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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01620268
Recruitment Status : Terminated (Lack of recruitment)
First Posted : June 15, 2012
Last Update Posted : December 5, 2018
Sponsor:
Information provided by (Responsible Party):
Changzheng-Cinkate

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.

Condition or disease Intervention/treatment Phase
Viruria Viremia Drug: Leflunomide and orotic acid Phase 2

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 24 participants
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
Actual Study Start Date : July 2012
Actual Primary Completion Date : June 2018
Actual Study Completion Date : June 2018

Resource links provided by the National Library of Medicine

Drug Information available for: Leflunomide

Arm Intervention/treatment
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




Primary Outcome Measures :
  1. 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 :
  1. 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

  2. Absence of Polyoma BK Nephropathy [ Time Frame: 12 weeks ]
    Absence of Polyoma BK Nephropathy

  3. No rejection of the renal allograft [ Time Frame: 12 weeks ]
    No rejection of the renal allograft



Information from the National Library of Medicine

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, Learn About Clinical Studies.


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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
Criteria

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.

Information from the National Library of Medicine

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


Locations
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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
Rush Univeristy
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
IU Health
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
Sponsors and Collaborators
Changzheng-Cinkate
Investigators
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Principal Investigator: James W Williams, MD Cinkate Corp

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Responsible Party: Changzheng-Cinkate
ClinicalTrials.gov Identifier: NCT01620268    
Other Study ID Numbers: CK2012-001
First Posted: June 15, 2012    Key Record Dates
Last Update Posted: December 5, 2018
Last Verified: December 2018
Keywords provided by Changzheng-Cinkate:
leflunomide
orotic acid
Polyoma BK Viruria
Polyoma BK Viremia
Polyoma BK Nephropathy
Renal Allograft Rejection
Additional relevant MeSH terms:
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Viremia
Virus Diseases
Sepsis
Systemic Inflammatory Response Syndrome
Inflammation
Pathologic Processes
Leflunomide
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs