This study will evaluate the clinical efficacy and safety of a combination of leflunomide and orotic acid in kidney transplant patients with high levels of Polyoma BK viruria for the purpose of preventing Polyoma BK viremia and Nephropathy that could lead to kidney transplant loss from viral damage, acute rejection or both.
This is a multicenter, randomized trial that will evaluate the effect of a combination of leflunomide and orotic acid for the treatment of Polyoma BK viruria. In this multicenter trial, renal allograft patients with the diagnosis of Polyoma BK viruria as determined by a viral level in the urine of 25 million or more copies/mL, and no detectable viremia, will complete a screening visit (V1) to determine eligibility for the study based on inclusion/exclusion criteria. Patients that meet the entrance criteria for this study will be randomly assigned to one of two treatment groups at Visit (2) and enter a 4 month dosing period.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Enrollment
24
Daily dose of leflunomide adjusted to target steady state blood levels of 50 ug/mL to 100 ug/mL of the active metabolite plus 600 mg orotic acid
University of Alabama, Birmingham
Birmingham, Alabama, United States
Tampa General Hospital
Tampa, Florida, United States
Rush Univeristy
Chicago, Illinois, United States
University of Illinois, Chicago
Clearance of viruria
Viral load of Polyoma BK virus in urine reduced from greater than or equal to 10 million copies/mL to less than 500,000 copies/mL or a 2 log reduction in copies/mL.
Time frame: 12 weeks
Absence of viremia
No more that 1000 copies of Polyoma BK Virus in the blood on two consecutive tests 2 weeks or more apart
Time frame: 12 weeks
Absence of Polyoma BK Nephropathy
Absence of Polyoma BK Nephropathy
Time frame: 12 weeks
No rejection of the renal allograft
No rejection of the renal allograft
Time frame: 12 weeks
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Chicago, Illinois, United States
The University of Chicago Transplant Center
Chicago, Illinois, United States
IU Health
Indianapolis, Indiana, United States
University of Lousiville
Louisville, Kentucky, United States
Beth Israel Deaconess Hospital
Boston, Massachusetts, United States
Methodist University Hospital
Memphis, Tennessee, United States