Ignite Creation Date:
2024-05-05 @ 11:13 PM
Last Modification Date:
2024-10-26 @ 10:31 AM
Study NCT ID:
NCT01289301
Status:
UNKNOWN
Last Update Posted:
2011-02-03
First Post:
2011-02-02
Brief Title:
Studying the Effect of Changing Immunosuppression in Case of Polyoma BK Virus Infection of the Renal Transplant
Sponsor:
Hannover Medical School
Organization:
Hannover Medical School
Study Overview
Official Title:
Polyomavirus BK Nephropathy After Renal Transplantation Randomized Clinical Trial to Demonstrate That Switching to mTOR Inhibitor is More Effective Than a Reduction of Immunosuppressive Therapy
Status:
UNKNOWN
Status Verified Date:
2010-10
Last Known Status:
NOT_YET_RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
BKVIRUS
Brief Summary:
Polyomavirus BK nephropathy is a serious complication after renal transplantation leading to graft loss in 40 of cases Since no virustatic drug exists the investigators want to study the best way to manage viral invasion by changing the immunosuppressive treatment comparing two treatment schemes The investigators hypothesis is that switching to an mTOR-based scheme is superior to a general decrease of a calcineurin inhibitor CNI-based scheme The study will be performed as a prospective randomized parallel group comparison
Detailed Description:
The study group n62 will be switched from CNI to everolimus while the control group n62 will get a general reduction of the CNI-based immunosuppression Follow-up and duration of intervention per patient will be 24 months duration of the trial 72 months including 4 years of recruitment
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