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Prevention of Skin Cancer in High Risk Patients After Conversion to a Sirolimus-based Immunosuppressive Protocol | Clinical Trials | Clareo Health

TERMINATEDPHASE4

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

NCT01797315•University Hospital of Berlin

View on ClinicalTrials.gov

Summary

Transplant recipients have a high risk to develop skin malignancies. This effect depends on the one hand on the immunosuppressive drugs themselves and relates on the other hand on the dosage. 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.

Eligibility

Age

18 - No limit years

Sex

ALL

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
•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)
•All contraindications to SRL (see package insert, appendix)
•Persons who are detained officially or legally to an official institute
•Acute infections (mycotic, viral or bacterial)
+8 more criteria

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 (300 mg/dl), Triglycerides \> 4 mmol/l (350 mg/dl)
•Leucopenia \< 2500/nl
•Thrombocytopenia \< 90/nl
•Pregnancy or breastfeeding
•Women of childbearing age without highly effective contraception
•Known allergy to macrolides
+2 more criteria

Key Dates

Start Date

March 1, 2007

Primary Completion Date

April 1, 2011

Completion Date

June 1, 2013

Last Updated

May 4, 2017

Enrollment

ACTUAL participants

Conditions

Renal Transplant Patients at High-risk for Skin Cancer

Interventions

Sirolimus

DRUG