Clinical trial NCT01034176: BK Treatment Study
Official title: Effect of Fluoroquinolones on BK Viremia in the Renal Transplant Recipient, A Multi-Center Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: BK Viremia
Keywords: BK viremia
kidney transplantation
BK viremia in kidney transplant recipients
Lead sponsor: Brigham and Women's Hospital
Sponsor class: OTHER
First posted: 2009-12-17
Enrollment: 43
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility 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

Primary outcomes:
measure: Percent Change From Baseline in BK Virus Copies at 3 Months
timeFrame: Baseline and 3 months
Secondary outcomes:
measure: Number of Patients With >50% Reduction in BK Virus Copies
timeFrame: Baseline and 6 months
Other outcomes:
Locations:
city: Boston
country: United States
facility: Massachusetts General Hospital
state: Massachusetts
city: Boston
country: United States
facility: Brigham and Women's Hospital
state: Massachusetts
city: Boston
country: United States
facility: Beth Israel Deaconess Medical Center
state: Massachusetts
city: Burlington
country: United States
facility: Lahey Clinic Medical Center
state: Massachusetts
city: Worcester
country: United States
facility: UMASS Memorial Medical Center
state: Massachusetts
city: Bronx
country: United States
facility: Montefiore Medical Center
state: New York
city: Burlington
country: United States
facility: Fletcher Allen Health Care/University of Vermont
state: Vermont
city: Madison
country: United States
facility: University of Wisconsin Hospital
state: Wisconsin
Study officials:
affiliation: Brigham and Women's Hospital
name: Anil Chandraker, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: Randhawa 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.
citation: Lee 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.