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

Hannover Medical School (MHH)

Status and phase: Unknown; Phase 4

Conditions: Disorder Related to Renal Transplantation; Virus Diseases; Immunosuppression Related Infectious Disease

Treatments: Drug: cyclosporine or tacrolimus; Drug: mTOR inhibitor (everolimus)

Study type: Interventional

Funder types: Other

Identifiers

NCT01289301

Polyoma IFB 29

Details and patient eligibility

About

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.

Full 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.

Enrollment: 124 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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124 participants in 2 patient groups

mTOR-receiving arm

Experimental group

Description:

switching from calcineurin-inhibitor-based immunosuppression to mTOR-based immunosuppression

Treatment:

Drug: mTOR inhibitor (everolimus)

calcineurin-inhibitor keeping arm

Active Comparator group

Description:

continuing calcineurin-inhibitor based immunosuppression

Treatment:

Drug: cyclosporine or tacrolimus