BK Polyomavirus DNAemia after kidney transplantation
Conditions
Brief summary
Time from randomization to end of BKPyV-DNAemia, where end of BKPyV-DNAemia is defined as the first time point after randomization with BKPyV DNA <1,000 IU/ml or a decline in BKPyV DNA of >1 log10 IU/ml (>90% curtailing) as the best-established surrogate marker in the literature for clearance of BKPyV infection.
Detailed description
Change from baseline to month 9 in estimated glomerular filtration rate (eGFR), Occurrence of acute rejection episodes, Occurrence of donor-specific antibodies, Occurrence of graft loss, Number and dose of immunosuppressants, Trough levels of immunosuppressants, Overall and CNI immunosuppressive scale (IS) units, Level of BKPyV-specific CD4 T cells, Occurrence of BKPyV re-infections
Interventions
DRUGPREDNISOLONE
DRUGMYCOPHENOLATE MOFETIL
DRUGSIROLIMUS
DRUGBELATACEPT
DRUGTACROLIMUS
DRUGEVEROLIMUS
DRUGAZATHIOPRINE
DRUGCICLOSPORIN
DRUGMYCOPHENOLIC ACID
Sponsors
GPOH gGmbH
Eligibility
Sex/Gender
All
Age
0 Years to No maximum
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Time from randomization to end of BKPyV-DNAemia, where end of BKPyV-DNAemia is defined as the first time point after randomization with BKPyV DNA <1,000 IU/ml or a decline in BKPyV DNA of >1 log10 IU/ml (>90% curtailing) as the best-established surrogate marker in the literature for clearance of BKPyV infection. | — |
Secondary
| Measure | Time frame |
|---|---|
| Change from baseline to month 9 in estimated glomerular filtration rate (eGFR), Occurrence of acute rejection episodes, Occurrence of donor-specific antibodies, Occurrence of graft loss, Number and dose of immunosuppressants, Trough levels of immunosuppressants, Overall and CNI immunosuppressive scale (IS) units, Level of BKPyV-specific CD4 T cells, Occurrence of BKPyV re-infections | — |
Countries
Germany
Outcome results
None listed