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

Primary Purpose

Kidney Transplantation, Skin Cancer

Status
Terminated
Phase
Phase 4
Locations
Germany
Study Type
Interventional
Intervention
Sirolimus
Azathioprine
Mycophenolate
Ciclosporin
Tacrolimus
Sponsored by
Charite University, Berlin, Germany
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Kidney Transplantation focused on measuring renal transplant-patients with high-risk for skin cancer

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Universitätsklinikum Erlangen, Hautklinik
  • Universitätsklinikum Erlangen, Medizinische Klinik IV
  • Klinikum der LMU München, Medizinische Poliklinik Innenstadt
  • Klinikum der LMU München, Klinik und Poliklinik für Dermatologie
  • Klinikum rechts der Isar, Klinik und Poliklinik für Dermatologie und Allergologie
  • Klinikum rechts der Isar, II. Medizinische Klinik und Poliklinik
  • Universität Regensburg, Dermatologie
  • Universität Regensburg, Nephrologie Innere Medizin II
  • Kliniken der Stadt Köln, Medizinische Klinik I
  • Universitätsklinikum Münster, Klinik und Poliklinik für Hautkrankheiten
  • Universitätsklinikum Münster, Med. Klinik und Poliklinik D
  • HELIOS Klinikum Wuppertal, Zentrum für Dermatologie, Allergologie und Umweltmedizin
  • Universitätsklinikum Schleswig-Holstein, Klinik für Dermatologie, Venerologie und Allergologie
  • Universitätsklinikum Schleswig-Holstein, Klinik für Nieren- und Hochdruckkrankheiten
  • Charité Universitätsmedizin, Klinik für Dermatologie, Venerologie und Allergologie

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

1

2

Arm Description

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

Patients will stay on their previous immunosuppressive regimen.

Outcomes

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

Full Information

First Posted
March 19, 2009
Last Updated
September 1, 2015
Sponsor
Charite University, Berlin, Germany
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1. Study Identification

Unique Protocol Identification Number
NCT00866684
Brief Title
Prevention of Skin Cancer in High Risk Patients After Conversion to a Sirolimus-based Immunosuppressive Protocol
Acronym
PROSKIN
Official Title
Prevention of Skin Cancer in High Risk Patients After Conversion to a Sirolimus-based Immunosuppressive Protocol
Study Type
Interventional

2. Study Status

Record Verification Date
September 2015
Overall Recruitment Status
Terminated
Why Stopped
Insufficient patient recruitment
Study Start Date
January 2007 (undefined)
Primary Completion Date
January 2011 (Actual)
Study Completion Date
July 2011 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Charite University, Berlin, Germany

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Kidney Transplantation, Skin Cancer
Keywords
renal transplant-patients with high-risk for skin cancer

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
44 (Actual)

8. Arms, Groups, and Interventions

Arm Title
1
Arm Type
Experimental
Arm Description
Patients will receive Sirolimus in addition to their previous immunosuppressive therapy.
Arm Title
2
Arm Type
Active Comparator
Arm Description
Patients will stay on their previous immunosuppressive regimen.
Intervention Type
Drug
Intervention Name(s)
Sirolimus
Other Intervention Name(s)
Rapamune, ATC code: L04AA10
Intervention Description
Dosage form: coated tablet; Dosage: 4-8 micrograms/litre; Route of administration: oral use; Frequency: one tablet per day; Duration: 24 month
Intervention Type
Drug
Intervention Name(s)
Azathioprine
Other Intervention Name(s)
ATC code: L04AX01
Intervention Description
Dosage form: Coated tablet; dosage: 1-4 milligrams/kilogram; Frequency: daily; Duration: 24 month
Intervention Type
Drug
Intervention Name(s)
Mycophenolate
Other Intervention Name(s)
ATC code: L04AA06
Intervention Description
Dosage form: Tablet; dosage: 2 gram; Frequency: daily; Duration: 24 month
Intervention Type
Drug
Intervention Name(s)
Ciclosporin
Other Intervention Name(s)
ATC code: L04AA01
Intervention Description
Dosage form: Capsule; Dosage: 50-80 micrograms/litre; Frequency: daily; Duration: 24 month
Intervention Type
Drug
Intervention Name(s)
Tacrolimus
Other Intervention Name(s)
ATC code: L04AA05
Intervention Description
Dosage form: Capsule; dosage: 3-5 micrograms/litre; Frequency: daily; Duration: 24 month
Primary Outcome Measure Information:
Title
Progression of actinic keratosis I and II to III or invasive squamous cell carcinoma (SCC) or incidence/reoccurrence of neoplastic skin tumors
Secondary Outcome Measure Information:
Title
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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Petra Reinke, Prof. Dr.
Organizational Affiliation
Charite University, Berlin, Germany
Official's Role
Principal Investigator
Facility Information:
Facility Name
Universitätsklinikum Erlangen, Hautklinik
City
Erlangen
State/Province
Bavaria
ZIP/Postal Code
91052
Country
Germany
Facility Name
Universitätsklinikum Erlangen, Medizinische Klinik IV
City
Erlangen
State/Province
Bavaria
ZIP/Postal Code
91054
Country
Germany
Facility Name
Klinikum der LMU München, Medizinische Poliklinik Innenstadt
City
München
State/Province
Bavaria
ZIP/Postal Code
80336
Country
Germany
Facility Name
Klinikum der LMU München, Klinik und Poliklinik für Dermatologie
City
München
State/Province
Bavaria
ZIP/Postal Code
80337
Country
Germany
Facility Name
Klinikum rechts der Isar, Klinik und Poliklinik für Dermatologie und Allergologie
City
München
State/Province
Bavaria
ZIP/Postal Code
80802
Country
Germany
Facility Name
Klinikum rechts der Isar, II. Medizinische Klinik und Poliklinik
City
München
State/Province
Bavaria
ZIP/Postal Code
81675
Country
Germany
Facility Name
Universität Regensburg, Dermatologie
City
Regensburg
State/Province
Bavaria
ZIP/Postal Code
93053
Country
Germany
Facility Name
Universität Regensburg, Nephrologie Innere Medizin II
City
Regensburg
State/Province
Bavaria
ZIP/Postal Code
93053
Country
Germany
Facility Name
Kliniken der Stadt Köln, Medizinische Klinik I
City
Köln
State/Province
North Rhine-Westphalia
ZIP/Postal Code
51109
Country
Germany
Facility Name
Universitätsklinikum Münster, Klinik und Poliklinik für Hautkrankheiten
City
Münster
State/Province
North Rhine-Westphalia
ZIP/Postal Code
48149
Country
Germany
Facility Name
Universitätsklinikum Münster, Med. Klinik und Poliklinik D
City
Münster
State/Province
North Rhine-Westphalia
ZIP/Postal Code
48149
Country
Germany
Facility Name
HELIOS Klinikum Wuppertal, Zentrum für Dermatologie, Allergologie und Umweltmedizin
City
Wuppertal
State/Province
North Rhine-Westphalia
ZIP/Postal Code
42283
Country
Germany
Facility Name
Universitätsklinikum Schleswig-Holstein, Klinik für Dermatologie, Venerologie und Allergologie
City
Kiel
State/Province
Schleswig-Holstein
ZIP/Postal Code
24105
Country
Germany
Facility Name
Universitätsklinikum Schleswig-Holstein, Klinik für Nieren- und Hochdruckkrankheiten
City
Kiel
State/Province
Schleswig-Holstein
ZIP/Postal Code
24105
Country
Germany
Facility Name
Charité Universitätsmedizin, Klinik für Dermatologie, Venerologie und Allergologie
City
Berlin
ZIP/Postal Code
10117
Country
Germany

12. IPD Sharing Statement

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

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