Text Size

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

December 16, 2009
October 9, 2012
February 2009
June 2012   (final data collection date for primary outcome measure)
decrease BK viremia [ Time Frame: 3 months after treatment completion ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01034176 on ClinicalTrials.gov Archive Site
decrease BK viremia [ Time Frame: 6 months after treatment ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
BK Treatment Study
Effect of Fluoroquinolones on BK Viremia in the Renal Transplant Recipient, A Multi-Center Study

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.
Not Provided
Interventional
Phase 4
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
BK Viremia
  • Drug: levofloxacin
    500 mg tablet, daily, 30 days
    Other Name: Levaquin
  • Drug: placebo
    no dose, tablet, daily, 30 days
  • Active Comparator: Levofloxacin
    Levofloxacin 500 mg every day (dose adjusted for renal function) for 30 days
    Intervention: Drug: levofloxacin
  • Placebo Comparator: placebo
    placebo identical to levofloxacin drug daily for 30 days
    Intervention: Drug: placebo

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
46
October 2012
June 2012   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01034176
2009p000020
No
Anil K. Chandraker, MD, Brigham and Women's Hospital
Brigham and Women's Hospital
Not Provided
Principal Investigator: Anil Chandraker, MD Brigham and Women's Hospital
Brigham and Women's Hospital
October 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP