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

H

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)

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

Trial contacts and locations

4

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Central trial contact

Anke Schwarz, Prof. Dr.; Hermann Haller, Prof. Dr.

Data sourced from clinicaltrials.gov

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