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

NCT00866684 PHASE4 TERMINATED Results posted

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.

Details

Lead sponsor	Charite University, Berlin, Germany
Phase	PHASE4
Status	TERMINATED
Enrolment	44
Start date	Mon Jan 01 2007 00:00:00 GMT+0000 (Coordinated Universal Time)
Completion	Tue Apr 19 2011 00:00:00 GMT+0000 (Coordinated Universal Time)

Conditions

• Skin Cancer

Interventions

• Sirolimus
• Azathioprine
• Mycophenolate
• Ciclosporin
• Tacrolimus

Countries

Germany