ERKNet

The European Rare Kidney Disease Reference Network

  

Research Project

Project Title:

IVIST Study

Project Type:

Clinical Trial, Enrolment terminated
Adjunct biobank: Serum, Plasma, Urine

Disease group(s):

Pediatric kidney transplantation

Project Summary:

Background:
The adminstration of immuosuppressive therapy required for graft survival following kidney transplantation is associated with impaired cellular immune defence associated with increased risks of viral complications. Furthermore, immunosuppression levels can not be accurately determined by trough level monitoring of immunosuppressants. We have already shown that virus-specific T cells (Tvis) correlated with control of viral replication as well as the degree of immunosuppression. The IVIST-Trial should prove if additional steering of immunosuppression and antiviral therapy by Tvis-levels leads to better graft function by avoidance overimmunosuppresion and drug toxicity.
Methods and Design
Pediatric patients will be prospectively enrolled in this study, randomized 4 weeks after transplantation, and treated either conservatively or with additional monitoring for Tvis. The randomization will be stratified by center and cytomegalovirus (CMV) prophylaxis. In the non-intervention group the immunosuppressive therapy (Cyclosporine A and Everolimus) will be based only on classical trough level monitoring and antiviral therapy performed according to our standard protocol. In the intervention group immunosuppressive therapy will be modified based on Tvis levels serving as a direct measure of the degree of immunosuppression in addition to classical trough level monitoring. In both groups, immunosuppressive medication will be adminstered in the normal target trough level range. The primary endpoint of the study will be the Glomerular filtration rate (GFR) two 2 years after transplantation.
Discussion
This trial with answer the question, if our new concept of immunosuppression and antiviral therapy by Tvis levels leads to better future graft function and therefore should be incorporated in routine care after kidney transplantation.

Lead principal investigator(s):

Lars Pape, Hannover

Project Period:

04/2014   -   04/2019

Sponsors:

Industry, National funding agency

EudraCT Nr.:

2009-012436-3

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