drugset / Trial / NCT01289301

Studying the Effect of Changing Immunosuppression in Case of Polyoma BK Virus Infection of the Renal Transplant

NCT01289301

Phase 4 Unknown 124 enrolled Hannover Medical School
RandomizedParallel-groupOpen-labelTreatment

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.

Timeline

Start
2011-10
Primary completion
2017-10
Completion
2018-10

Drugs

EvaluationDrugModalityDoseRoute
Subject Everolimus Small molecule
Comparator Cyclosporine Peptide
Comparator Tacrolimus Small molecule