Prevention of Skin Cancer in High Risk Patients After Conversion to a Sirolimus-based Immunosuppressive Protocol
Summary
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.
Timeline
- Start
- 2007-01-01
- Primary completion
- 2011-04-19
- Completion
- 2011-04-19
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Sirolimus | Small molecule | 4 ng/ml | Oral |
| Subject | Sirolimus | Small molecule | 8 ng/ml | Oral |
| Comparator | Azathioprine | Small molecule | 1 mg/kg | — |
| Comparator | Azathioprine | Small molecule | 4 mg/kg | — |
| Comparator | Cyclosporine | Peptide | 50 ng/ml | — |
| Comparator | Cyclosporine | Peptide | 80 ng/ml | — |
| Comparator | Mycophenolate Sodium | Unknown | 2 g | — |
| Comparator | Tacrolimus | Small molecule | 3 ng/ml | — |
| Comparator | Tacrolimus | Small molecule | 5 ng/ml | — |