BK Treatment Study
Effect of Fluoroquinolones on BK Viremia in the Renal Transplant Recipient, A Multi-Center Study
1 other identifier
interventional
43
1 country
8
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_4
Started Feb 2009
Longer than P75 for phase_4
8 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
February 1, 2009
CompletedFirst Submitted
Initial submission to the registry
December 16, 2009
CompletedFirst Posted
Study publicly available on registry
December 17, 2009
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2012
CompletedStudy Completion
Last participant's last visit for all outcomes
October 1, 2012
CompletedResults Posted
Study results publicly available
March 6, 2017
CompletedApril 24, 2017
March 1, 2017
3.3 years
December 16, 2009
January 21, 2014
March 24, 2017
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Percent Change From Baseline in BK Virus Copies at 3 Months
Percent change in BK virus copies/mL from Baseline to 3 months
Baseline and 3 months
Secondary Outcomes (1)
Number of Patients With >50% Reduction in BK Virus Copies
Baseline and 6 months
Study Arms (2)
Levofloxacin
ACTIVE COMPARATORLevofloxacin 500 mg every day (dose adjusted for renal function) for 30 days
placebo
PLACEBO COMPARATORplacebo identical to levofloxacin drug daily for 30 days
Interventions
Eligibility Criteria
You may qualify if:
- Living and cadaveric kidney transplant recipients over the age of 18 years with BK viremia
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (8)
Massachusetts General Hospital
Boston, Massachusetts, 02114, United States
Brigham and Women's Hospital
Boston, Massachusetts, 02115, United States
Beth Israel Deaconess Medical Center
Boston, Massachusetts, 02215, United States
Lahey Clinic Medical Center
Burlington, Massachusetts, 01805, United States
UMASS Memorial Medical Center
Worcester, Massachusetts, 01655, United States
Montefiore Medical Center
The Bronx, New York, 10467, United States
Fletcher Allen Health Care/University of Vermont
Burlington, Vermont, 05401, United States
University of Wisconsin Hospital
Madison, Wisconsin, 53792, United States
Related Publications (4)
Leung AY, Chan MT, Yuen KY, Cheng VC, Chan KH, Wong CL, Liang R, Lie AK, Kwong YL. Ciprofloxacin decreased polyoma BK virus load in patients who underwent allogeneic hematopoietic stem cell transplantation. Clin Infect Dis. 2005 Feb 15;40(4):528-37. doi: 10.1086/427291. Epub 2005 Jan 21.
PMID: 15712075BACKGROUNDRandhawa PS. Anti-BK virus activity of ciprofloxacin and related antibiotics. Clin Infect Dis. 2005 Nov 1;41(9):1366-7; author reply 1367. doi: 10.1086/497080. No abstract available.
PMID: 16206122BACKGROUNDWajih Z, Karpe KM, Walters GD. Interventions for BK virus infection in kidney transplant recipients. Cochrane Database Syst Rev. 2024 Oct 9;10(10):CD013344. doi: 10.1002/14651858.CD013344.pub2.
PMID: 39382091DERIVEDLee BT, Gabardi S, Grafals M, Hofmann RM, Akalin E, Aljanabi A, Mandelbrot DA, Adey DB, Heher E, Fan PY, Conte S, Dyer-Ward C, Chandraker A. Efficacy of levofloxacin in the treatment of BK viremia: a multicenter, double-blinded, randomized, placebo-controlled trial. Clin J Am Soc Nephrol. 2014 Mar;9(3):583-9. doi: 10.2215/CJN.04230413. Epub 2014 Jan 30.
PMID: 24482066DERIVED
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Dr. Anil Chandraker
- Organization
- Brigham and Women's Hospital
Study Officials
- PRINCIPAL INVESTIGATOR
Anil Chandraker, MD
Brigham and Women's Hospital
Publication Agreements
- PI is Sponsor Employee
- No
- Restrictive Agreement
- No
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Medical Director of Renal Transplantation
Study Record Dates
First Submitted
December 16, 2009
First Posted
December 17, 2009
Study Start
February 1, 2009
Primary Completion
June 1, 2012
Study Completion
October 1, 2012
Last Updated
April 24, 2017
Results First Posted
March 6, 2017
Record last verified: 2017-03