An Open-Label, Study to Treat Patients With Renal Allograft and Polyoma BK Viruria

Stopped early · Phase 2

Conditions studied: Viruria, Viremia

In brief

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.

Key facts

Study ID

NCT01620268

Run by

Changzheng-Cinkate

People needed

24

Starts

2012-07-01

Expected to finish

2018-06-01

Last updated by the study team

2018-12-05

Who can join

Age: any, up to 75. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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
• No other active infections
• Receiving CyA or Tacrolimus, Mycophenolate/Azathioprine + prednisone.
• Is not pregnant as verified by a pregnancy test

You may not qualify if…

• 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),
• Has a cancer diagnosis within past five years with potential for recurrence.
• Has received experimental drug within past 3 months.
• Is receiving immune suppressive drug other than those listed above calcineurin inhibitor, mycophenolate/azathioprine and +/- corticosteroid)
• Is a woman of child bearing potential or is a male with female partner of child bearing potential who is unwilling to use reliable contraception.
• Has any neurologic abnormalities including peripheral neuropathy.
• Is receiving concomitant therapy with drug known to have hepatotoxic risk.
• Has known or suspected liver disease or current alcohol abuse.

Where it is running

• 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 — 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

Full record on ClinicalTrials.gov

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