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BK Treatment Study

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. Identifier: NCT01034176
Recruitment Status : Completed
First Posted : December 17, 2009
Results First Posted : March 6, 2017
Last Update Posted : April 24, 2017
Information provided by (Responsible Party):
Anil K. Chandraker, MD, Brigham and Women's Hospital

Brief Summary:
Our hypothesis is that 30 days of oral levofloxacin (FDA approved antibiotic) in patients with persistent viremia (BK virus found in blood) will impair progress to BK virus induced kidney damage by significantly decreasing or eliminating BK virus in the blood.

Condition or disease Intervention/treatment Phase
BK Viremia Drug: levofloxacin Drug: placebo Phase 4

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 43 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Effect of Fluoroquinolones on BK Viremia in the Renal Transplant Recipient, A Multi-Center Study
Study Start Date : February 2009
Actual Primary Completion Date : June 2012
Actual Study Completion Date : October 2012

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Active Comparator: Levofloxacin
Levofloxacin 500 mg every day (dose adjusted for renal function) for 30 days
Drug: levofloxacin
500 mg tablet, daily, 30 days
Other Name: Levaquin

Placebo Comparator: placebo
placebo identical to levofloxacin drug daily for 30 days
Drug: placebo
no dose, tablet, daily, 30 days

Primary Outcome Measures :
  1. Percent Change From Baseline in BK Virus Copies at 3 Months [ Time Frame: Baseline and 3 months ]
    Percent change in BK virus copies/mL from Baseline to 3 months

Secondary Outcome Measures :
  1. Number of Patients With >50% Reduction in BK Virus Copies [ Time Frame: Baseline and 6 months ]
    Number of patients with >50% reduction in BK viral load at 6 months

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Living and cadaveric kidney transplant recipients over the age of 18 years with BK viremia

Exclusion Criteria:

  • Female patients of childbearing age who are pregnant or in whom adequate contraception cannot be maintained.
  • Patients with active infections, history of malignancy/Posttransplant Lymphoproliferative Disease (PTLD) serologic positivity to HIV.
  • Patients with evidence of urinary tract obstruction causing allograft dysfunction, unless corrected by time of enrollment.
  • Patients with clinical or morphological evidence of recurrence of primary disease.
  • Patients with a history of allergic reaction to quinolone antibiotics.
  • Patients with history of prolong QT interval
  • Patients with recurrent hypoglycemic episodes
  • Patients with history of myasthenia gravis
  • Patients taking Thioridazine

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 identifier (NCT number): NCT01034176

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United States, Massachusetts
Massachusetts General Hospital
Boston, Massachusetts, United States, 02114
Brigham and Women's Hospital
Boston, Massachusetts, United States, 02115
Beth Israel Deaconess Medical Center
Boston, Massachusetts, United States, 02215
Lahey Clinic Medical Center
Burlington, Massachusetts, United States, 01805
UMASS Memorial Medical Center
Worcester, Massachusetts, United States, 01655
United States, New York
Montefiore Medical Center
Bronx, New York, United States, 10467
United States, Vermont
Fletcher Allen Health Care/University of Vermont
Burlington, Vermont, United States, 05401
United States, Wisconsin
University of Wisconsin Hospital
Madison, Wisconsin, United States, 53792
Sponsors and Collaborators
Brigham and Women's Hospital
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Principal Investigator: Anil Chandraker, MD Brigham and Women's Hospital
Publications automatically indexed to this study by Identifier (NCT Number):
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Responsible Party: Anil K. Chandraker, MD, Medical Director of Renal Transplantation, Brigham and Women's Hospital Identifier: NCT01034176    
Other Study ID Numbers: 2009p000020
First Posted: December 17, 2009    Key Record Dates
Results First Posted: March 6, 2017
Last Update Posted: April 24, 2017
Last Verified: March 2017
Keywords provided by Anil K. Chandraker, MD, Brigham and Women's Hospital:
BK viremia
kidney transplantation
BK viremia in kidney transplant recipients
Additional relevant MeSH terms:
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Virus Diseases
Systemic Inflammatory Response Syndrome
Pathologic Processes
Anti-Infective Agents, Urinary
Anti-Infective Agents
Renal Agents
Anti-Bacterial Agents
Topoisomerase II Inhibitors
Topoisomerase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Cytochrome P-450 CYP1A2 Inhibitors
Cytochrome P-450 Enzyme Inhibitors