BK Treatment Study

Completed · Phase 4 · Has a placebo group

Conditions studied: BK Viremia

In brief

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.

Key facts

Study ID

NCT01034176

Run by

Brigham and Women's Hospital

People needed

43

Starts

2009-02-01

Expected to finish

2012-10-01

Last updated by the study team

2017-04-24

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

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

Where it is running

• Massachusetts General Hospital — Boston, Massachusetts, United States
• Brigham and Women's Hospital — Boston, Massachusetts, United States
• Beth Israel Deaconess Medical Center — Boston, Massachusetts, United States
• Lahey Clinic Medical Center — Burlington, Massachusetts, United States
• UMASS Memorial Medical Center — Worcester, Massachusetts, United States
• Montefiore Medical Center — The Bronx, New York, United States
• Fletcher Allen Health Care/University of Vermont — Burlington, Vermont, United States
• University of Wisconsin Hospital — Madison, Wisconsin, United States

Full record on ClinicalTrials.gov

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