Agents
Calcineurin Inhibitors
Anti-Bacterial Agents
Antibiotics, Antineoplastic
Antineoplastic Agents
Antimetabolites, Antineoplastic processed this record on May 23, 2017