BK Treatment Study

March 24, 2017 updated by: Anil K. Chandraker, MD, Brigham and Women's Hospital

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

43

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Massachusetts
      • Boston, Massachusetts, United States, 02215
        • Beth Israel Deaconess Medical Center
      • Boston, Massachusetts, United States, 02115
        • Brigham and Women's Hospital
      • Boston, Massachusetts, United States, 02114
        • Massachusetts General Hospital
      • Burlington, Massachusetts, United States, 01805
        • Lahey Clinic Medical Center
      • Worcester, Massachusetts, United States, 01655
        • UMass Memorial Medical Center
    • New York
      • Bronx, New York, United States, 10467
        • Montefiore Medical Center
    • Vermont
      • Burlington, Vermont, United States, 05401
        • Fletcher Allen Health Care/University of Vermont
    • Wisconsin
      • Madison, Wisconsin, United States, 53792
        • University Of Wisconsin Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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 Names:
  • Levaquin
Placebo Comparator: placebo
placebo identical to levofloxacin drug daily for 30 days
Drug: placebo
no dose, tablet, daily, 30 days

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Percent Change From Baseline in BK Virus Copies at 3 Months
Time Frame: Baseline and 3 months
Percent change in BK virus copies/mL from Baseline to 3 months
Baseline and 3 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of Patients With >50% Reduction in BK Virus Copies
Time Frame: Baseline and 6 months
Number of patients with >50% reduction in BK viral load at 6 months
Baseline and 6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Brigham and Women's Hospital

Investigators

  • Principal Investigator: Anil Chandraker, MD, Brigham and Women's Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

February 1, 2009

Primary Completion (Actual)

June 1, 2012

Study Completion (Actual)

October 1, 2012

Study Registration Dates

First Submitted

December 16, 2009

First Submitted That Met QC Criteria

December 16, 2009

First Posted (Estimate)

December 17, 2009

Study Record Updates

Last Update Posted (Actual)

April 24, 2017

Last Update Submitted That Met QC Criteria

March 24, 2017

Last Verified

March 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2009p000020

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on BK Viremia

Clinical Trials on levofloxacin

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in France

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe