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Clinical Trials/EUCTR2006-001528-38-DE
EUCTR2006-001528-38-DE
Active, not recruiting
Not Applicable

Prevention of skin cancer in high risk patients after conversion a to Sirolimus-based immunosuppressive - PROSKI

Charité Universitätsmedizin Berlin0 sitesOctober 17, 2006
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ConditionsMedical condition: renal transplant-patients at high-risk for skin cancerTransplant recipients have a high risk to develop skin malignancies. This depends on the immunosuppressive drugs and is related to the dosage. This study assesses whether a switch to a SRL-immunosuppressive therapy decreases the incidence/reoccurence of skin neoplasm.
DrugsRapamune

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Medical condition: renal transplant-patients at high-risk for skin cancerTransplant recipients have a high risk to develop skin malignancies. This depends on the immunosuppressive drugs and is related to the dosage. This study assesses whether a switch to a SRL-immunosuppressive therapy decreases the incidence/reoccurence of skin neoplasm.
Sponsor
Charité Universitätsmedizin Berlin
Status
Active, not recruiting
Last Updated
14 years ago
OverviewInvestigatorsEligibility CriteriaOutcomesSimilar Trials

Overview

Brief Summary

No summary available.

Registry
who.int
Start Date
October 17, 2006
End Date
TBD
Last Updated
14 years ago
Study Type
Interventional clinical trial of medicinal product
Sex
All

Investigators

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)
  • •Are the trial subjects under 18? no
  • •Number of subjects for this age range:
  • •F.1\.2 Adults (18\-64 years) yes

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

Outcomes

Primary Outcomes

Not specified

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