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

Kidney Transplantation Clinical Trial

— PROSKIN  

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00866684
• Other study ID #: PROSKIN 01
• Status: Terminated
• Phase: Phase 4
• First received: March 19, 2009
• Last updated: September 1, 2015
• Start date: January 2007
• Est. completion date: July 2011

Study information

• Verified date: September 2015
• Source: Charite University, Berlin, Germany
• Contact: n/a
• Is FDA regulated: No
• Health authority: Germany: Federal Institute for Drugs and Medical Devices
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 44
• Est. completion date: July 2011
• Est. primary completion date: January 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention

Related Conditions & MeSH terms

• Kidney Transplantation
• Skin Cancer
• Skin Neoplasms

Intervention

Drug:
• Sirolimus
Dosage form: coated tablet; Dosage: 4-8 micrograms/litre; Route of administration: oral use; Frequency: one tablet per day; Duration: 24 month
• Azathioprine
Dosage form: Coated tablet; dosage: 1-4 milligrams/kilogram; Frequency: daily; Duration: 24 month
• Mycophenolate
Dosage form: Tablet; dosage: 2 gram; Frequency: daily; Duration: 24 month
• Ciclosporin
Dosage form: Capsule; Dosage: 50-80 micrograms/litre; Frequency: daily; Duration: 24 month
• Tacrolimus
Dosage form: Capsule; dosage: 3-5 micrograms/litre; Frequency: daily; Duration: 24 month

Locations

Country	Name	City	State
Germany	Charité Universitätsmedizin, Klinik für Dermatologie, Venerologie und Allergologie	Berlin
Germany	Universitätsklinikum Erlangen, Hautklinik	Erlangen	Bavaria
Germany	Universitätsklinikum Erlangen, Medizinische Klinik IV	Erlangen	Bavaria
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	Kliniken der Stadt Köln, Medizinische Klinik I	Köln	North Rhine-Westphalia
Germany	Klinikum der LMU München, Klinik und Poliklinik für Dermatologie	München	Bavaria
Germany	Klinikum der LMU München, Medizinische Poliklinik Innenstadt	München	Bavaria
Germany	Klinikum rechts der Isar, II. Medizinische Klinik und Poliklinik	München	Bavaria
Germany	Klinikum rechts der Isar, Klinik und Poliklinik für Dermatologie und Allergologie	München	Bavaria
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	Universität Regensburg, Dermatologie	Regensburg	Bavaria
Germany	Universität Regensburg, Nephrologie Innere Medizin II	Regensburg	Bavaria
Germany	HELIOS Klinikum Wuppertal, Zentrum für Dermatologie, Allergologie und Umweltmedizin	Wuppertal	North Rhine-Westphalia

Sponsors (1)

Lead Sponsor	Collaborator
Charite University, Berlin, Germany

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Progression of actinic keratosis I and II to III or invasive squamous cell carcinoma (SCC) or incidence/reoccurrence of neoplastic skin tumors			No
Secondary	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			Yes