An Open-Label, Study to Treat Patients With Renal Allograft and Polyoma BK Viruria (NCT01620268) | Clinical Trial Compass
TerminatedPhase 2
An Open-Label, Study to Treat Patients With Renal Allograft and Polyoma BK Viruria
Stopped: Lack of recruitment
United States24 participantsStarted 2012-07
Plain-language summary
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.
Who can participate
Age range75 Years
SexALL
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Inclusion criteria
✓. Patients, 75 years of age or less, with the diagnosis of renal allograft Polyoma BK viruria of 10 million or more copies/mL in their urine confirmed by PCR at the central laboratory.
✓. No viremia (viremia is defined as greater than 1,000 copies/ml plasma on two consecutive tests two weeks or more apart as measured at the designated central laboratory),
✓. Serum creatinine \<2.0 mg/dL
✓. Hct \> 30%
✓. WBC \> 3,500 x 103/L
✓. Platelet count \> 150,000 x 103/L
✓. Normal values for ALT, AST and bilirubin; Alk Phos \< 2 X upper limits of normal
✓. No symptomatic cardiac, pulmonary, GI, hepatic or neurologic disease
Exclusion criteria
✕. Is not able to comply with study procedures and dosing.
✕. Has psychiatric instability.
✕. Has an active systemic infection including Hepatitis B or C, HIV, or on anti-viral therapy within seven days of entering the study. Note however, that the subjects may be taking ganciclovir, valaciclovir, acyclovir and valganciclovir and therefore these are not exclusionary antiviral medications.
✕. Has BK viremia (viremia is defined as greater than 1,000 copies/ml plasma on two consecutive tests two weeks or more apart as measured at the designated central laboratory), or has had a single episode of BK viremia. (viremia is defined as greater than 1,000 copies/ml plasma on two consecutive tests two weeks or more apart as measured at the designated central laboratory or the local laboratory),