An Open-Label, Study to Treat Patients With Renal Allograft and Polyoma BK Viruria
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|ClinicalTrials.gov Identifier: NCT01620268|
Recruitment Status : Terminated (Lack of recruitment)
First Posted : June 15, 2012
Last Update Posted : December 5, 2018
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|Condition or disease||Intervention/treatment||Phase|
|Viruria Viremia||Drug: Leflunomide and orotic acid||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||24 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||An Open-Label, Phase 2 Study to Treat Patients With Renal Allograft and Polyoma BK Viruria to Prevent Polyoma BK Viremia, Polyoma BK Nephropathy and Renal Allograft Rejection|
|Actual Study Start Date :||July 2012|
|Actual Primary Completion Date :||June 2018|
|Actual Study Completion Date :||June 2018|
No Intervention: Control Group
Patients receive standard of care.
Experimental: Treatment Group
Dose adjusted leflunomide plus 600 mg orotic acid.
Drug: Leflunomide and orotic acid
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
- Clearance of viruria [ Time Frame: 12 weeks ]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.
- Absence of viremia [ Time Frame: 12 weeks ]No more that 1000 copies of Polyoma BK Virus in the blood on two consecutive tests 2 weeks or more apart
- Absence of Polyoma BK Nephropathy [ Time Frame: 12 weeks ]Absence of Polyoma BK Nephropathy
- No rejection of the renal allograft [ Time Frame: 12 weeks ]No rejection of the renal allograft
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|Ages Eligible for Study:||up to 75 Years (Child, Adult, Older Adult)|
|Sexes Eligible for Study:||All|
|Accepts Healthy Volunteers:||No|
- 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
- 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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01620268
|United States, Alabama|
|University of Alabama, Birmingham|
|Birmingham, Alabama, United States, 35294|
|United States, Florida|
|Tampa General Hospital|
|Tampa, Florida, United States, 33606|
|United States, Illinois|
|Chicago, Illinois, United States, 60612|
|University of Illinois, Chicago|
|Chicago, Illinois, United States, 60612|
|The University of Chicago Transplant Center|
|Chicago, Illinois, United States, 60637|
|United States, Indiana|
|Indianapolis, Indiana, United States, 46202|
|United States, Kentucky|
|University of Lousiville|
|Louisville, Kentucky, United States, 40202|
|United States, Massachusetts|
|Beth Israel Deaconess Hospital|
|Boston, Massachusetts, United States, 02215|
|United States, Tennessee|
|Methodist University Hospital|
|Memphis, Tennessee, United States, 38104|
|Principal Investigator:||James W Williams, MD||Cinkate Corp|
|Other Study ID Numbers:||
|First Posted:||June 15, 2012 Key Record Dates|
|Last Update Posted:||December 5, 2018|
|Last Verified:||December 2018|
Polyoma BK Viruria
Polyoma BK Viremia
Polyoma BK Nephropathy
Renal Allograft Rejection
Systemic Inflammatory Response Syndrome
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs