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

February 26, 2025 updated by: Prof. Dr. Petra Reinke, Charite University, Berlin, Germany

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.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

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, once daily preferably 4 hours after calcineurin-inhibitor medication or in case without calcineurin-inhibitor co-medication in the morning. The dose of SRL will be correlated to the former immunosuppressive therapy according to the study's conversion protocol.

Study Type

Interventional

Enrollment (Actual)

44

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 1 Sirolimus
Patients will receive Sirolimus in addition to their previous immunosuppressive therapy.
Drug: Sirolimus
Treatment arm Dosage: 4-8 micrograms/litre; Route of administration: oral use; Frequency: one tablet per day
Other Names:
  • Rapamune, ATC code: L04AA10
Active Comparator: 2 Standard
Patients will stay on their previous immunosuppressive regimen.
Drug: Azathioprine
control arm Dosage form: Coated tablet; dosage: 1-4 milligrams/kilogram; Frequency: daily; Duration: 24 month
Other Names:
  • ATC code: L04AX01
Drug: Mycophenolate
Control arm Dosage form: Tablet; dosage: 2 gram; Frequency: daily; Duration: 24 month
Other Names:
  • ATC code: L04AA06
Drug: Ciclosporin
Control arm Dosage form: Capsule; Dosage: 50-80 micrograms/litre; Frequency: daily; Duration: 24 month
Other Names:
  • ATC code: L04AA01
Drug: Tacrolimus
Control arm Dosage form: Capsule; dosage: 3-5 micrograms/litre; Frequency: daily; Duration: 24 month
Other Names:
  • ATC code: L04AA05

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of Events of Reoccurrence of Skin Cancer
Time Frame: 24 month
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)
24 month

Secondary Outcome Measures

Outcome Measure
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Charite University, Berlin, Germany

Investigators

  • Principal Investigator: Petra Reinke, Prof. Dr., Charite University, Berlin, Germany

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 1, 2007

Primary Completion (Actual)

April 19, 2011

Study Completion (Actual)

April 19, 2011

Study Registration Dates

First Submitted

March 19, 2009

First Submitted That Met QC Criteria

March 19, 2009

First Posted (Estimated)

March 20, 2009

Study Record Updates

Last Update Posted (Actual)

March 25, 2025

Last Update Submitted That Met QC Criteria

February 26, 2025

Last Verified

February 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • PROSKIN 01

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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