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

NCT00866684 | Terminated Phase 4 Results

• 1 other identifier: PROSKIN 01
• Study Type: interventional
• Target: 44
• Locations: 1 country
• Sites: 15

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 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.

Conditions

Skin Cancer

Keywords

Renal transplant-patients with high-risk for skin cancer

Outcome Measures

Primary Outcomes (1)

• Number of Events of Reoccurrence of Skin Cancer

  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

Study Arms (2)

1 Sirolimus

EXPERIMENTAL

Patients will receive Sirolimus in addition to their previous immunosuppressive therapy.

Drug: Sirolimus

2 Standard

ACTIVE COMPARATOR

Patients will stay on their previous immunosuppressive regimen.

Drug: Azathioprine; Drug: Mycophenolate; Drug: Ciclosporin; Drug: Tacrolimus

Interventions

Sirolimus DRUG

Treatment arm Dosage: 4-8 micrograms/litre; Route of administration: oral use; Frequency: one tablet per day

Also known as: Rapamune, ATC code: L04AA10

1 Sirolimus

Azathioprine DRUG

control arm Dosage form: Coated tablet; dosage: 1-4 milligrams/kilogram; Frequency: daily; Duration: 24 month

Also known as: ATC code: L04AX01

2 Standard

Mycophenolate DRUG

Control arm Dosage form: Tablet; dosage: 2 gram; Frequency: daily; Duration: 24 month

Also known as: ATC code: L04AA06

2 Standard

Ciclosporin DRUG

Control arm Dosage form: Capsule; Dosage: 50-80 micrograms/litre; Frequency: daily; Duration: 24 month

Also known as: ATC code: L04AA01

2 Standard

Tacrolimus DRUG

Control arm Dosage form: Capsule; dosage: 3-5 micrograms/litre; Frequency: daily; Duration: 24 month

Also known as: ATC code: L04AA05

2 Standard

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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
• All contraindications to SRL (see package insert, appendix)
• Persons who are detained officially or legally to an official institute

Sponsors & Collaborators

• Charite University, Berlin, Germany: lead

Study Sites (15)

Universitätsklinikum Erlangen, Hautklinik

Erlangen, Bavaria, 91052, Germany

Location

Universitätsklinikum Erlangen, Medizinische Klinik IV

Erlangen, Bavaria, 91054, Germany

Location

Klinikum der LMU München, Medizinische Poliklinik Innenstadt

München, Bavaria, 80336, Germany

Location

Klinikum der LMU München, Klinik und Poliklinik für Dermatologie

München, Bavaria, 80337, Germany

Location

Klinikum rechts der Isar, Klinik und Poliklinik für Dermatologie und Allergologie

München, Bavaria, 80802, Germany

Location

Klinikum rechts der Isar, II. Medizinische Klinik und Poliklinik

München, Bavaria, 81675, Germany

Location

Universität Regensburg, Dermatologie

Regensburg, Bavaria, 93053, Germany

Location

Universität Regensburg, Nephrologie Innere Medizin II

Regensburg, Bavaria, 93053, Germany

Location

Kliniken der Stadt Köln, Medizinische Klinik I

Cologne, North Rhine-Westphalia, 51109, Germany

Location

Universitätsklinikum Münster, Klinik und Poliklinik für Hautkrankheiten

Münster, North Rhine-Westphalia, 48149, Germany

Location

Universitätsklinikum Münster, Med. Klinik und Poliklinik D

Münster, North Rhine-Westphalia, 48149, Germany

Location

HELIOS Klinikum Wuppertal, Zentrum für Dermatologie, Allergologie und Umweltmedizin

Wuppertal, North Rhine-Westphalia, 42283, Germany

Location

Universitätsklinikum Schleswig-Holstein, Klinik für Dermatologie, Venerologie und Allergologie

Kiel, Schleswig-Holstein, 24105, Germany

Location

Universitätsklinikum Schleswig-Holstein, Klinik für Nieren- und Hochdruckkrankheiten

Kiel, Schleswig-Holstein, 24105, Germany

Location

Charité Universitätsmedizin, Klinik für Dermatologie, Venerologie und Allergologie

Berlin, 10117, Germany

Location

MeSH Terms

Conditions

Skin Neoplasms

Interventions

Sirolimus; Azathioprine; Mycophenolic Acid; Cyclosporine; Tacrolimus

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Macrolides; Lactones; Organic Chemicals; Thionucleosides; Sulfur Compounds; Mercaptopurine; Purines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Nucleosides; Nucleic Acids, Nucleotides, and Nucleosides; Caproates; Acids, Acyclic; Carboxylic Acids; Fatty Acids; Lipids; Cyclosporins; Peptides, Cyclic; Macrocyclic Compounds; Polycyclic Compounds; Peptides; Amino Acids, Peptides, and Proteins

Results Point of Contact

• Title: Prof. Dr. Petra Reinke
• Organization: Charité Universitätsmedizin Berlin Augustenburger Platz 1 13353 Berlin

petra.reinke@charite.de

+49 30 450 653 490

Study Officials

• Petra Reinke, Prof. Dr.

  Charite University, Berlin, Germany

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Prof. Dr. med.

Study Record Dates

• First Submitted: March 19, 2009
• First Posted: March 20, 2009
• Study Start: January 1, 2007
• Primary Completion: April 19, 2011
• Study Completion: April 19, 2011
• Last Updated: March 14, 2025
• Results First Posted: March 14, 2025

Record last verified: 2025-02

Locations

DE (15)