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

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Charité University Medicine Berlin

Status and phase

Terminated
Phase 4

Conditions

Kidney Transplantation
Skin Cancer

Treatments

Drug: Sirolimus
Drug: Tacrolimus
Drug: Mycophenolate
Drug: Azathioprine
Drug: Ciclosporin

Study type

Interventional

Funder types

Other

Identifiers

NCT00866684
PROSKIN 01

Details and patient eligibility

About

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.

Enrollment

44 patients

Sex

All

Ages

18+ years old

Volunteers

No 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

Trial design

Primary purpose

Prevention

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

44 participants in 2 patient groups

1
Experimental group
Description:
Patients will receive Sirolimus in addition to their previous immunosuppressive therapy.
Treatment:
Drug: Sirolimus
2
Active Comparator group
Description:
Patients will stay on their previous immunosuppressive regimen.
Treatment:
Drug: Ciclosporin
Drug: Azathioprine
Drug: Mycophenolate
Drug: Tacrolimus

Trial contacts and locations

15

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Data sourced from clinicaltrials.gov

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