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BK Treatment Study

Primary Purpose

BK Viremia

Status
Completed
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
levofloxacin
placebo
Sponsored by
Brigham and Women's Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for BK Viremia focused on measuring BK viremia, kidney transplantation, BK viremia in kidney transplant recipients

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Massachusetts General Hospital
  • Brigham and Women's Hospital
  • Beth Israel Deaconess Medical Center
  • Lahey Clinic Medical Center
  • UMASS Memorial Medical Center
  • Montefiore Medical Center
  • Fletcher Allen Health Care/University of Vermont
  • University of Wisconsin Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

Levofloxacin

placebo

Arm Description

Levofloxacin 500 mg every day (dose adjusted for renal function) for 30 days

placebo identical to levofloxacin drug daily for 30 days

Outcomes

Primary Outcome Measures

Percent Change From Baseline in BK Virus Copies at 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
Number of patients with >50% reduction in BK viral load at 6 months

Full Information

First Posted
December 16, 2009
Last Updated
March 24, 2017
Sponsor
Brigham and Women's Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT01034176
Brief Title
BK Treatment Study
Official Title
Effect of Fluoroquinolones on BK Viremia in the Renal Transplant Recipient, A Multi-Center Study
Study Type
Interventional

2. Study Status

Record Verification Date
March 2017
Overall Recruitment Status
Completed
Study Start Date
February 2009 (undefined)
Primary Completion Date
June 2012 (Actual)
Study Completion Date
October 2012 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Brigham and Women's Hospital

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
BK Viremia
Keywords
BK viremia, kidney transplantation, BK viremia in kidney transplant recipients

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
43 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Levofloxacin
Arm Type
Active Comparator
Arm Description
Levofloxacin 500 mg every day (dose adjusted for renal function) for 30 days
Arm Title
placebo
Arm Type
Placebo Comparator
Arm Description
placebo identical to levofloxacin drug daily for 30 days
Intervention Type
Drug
Intervention Name(s)
levofloxacin
Other Intervention Name(s)
Levaquin
Intervention Description
500 mg tablet, daily, 30 days
Intervention Type
Drug
Intervention Name(s)
placebo
Intervention Description
no dose, tablet, daily, 30 days
Primary Outcome Measure Information:
Title
Percent Change From Baseline in BK Virus Copies at 3 Months
Description
Percent change in BK virus copies/mL from Baseline to 3 months
Time Frame
Baseline and 3 months
Secondary Outcome Measure Information:
Title
Number of Patients With >50% Reduction in BK Virus Copies
Description
Number of patients with >50% reduction in BK viral load at 6 months
Time Frame
Baseline and 6 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Anil Chandraker, MD
Organizational Affiliation
Brigham and Women's Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Massachusetts General Hospital
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02114
Country
United States
Facility Name
Brigham and Women's Hospital
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02115
Country
United States
Facility Name
Beth Israel Deaconess Medical Center
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02215
Country
United States
Facility Name
Lahey Clinic Medical Center
City
Burlington
State/Province
Massachusetts
ZIP/Postal Code
01805
Country
United States
Facility Name
UMASS Memorial Medical Center
City
Worcester
State/Province
Massachusetts
ZIP/Postal Code
01655
Country
United States
Facility Name
Montefiore Medical Center
City
Bronx
State/Province
New York
ZIP/Postal Code
10467
Country
United States
Facility Name
Fletcher Allen Health Care/University of Vermont
City
Burlington
State/Province
Vermont
ZIP/Postal Code
05401
Country
United States
Facility Name
University of Wisconsin Hospital
City
Madison
State/Province
Wisconsin
ZIP/Postal Code
53792
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
15712075
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.
Results Reference
background
PubMed Identifier
16206122
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.
Results Reference
background
PubMed Identifier
24482066
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.
Results Reference
derived

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BK Treatment Study

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