Using mTOR Inhibitors in the Prevention of BK Nephropathy

Study Status

Open to Enrollment

Study Description

BK virus nephropathy has become an important cause of graft loss of transplanted kidneys.  To prevent BKV nephropathy, patients are monitored for BK viremia.  Intervention at the stage of viremia may prevent BK virus nephropathy.  Standard intervention when BK viremia is detected is to reduce immunosuppressive agents. The majority of patients are maintained on two standard immunosuppressive agents: Tacrolimus, a calcineurin inhibitor, and Mycophenolic Acid.  

This is an open-label, randomized, prospective study to examine whether substitution of Tacrolimus with Sirolimus, an mTOR inhibitor, lowers BK viremia in post-transplant patients better than the typical reduction of calcineurin inhibition by Tacrolimus. 

Approximately 60 post-transplant subjects with detected BK viremia will be recruited from Columbia University Medical Center and Weill Cornell Medical College (approximately 30 subjects from WCMC are expected).  Subjects will be randomized to receive either:

1)       a reduction of Tacrolimus and Mycophenolic Acid; or

2)       a substitution of Tacrolimus with Sirolimus, with a reduction of Mycophenolic Acid. 

Subjects will be followed for 12-24 months, with lab tests at regular intervals, according to standard of care.  Research-specific blood and urine will be collected for biomarker testing at enrollment, at the time of standard-of-care biopsies, and when substantial changes in BK viremia are detected. 

This study will also measure the incidence of BK nephropathy, incidence of proteinuria, patient and allograft survival at one-year post-transplant, and estimate GFR (MDRD).

Sponsor

Pfizer, Columbia University

Key Eligibility

  • At least 18 years old
  • Received a transplant at Columbia University Medical Center or Weill Cornell Medical Center
  • Currently receiving standard-of-care immunosuppressive treatment of Tacrolimus (Prograf) + Mycophenolic Acid (MMF)
  • Have BK viremia (>600 copies/ml). Patients will not be randomized until the viral load exceeds 5000 copies/ml

Principal Investigator

Darshana Dadhania, MD

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Contact Us

For general inquiries, or if you need assistance finding a study, please contact:

Robert Hagerty
Subject Recruitment Manager
Tel: (646) 962-9340
[email protected]

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