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BK Treatment Study

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01034176
First Posted: December 17, 2009
Last Update Posted: April 24, 2017
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.
Information provided by (Responsible Party):
Anil K. Chandraker, MD, Brigham and Women's Hospital
  Purpose
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 Intervention Phase
BK Viremia Drug: levofloxacin Drug: placebo Phase 4

Study Type: Interventional
Study Design: 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

Resource links provided by NLM:


Further study details as provided by Anil K. Chandraker, MD, Brigham and Women's Hospital:

Primary Outcome Measures:
  • 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:
  • 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


Enrollment: 43
Study Start Date: February 2009
Study Completion Date: October 2012
Primary Completion Date: June 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Information from the National Library of Medicine

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

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
  Contacts and Locations
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): NCT01034176


Locations
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
Investigators
Principal Investigator: Anil Chandraker, MD Brigham and Women's Hospital
  More Information

Publications:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Anil K. Chandraker, MD, Medical Director of Renal Transplantation, Brigham and Women's Hospital
ClinicalTrials.gov Identifier: NCT01034176     History of Changes
Other Study ID Numbers: 2009p000020
First Submitted: December 16, 2009
First Posted: December 17, 2009
Results First Submitted: January 21, 2014
Results First Posted: April 24, 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:
Viremia
Virus Diseases
Sepsis
Systemic Inflammatory Response Syndrome
Inflammation
Pathologic Processes
Levofloxacin
Ofloxacin
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