BK Treatment Study

Phase 4

Completed

• Conditions: BK Viremia
• Interventions: Drug: placebo; Drug: levofloxacin

• Registration Number: NCT01034176
• Lead Sponsor: Brigham and Women's Hospital

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2009-02
• Study First Submitted: 2009-12-16
• Study First Submitted QC: 2009-12-16
• Study First Posted: 2009-12-17
• Primary Completion: 2012-06
• Study Completion: 2012-10
• Results First Submitted: 2014-01-21
• Results First Submitted QC: 2017-01-15
• Status Verified: 2017-03
• Results First Posted: 2017-03-06
• Last Update Submitted: 2017-03-24
• Last Update Posted: 2017-04-24

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 43

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
placebo	placebo	placebo identical to levofloxacin drug daily for 30 days
Levofloxacin	levofloxacin	Levofloxacin 500 mg every day (dose adjusted for renal function) for 30 days

Primary Outcome Measures

Name	Time	Method
Percent Change From Baseline in BK Virus Copies at 3 Months	Baseline and 3 months	Percent change in BK virus copies/mL from Baseline to 3 months

Secondary Outcome Measures

Name	Time	Method
Number of Patients With >50% Reduction in BK Virus Copies	Baseline and 6 months	Number of patients with \>50% reduction in BK viral load at 6 months

Trial Locations

Locations (8)

Massachusetts General 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

Fletcher Allen Health Care/University of Vermont; 🇺🇸 Burlington, Vermont, United States

Brigham and Women's Hospital; 🇺🇸 Boston, Massachusetts, United States

University of Wisconsin Hospital; 🇺🇸 Madison, Wisconsin, United States

Montefiore Medical Center; 🇺🇸 Bronx, New York, United States