Clinical trial NCT01289301: Studying the Effect of Changing Immunosuppression in Case of Polyoma BK Virus Infection of the Renal Transplant
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
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Disorder Related to Renal Transplantation
Immunosuppression Related Infectious Disease
Virus Diseases
Keywords: renal transplantation
polyoma BK virus infection
everolimus
calcineurin inhibitor
mTOR inhibitor
Lead sponsor: Hannover Medical School
Sponsor class: OTHER
First posted: 2011-02-03
Enrollment: 124
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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 (n=62) will be switched from CNI to everolimus while the control group (n=62) 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.

Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

* allergy or non-tolerance of the study medication everolimus
* pregnancy

Primary outcomes:
measure: death or graft loss
timeFrame: 2 years of observation
Secondary outcomes:
measure: decrease of polyomavirus serum PCR
timeFrame: 2 years
measure: decrease of creatinine
timeFrame: 2 years observation
measure: progression of chronic changes in renal histology
timeFrame: renal biopsy 3 months after intervention
measure: number of rejections following intervention
timeFrame: 2 years after intervention
measure: increase of BKV-specific T-cells
timeFrame: 2 years observation
Other outcomes:
Locations:
city: Freiburg
country: Germany
facility: University Hospital Freiburg, Transplant Outpatient Clinic
state: Baden-Württemberg
city: Erlangen
country: Germany
facility: University of Erlangen/ Nürnberg, Transplant Outpatient Clinic
state: Bayern
city: Hannover
country: Germany
facility: Hannover Medical School, Transplant Outpatient Clinic
state: Niedersachsen
city: Essen
country: Germany
facility: University of Essen, Transplant Outpatient Clinic
state: Ruhrgebiet
Study officials:
affiliation: Hannover Medical School, Nephrology
name: Anke Schwarz, Prof. Dr.
role: PRINCIPAL_INVESTIGATOR
affiliation: Hannover Medical School, Nephrology
name: Hermann Haller, Prof. Dr.
role: PRINCIPAL_INVESTIGATOR
affiliation: Hannover Medical School, Nephrology
name: Silvia Linnenweber, Dr.
role: STUDY_CHAIR
affiliation: Hannover Medical School, Biometry
name: Armin Koch, Prof. Dr.
role: STUDY_DIRECTOR
affiliation: Hannover Medical School, Virology
name: Albert Heim, PD Dr.
role: STUDY_DIRECTOR
affiliation: Hannover Medical School, Pathology
name: Verena Broecker, Dr.
role: STUDY_CHAIR
References: