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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified May 2009 by Charite University, Berlin, Germany.
Recruitment status was  Active, not recruiting
Sponsor:
Information provided by:
Charite University, Berlin, Germany
ClinicalTrials.gov Identifier:
NCT00866684
First received: March 19, 2009
Last updated: May 18, 2009
Last verified: May 2009
History of Changes

March 19, 2009
May 18, 2009
January 2007
January 2011   (final data collection date for primary outcome measure)
Progression of actinic keratosis I and II to III or invasive squamous cell carcinoma (SCC) or incidence/reoccurrence of neoplastic skin tumors [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT00866684 on ClinicalTrials.gov Archive Site
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 [ Designated as safety issue: Yes ]
Same as current
 
 
 
Prevention of Skin Cancer in High Risk Patients After Conversion to a Sirolimus-Based Immunosuppressive Protocol
Prevention of Skin Cancer in High Risk Patients After Conversion to a Sirolimus-Based Immunosuppressive Protocol

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.
 
Interventional
Phase 4
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
  • Kidney Transplantation
  • Skin Cancer
  • 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
  • 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
  • Experimental: 1
    Patients will receive Sirolimus in addition to their previous immunosuppressive therapy.
    Intervention: Drug: Sirolimus
  • Active Comparator: 2
    Patients will stay on their previous immunosuppressive regimen.
    Interventions:
    • Drug: Azathioprine
    • Drug: Mycophenolate
    • Drug: Ciclosporin
    • Drug: Tacrolimus
 

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
280
July 2011
January 2011   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Germany
 
NCT00866684
PROSKIN 01
No
Petra Reinke, Prof. Dr. med., Charité Universitätsmedizin Berlin, Nephrologie u. internistische Intensivmed.
Charite University, Berlin, Germany
 
Principal Investigator: Petra Reinke, Prof. Dr. Charite University, Berlin, Germany
Charite University, Berlin, Germany
May 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP