Study Stopped
Lack of recruitment
An Open-Label, Study to Treat Patients With Renal Allograft and Polyoma BK Viruria
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
1 other identifier
interventional
24
1 country
9
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_2
Started Jul 2012
Longer than P75 for phase_2
9 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
June 13, 2012
CompletedFirst Posted
Study publicly available on registry
June 15, 2012
CompletedStudy Start
First participant enrolled
July 1, 2012
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2018
CompletedStudy Completion
Last participant's last visit for all outcomes
June 1, 2018
CompletedDecember 5, 2018
December 1, 2018
5.9 years
June 13, 2012
December 3, 2018
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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.
12 weeks
Secondary Outcomes (3)
Absence of viremia
12 weeks
Absence of Polyoma BK Nephropathy
12 weeks
No rejection of the renal allograft
12 weeks
Study Arms (2)
Control Group
NO INTERVENTIONPatients receive standard of care.
Treatment Group
EXPERIMENTALDose adjusted leflunomide plus 600 mg orotic acid.
Interventions
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
Eligibility Criteria
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 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (9)
University of Alabama, Birmingham
Birmingham, Alabama, 35294, United States
Tampa General Hospital
Tampa, Florida, 33606, United States
Rush Univeristy
Chicago, Illinois, 60612, United States
University of Illinois, Chicago
Chicago, Illinois, 60612, United States
The University of Chicago Transplant Center
Chicago, Illinois, 60637, United States
IU Health
Indianapolis, Indiana, 46202, United States
University of Lousiville
Louisville, Kentucky, 40202, United States
Beth Israel Deaconess Hospital
Boston, Massachusetts, 02215, United States
Methodist University Hospital
Memphis, Tennessee, 38104, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
James W Williams, MD
Cinkate Corp
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
June 13, 2012
First Posted
June 15, 2012
Study Start
July 1, 2012
Primary Completion
June 1, 2018
Study Completion
June 1, 2018
Last Updated
December 5, 2018
Record last verified: 2018-12