Studying the Effect of Changing Immunosuppression in Case of Polyoma BK Virus Infection of the Renal Transplant
BKVIRUS
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
1 other identifier
interventional
124
1 country
4
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_4
Started Oct 2011
Longer than P75 for phase_4
4 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
February 2, 2011
CompletedFirst Posted
Study publicly available on registry
February 3, 2011
CompletedStudy Start
First participant enrolled
October 1, 2011
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 1, 2017
CompletedStudy Completion
Last participant's last visit for all outcomes
October 1, 2018
CompletedFebruary 3, 2011
October 1, 2010
6 years
February 2, 2011
February 2, 2011
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
death or graft loss
after experimental intervention (switch to mTOR inhibitor in group 1) and control intervention (general reduction of immunosuppression) observation of graft function
2 years of observation
Secondary Outcomes (5)
decrease of polyomavirus serum PCR
2 years
decrease of creatinine
2 years observation
progression of chronic changes in renal histology
renal biopsy 3 months after intervention
number of rejections following intervention
2 years after intervention
increase of BKV-specific T-cells
2 years observation
Study Arms (2)
mTOR-receiving arm
EXPERIMENTALswitching from calcineurin-inhibitor-based immunosuppression to mTOR-based immunosuppression
calcineurin-inhibitor keeping arm
ACTIVE COMPARATORcontinuing calcineurin-inhibitor based immunosuppression
Interventions
calcineurin-inhibitor based immunosuppression will be switched to immunosuppression based on m-TOR inhibitor (everolimus trough level 3-7ng/mL)
calcineurin inhibitor (cyclosporine or tacrolimus) will be continued (trough level 60-90ng/mL resp 3-7ng/mL)
Eligibility Criteria
You may qualify if:
- preceding renal transplantation
- functioning graft with a permanent creatinine clearance of more than 25mL/min
- biopsy-confirmed polyoma BK virus nephropathy
- age over 18 years old
You may not qualify if:
- allergy or non-tolerance of the study medication everolimus
- pregnancy
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (4)
University Hospital Freiburg, Transplant Outpatient Clinic
Freiburg im Breisgau, Baden-Wurttemberg, D-79104, Germany
University of Erlangen/ Nürnberg, Transplant Outpatient Clinic
Erlangen, Bavaria, D-91054, Germany
Hannover Medical School, Transplant Outpatient Clinic
Hanover, Lower Saxony, D-30625, Germany
University of Essen, Transplant Outpatient Clinic
Essen, Ruhrgebiet, D-45122, Germany
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Anke Schwarz, Prof. Dr.
Hannover Medical School, Nephrology
- PRINCIPAL INVESTIGATOR
Hermann Haller, Prof. Dr.
Hannover Medical School, Nephrology
- STUDY CHAIR
Silvia Linnenweber, Dr.
Hannover Medical School, Nephrology
- STUDY DIRECTOR
Armin Koch, Prof. Dr.
Hannover Medical School, Biometry
- STUDY DIRECTOR
Albert Heim, PD Dr.
Hannover Medical School, Virology
- STUDY CHAIR
Verena Broecker, Dr.
Hannover Medical School, Pathology
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
Study Record Dates
First Submitted
February 2, 2011
First Posted
February 3, 2011
Study Start
October 1, 2011
Primary Completion
October 1, 2017
Study Completion
October 1, 2018
Last Updated
February 3, 2011
Record last verified: 2010-10