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BK Treatment Study

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Anil K. Chandraker, MD, Brigham and Women's Hospital
ClinicalTrials.gov Identifier:
NCT01034176
First received: December 16, 2009
Last updated: October 9, 2012
Last verified: October 2012
History of Changes
  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
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, 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:

U.S. FDA Resources

Further study details as provided by Brigham and Women's Hospital:

Primary Outcome Measures:
  • decrease BK viremia [ Time Frame: 3 months after treatment completion ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • decrease BK viremia [ Time Frame: 6 months after treatment ] [ Designated as safety issue: No ]

Enrollment: 46
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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01034176

Locations
United States, Massachusetts
Brigham and Women's Hospital
Boston, Massachusetts, United States, 02115
Beth Israel Deaconess Medical Center
Boston, Massachusetts, United States, 02215
Massachusetts General Hospital
Boston, Massachusetts, United States, 02114
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:

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
Study First Received: December 16, 2009
Last Updated: October 9, 2012
Health Authority: United States: Institutional Review Board
United States: Food and Drug Administration

Keywords provided by 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
Ofloxacin
Anti-Bacterial Agents
 Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions
Nucleic Acid Synthesis Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Anti-Infective Agents, Urinary
Renal Agents

ClinicalTrials.gov processed this record on May 23, 2013