Ignite Creation Date:
2024-05-05 @ 9:19 PM
Last Modification Date:
2024-10-26 @ 10:03 AM
Study NCT ID:
NCT00866684
Status:
TERMINATED
Last Update Posted:
2015-09-02
First Post:
2009-03-19
Brief Title:
Prevention of Skin Cancer in High Risk Patients After Conversion to a Sirolimus-based Immunosuppressive Protocol
Sponsor:
Charite University Berlin Germany
Organization:
Charite University Berlin Germany
Study Overview
Official Title:
Prevention of Skin Cancer in High Risk Patients After Conversion to a Sirolimus-based Immunosuppressive Protocol
Status:
TERMINATED
Status Verified Date:
2015-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Insufficient patient recruitment
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
PROSKIN
Brief Summary:
Transplant recipients have a high risk to develop skin malignancies This effect depends on the one hand on the immunosuppressive drugs themselves ie azathioprine and relates on the other hand on the dosage ie 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 incidencereoccurrence of skin neoplasm
This study was designed to assess whether a switch to a SRL-immunosuppressive therapy decreases the incidencereoccurrence of skin neoplasm
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None