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

This study is currently recruiting participants.
See Contacts and Locations
Verified July 2016 by Changzheng-Cinkate
Information provided by (Responsible Party):
Changzheng-Cinkate Identifier:
First received: June 13, 2012
Last updated: July 25, 2016
Last verified: July 2016
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.

Condition Intervention Phase
Viruria Viremia Drug: Leflunomide and orotic acid Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
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

Resource links provided by NLM:

Further study details as provided by Changzheng-Cinkate:

Primary Outcome Measures:
  • 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.

Secondary Outcome Measures:
  • 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

Estimated Enrollment: 60
Study Start Date: July 2012
Estimated Study Completion Date: March 2018
Estimated Primary Completion Date: December 2017 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

Detailed Description:
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.

Ages Eligible for Study:   up to 75 Years   (Child, Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  1. 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.
  2. 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),
  3. Serum creatinine <2.0 mg/dL
  4. Hct > 30%
  5. WBC > 3,500 x 103/L
  6. Platelet count > 150,000 x 103/L
  7. Normal values for ALT, AST and bilirubin; Alk Phos < 2 X upper limits of normal
  8. No symptomatic cardiac, pulmonary, GI, hepatic or neurologic disease
  9. No other active infections
  10. Receiving CyA or Tacrolimus, Mycophenolate/Azathioprine + prednisone.
  11. Is not pregnant as verified by a pregnancy test

Exclusion Criteria:

  1. Is not able to comply with study procedures and dosing.
  2. Has psychiatric instability.
  3. 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.
  4. 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),
  5. Has a cancer diagnosis within past five years with potential for recurrence.
  6. Has received experimental drug within past 3 months.
  7. Is receiving immune suppressive drug other than those listed above calcineurin inhibitor, mycophenolate/azathioprine and +/- corticosteroid)
  8. 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.
  9. Has any neurologic abnormalities including peripheral neuropathy.
  10. Is receiving concomitant therapy with drug known to have hepatotoxic risk.
  11. Has known or suspected liver disease or current alcohol abuse.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT01620268

Contact: James W. Williams, MD 7734263209
Contact: James L Yeager, PhD 8472839176

United States, Alabama
University of Alabama, Birmingham Recruiting
Birmingham, Alabama, United States, 35294
Contact: Tina Ayer, BS,CCRP    205-996-2577   
Principal Investigator: Clifton Kew, MD         
United States, Florida
Tampa General Hospital Recruiting
Tampa, Florida, United States, 33606
Contact: Deborah Fernandez, RN    813-844-5692   
Principal Investigator: Rajendra Baliga, MD         
United States, Illinois
Rush Univeristy Recruiting
Chicago, Illinois, United States, 60612
Contact: Cherese Pullum, BSN    312-563-4249   
Principal Investigator: Edward Hollinger, MD         
University of Illinois, Chicago Recruiting
Chicago, Illinois, United States, 60612
Contact: Patricia Thielke, PharmD    312-996-5695   
Principal Investigator: Ignatus Tang, MD         
The University of Chicago Transplant Center Recruiting
Chicago, Illinois, United States, 60637
Contact: Mark Lockwood, MSN, RN    773-834-0684   
Principal Investigator: Michelle Josephson, MD         
United States, Indiana
IU Health Recruiting
Indianapolis, Indiana, United States, 46202
Contact: Kristen Ponsler-Sipes    317-944-7580   
Principal Investigator: Tim Taber, MD         
United States, Kentucky
University of Lousiville Recruiting
Louisville, Kentucky, United States, 40202
Contact: Anne M Webb, RN, BSN    502-587-4106   
Principal Investigator: Mary Eng, MD         
Principal Investigator: Rosmary Ouseph, MD         
United States, Massachusetts
Beth Israel Deaconess Hospital Recruiting
Boston, Massachusetts, United States, 02215
Contact: Susan M McDermott, RN, MPH    617-632-9841   
Principal Investigator: Martha Pavlakis, MD         
United States, Tennessee
Methodist University Hospital Recruiting
Memphis, Tennessee, United States, 38104
Contact: Carol B Jones, RN, BSN    901-516-8078   
Principal Investigator: Vinaya Rao, MD         
Sponsors and Collaborators
Principal Investigator: James W Williams, MD Cinkate Corp
  More Information

Responsible Party: Changzheng-Cinkate Identifier: NCT01620268     History of Changes
Other Study ID Numbers: CK2012-001
Study First Received: June 13, 2012
Last Updated: July 25, 2016

Keywords provided by Changzheng-Cinkate:
orotic acid
Polyoma BK Viruria
Polyoma BK Viremia
Polyoma BK Nephropathy
Renal Allograft Rejection

Additional relevant MeSH terms:
Virus Diseases
Systemic Inflammatory Response Syndrome
Pathologic Processes
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Antirheumatic Agents processed this record on August 18, 2017